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ABSTRACT REVIEW
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BAR14-0042 Efficacy and safety of Vinflunine in Urothelial Carcinoma Co-authors
L. Bravo Garcia-Cuevas1, T. Jaraquemada2, I. Santos Hurtado1, S. Martin Clavo1, L. Braga Fuentes1, C. Bonilla Galán1, D. Briegas Morera1, M.J. Estepa Alonso1, J.F. Rangel Mayoral1, L. Romero Soria1. 1Hospital Infanta Cristina, Farmacy, Badajoz, Spain. 2Hospital Infanta Cristina, Oncology, Badajoz, Spain.
Background Now Vinflunine is the elction drug for tratment in second line of Urothelial Carcinoma (UC)
Purpose To assess the efficacy and safety of Vinflunine in UC
Materials and Methods Observational, retrospective study of patients with UC treated with Vinflunine in second line from September 2011 until April 2013. From the clinical histories the following data were collected: sex, age, number and location of metastases, number of cycles with Vinflunine and adverse reactions (AR). We evaluated the efficacy by progression-free survival (PFS), overall survival (OS) and the type of response (complete response (CR), partial response (PR), stable disease (SD) and no response (NR)) according to clinical and radiological criteria. To assess the safety profile, adverse reactions (AR) were taken into account
Results Were included 7 patients (5 men) with an average age of 65±13 years. Six patients had metastatic disease, 3 patients in 1 location, 2 patients at 2 locations and 1 patient in 3 different locations being the lung (42.85% of patients) and bone (28.57%) the most common. Were given an average of 6 cycles of Vinflunine (320 mg/m² every 21 days). In all patients was used in the second line. The dose was reduced in 3 patients, 2 for AR and one for kidney failure. All were treated with the granulocyte colony-stimulating factors (G-CSF). Responded to treatment 4 patients (PR 1, SD 3) and 3 NR. The median PFS was 4 months (95% CI 0.74-7.26) and the OS was 5 months (CI 95%, 2.95-7.05). The treatment was suspended in 6 patients, 3 for disease progression, other 3 for death. In none of the patients had to suspend treatment for AR. There was no hematological AR. The most frequent AR were: infections (5 patients), asthenia (4 patients), and constipation (2 patients, one of them led to reduction of dose)
Conclusions The indication and treatment line were adapted to the Protocol agreed at the Commission of Pharmacy and Therapeutics hospital, reserving Vinflunine for treatment in second line in patients progressing to a prior treatment with Platinum derivatives. This study shows Vinflunine as a safe and effective drug for the treatment of UC. Comparing the results with those obtained in the pivotal studies is observed a higher median of PFS (4 vs. 3 months) and lower OS (5 vs. 6.9 months). Although 4 patients respond to treatment, only one gets a partial response and no complete response. It must be emphasized the absence of AR hematologic in our sample of patients, although all of them were treated with G-CSF. More studies with one larger sample size are needed to confirm the efficacy and further evaluate the safety of Vinflunine in UC
Conflict of interest: Enter Yes or No: No
Keywords Vinflunine;Urothelial Carcinoma;Efficacy;
Authors letter
Score: 100 Remarks all reviewers: Stemer, Gunar: Conclusion warranted Conflict of interest clear Rejected 1.2.3.4. Reason for reject: ; ; ; ; n=7, no authors' letter, drug used in indication; the investigate effectiveness, not efficacy Chrapkova, Kornelia: Conclusion warranted Conflict of interest clear Rejected 2. Reason for reject: ; too small group vinflunine already approved for urothelial carcinoma
BAR14-0058 EXPERIENCE IN USE OF CRIZOTINIB IN A REGIONAL HOSPITAL. EFFECTIVENESS, SAFETY AND COST Co-authors
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E. Alonso Serrano1, M.T. Martinez Lazcano1, A. Cabello Muriel1. 1Hospital del Vinalopo, Hospitalary Pharmacy, Alicante, Spain.
Background
The mutation of the fusion gene EML4-ALK, anaplastic lymphoma kinase, is very rare in small cell lung cancer (NSCLC) (2-7%). These tumors 'ALK positive' are highly sensitive to targeted therapy with selective inhibitors of ALK.
Purpose
To present the user experience with Crizotinib, drug selective inhibitor of tyrosine kinase receptor ALK in ALK positive NSCLC patients, assessing the effectiveness, safety and economic impact.
Materials and Methods
Descriptive retrospective case series study (period May 2012 - March 2013) of patients with ALK positive NSCLC treated with Crizotinib.
We analyzed the following variables: demographics, previous treatment lines, general statement, as measured by the ECOG scale, smoking history, response to treatment as assessed by RECIST criteria every 3 months, overall survival (OS), progression-free survival (SLP). We evaluated the analytical values and the adverse effect profile.
Results
We included 2 patients (males), diagnosed adenocarcinoma NSCLC stage IV ALK positive, determined by FISH technique. The range of ages were 33.5 ± 6.5 years. The study period was 10 months. Both patients received two previous treatment lines, and showed an ECOG 0. One patient was ex-smoker. They took Crizotinib 250 mg orally every 12 hours. Both patients presented partial response after 3 months of treatment. The median PFS was 8.5 ± 1.5 months. One patient had disease progression after 7 months of treatment. The OS was 10 months.
Adverse effects were diarrhea grade I (50%), headache (50%), visual disturbance (100%). One patient had GPT increased 6 times the upper limit of normal (ULN) and increased alkaline phosphatase less than 2 times ULN, highlighting GGT increased 48 times ULN. This patient had liver tumor infiltration. One patient presented acneiform skin changes. Consumption of Crizotinib (Xalkori ®) in the study period was 1,140 tablets, assuming a cost of € 127,338.
Conclusions
Crizotinib has proven effective, increasing PFS by 8.5 months, presenting partial response in one patient maintained during the study period and becoming almost complete. It proved to be quite safe, unable to associate abnormal liver profile to crizotinib, the patient had liver tumor infiltration. Treatment with crizotinib represents an annual cost per patient of € 80,400. Studies are needed with larger numbers of patients to draw definitive conclusions.
Conflict of interest: Enter Yes or No: No
Keywords crizotinib;effectiveness;safety;
Authors letter To the attention of The EAHP Scientific Committee 1) Relevance: The mutation of the fusion gene EML4- ALK, anaplastic lymphoma kinase, is very rare in small cell lung cancer (NSCLC). It appears only in 2-7% of this population. These tumors "ALK positive" are highly sensitive to targeted therapy with selective inhibitors of ALK. 2) Innovation: Crizotinib is a new drug that acts on selective inhibitor of tyrosine kinase receptor ALK in ALK positive NSCLC patients. It can be used as an alternative therapy in this kind of patients who have a short life prognosis. 3) Implication for future pharmacy practice: The clinical pharmacist could advise the oncologist to choose the most cost-effective treatment.
Score: 0 Remarks all reviewers: Stemer, Gunar: Conclusion warranted Conflict of interest clear Rejected 1.4. Reason for reject: ; ; New category: T3 The authors are encouraged to come back if they have collected more data. n=2; Open for discussions with cancer experts if of relevance with this new drug. Chrapkova, Kornelia:
Rejected 2. Reason for reject: ;
BAR14-0097
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Evaluation of Octreotide prescriptions and clinical results in peritoneal carcinomatosis after distribution ofrecommendations edited by the University Hospital of Montpellier. Co-authors
Y. audurier1, S. pelegrin1, F. bringer1, M.P. ponrouch1, I. roch-torreilles1, D. rosant1, P. rambourg1. 1chru de montpellier, pharmacy unit, montpellier, France.
Background
The Drug Committee (DC) has edited some recommendations for the therapeutic care of bowel obstruction in inoperable peritoneal carcinomatosis : starting dose of octreotide 600 μg/24h, stopped when clear reversal of occlusion, relayed by 30 mg long-acting (LA) form in case of partial occlusion, or increased to 900 μg/24h relayed by 30mg LA form in case of failure. When 600 μg or 900 μg/24h are not efficacy, the pose of a venting gastrostomy is proposed as an alternative.
Purpose
Verify the good understanding and implementation of the DC recommendations and provide an overview of the clinical evolution of the patients following this protocol.
Materials and Methods
A retrospective analysis is made over six months (January-June 2013) of the prescriptions of immediaterelease octreotide in the indication of bowel obstruction reversal during peritoneal carcinomatosis. The statement of requirements was made via the software of prescription 'DxCare'. The requirements have been classified: Situation 1: Partial reversal with 600 μg and relay with LA 30mg; Situation 2: Clear reversal with 600μg and stop of octreotide; Situation 3: Failure with 600 μg or 900 μg but not gastrostomy as unstable patient; Situation 4 : Transition to 900 μg successful and relay to LA 30 mg; Situation 5: venting colostomy after failure with 600 μg; Situation 6 venting colostomy after failure with 900 μg; Situation 7: prescriptions outside the recommendations.
Results
The population of 25 patients has a mean age of 61.6 ans. 92% of prescriptions follow the DC recommendations (n = 23). Situation 1: 28% (n = 7) Situation 2: 32% (n = 8) Situation 3: 12% (n = 3) Situation 4: 4% (n = 1) Situation 5: 12% ( n = 3) Situation 6: 4% (n = 1) 7 Situation: 8% (n = 2). From a clinical point of view, this protocol has removed (at least partially) occlusion in 78% of cases (n = 18). The DC recommendations were followed. For two prescriptions out recommendations, the divergence is related to the relay, one was made by immediate release SC octreotide for 14 days and the other by 60 mg LA octreotide.
Conclusions
The DC recommendations have been complied, except for two situations with the LA form. New information on octreotide LA 30 mg will be distributed. From a clinical point of view, the results seem encouraging.
No conflict of interest
Keywords octreotide;recommendations;peritoneal carcinomatosis;
Authors letter Respect of recommendations done by the drugs comettee will create a better utilisation of octreotide and avoid misuses with this drug. Moreover the price of delay form is very expensive, so pharmacist must watch closely if rules of prescriptions are respected, especially for indication of peritoneal carcinomatosis in our case.
Score: 0 Remarks all reviewers: Kart, Trine:
Rejected 4.10. Reason for reject: ; ; You could maybe collaborate with colleagues working in other hospitals to have more patients and then make an evaluation Sviestina, Inese:
Rejected 1. Reason for reject: ;
BAR14-0114 Pharmaceutical action cards- A step stone to reflections and interdisciplinary dialog Co-authors
K. Fjaere1, T. Boegelund1. 1The Capital Region Hospital Pharmacy, Clinical Pharmaceutical Service Bispebjerg Hospital, Copenhagen, Denmark.
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Background
Safety and quality in the medicine rooms are top priorities for pharmacists and pharmaceutical technicians working at Bispebjerg Hospital, Denmark. During 2012 and 2013 they have prepared pharmaceutical action cards based on The Capital Regional guidelines, hereby establishing a systematic approach that pinpoints and deepen different aspects of set standards for drug related prior rules.
Purpose
Help communicate and comply regional guidelines in a positive and humoristic manner to the hospital personnel. The action cards herby function as a step stone to information and reflections, followed by an interdisciplinary dialog about the set regional standards.
Materials and Methods
The Capital Regional guidelines within drug storage are the primary work tools for pharmacists and pharmaceutical technicians. Having their daily workflow in the medicine rooms, they therefore have a justified idea to what set standards that it would be relevant to focus on throughout the year.
The pharmaceutical action cards are judiciously prepared by carefully selecting the set standard of the month. Different views and perspectives are included, making sure the message will be correctly received, before being communicated to the hospital personnel. Hence, preparation is an ongoing process and involves, besides the pharmaceutical personnel, members of the local drug committee and the quality department.
Results
During 2012 and 2013 twelve action cards were implemented and include various topics such as hygiene, durability, correct labelling, storage and prescriptions of drugs. Random sampling, before and after the action cards, show a 70 % improvement of discharging vials after usage and a 33 % improvement of correct prescription of Proton Pump Inhibitors in hospital charts.
Conclusions
Pharmaceutical action cards increase awareness of The Capital Regional guidelines and leads to reflections and interdisciplinary dialog, which hereby contribute to the safety and quality of patient medication upon hospitalization.
No conflict of interest
Keywords Action cards;Regional guidelines;Interdisciplinary dialog;
Authors letter - increased awareness of regional guidelines - improved collaboration with the department for patient safety and the quality department
Score: 40 Remarks all reviewers: Kart, Trine:
Rejected 9. Reason for reject: ; Sviestina, Inese: Conclusion warranted Conflict of interest clear Rejected 10. Reason for reject: ; It is not clear what exactly was done; how it really would be possible to evaluate outcomes
BAR14-0121 Tolerance of enteral nutrition administered by gastrostomy the same day of percutaneous radiologic gastrostomy Co-authors
P. CARMONA OYAGA1, C. Ripa Ciaurriz1, M. Ercilla Liceaga1, M.J. Gayan Lera1, L. Leunda Eizmendi1, B. Odriozola Cincunegui1, M.D. Mauleon Echeverria1, J. Barral Juez1, M. Umerez Igartua1, A. Lizardi Mutuberria1. 1Donostia University Hospital, hospital pharmacy, San Sebastián, Spain.
Background
In our hospital the digestive tolerance has been typically started the following day of percutaneous radiologic gastrostomy (PRG). Recently a new protocol where tolerance begins the same day of the PRG has been approved. If patient is conscious, 250 ml of standard nutritional preparation is administered in 2 h, if patient is deteriorated or disoriented is administered in continuous infusion (rate: 42 ml/h)
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Purpose
To assess the tolerance of Enteral Nutrition (EN) the same day of PRG.
Materials and Methods
All patients who underwent a PRG between January and September 2013 were retrospectively selected. Data were obtained from the patient’s medical record. Sex, age, anthropometric data, EN indication and EN tolerance (gastrointestinal disorders) were registered.
Results
37 patients (30 men and 7 women) were included, mean age 61.5, mean body mass index: 23.4 kg/m2.
Indications of EN were: oropharyngeal neoplasia (13), amyotrophic lateral sclerosis (8), stroke (8), leukoencephalopathy grade III (1), multiorgan failure (1), head trauma (1), Lafora disease (1) and brain tumor (3).
31 patients began EN the same day of PRG. En was good in 29 patients (93.5%); Two patients referred fullness and nausea, respectively.
6 patients didn’t start EN the day of PRG, 3 of them showed a blood residue in the previous exploration, 1 was hemodynamically unstable, 1 had problems with the gastrostomy and another one had repeated seizures.
Conclusions
Tolerance of EN in patients who underwent a PRG following the new protocol was good in 93.5% of the patients. The early onset of EN can contribute to improve the nutritional status and could forward the discharge in those patients admitted only to perform the PRG.
No conflict of interest
Keywords Percutaneous radiologic gastrostomy;Enteral Nutrition;Tolerance;
Authors letter The grade of relevance, innovation and implication for future hospital pharmacy practice of this abstract is high because the early onset of Enteral Nutrition can contribute to improve the nutritional status and could forward the discharge in those patients admitted only to perform the PRG.
Score: 80 Remarks all reviewers: Kart, Trine:
Rejected 5. Reason for reject: ; The topic is relevant for the congress but the content of the study is difficult to follow. Sviestina, Inese: Conclusion warranted Conflict of interest clear Rejected 3.10. Reason for reject: ; ; Description of daily practice. English
BAR14-0122 Triple therapy-based treatment assessment in coinfected HIV hepatitis C patients in a tertiary hospital Co-authors
M.J. Gayan Lera1, P. Carmona Oyaga1, G. Lopez Arzoz1, M. Ercilla Liceaga1, C. Ripa Ciaurriz1, B. Odriozola Cincunegui1, L. Lombera Saez1, J. Barral Juez1, M. Umerez Igartua1, A. Lizardi Mutuberria1. 1Donostia University Hospital, hospital pharmacy, San Sebastián, Spain.
Background
Basque Health System (Osakidetza) has established off-label use criteria to initiate triple therapy with ribavirin, telaprevir and peginterferon-α-2b in coinfected Hepatitis C (HCV) and HIV patients.
Purpose
To assess the compliance with these prescription criteria of triple therapy-based treatment and analyze the effectiveness at week 24 of treatment.
Materials and Methods
Treatments started from 2012/07/01 to 2013/06/30 were analyzed and compliance with the following criteria was assessed:
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- Infection with HCV genotype 1, naïve or pretreated.
- F3-F4 fibrosis, confirmed by biopsy or liver stiffness.
- Compensated chronic liver disease (Child Pugh A).
- Hemoglobin (Hb) > 11 g/dl in women and > 12 g/dl in men.
- CD4 >200 copies/ml (or >14%)
- HIV Viral Load (VL) <100 copies/ml
HCV VL was registered at week 24.
Results
18 patients were included, 16 (89%) were male, 12 (67%) were genotype 1a and 6 (33%) 1b, 6 (33%) were naive, and 12 (67%) pretreated: 6 (33%) were prior relapsers, 3 partial responders (didn’t fullfill inclusion criteria) and 3 null responders (didn’t fullfill inclusion criteria). 16 (84%) were F4. All of them fulfilled the criteria of Hb and were Child Pugh A.
15 patients reached week 24:
10 (67%) had undetectable VL (<15) at week 24: 3 (30%) were naive, 4 (40%) relapsers, 3 (30%) partial responders.
5 had VL >15 before week 24: 2 (40%) were naive and 3 (60%) null responders.
Conclusions
Inclusion criteria were met in 67% of coinfected patients.
Effectiveness of triple therapy for HCV was 67% at week 24.
If viral response is achieved at the end of treatment, we might consider the possibility of including them in the inclusion criteria.
No conflict of interest
Keywords Effectiveness;Hepatitis C;Coinfected HIV;
Authors letter The grade of relevance, innovation and implication for future hospital pharmacy practice of this abstract is very high because is about a new drug in a poor studied population.
Score: 0 Remarks all reviewers: Kart, Trine:
Rejected 4. Reason for reject: ; You could maybe collaborate with colleagues working in other hospitals to have more patients and then make an evaluation?. Sviestina, Inese: Conclusion warranted Conflict of interest clear Rejected 1. Reason for reject: ;
BAR14-0129 Effectiveness and safety of the new protease inhibitors for the treatment of hepatitis C Co-authors
P. Hidalgo-Collazos1, L. Marín Ventura1, T. Rico-Gutiérrez1, R. Aguilella-Vizcaíno1, M.T. Criado Illana1. 1HOSPITAL GENERAL DE SEGOVIA, Hospital Pharmacy, Segovia, Spain.
Background Use of new drugs for chronic hepatitis C.
Purpose To assess the effectiveness and safety of new protease inhibitors boceprevir and telaprevir in patients with chronic hepatitis C.
Materials and Methods Observational, prospective, preliminary 14-month evolution research, which included all patients treated with boceprevir or telaprevir in combination with peg-interferon and ribavirin.
The following variables were analyzed: sex, age, genotype, fibrosis amount, response to previous treatment, viral load, hematologic parameters (hemoglobin, neutrophils and platelets), dosage, supportive therapy and adverse effects. Also, all pharmaceutical interventions were registered during this period.
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Results A total of 12 patients (9 men and 3 women) were included, with an average age of 58 years (range: 47-75 years). All patients had genotype 1 (3 with genotype 1a and 9 with genotype 1b), and one of them presenting HIV-1 coinfection. Fibrosis amount was grade 3 in 5 patients, and grade 4 in 7 patients.
Out of all patients, 11 received triple therapy with telaprevir, and one with boceprevir due to existence of psoriasis. One patient was naïve, 7 were non-responders, 2 were partial responders and 2 of them suffered a relapse.
Out of the 12 patients, 2 failed first stopping rule, 1 patient failed second stopping rule in accordance with technical sheet, and 4 patients discontinued treatment (average duration 15 weeks) due to adverse effects (3 due to grade 3 exanthema and 1 due to grade 4 anemia (Hb<4g/dl)). Sustained viral response was only achieved in 41.6% of patients.
5 patients needed peg-interferon dose reduction due to neutropenia, thrombocytopenia, or both of them; and 6 patients needed ribavirin dose reduction due to hemoglobin<10g/dl, 3 patients required blood transfusions and erythropoietin 40.000U/ml/week administration.
Conclusions Worst effectiveness and safety triple therapy treatment results were obtained in our patients compared to those described in pivotal clinical trials, due to suspension due to adverse effects. It's necessary to monitor these patients to prevent side effects, enabling treatment continuity and minimizing its suspension.
No conflict of interest
Keywords Effectiveness;safety;protease inhibitors;
Authors letter It is important to know the effectiveness and safety of new drugs used for hepatitis c virus due to its recent introduction into therapeutic
Score: 0 Remarks all reviewers: Kart, Trine:
Rejected 4. Reason for reject: ; You could maybe collaborate with colleagues working in other hospitals to have more patients and then make an evaluation Sviestina, Inese:
Rejected 1. Reason for reject: ;
BAR14-0133 Triple therapy-based treatment assessment in monoinfected hepatitis C patients in a tertiary hospital Co-authors
P. CARMONA OYAGA1, M.J. Gayan Lera1, G. Lopez Arzoz1, M. Ercilla Liceaga1, C. Ripa Ciaurriz1, K. Andueza Granados1, J. Barral Juez1, M. Umerez Igartua1, A. Lizardi Mutuberria1, M.P. Bachiller Cacho1. 1Donostia University Hospital, hospital pharmacy, San Sebastián, Spain.
Background Basque Health System (Osakidetza) has established different inclusion criteria to initiate protease inhibitor- based triple therapy with ribavirin, telaprevir and peginterferon-α-2b in monoinfected hepatitis C (HCV) patients to guarantee an efficient use of new protease inhibitors.
Purpose To assess the compliance with established criteria and analyze the effectiveness at week 24 of treatment.
Materials and Methods Treatments started from 2012/07/01 to 2013/06/30 were analyzed and compliance was assessed with the following criteria:
- Infection with genotype 1 HCV, naïve or pretreated.
- F3-F4 fibrosis, confirmed by biopsy or liver stiffness.
- Compensated chronic liver disease (Child Pugh A).
- Hemoglobin (Hb) > 11 g/dl in women and > 12 g/dl in men.
Viral load (VL), dropouts and adverse reactions were registered at week 24.
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Results 36 patients were included, 30 (83%) were men, 16 (44%) were genotype 1a, 19 (53%) 1b and 1 (3%) not subtipable, 17 (47%) were naive and 19 (53%) pretreated: 5 prior relapsers, 3 partial responders and 11 nonresponders. 29 (81%) were F4. All of them fulfilled the criterion of Hb and were Child Pugh A.
32 patients reached week 24:
24 patients (75%) have VL <15 at week 24: 13 (54%) were naive, 3 (12.5%) prior relapsers, 3 (12.5%) partial responders and 5 (21%) null responders.
5 patients have detectable VL (>15) before week 24: 4 (80%) were null responders and 1 (20%) naive.
3 patients discontinued treatment before week 24: 1 encephalopathy, 1 hepatocellular carcinoma and 1 erythema multiforme.
Conclusions 100% of HCV monoinfected patients met the established inclusion criteria, being treatment effectiveness 75% at week 24.
No conflict of interest
Keywords Hepatitis C virus;triple therapy;Effectiveness;
Authors letter The grade of relevance, innovation and implication for the future hospital pharmacy practice of this abstract is high because it is about a new drug.
Score: 0 Remarks all reviewers: Kart, Trine:
Rejected 1.3. Reason for reject: ; ; Sviestina, Inese:
Rejected What is "being treatment effectiveness "? Almost all the same authors as in the abstract N0 122, rather similar topic ... Small population - more than 30 but only 36 patients. Would be better to collaborate with colleagues from other hospitals
BAR14-0137 Heparin anticoagulant therapy protocol in special situations Co-authors
N. Manresa-Ramón1, I. Sánchez-Martínez1, M.D. Nájera-Perez1, A. Rizo-Cerda1, P. Selvi-Sabater1, B. Arribas-Diaz1, M.C. Sánchez-Mulero1, I. De Gorostiza-Frias1, M.T. Alonso-Dominguez1, I. Sánchez-Quiles1. 1hospital morales meseguer, Pharmacy, murcia, Spain.
Background The usage of low molecular weight heparin(LMWH) in selected patients requires special control to avoid adverse effects and to generate efficacy.
Purpose Development of a practical guide agreed with the Department of Internal Medicine and Hematology for dosing and monitoring recommendations LMWH in hospitalized patients with certain clinical characteristics.
Materials and Methods Literature review in Micromedex® and PubMed® from 2002-2012, the keywords: LMWH, kidney failure, obesity, over 75 years, pregnancy.
Results The LMWH greatest clinical evidence accumulates is the enoxaparin. The protocol summary is as follows: 1) Renal impairment. Prophylaxis: renal clearance(CrCl), CrCl<30ml/min, recommend enoxaparin 20mg/24h(monitored after 10 days of treatment). Treatment: -CrCl<15ml/min: unfractionated heparin (dose adjusted according to weight and aPTT levels). -CrCl 15-30 ml/min: enoxaparin 1mg/kg/24h. In patients over 75 years old with acute myocardial infarction without ST segment elevation(STEMI) 0.75mg/kg/24h (the anti-Xa monitoring). -CrCl 30-80 ml/min: 1mg/kg/12h and monitoring enoxaparin after 10 days of treatment. 2) Elderly>75 years in treatment, enoxaparin 1 mg/kg/12h. With STEMI reduced to 0.75 mg/kg/12h (the anti-Xa monitoring). 3) Obesity: prophylaxis BMI>40 kg/m2, enoxaparin 60mg/24h and IMC=30-39kg/m2, 40 mg/24h. In treatment, BMI<40 kg/m2(weight up to 150 kg) administered enoxaparin 1mg/kg/12h. 4) Pregnant: enoxaparin 1 mg/kg/12h (the anti-Xa monitoring). Establishing a range of anti-Xa:
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-Acute myocardial infarction, enoxaparin every 12 hours (0.5-1.5UI/ml). -Thromboembolism prophylaxis with enoxaparin (0.2-0.4UI/ml). Treatment with enoxaparin every 24 hours (1-2 UI/ml) and every 12h (0.5-1UI/ml). Nomogram orientation: <0.35UI/ml (increase 25% dose), 0.35-0.4UI/ml (increase 10%), 0.5-1 UI/ml (hold), 1.1-1.5 UI/ml (20% reduction), 1.6-2 UI/ml (reduce 30 %), greater than 2 UI/ml (40% reduction).
Conclusions -The development of a consensus protocol allows better monitoring of these patients. -It is important to monitor the amount of enoxaparin doses according to different clinical characteristics. -The anti-Xa monitoring to adjust the pattern of selected patients.
Conflict of interest: Enter Yes or No: No
Keywords anticoagulant;kidney failure;obesity;
Authors letter The protocol of low molecular weight heparin(LMWH) in selected patients requires special control to avoid adverse effects and to generate efficacy.
Score: 0 Remarks all reviewers: Kart, Trine:
Rejected 6.9. Reason for reject: ; ; Sviestina, Inese: Conclusion NOT warranted Conflict of interest clear Rejected I do not see from results that "The development of a consensus protocol allows better monitoring of these patients". It would be useful to do a study evaluating the statement mentioned before and then come back the next year with a poster.
BAR14-0140 Prioritizing hospital pharmacy investment in a financially restricted Health Care organization leads to a permanent pharmaceutical service Co-authors
M.G. Kruse1, L. Jeffery1, S.P.K. Herping1. 1Regionshospitalet Viborg, Silkeborg Regional Hospital, Silkeborg, Denmark.
Background
Healthcare systems in hospitals are becoming more and more specialized, despite complex patients with multimorbidities requiring a more holistic approach. The Diagnostic Center (DC) at Silkeborg Regional Hospital focuses on a multidisciplinary approach using innovative methods to ensure the patient is the focal point in the process. Diagnostic Center has two multidisciplinary out-patient clinics – Clinic for patients with Multimorbidity and Polypharmacy (CMP) and Clinic for patients with Non-specific Cancer Symptoms (CNCS) – both clinics are the first of their type in Denmark.
Purpose To describe the development of pharmaceutical services at a Danish regional hospital, where the pharmacist became an integrated member of the multidisciplinary outpatient diagnostic team.
Materials and Methods The local pharmacist worked up a good dialog with the Medical Director at DC. The Medical Director contacted the hospital pharmacy in April 2012 requesting that a pharmacist be part of an innovative Clinic for patients with Multimorbidities. The hospital pharmacy agreed to prioritise the required resources despite the lack of financial support from DC from the start.
Results The hospital pharmacy management felt that pharmacist integration into the clinic was so important for the development of pharmacy services, that they were willing to prioritize investment in the service. Six months after the CMP started, funding for the pharmacist was found by the Medical Director, which is now a permanent service. In September 2013 the Medical Director requested that a pharmacist be part of another new clinic diagnosing patients with polyfarmaci issues, which the pharmacy agreed again to support. The CNCS currently has a similar, but project based, pharmaceutical service which it hopes to make permanent following the good experience.
Conclusions Hospital pharmacy investment in innovative initiatives is found to give rewards over time, with permanent funding in this case. The pharmacist’s success in these out-patient clinics has open up for new work areas for pharmacists.
No conflict of interest
Keywords
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hospital pharmacy investment;out-patient clinic;permanent pharmaceutical service;
Authors letter 1. Our experience shows how hospital pharmacy service can be developed further in a financially restricted Health Care organization. 2. Prioritizing resources in innovative initiatives can be worthwhile. 3. Initial hospital pharmacy investment has led to permanent external funding of pharmaceutical services.
Score: 40 Remarks all reviewers: Kart, Trine:
Rejected 9. Reason for reject: ; Sviestina, Inese: Conclusion NOT warranted Conflict of interest clear Rejected 10. Reason for reject: ; It not clear what exactly was done.
BAR14-0147 Analysis of biological treatment in rheumatic pathology Co-authors
M. Camps1, V. Garcia1, Q. Moreno1, A. Sánchez1, L.L. Campins1, C. Agustí1, T. Gurrera1, X. Fabregas1, D. López1. 1Hospital de Mataró, Pharmacy, Barcelona, Spain.
Background Biological agents are effective therapies for rheumatic diseases. Following the recommendations of The European League Against Rheumatism (EULAR) and based on the experience of recent years, is not clear scientific evidence of the superiority of one drug over another in biological treatment combined with synthetic disease modifying antirheumatic drugs (DMARD). Consider that, if there is no contraindication, all patients should receive a drug combined with a biological agent, preferably methotrexate. Purpose
Analysis of prescription of biological drugs in rheumatic diseases in a community hospital.
Materials and Methods
Cross sectional study of the use of biological drugs in patients Rheumatology Unit conducted in 7th October 2013.
Results
92 patients being treated with biological agents (51% women), mean age was 51.7 years. The main therapautic indication was rheumatoid arthritis in 50% of cases, followed by ankylosing spondylitis (23.9%), psoriatic arthritis (20.6%), undifferentiated spondyloarthritis (3.3%) and juvenile idiopathic arthritis and seronegative polyarthritis both indications with 1,08%.
The highest volume of prescriptions corresponded to etanercept with 65.2%, adalimumab 27.2%, infliximab and rituximab 4.3% and 3.3% respectively. Most patients are on the first line of biological treatment (71.7%), 20.65% of patients on second line, 6,5% on third line and only 1.1% on fourth line. The reason for change biological agent was in 70% of cases (23 patients) due to lack of response, in 24.2% of cases (8) to adverse reactions, and finally 6% (2) contraindication. A 55.4% of all patients had prescribed a synthetic disease modifying antirheumatic drugs of which methotrexate was the most used (78.4%). A 28.3 % of patients increased the interval between injections. (See table 1)
Conclusions Although increasing the interval between injections does not appear in the clinical practice guidelines, in a significant number of patients in remission is used as a measure of efficiency. It is also noteworthy, the high percentage of patients without synthetic DMARD. Table FREQUENCY Nº PATIENTS ETANERCEPT Nº PATIENTS ADALIMUMAB EVERY 8 DAYS 2 - EVERY 10 DAYS 6 - EVERY 15 DAYS 6 - EVERY 21 DAYS 2 7 EVERY MONTH 1 2 TOTAL 17 (65.4%) 9 (34.6%)
Conflict of interest: Enter Yes or No: No
Keywords Biological agents;Disease modifyng antirheumatic drugs;Rheumatic diseases;
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Authors letter These drugs have a high cost, for this reason its use is restricted and are implementing strategies to improve efficiency. This study will serve to analyze the current situation of these drugs in our hospital and to employ measures to improve
Score: 80 Remarks all reviewers: Kart, Trine: Conclusion warranted Conflict of interest clear Rejected 2.3. Reason for reject: ; ; Sviestina, Inese: Conclusion NOT warranted Conflict of interest clear Rejected Numbers are not correct: "rheumatoid arthritis in 50% of cases, followed by ankylosing spondylitis (23.9%), psoriatic arthritis (20.6%), undifferentiated spondyloarthritis (3.3%) and juvenile idiopathic arthritis and seronegative polyarthritis both indications with 1,08%" - there are no 100%.How did you get " 70% of cases (23 patients)"? Do not use decimals.
BAR14-0162 Carboplatin and weekly paclitaxel doublet chemotherapy in elderly patients with advanced non-small-cell lung cancer (NSCLC) : dose reduction and toxicity outcomes Co-authors
B. Glaser1, Z. Ramjaun2, S. Perriat2, J.M. Canonge2, A. Grand2, L. Bigay-Game3, J. Mazieres3. 1CENTRE HOSPITALIER JEAN ROUGIER, pharmacie, Cahors Cedex 9, France. 2CHU de Toulouse, upco, Toulouse, France. 3CHU de Toulouse, pneumologie, Toulouse, France.
Background A recent phase 3 clinical trial called IFCT-0501 proved the benefits on morbi-mortality of monthly AUC 6 carboplatin and 90mg/m2 paclitaxel (days 1, 8 and 15), for NSCLC patients aged 70 years and older, despite increased toxic effects.
Purpose Our study aims at analysing the protocol adaptations due to the age of the patients and the different toxicities observed in practice.
Materials and Methods In a retrospective study from August 2010 to March 2012, we analysed the medical files of every patients treated with this doublet chemotherapy for advanced NSCLC. Monitoring of every chemotherapy cycle including interval duration, doses administered, days of treatment cancelled and Relative Dose Intensity (RDI) has been done. Patients’ biology and health status evolution (ECOG toxicity scale and WHO performance status score) has been followed.
Results 23 patients have been studied. Their mean age is 74.8 years (95% C.I. [70.9 ; 78.7]), 91% of them are men. Before treatment, 78% of the patients have a WHO performance status score between 0 and 1. After treatment, the mean WHO score rises significantly of 0.3 points (p<0.005). Their creatinin clearance 95% C.I is [64.8 ; 79.6] mL/min (Cockroft formula). The mean number of cycles is 3.2 (95% C.I. [2.7 ; 3.7]) and their interval duration 95% C.I is [28.5 ; 30.0] days (theoretical interval : 28 days). 56.5% of patients start with AUC 6 carboplatin and there is a meaningful dose decrease from 1 to 3 AUC points for 26.1% of the population studied (p<0.025). AUC 6 carboplatin is achieved in only 53.5% of all cycles compared to 84.2% in the clinical trial. 13.2% of paclitaxel administrations are cancelled during cycles because of toxicity or infection. The RDI for carboplatin is 83.0% (95% C.I. [78.2 ; 87.7%]) and 81.9% for paclitaxel (95% C.I. [75.7%; 88.1%]). About grade 3 and 4 toxicities : 2 patients have worsening general condition, 2 have diarrhoea, nausea or vomiting and 2 have haematological toxicity (neutrophil and platelet). Only 2 have no toxicity but stopped treatment after 1 or 2 cycles.
Conclusions Standards are especially deviated by reducing the daily dose of carboplatin even before protocol inclusion. This reduction is not statistically significant because our population studied is way smaller than in the clinical trial. But in practice, we can conclude that the total dose of carboplatin administered per patient is equivalent to an AUC 5 intermediate dose during the whole treatment. Platinum doublet chemotherapy is indicated for fit elderly patients with advanced NSCLC but guidelines tend to be reconsidered for safety reasons.
No conflict of interest
Keywords chemotherapy;toxicity;dose adaptation;
Authors letter This abstract warns us about the toxic effects of high dose carboplatin associated with taxol especially by older patients. It also suggests that lowering the dose of carboplatin directly to an AUC 5 instead of AUC 6 might be safier. In the future, hospital pharmacists could watch more over carboplatin and taxol toxicities and suggest adapting doses according to patients' health status
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Score: 100 Remarks all reviewers: Kart, Trine:
Rejected 1.4. Reason for reject: ; ; You could maybe collaborate with colleagues working in other hospitals to have more patients and then make an evaluation Sviestina, Inese: Conclusion warranted
Rejected 1. Reason for reject: ; Small number of patients. Please, collaborate with other hospitals
BAR14-0182 Low dose intensity in elderly patients treated with chemotherapy for colorectal cancer Co-authors
M. Soussan Dahan1, B. Glaser1, Z. Ramjaun1, S. Perriat1, A. Grand1, J.M. Canonge1. 1University Hospital, Pharmacy, Toulouse, France.
Background
Colorectal cancer is predominantly a disease of the elderly. Frequently, the optimal Dose Intensity (DI) of the chemotherapy is difficult to be delivered. Indeed, few elderly cancer patients are included in clinical trials, resulting insuffisant data of the effectiveness.
Purpose
The aim of our work was to assess, in this population, the delivered doses of anticancer drugs in clinical practice.
Materials and Methods
We conducted a retrospective observational study at the university hospital of Toulouse. Patients aged 75 years and above which have received a first line chemotherapy for a colorectal cancer between September 2011 and April 2012 were selected. The main outcome measure was the median of Relative Dose Intensity (RDI) for each molecule. The calculation of DI variables was done according to the method proposed by Hryniuk and Bush.
Results
Eighteen patients were eligible. The median age was 80 years [75;87], sex ratio was 1.25. Before the beginning of the chemotherapy, the WHO stage was 0-1 in 94.4% of subjects. For all patients, an adenocarcinoma was confirmed, mainly localized in the colon (61%) and most often metastatic (78%). A proportion of 33% of patients was evaluated by a geriatric oncology consultation. The most frequently chemotherapy regimens used were FOLFIRI (44%) and FOLFOX (39%), then 5FU/LV (17%). Two patients received bevacizumab. The median number of cycles was 10 [2-12]. A proportion of 33% of patients received fewer cycles than expected by the protocol, because of delayed chemotherapy. A proportion of 67% of patients had a concession at the beginning of the chemotherapy. All confounded regimens, the medians of the RDI for irinotecan, oxaliplatin, leucovorin, 5-FU and bevacizumab were 84.1% [66.6;100], 64.9% [55.2;99.6], 99.9% [99.7;100], 74.7% [43;100] and 68.8% [37.5;100], respectively. All confounded molecules, the median of the average RDI was 80.2% [68.8;99.9]. A proportion of 61% of patients tolerated their chemotherapy. For the others, the main side effects were hypertension, nausea, diarrhea, peripheral neuropathy, asthenia, thrombocytopenia. Three months after their last administration, the imaging showed for 45% of patients stable lesions, for 22% of patients an improvement and for 33% of patients a progression (including 3 patients with symptoms related to cancer). During these 3 months, 39% of patients changed their line chemotherapy (1 5FU/LV, 2 FOLFOX, 2 FOLFORI +/- cetuximab, 1 XELOX, 1 VP16).
Conclusions
The majority of patients (94%) had a concession in the chemotherapy doses. Only one patient kept a full dose throughout his period of treatment. Our study showed that chemotherapy can be conducted in the elderly, as 67% of patients aged 75 years and above had stable or improved disease after treatment. However, specific geriatric assessments are necessary to identify and to target eligible patients to chemotherapy and to adapt doses.
Conflict of interest: Enter Yes or No: No
Keywords dose intensity;chemotherapy;elderly patients;
Authors letter Dear Madam, Dear Sir, (1) Colorectal cancer is predominantly a disease of the elderly. (2) However, few elderly cancer patients are included in clinical trials, resulting insuffisant data of the effectiveness and the tolerance of chemotherapy in this population. The aim of this study was to assess the delivered doses of anticancer drugs for elderly patients treated for a colorectal cancer in clinical practice. (3) To the best of our
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knowledge, the age is considered as an important factor for the decision of chemotherapy of the elderly cancer patients. Our study showed that chemotherapy can be conducted in the elderly, as 67% of patients aged 75 years and above had stable or improved disease after treatment. Rather than the criteria of age, co-morbidities should be considered. However, specific geriatric assessments are necessary to identify and to target eligible patients to chemotherapy and to adapt doses. We would like to publish these innovative results and we hope that our work will be of interest for Congress of the EAHP. We look forward to hearing from you. Yours faithfully, Marlène Soussan Dahan
Score: 0 Remarks all reviewers: Kart, Trine:
Rejected 1.4. Reason for reject: ; ; You could maybe collaborate with colleagues working in other hospitals to have more patients and then make an evaluation Sviestina, Inese: Conclusion warranted Conflict of interest clear Rejected 1. Reason for reject: ; Please, come back next year with more patients. Perhaps it would be useful to collaborate with colleagues from other hospitals dealing with the same study topic.
BAR14-0350 Study of Vinflunine in adult patients with advanced or metastatic transitional cell carcinoma of the urothelial tract Co-authors
E. Castillo1, M.A. Arias1, M. Bonilla1, M. Panadero1, F.J. Becares1, M. Hernandez1, M. Gómez1, G. Toledano1, E. Tortajada1, E.M. Martin1. 1Hospital Universitario fundación Jímenez Díaz, farmacia, madrid, Spain.
Background
Vinflunine has been established in a phase III clinical trial (CT), 253 patients were randomised to vinflunine + BSC (best supportive care) and 117 to BSC.
The median overall survival was 207 vs. 138 days (d) , respectively, but the difference did not reach statistical significance. A statistically significant effect was seen on progression-free survival (PFS) ( Median: 90 vs 45 d) .
In addition a pre-specified multivariate analysis performed on the ITT population demonstrated that vinflunine had a statistically significant treatment effect (p=0.036) on overall survival (OS) when prognostic factors (PS, visceral involvement, alkaline phosphatases, haemoglobin, pelvic irradiation) were taken into consideration.
Purpose To compare the characteristics, OS and PFS of patients who have received vinflunine in metastatic transitional cell carcinoma of the urothelial tract as second or third-line therapy . Materials and Methods
Retrospective observational study, including all patients who have received vinflunine until October 2013. Data collected: diagnosis, ECOG, renal and hepatic function, Tac-body and not pelvic irradiation 30 days before treatment.
Results
Seven patients were treated with vinflunine:
Ø ECOG 0-1: 71 %
Ø Renal and hepatic function correct: 71% and 57%
Ø Not pelvic irradiation:100%
Ø Body CT before treatment: 100%
In October 2013, 4 patients had died, these patients did not meet prognostic factors of CT, and their OS and PFS were 39 and 23 days respectively.
Three patients met prognostic factors of CT: median PFS is 168 days
Conclusions
OS and PFS were lower in patients who did not meet inclusion criteria of CT. PFS in patients who met this prognostic factors was higher, but not reach results of CT.
In our hospital only patients who met prognostic factors of CT begin treatment with vinflunine.
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Conflict of interest: Enter Yes or No: no Ownership: Eva Castillo Advisory board: Eva Castillo Board of directors: [email protected]
Keywords vinflunine;Clinical trial;clinical practice;
Authors letter Vinflunine is a relatively new drug; we think that in these drugs is important to do efficacy studies despite the small number of patient. Many times the patients included in clinical trials do not have the same characteristics as the patients who will be treated later in clinical practice and the results of clinical trials are not correlated with those obtained in normal clinical practice. We want to confirm that to obtain results similar to those of the clinical trial, patients must meet inclusion and exclusion criteria of clinical trial.
Score: 80 Remarks all reviewers: Santolaya, Rosario:
Rejected 1.4. Reason for reject: ; ; Venturini, Francesca: Conclusion NOT warranted Conflict of interest clear Rejected 4.5. Reason for reject: ; ;
BAR14-0360 use of cabazitaxel for metastatic prostate cancer in clinical practice Co-authors
M. bonilla1, E. castillo1, M. hernandez1, B. rodriguez1, F.J. becares1. 1hospital universitario fundacion jimenez diaz, pharmacy, madrid, Spain.
Background
Cabazitaxel has been recently aproved by the Spanish Medicine Agency for metastatic castration-resistant prostate cancer with progressive disease after docetaxel-based treatment
Purpose Describe the use of cabazitaxel in clinical practice compared with the pivotal essay, TROPIC Materials and Methods Retrospective review from March 2011 to October 2013 of all patients that were treated with cabazitaxel 25 mg/m2 every 3 weeks in combination with oral prednisone. We review the following variables: age, ECOG, haematological, hepatic, renal and cardiac function at the beginning of treatment, time from last docetaxel dose to disease progression, number of cabazitaxel cycles and time to tumor progression Results
Seven patients received cabazitaxel during the study period, the median age was 66,4 years (59-75), all patients had ECOG < 2 and adecuate haematological, hepatical, renal and cardiac function. The time from last docetaxel dose to disease progression was more than 6 months in two patients and less than 6 months in five, the median time from last docetaxel dose to disease progression for cabazitaxel group in the TROPIC trial was 0,7 months (0-2,9). The median time to tumour progression in our patients was 6,5 months (3-13,5) compared with 8,8 months published in the pivotal study. Two patients obtained radiological and clinical response during 13,5 months after 10 cycles of cabazitaxel, with stable disease after 5 and 4 months. The other five patients had progression disease before the 5 cycle of cabazitaxel.
Conclusions
The use of cabazitaxel in clinical practice in patients with the same inclusion criteria that in the main study submitted do not offer the same results in progression-free survival and median time to tumour progression. Patients with the same clinical inclusion criteria as the main study TROPIC obtained a median time to tumor progession shorter than 8,8 months published in the study.
No conflict of interest
Keywords cabazitaxel;clinical efficacy;metastatic prostate cancer;
Authors letter Cabazitaxel has been recently aproved by the Spanish Medicine Agency for metastatic castration-resistant prostate cancer with progressive disease after docetaxel-based treatment. To know the efficacy of the new drugs in the clinical practice may help clinicians make decisions about high-cost drugs
Score: 100
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Remarks all reviewers: Santolaya, Rosario: Conclusion warranted Conflict of interest clear Rejected 4. Reason for reject: ; Venturini, Francesca: Conclusion warranted Conflict of interest clear Rejected 4. Reason for reject: ;
BAR14-0374 FOTEMUSTINE: SECOND-LINE THERAPY IN PATIENTS WITH GLIOMA Co-authors
L. Baladé Martinez1, G. Casado Abad1, A. Sierra Muñoz1, C. Rueda Perez1, A. Herrero Ambrosio1, M. De Sebastian Rueda1. 1Hospital la paz, Pharmacy, Madrid, Spain.
Background Despite recent therapeutic advances, most patients with glioblastoma experience disease recurrence, with very poor prognosis. Fotemustine is one of the second.line therapies recognized in glioma. Purpose Compare effectiveness and safety of Fotemustine with the scheme of Addeo, in patients with glioma after progression to surgery, radiation and temozolamide Materials and Methods
A retrospective, observational and descriptive study. All patients were treated according to the scheme of Addeo from August 2012 to April 2013, being the average of cycles received three cycles. Chemotherapy data were obtained fromOncofarm ® Oncology Pharmacy Management program. Reviewing medical records, we collected the following data of each patient: sex, age, type of glioma, number of cycles received from fotemustina and the drug's adverse effects.
Results
Four patients (2 men and 2 women) with a mean age of 59 years were collected. The histological types of glioma suffered were: oligodendroglioma anaplastic (1 patient), glioblastoma multiforme (2 patients) and astrocytoma anaplastic (1 patient). Of the four patients, one ended five cycles of induction with partial response (PR), and now he is in maintenance. Two of the patients didn’t complete the induction because of progression (PD), one of whom died. The fourth patient is in induction. The adverse events recorded were: thrombocytopenia (3 patients), neutropenia (1 patient) and increase in transaminases (1 patient).With the purpose of control thrombocytopenia, in one of the patients dose was reduced 25% and in two patients the next cycle was delayed a week.
Conclusions
There isn’t a general consensus of what is the second-line therapy of choice. The evidence of Fotemustine in glioma come from clinical trials in phase II, prospective, non-randomized and single arm. Effectiveness and safety obtained in this study were similar to the study Addeo. However, more clinical trials phase III with more patients are required to evaluate the potential benefit.
No conflict of interest
Keywords Fotemustine;glioma;second-line;
Authors letter (1) With this study we can learn if the patients completed the cycle of chemotherapy and the tolerance of fotemustine. (2) There are very few studies published that demonstrate effectiveness and safety of fotemustine in recurrent glioma. (3) To evaluate if it is worthy to introduce Fotemustine in the hospital for the indication of recurrent glioma.
Score: 100 Remarks all reviewers: Santolaya, Rosario: Conclusion NOT warranted Conflict of interest clear Rejected 4. Reason for reject: ; Venturini, Francesca: Conclusion warranted Conflict of interest clear Rejected 4.5. Reason for reject: ; ;
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BAR14-0434 Reviewing and sharing of Therapeutic Protocols in Oncology in setting Central: Local Health Authority (AUSL) of Bologna Co-authors
G. Santilli1, R. Cesari1, D. Scarlattei1, M. Marotta1, M. Borsari1. 1Ospedale Maggiore-Bellaria Ausl Bologna, Farmaceutico, Bologna, Italy.
Background
In 2012 it was brought to completion the unit anticancer drugs AUSL Bologna, whose implementation is part of a project of centralization and taken over by the Pharmacy dell'allestimento of anticancer therapies for cancer DH 7 ASL Bologna started in 2010, also in accordance with the instructions provided in the Regional Oncology Network.
Purpose
The main objective of the project was to define a new organizational structure, new diagnostic and therapeutic clinical pathways share a common system of information and education in order to homogenize the various activities in the individual DH to be redistributed throughout the AUSL of Bologna.The ultimate aim therefore is to provide a quality service and efficiency, through common paths defined to ensure: safety of the final product and operators, clinical risk management, reduction of errors, resource optimization.
Materials and Methods
The establishment of Team has enabled the sharing and integration of multidisciplinary skills.(Doctor, Pharmacist and Nurse), and then an assessment of: prescriptive and constant updating of the protocols Therapeutic and their timely computer storage.The clinical undertakes a rigorous process, which required the adoption of a management Software Log80, the objective of uniformity of all processes such as: tracking and tracing of all activities and constant updating of the protocols Therapeutic and related requirements clinics.The Software provides, in fact, registration and validation by the clinician and the pharmacist of each treatment protocol.
Results It started in 2012 from the analysis of protocols 364 of 553 total areas used by the former (183 City, 178 South and 192 North) at 31 May 2013, have been revised, standardized and adjusted to 155 protocols prescription on the whole territory for AUSL.S’ analysis of the 155 protocols it is seen that the distribution is 46% Breast, Colon, 26%, 9% of non-small cell lung, 2% Brain (gliomas), Prostate 6% and 11% Other. Therefore, if it is necessary and timely aligning the protocols in the initial phase of centralization AUSL, the remaining 189 protocols are still under review. The work is ongoing and dynamic, fully integrated into a system of constant updating of our daily activities Conclusions
The daily confrontation between professionals has allowed homogenization of clinical treatments to patients, which, although logistically located in different geographical areas of the AUSL has ensured equal therapeutic treatment and is an added value in the governance and management of the therapy.
No conflict of interest
Keywords Therapeutic protocol;oncology drug;clinical risk;
Authors letter This abstract is relevant to a new management schemes that therapeutic Oncology standardized give a guarantee of uniformity and equity management therapies for each patient. The management system used allows through computerized tracking and tracing of all data entered : clinical indications , patient demographics , personalized access with login and password to your doctor, pharmacist and nurse . Aimed at a careful monitoring and reduction of clinical risk . It follows a reorganization of the management of therapies in accordance with the appropriateness of the clinical prescription , definition of treatment pathways and standards can be constantly updated and shared between different health professionals involved . Particularly relevant to the doctor in constant update and comparison of medical and identification of any responsibility. For a pharmacist implentazione and updating of all the forms of medicines ( oncologic and ancillary ) in accordance with the clinical indications , dosages and drug interactions For nurses in control of all the sheets therapy related to the format of therapies for individual patients and also control the volume and timing of administration
Score: 0 Remarks all reviewers: Santolaya, Rosario: Conclusion NOT warranted Conflict of interest clear Rejected 3.5. Reason for reject: ; ; Venturini, Francesca: Conflict of interest clear Rejected 5.9. Reason for reject: ; ;
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BAR14-0451 Effectiveness and safety of chronic hepatitis C treatment based on triple therapy with boceprevir/telaprevir in HIV/HCV-coinfected patients Co-authors
M. Pellicer Corbí1, S.M. Matoses Asensio1, C. Garcia Muñoz2, C. Herranz Muñoz1, M. Ortiz Campos1, M.R. Luque Infantes1. 1Hospital Universitario Príncipe de Asturias, Pharmacy, Alcalá de Henares, Spain. 2Hospital Universitario Doce de Octubre, Pharmacy, Madrid, Spain.
Background
The use of triple therapy (TT) produces favorable results in HCV-monoinfected patients, but there is insufficient data on HIV/HCV-coinfected patients.
Purpose
To evaluate the effectiveness and safety of an off-label treatment with TT in HIV/HCV-coinfected genotype 1 patients at 4, 12 and 24 weeks from the start. To evaluate the impact of IL28B genotype as a predictive response factor.
Materials and Methods
Retrospective observational study (December 2012-September 2013). HIV/HCV-coinfected patients, treated with TT for at least 4 weeks were included. Data were collected from Outpatient Management Software (Farmatools®), medical charts and clinical analysis database (Servolab®).We recorded age, sex, initial liver fibrosis grade, IL28B genotype and patient type based on response to previous HCV treatment. The effectiveness was measured as rapid viral response (RVR) and early viral response (EVR) (complete cEVR/partial pEVR). Viral load (VL) at baseline, 4, 12 and 24 weeks was recorded. Safety was assessed by changes in haemoglobin, platelets and neutrophils count at baseline, 4, 12 and 24 weeks, need of darbepoetin or filgrastim treatment, need of blood transfusion and presence of severe skin reactions.
Results
Six patients were included, all treated with telaprevir, F4 liver fibrosis grade. Average age was 50 years (44- 63), 66.6% were male. IL28B genotype was: CC (n=4), TT(n=1), unknown (n=1). Regarding the response to previous HCV treatment, 33.3% of patients were naïve, 50% were relapsers and 16.7% were partial responders. RVR was achieved in 83.3%(n=5) of patients (CC:60%, TT:20%, unknown:20%). 4 patients reached week 12 of treatment, patient who didn’t get undetectable VL at week 4, finally got it in week 12 (cEVR). 3 patients completed 24 weeks of treatment, all with undetectable VL (CC:100%). All patients had anemia and thrombocytopenia, neutropenia occurred in 83.3%(n=5) of patients; administration of darbepoetin was necessary in 33.3%(n=2) of patients and filgrastim in 50%(n=3). No blood transfusion required. There were no serious adverse cutaneous events.
Conclusions
TT with telaprevir is effective but it causes significant hematologic side effects. It doesn’t seem that the impact of IL28B genotype can be used as a response predictor factor. More follow-up time would be necessary to evaluate sustained viral response.
No conflict of interest
Keywords telaprevir;HIV/HCV-coinfected patients;effectiveness;
Authors letter 1. This abstract is relevant because treatment based on triple therapy is a very novel therapy for HCV infected patients. 2. There are many published studies about monoinfected patients but there is insufficient data on HIV/HCV-coinfected patients. 3. It is important to have data of efficacy and safety about off-label triple therapy to consider possible future treatments.
Score: 180 Remarks all reviewers: Santolaya, Rosario: Conclusion NOT warranted Conflict of interest clear Rejected 4. Reason for reject: ; Venturini, Francesca: Conclusion warranted Conflict of interest clear Rejected 4. Reason for reject: ;
BAR14-0589 prescription fitness and associated cost for botulinum toxin in a second level hospital Co-authors
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E. Zamora Ferrer1, P. Araque Arroyo1, E. Jérez Fernández1, JL. Sánchez Serrano1, MC. Conde García1, N. Andrés Navarro1. 1H.G. La Mancha Centro, Pharmacy, Alcazar de San Juan, Spain.
Background It is needed to formalize the hospitalary use of botulinum toxin.
Purpose To analyze the appropriateness and associated cost of botulinum toxin use.
Materials and Methods Retrospective observational follow-up one year (2012) of the use of botulinum toxin A (Botox® and Dysport®) and B (Neurobloc®). The indication for use is structured in 3 categories: A: Indications approved by EMA (European Medicin Agency), B: Indications approved by Food and Drug Administration, but not by EMA, C: Indications unapproved by both of these regulatory agencies.
Results 174 patients (median age 51 years) were treated with botulinum toxin, whith a total cost of 55.291€ (Botox® 87%; 12% Dysport®; 1% Neurobloc®). 110 patients were assigned to Category A, and 49 and 15 patients to categories C and B, respectively. The Neurology Service contributed 72% of the patients [99% Botox®], representing 78% of the cost. 69% of the patients were assigned to category A (61% for blepharospasm and facial hemispasm); 27% category C (56% headache); 4% category B (upper limb spasticity). 24 patients were treated by Rehabilitation Service (17% of cost). Of these, 6 patients were treated with Botox® (4% of total cost); 18 patients were treated with Dysport® (12% of cost). 8, 8 and 2 patients were assigned to category A (63% blepharospasm), C and B, respectively. 11 patients were treated by the Ophtalmology Service for strabismus (46% category C; 54% category B) involving 3% of cost. The Dermatology Service treated 6 patients with Botox® (2% of the cost, category A).
Conclusions The analysis of the use of botulinum toxin in our hospital revealed that 72% of prescriptions fit Datasheet. However, nearly a third of them do not fit indication. Neurology prescriptions represent the greatest contribution. Underlying therefore the requeriment of a hospital pharmacist involved in an exhaustive monitoring of this drug.
No conflict of interest
Keywords botulinum;toxin;cost;
Authors letter Botulinum toxin is one of the most toxic grug used in the hospitals. It needs a special control and an appropiate use to be sure for the patients.
Score: 80 Remarks all reviewers: Bermejo Vicedo, Teresa: Conclusion warranted Conflict of interest NOT clear Rejected 2.3.6.8.10. Reason for reject: ; ; ; ; ; Not cost in methodoly. It´s a retrospective study, not following Rieutord, André: Conclusion NOT warranted Conflict of interest clear Rejected 1.2.3. Reason for reject: ; ; ; PLease carry out the monitoring you suggest in the conclusion and get back to us
BAR14-0610 Arsenic Trioxide in Acute Promyelocytic Leukemia. A case report Co-authors
M. Del Barrio-Aranda1, B. Mora-Rodriguez1, M.A. Rosado-Souviron1, C. Andrés- González1, I.M. Muñoz- Castillo1. 1Hospital Regional Málaga, Pharmacy, Malaga, Spain.
Background Arsenic trioxide (ATO) is indicated for induction of remission and consolidation in adult patients with relapsed/refractory acute promyelocytic leukaemia (APL), characterised by the presence of the t(15;17) translocation and/or the presence of the Pro-Myelocytic Leukemia/Retinoic-Acid-Receptor-alpha (PML/RAR-alpha) gene. Previous treatment should have included a retinoid and chemotherapy.
Purpose To evaluate the efficacy and safety of ATO in a patient with relapsed APL.
Materials and Methods A descriptive study of the clinical course of a 41-year-old man who was diagnosed with intermediate-risk APL in August 2011. The illness began with a disseminated intravascular coagulation episode that needed
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the administration of a platelet concentrate. Also an impaired blood count and coagulation was present: 9.6% Luc cells and presence of Auer rods. After the induction therapy with Cytarabine and Idarubicin, the patient received consolidation therapy with Idarubicin and all-trans retinoic acid (ATRA), a second consolidation with Mitoxantrone and ATRA and a third consolidation with ATRA and Idarubicin four months from the start. The patient remained in complete remission until May 2012 In October, due to persistent cytopenia, a new bone marrow aspiration was done confirming the presence of blasts and positivity of PML/RAR-alpha in peripheral blood.
Results After relapse the patient began induction therapy with ATO at a dose of 0.15 mg/kg/day plus ATRA 45 mg/m2/day. A prolonged QT interval was observed on an electrocardiogram and the ATO was suspended for 2 days. It was restarted with 50% of the initial dose to complete the induction during 5 weeks. Once the complete post-induction response was achieved, with negative PML/RAR-alpha, in December 2012, another consolidation treatment was begun. It consisted of two cycles of 25 doses each, administered five days a week for five weeks with four weeks of rest in the middle. The second cycle was started at a dose of 0.075 mg/kg/day; it was gradually increased up to 0.15 mg/kg/day and was ended in March 2013. The patient remained stable in complete remission. In June 2013 he received an unrelated bone marrow transplant.
Conclusions Low-dose ATRA and ATO combination therapy may be more effective for the treatment of APL.Cardiotoxicity was the indication to reduce the dose of ATO but it did not compromise the effectiveness of treatment.
No conflict of interest
Keywords arsenic;cardiotoxicty;acute promyelocytic leukemia;
Authors letter Cure of acute promyelocity leukemia is a possibility for most patients with the use of chemotherapy. Given the high antileukemic efficacy observed with arsenic trioxide in patient relapsing after ATRA- containing regimens, this agent is currently regarded a treatment option in this setting. Our purpose with this study is to describe the treatment in a relapsed patient with ATO and ATRA.
Score: 120 Remarks all reviewers: Bermejo Vicedo, Teresa: Conclusion NOT warranted Conflict of interest NOT clear Rejected 1.8.10. Reason for reject: ; ; ; They only describe one case that is not enough data for a study which objective is to evaluate the efficacy and safety of arsenic trioxide.It is not explained in the methodology how the efficacy and safety was evaluated. Rieutord, André: Conclusion warranted Conflict of interest clear Rejected 4. Reason for reject: ; it is just a story
BAR14-0613 CEFTAROLINE, A NEW CEPHALOSPORIN. A CASE REPORT Co-authors
A. Ibáñez Zurriaga1, E. Ramirez Herraíz1, M.A. Ruiz Gómez1, E. Deben Tiscar1, M. Pérez Abanades1, J.M. Serra López-Matencio1, C. Martinez Nieto1, E. Alañón Plaza1, T. Gallego Aranda1, A. Morell Baladrón1. 1Hospital Universitario de la Princesa, Pharmacy, Madrid, Spain.
Background Ceftaroline is a new cephalosporin whose activity spectrum includes methicillin-resistant Staphylococcus aureus (MRSA) and multidrug-resistant Streptococcus pneumoniae. The European Medicines Agency has approved its use in adults for the treatment of complicated skin and soft tissue infections and community- acquired pneumonia (CAP). Purpose
To describe the off-label use of ceftaroline in a patient with a severe respiratory infection.
Materials and Methods A 63-year-old woman with a 3-day history of flu-like symptoms was admitted to the Emergency Department with a temperature of 38.8ºC. Due to acute respiratory failure and severe sepsis in the context of CAP, she was transferred to the Intensive Care Unit (ICU). Results
At the Emergency Department, cefotaxime 2g/8h and levofloxacin 500mg/12h were administered. 24h later progressive worsening of respiratory mechanics required intubation. In the ICU the treatment was changed to meropenem, levofloxacin, and linezolid for MRSA, adding ganciclovir for cytomegalovirus and oseltamivir for influenza virus. MRSA was isolated in the bronchoaspirate (BAS) and type B influenza H1N1virus in the
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nasopharyngeal exudate, and the treatment was changed to high doses of linezolid, plus meropenem and oseltamivir. As the patient failed to improve, fosfomycin was added to promote drug synergy but the patient worsened, with fever, septic shock and secondary effects related with the fosfomycin or linezolid (hypernatremia, diarrhea and thrombocytopenia).
Fosfomycin and meropenem were therefore withdrawn and an off-label high dose treatment with ceftaroline was initiated: 600mg/6h (2 days), 600mg/8h (3 days) and 600mg/12h (7 days).
Ceftaroline-related side effects (liver toxicity with increased transaminases, negative stool diarrhea, rash on the trunk and lower limbs, and hemolytic anemia requiring transfusion) disappeared as the dose was reduced.
Three days after suspending the antibiotic therapy, the patient presented a fever spike and increased secretions. A new BAS was taken, plus a stool and urine culture, isolating Stenotrophonomas maltophila, Enterococcus faecalis and Pseudomonas aeruginosa. Cotrimoxazol and levofloxacine were therefore given. Due to the possibility of MRSA recurrence, linezolid was reintroduced for 9 days, until the patient was discharged form the ICU to the the infectious diseases ward. She was later discharged home with no infection.
Conclusions
Ceftaroline represented a new alternative treatment in our patient given the side effects and poor evolution related with the standard treatment. Ceftaroline is a new option (in mono or polytherapy) for the empiric treatment of hospitalized patients with CAP who require intravenous antibiotic therapy.
The safety profile is similar to that of other cephalosporins, with few side effects that disappear when treatment is suspended.
No conflict of interest
Keywords ceftaroline;Staphylococcus aureus;community-acquired pneumonia;
Authors letter relevance and innovation: it´s a new approval antibiotic with off-labell use. Implication: new alternative of treatment in critical patients
Score: 140 Remarks all reviewers: Bermejo Vicedo, Teresa: Conclusion warranted Conflict of interest NOT clear Rejected 3.10. Reason for reject: ; ; It was a description of an off-label high dose treatment with ceftaroline, but it does not added new value to the drug data that it is known. Rieutord, André: Conclusion warranted
Rejected 1.4. Reason for reject: ; ;
BAR14-0712 MANAGEMENT A CLINICAL TRIAL: COLLABORATION BETWEEN PHYSICIAN AND PHARMACIST TO EVALUATE A THERAPEUTIC ALTERNATIVE FOR THE TREATMENT OF ADDISON'S DISEASE Co-authors
T.C. Paone1, P. Crosasso1, M. Burlando1, M.R. Chiappetta1, S. Stecca1, R. Berardelli2, R. Giordano2. 1A.O Città della salute e della scienza, Health Department -Pharmacy, turin, Italy. 2A.O Città della salute e della scienza, Department of Medicine in the SGB University Hospital, turin, Italy.
Background
Italian law allows hospital pharmacies to produce investigator medicinal products to be used exclusively for non-profit clinical trial.
Purpose
This work aims to be an example of how a pharmacist and a physician can collaborale for the conduct of clinical trials according to GCP. It also wants to emphasize that the role of the pharmacist may crucial for its implementation and management
Materials and Methods
The pharmacist was involved in the clinical trial: protocol writing, preparation investigator medicinal products, randomized, double-blind and data monitoring. The study involved 15 patients with Addison's disease in glucocorticoid and mineralocorticoid therapy. Objective was to evaluate the effect of a 24-month treatment with DHEA (50 mg orally , 8 patients in arm A) versus placebo (arm B 7 patients) on clinical, metabolic, hormonal changes and the existence of side effects of a long-term treatment with DHEA.
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Results
We enrolled all patients. All patients, except one that after 18 months withdrew consent, were subjected to views : T0 , T1 after 6 months from the start of this therapy , T2 and T3 after 12 after 24.
The assessments made ??during the views it was found that:
T1: there was no significant difference between arm A and arm B with respect to BMI, waist circumference , blood pressure , levels of estradiol , blood glucose, total cholesterol and HDL cholesterol. While in arm A were higher levels of DHEAS , androstenedione , testosterone, insulin levels and HOMA
T2 were not observed deviations from T1 except for estradiol levels that are higher in the arm A. T3 compared to T2 in arm A, the levels of DHEAS , androstenedione , estradiol, and testosterone were significantly higher than the T0 phase, while in arm B androstenedione and DHEAS levels were significantly lower than the phase T0 and estradiol and testosterone more . In arm A and arm B was observed a significant reduction in blood glucose levels compared to T0.
Conclusions
The arm A, compared to T0, showed an improvement of glucose profiles, expressed in glucose values?? and lipid metabolism expressed in values ??of LDL . Moreover, the treatment with DHEA bears side effects of mild that not foreclose the state of health of the patient. The conduct of this study has produced evidence on which the pharmacist and the physician will evaluate whether to treat patients with Addison's disease with what appeared to be a new therapeutic alternative to the glucocorticoid and mineralocorticoid therapy
No conflict of interest
Keywords addison's disease;dhea;clinical trial;
Authors letter COLLABORATION BETWEEN DOCTOR AND PHARMACIST IN THE MANAGEMENT OF A NEW HEALTH CARE EVALUATION OF A NEW THERAPEUTIC OPPORTUNITIES PRODUCTION OF SCIENTIFIC EVIDENCE ON WHICH TO BASE OF CLINICAL CHOICES
Score: 40 Remarks all reviewers: Bermejo Vicedo, Teresa: Conclusion NOT warranted Conflict of interest NOT clear Rejected 6.7. Reason for reject: ; ; The abstract is not presenting a study with a defined aim, a described method to obtain results, presentation of the obtained results and a conclusion based on these findings Rieutord, André: Conclusion NOT warranted Conflict of interest clear Rejected 3.7.9. Reason for reject: ; ; ; quite messy
BAR14-0724 Late-onset Pompe's disease treatment with acid alpha-glucosidase Co-authors
R. Garcia Ramos1, M. Rodriguez Prada1, J. Pardo Fernandez2, A.M. Taboada Barcia1, M.S. Rodriguez Cobos1, A. Garcia Lopez1, P. Suarez Artime1. 1Complejo Hospitalario Universitario de Santiago de Compostela, Hospital Pharmacy, Santiago de Compostela, Spain. 2Complejo Hospitalario Universitario de Santiago de Compostela, Neurology, Santiago de Compostela, Spain.
Background
Pompe disease is a rare metabolic myopathy, a progressive neuro-muscular disease caused by a deficiency of acid alpha-glucosidase (AAG). Replacement treatment with this enzyme has a high cost and controversial results in older patients.
Purpose To analyze the evolution, safety and cost of treatment with AAG of a patient suffering from late-onset Pompe disease (LOPD). To review possible dose reduction experiences as in other enzyme replacement therapies (ERT).
Materials and Methods
Patient dose according to label use: 20mg/kg IV of recombinant human AAG every 14 days. We describe concomitant medication and disease-related complementary tests indicative of disease progression. We
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estimate the annual cost of drug treatment. A literature review was carried out for evidence of dose reduction in LOPD.
Results
Male 65 year-old treated with AAG since August 2011, with 35 years of evolution that started with muscle weakness and progressive respiratory distress. In recent years he required mechanical ventilation, and for the last 3 years he has required a wheelchair. 1,500 mg per cycle were administered according to the protocol of Pharmacy Service. AAG annual cost was 358,524€ (14,940€/cycle). Pre-medication administered: dexchlorpheniramine and paracetamol. Twelve months before starting ERT therapy he presented chronic constipation, abdominal pain, ocassional diarrhea and occasional episodes of partial bowel obstruction. After 4 months of ERT with AAG, gastrointestinal symptoms disappeared and the patient began ambulation with physical support. Concomitant therapy: Octreotide acetate off-label to treat gastrointestinal symptoms initiated prior to ERT. Other significant information: after one year of ERT, CK was reduced from 283 U/L in 2010 to 226 U/L (ref. 30-172). There were no adverse reactions.
Conclusions
AAG was well tolerated. Intestinal, respiratory and muscular symptoms experienced an improvement. After 24 months of treatment, the disease has stabilized. Treatment cost is very high (Orphan drug). No literature was found supporting dose reduction or spacing after stabilization treatment.
No conflict of interest
Keywords Late onset Pompe´s disease;alpha-glucosidase acid;outcome;
Authors letter 1. There is little literature about treatment of late onset Pompe´s disease with controversial results. Treatment with alpha-glucosidase acid has a high cost. The results of a patient who experienced improvement with this treatment are presented. 2. Literature review is done given the high cost in order to reduce the dose or extend the interval between administrations. 3. It is an experience in the treatment of the disease that requires prior preparation and will be presented in the poster.
Score: 140 Remarks all reviewers: Gouveia, Antonio Melo: Conclusion warranted
Rejected 2.4. Reason for reject: ; ; Bonnabry, Pascal: Conclusion warranted Conflict of interest clear Rejected 4. Reason for reject: ;
BAR14-0736 Efficacy of imatinib in pulmonary arterial hypertension Co-authors
AM Villalba-Moreno1, M.A. Pérez Moreno1, H. Acosta Garcia1, J. Cotrina Luque1, M. Galvan Banqueri1, E.R. Alfaro Lara1. 1Hospital Universitario Virgen del Rocio, Pharmacy, Seville, Spain.
Background Results from the phase III IMPRES clinical trial showed an additional benefit of imatinib added to conventional combination therapy for severe pulmonary arterial hypertension (PAH) patients, due to its antiproliferative action.
Purpose To study the clinical evolution of patients with functional class (FC) IV PAH receiving 'off-label' treatment with imatinib added to conventional therapy.
Materials and Methods Retrospective study. Inclusion criteria: patients with FC-IV PAH that received imatinib as third line treatment. Data collected: patients age and gender, pre-treatment lines, imatinib dose and duration. Follow-up after starting imatinib data: FC, echocardiographic (systolic pulmonary artery pressure -PAPs- and the tricuspid annular plane systolic excursion –TAPSE-), exercise capacity (walking test 6 minutes -6MWT-) and Borg Scale –BS-), and biochemical markers (NT-proBNP).
Results 2 patients were recruited, a 40 year old man and a 71 year old woman. Both took 3 lines of treatment (Endothelin Receptor Antagonists, sildenafil and prostanoids) and started imatinib 100-mg/24 h, with duration of 10 and 14 months, respectively. They started with CF-IV and 10 months later 1 patient reverted to CF-II. At 6 months, 1 patient with PAPs of 80 mmHg and TAPSE of 17 mm basal became to PAPs of 70 mmHg and TAPSE of 19 mm (without echocardiographic data on the other), whereas 1 patient with
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baseline 6MWT of 480 m with BS-3 increased to 540 m with BS-3 (could not perform the test in the other patient). NT-proBNP levels increased a median of 330 pg/ml throughout the treatment in both periods. All patients died (1 by causes beyond the disease and another because of being in advanced stages of the disease).
Conclusions Improvement in echocardiographic parameters and the 6MWT are observed in FC-IV PAH patients treated with 'off label' imatinib added to conventional therapy. However, the disease stage makes these results not clinically relevant.
No conflict of interest
Keywords Efficacy;Imatinib;Hypertension;
Authors letter Pulmonary arterial hypertension is a severe disease that progressively deteriorating lung function of patients. The scientific evidence in terms of efficacy of imatinib in advanced stage of pulmonary arterial hypertension is hopeful according to results from the phase III IMPRES clinical trial. This showed an additional benefit of imatinib added to conventional combination therapy for severe pulmonary arterial hypertension patients, due to its antiproliferative action. However, it is necessary provide cases treated in the hospital to increasing scientific evidence.
Score: 140 Remarks all reviewers: Gouveia, Antonio Melo: Conclusion warranted Conflict of interest clear Rejected 4. Reason for reject: ; 2 patients, prevalence 15-52 patients per million in Europe, Bonnabry, Pascal: Conclusion warranted Conflict of interest clear Rejected 4. Reason for reject: ;
BAR14-0752 Effect of romiplostim treatment in patients with Immune Thrombocytopenia at Hospital Santa Maria, Lisbon, Portugal, descriptive study Co-authors
S. Amaral1, A. Ferreira1, F. Cosme Silva1, V. Rodrigues1, J.P. Cruz2, A. Rodrigues Azevedo Castro Carvalho Moreira2, M.P. Ferreira3. 1HOSPITAL DE SANTA MARIA, Farmacotecnia, Lisbon, Portugal. 2HOSPITAL DE SANTA MARIA, Unidade de Gestão, Lisbon, Portugal. 3CHLN EPE, Serviço de Gestão Técnico- Farmacêutica, Lisbon, Portugal.
Background Immune thrombocytopenia (ITP) is an autoimmune bleeding disorder.(1) Romiplostim is indicated for adult chronic ITP splenectomised patients refractory to other treatments and also in second line treatment for adult non-splenectomised where surgery is contra-indicated.(2) Considering that romiplostim was licensed in Portugal in 2010, few data has been reported so far, and therefore it is important to understand how patients respond in order to manage the therapeutical options more accurately.
Purpose This study aims to characterize the patients treated with romiplostim in Hospital Santa Maria (HSM) and also to evaluate the primary and the overall platelet's response as an indicator of patients' response.
Materials and Methods An observational, descriptive retrospective study was carried out in a 1200 bed main hospital. Data was collected between May/2010 and August/2013 from medical prescriptions and laboratorial results, from 8 patients treated in Hematology department. Primary platelet response was determinated based on 25 weeks of follow-up. Romiplostim was considered effective if platelet counts were ≥ 50 x 109/L at least in 6 weekly evaluations during the last 8 weeks of treatment (3). The overall platelet response sas studied in patients treated for a period of 2 years, after a stable platelet count (values ≥ 50 x 109/L during at least 4 consecutive weeks, without dose adjustment). The treatment was effective if platelet counts were ≥ 50 x 109/L without rescue medication, in at least 75% of the weeks. The rescue medication was defined as the introduction of a new drug due to a poor romiplostim response.
Results The present report describes the experience with 8, 1 male and 7 females. The average age was 63 years old and 6 patients were splenectomised. All patients had been treated before with corticosteroids and immunoglobulins. In addition, 3 of them had also been treated with rituximab, 2 with azathioprine and 1 with vincristine. Only one of the patients needed rescue therapy. None was hospitalized or had to discontinue the treatment. A primary platelet response was observed in 4 patients and in 2 there was no sufficient data available.
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Considering the overall platelet response, only 5 patients were treated for at least 2 years. In 3 of them, the platelet count was ≥ 50 x 109/L in more than 75% of the weeks. Despite the fluctuation of platelet counts, a dose stabilization was achieved in all the patients studied.
Conclusions In spite of the observed variability of responses, romiplostim appears to be a treatment option for ITP as it has been associated with increased platelet counts and low rate of rescue therapy or hospitalization. However the lack of laboratory data in some of the weeks of the study may have somewhat biased the results, which is why more data would be required to further conclusions and also to assess the long-term tolerability of the drug and the impact on the quality of life of the patients in the management of chronic ITP.
Conflict of interest: Enter Yes or No: No
Keywords Immune Thrombocytopenia;Romiplostim;Platelet Response;
Authors letter The introduction of romiplostim, a thrombopoetic agent, has provided clinicians with a novel approach for the treatment of chronic refractory ITP by stimulating platelet production. As it was recently licensed in Portugal (2010) few data on its use is available and therefore a close follow-up of the patients treated is crucial to monitorize its use and collect data in order to choose the best therapeutic option for each case. Considering the hospital pharmacy practice,the present report will provide information about the experience with romiplostim in our Hospital as well as the enrollment of the hospitalar pharmacist in the monitorization process.
Score: 120 Remarks all reviewers: Gouveia, Antonio Melo: Conclusion NOT warranted Conflict of interest clear Rejected 1.2.3.4.6.10. Reason for reject: ; ; ; ; ; ; data reported is inconclusive and well known. Only 8 patients for a disease with a prevalence of about 10 per 100 000 Bonnabry, Pascal: Conclusion warranted Conflict of interest clear Rejected 4. Reason for reject: ;
BAR14-0761 DISPENSATION ANALYSIS OF ICATIBANT ACETATE AND C1 INHIBITOR CONCENTRATE IN HEREDITARY ANGIOEDEMA TREATMENT FROM THE PHARMACY SERVICE Co-authors
R. MARTINEZ DE ARRIBA1, B. OCA LUIS1, S. BARBADILLO VILLANUEVA1, S. ALONSO CASTELLANOS1, A. PEDROSA NAUDIN1, E. BRIONES CUESTA1, A. LOPEZ INSUA1, V. BENITO IBAÑEZ1, M. ESPEJA MARTINEZ1, M.A. MACHIN MORON1. 1HOSPITAL UNIVERSITARIO DE BURGOS, HOSPITAL PHARMACY, Burgos, Spain.
Background Hereditary Angioedema(HAE) is an orphan disease. Among treatments used we find Icatibant acetate(IA), indicated for symptomatic treatment of acute attacks of HAE, and C1 inhibitor concentrate(C1-INH) indicated in acute crisis, routine prophylaxis and preoperative in patients with HAE. Both drugs have a high economic impact.
Purpose The aim of our study is to analyse dispensations of these drugs from Pharmacy Service.
Materials and Methods
Retrospective study of IA and C1-INH dispensations , from January 2010 to December 2012. The list of patients, annual consumptions per drug and clinical unit, were obtained from Outpatient´s and Economical Management softwares.
Results
7 patients were treated during this period. All of them received IA. Two were additionally treated with C1- INH, due to preoperative prophylaxis and in adverse reaction to IA. Total dispensations of both drugs were 98;35.7% IA and 64.3% C1-INH. From dispensations of IA,94.3% were performed in Outpatient Dispensations Unit(ODU),2.85% to Gastroenterology Service and 2.85% to Emergency Room(ER). From the dispensations of C1-INH,80.9% were performed in the ODU,7.9% to ER,6.4% to Allergy Service,3.2% to Internal Medicine Service and 1.6% to Hematology Service. Direct cost associated to treatment of HAE with these drugs during the study period was 90938.45€;64% to IA(58270.40€) and 36% to C1-INH(32668.05€)
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When analysing dispensations by patient, it was observed that the patient that showed the adverse reaction to IA consumed 71.8% of it, and 94.1% of C1-INH.
Conclusions
85% dispensations are performed from ODU. There are large differences between patients, due to the variability of number of HAE outbreaks and units of drug used in each outbreak. This is reflected in irregular consumption within the three years of the retrospective study. Due to the easy administration of IA(subcutaneous), there has been an increase in ambulatory use for the outbreaks treatment, while the C1-INH(intravenous) remains the only one indicated for routine prophylaxis and preoperative.
Conflict of interest: Enter Yes or No: NO
Keywords HEREDITARY ANGIOEDEMA;ICATIBANT ACETATE;C1 INHIBITOR CONCENTRATE;
Authors letter ICATIBANT ACETATE and C1 INHIBITOR CONCENTRATE are drugs of high economic impact The Outpatient´s Dispensaton Unit of the Pharmacy Service, due to different HAE outbreaks treatments, differents indications and specific adverse reactions, should have stock of both drugs. A thorougher control of HEREDITARY ANGIOEDEMA patients would provide a better management of their condition
Score: 80 Remarks all reviewers: Gouveia, Antonio Melo: Conclusion warranted Conflict of interest clear Rejected 2.3.9. Reason for reject: ; ; ; prevalence 1-9 per 100 000. Bonnabry, Pascal: Conclusion warranted Conflict of interest clear Rejected 4. Reason for reject: ;
BAR14-0781 Pegloticase in chronic severe tophaceous gout and cardiac comorbidity: a case report Co-authors
E. Santiago Prieto1, A. Sánchez Guerrero1, M. Jiménez Palop2, A. Torralba Arranz1. 1Hospital Universitario Puerta de Hierro, Pharmacy, Madrid, Spain. 2Hospital Universitario Puerta de Hierro, Rheumatology, Madrid, Spain.
Background Pegloticase is a recombinant uricase, indicated for the treatment of severe chronic tophaceous gout. In our country this drug is still not marketed, and so far, only one patient has been treated with it in our hospital. Purpose
To describe the progress of a patient with poorly controlled, chronic gout who was treated with pegloticase, and evaluate the efficacy and safety of this treatment.
Materials and Methods Observational study. We reviewed clinical and analytical data from the patinet´s medical history from August 2012 to April 2013. Results
59-year-old man, with severe tophaceous gout caused by diuretics. Comorbidities: allergy to allopurinol, type 2 diabetes, chronic kidney disease, dilated cardiomyopathy, cardiac cirrhosis, pulmonary hypertension with contraindication for heart transplantation. Previous treatments and causes of discontinuation were: flebuxostat (possible allergic reaction), benzbromanone (lack of effectiveness due to patient´s low renal function), rasburicase (initial effectiveness declined after four treatment cycles). Analytical data prior to infusion of pegloticase were (mg/dl): creatinine: 1.6, uric acid: 13.
One week after infusion, he had an episode of gouty arthritis requiring steroid injections. Six weeks after, analytical data had improved remarkably (mg/dl): creatinine 1.3, uric acid mg/dl. After six months, these parameters have been stabilized (mg/dl): creatinine: 1.3, uric acid: 7.5; without need of new administrations. Due to it effectiveness after the first administration, it was decided to try again flebuxostat, after evaluation of tolerance. This improvement reduced the need of paracentesis and allowed his re-evaluation for heart transplantation.
Conclusions
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Pegloticase has proven to be an effective and safe treatment, reducing uric acid levels significantly and improving the patient´s general condition. The only noteworthy adverse event was a gout flare. This effectively allowed the discontinuation of treatment and its replacement to flebuxostat, an orally drug with greater comfort for the patient, and his re-evaluation for transplantation.
Conflict of interest: Enter Yes or No: No
Keywords pegloticase;gout;comorbidity;
Authors letter Dear Scientific Committee members, We are submitting our abstract entitled "Pegloticase in chronic severe tophaceous gout and cardiac comorbidity: a case report" for consideration for display at the annual EAHP congress. The relevance of the case lies not only in describing the effectiveness of a drug with which we have no previous experience of use, not only from the standpoint of handling the complicated gout, indication for which it is approved, but also in improvement of other comorbidities. We hope the result of this work can help to position this drug in the management of patients with complicated gout with difficult control. This work has not been submitted to any other type of publication. The authors received no financial support for the research and/or authorship of this study. The authors declare that they have no conflict of interest to the publication of this work. Yours sincerely, Elvira Santiago Amelia Sánchez Guerrero Mercedes Jiménez Palop Amalia Torralba Arranz
Score: 80 Remarks all reviewers: Gouveia, Antonio Melo:
Rejected 4.6.10. Reason for reject: ; ; ; only one patient, EMA approved indication Bonnabry, Pascal: Conclusion warranted Conflict of interest clear Rejected 4. Reason for reject: ;
BAR14-0784 Efectiveness and safety of fidaxomicin in a patient with recurrent Clostridium difficile associate diarrhoea Co-authors
B. Leboreiro Enriquez1, A. Perez Landeiro1, K. Lorenzo Lorenzo1, S. Gonzalez Costas1, E.Y. Romero Ventosa1, G. Piñeiro Corrales1. 1Hospital Xeral-Cies (CHUVI), Pharmacy, Vigo, Spain.
Background Fidaxomicin is a recently marketed antibiotic belonging to the macrocyclic class of antibacterials. Fidaxomicin is bactericidal and inhibits RNA synthesis by bacterial RNA polymerase. Is indicated in adults for the treatment of Clostridium difficile infections. The most common adverse reactions associated with fidaxomicin are vomiting, nausea and abdominal pain. Although the usage is still limited, it seems to be a good alternative to conventional treatment in some cases with relapses.
Purpose To evaluate the effectiveness and safety of fidaxomicin for the treatment of an adult patient with recurrent Clostridium difficile associated diarrhea.
Materials and Methods Data was collected from a system that dispenses drugs in unitary doses and from the medical electronic records.
Results The patient had three episodes of diarrhea associated with hospital admission and antimicrobial treatment during the last year, with good response to oral vancomycin and/or oral metronidazole. Clostridium difficile toxin was negative in the two first episodes and positive in the last one. The patient relapsed, worsening with conventional treatment. Then, she was successfully home treated with fidaxomicin with no adverse reactions. In the follow-up time (8 months) the patient had no relapses.
Conclusions The fidaxomicin was effective, both in the acute episode, as in avoiding relapses. The treatment was well tolerated with no significant adverse reactions. In our case fidaxomicin allowed treatment at home, avoiding a new hospital admission. Fidaxomicin seems to be an efective and safety alternative for patients with recurrent Clostridium difficile diarrhea.
Conflict of interest: Enter Yes or No: No
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Keywords Fidaxomicin;Clostridium difficile infection;Efectiviness;
Authors letter Fidaxomicin is under additional monitoring by the EMA. This means that it is being monitored even more intensively than other medicines. Because it is new to the market and there is less information available on it than on other medicines. So, we think that is relevant to comunicate our experience with this new medicine. It may be useful considering that hospital pharmacists are involved in the establishment of use criteria of new drugs in our hospitals.
Score: 80 Remarks all reviewers: Gouveia, Antonio Melo: Conclusion NOT warranted Conflict of interest clear Rejected 2.3.4.10. Reason for reject: ; ; ; ; only one patient, EMA approved indication Bonnabry, Pascal: Conclusion warranted Conflict of interest clear Rejected 4. Reason for reject: ;
BAR14-0788 Adherence to the recommendations of the Pharmacy and Therapeutics Committee and effectiveness of oncology treatments off-label use Co-authors
M. Toscano Guzmán1, M. Galván-Banqueri1, A. Rodríguez-Pérez1, M.I. Sierra-Torres1, J. González-Bueno1, A.M. Villalba-Moreno1. 1Hospital Universitario Virgen del Rocio, Pharmacy, Seville, Spain.
Background
The Pharmacy and Therapeutics Committee (PCT) evaluates the request of off-label uses with report format.
Purpose
To assess the adherence to the PCT recommendations for off-label oncology. To evaluate the effectiveness of off-label cancer drugs.
Materials and Methods
Retrospective observational study of oncology off-label reports requested to the PTC from 2010 to 2012. Demographic variables, tumor stage, performance status of Eastern Cooperative Oncology Group (ECOG) and recommendations of the PTC (approval or alternative therapy) were collected from patient´s medical history. Adherence and effectiveness were evaluated. A report was consider adherent when the final treatment followed the recommendations of the PTC in the proposed drug, dose and duration. Effectiveness was measured during six months according to RECIST criteria (CR: complete response, PR: partial response, SS: stable disease, DP: disease progression and NR: no response).
Results
Twelve patient´s (mean age 48 years old) reports were reviewed. Tumors were all in stage III-IV. The performance status was ECOG 0 in 3 patients, ECOG 1 (8) ECOG 2 (1). The PTC recommendations was to approve 8 and propose an alternative in 4 cases. The global adherence to the recommendations was 83%, being 100% if the final decision was to approve the request. If the PTC recommended an alternative the adherence was 50%. Regarding effectiveness, 17% (2 patients) achieved CR, 42% (5) SS, 33% (4) had DP and 8% (one) NR. The assessment of the effectiveness based on adherence was: -Adherent report: 25% RC (2), 62, 5 %SS (5) and 12,5% DP (1) -Not adherent report: 75% DP (3) and 25% NR(1)
Conclusions
The adherence to the PCT recommendations is high, and full if the the drug requested is finally approved. The evaluation of effectiveness shows that more than half of patients get complete response or stable disease. Being adherent to the recommendations is correlated with better effectiveness.
No conflict of interest
Keywords off-label;oncology;Pharmacy and Terapeutics Committee;
Authors letter
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The evaluation of the request reports of oncology treatments off-label use is a common practice in the routine of the pharmacy and therapeutics commitee activity, so it is necessary to evaluate the grade of adherence to their recommendations To date, it is the first study on adherence to the recommendations made by the pharmacy and therapeutics committee about off-label use of cancer drugs. This abstract can drive an improvement in the adherence to the recommendations due to the fact that the adherence provides more effectiveness
Score: 120 Remarks all reviewers: Gouveia, Antonio Melo: Conclusion NOT warranted Conflict of interest clear Rejected 1.5.8.10. Reason for reject: ; ; ; ; only 12 cases, conclusion is that, when PTC agrees with MD, MD agree with PTC Bonnabry, Pascal: Conclusion NOT warranted Conflict of interest clear Rejected 4. Reason for reject: ;
BAR14-0789 Prevention of hepatic complications in paediatric parenteral nutrition Co-authors
L. Yunquera Romero1, M. Gajardo Alvarez1, R. Tamayo Bermejo1, C. Gallego Fernández1, J. González Chávez1. 1HOSPITAL REGIONAL UNIVERSITARIO CARLOS HAYA, UGC Farmacia, Málaga, Spain.
Background
Total parenteral nutrition (TPN)-induced liver disease develops in 40-60% of infants requiring long-term TPN for intestinal failure. Different actions can be done in order to prevent hepatic failure associated with this kind of nutritional support.
Purpose
To describe, analise and evaluate pharmaceutical care activities held in a paediatric patient with a short bowel syndrome in order to prevent hepatic complications associated with long-term parenteral nutrition.
Materials and Methods Prospective study conducted in a 12 year old patient diagnosed from short bowel syndrome receiving TPN for 166 days. During this period different strategies were held in association with Pediatric Gastroentherology Unit to prevent associated hepatic complications. Every pharmaceutical intervention during this period was registred, clasified and analysed
Results
The management strategies for the prevention of TPN-induced liver disease included restriction of caloric intake with regards to macronutrient proportions to avoid steatosis and early enteral feeding to stimulate remanent intestinal tissue tropism and prevent from alimentary conduct disorders. We chose olive-MCT- soy-fish oil based lipid emulsions which reduces inflammation and fatty infiltration of the liver when compared with LCT based lipid emulsions. We selected a cysteine rich protein solution which has been showed to prevent from liver desease. In order to prevent cholestasis, cyclic (discontinuous) infusion of TPN was prefered as it presents a clear practical advantage over continuous 24-hour infusion in patients receiving long-term PN. Glutamine was also added to the formula as it has an immunomodulatory, anti- inflammatory, antioxidant and protective effect in stressful situations and reduces intestinal atrophy.
Conclusions
All the strategies conducted to prevent TPN-induced liver disease were efficient as liver function was preserved non hepatic complications occurred.
No conflict of interest
Keywords nutrition;parenteral;complications;
Authors letter Clinical Nutrition is one of the skills Hospital Pharmacists must develope in our daily practice. We usually deal with difficult patients suffering from severe pathology without taking into account that providing them with parenteral nutrition support might produce clinical complications by itself. Liver damage has been identified as one of the most prevalent complications related to Parenteral Nutrition Support. In this case report, we gather all the effective known strategies associated with its prevention, as we consider them relevant for any Hospital Pharmacist dedicated to this area.
Score: 80
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Remarks all reviewers: Gouveia, Antonio Melo: Conclusion NOT warranted Conflict of interest clear Rejected 2.4.7.10. Reason for reject: ; ; ; ; one case, good standard practice leads to good results, nothing new Bonnabry, Pascal: Conclusion warranted Conflict of interest clear Rejected 4. Reason for reject: ;
BAR14-0800 EFFICACY AND SAFETY OF INFLIXIMAB IN UVEITIS Co-authors
T. Rico-Gutiérrez1, R. Coloma Peral1, P. Hidalgo-Collazos1, R. Aguilella-Vizcaíno1, M.T. Criado Illana1. 1HOSPITAL GENERAL DE SEGOVIA, Hospital Pharmacy, Segovia, Spain.
Background Alternative treatment for uveitis vascular. Purpose
Evaluate de efficacy and safety of infliximab in uveitis.
Materials and Methods
Case description: 24 year old woman, diagnosed in 2006 of etiology idiopathic retinal vasculitis in both eyes, mainly periphlebitis, treatment with oral corticosteroids and methotrexate weekly, dose based varibales according to evolution. The patient developed uveitis in both eyes which remains controlled with treatment until March 2007 that changed to cyclosporine. There was a significant improvement without achieving control symptoms vasculitis. Due to the deterioration in renal function by cyclosporine treatment was started in October 2007 with infliximab 5 mg / kg in basal tone, at 2 and 4 weeks and then every 6-8 weeks depending on the response. The parameters evaluated were: intraocular pressure (IOP), visual acuity and glasses hemorrhagic activity.
Results
Were administered 6 infliximab cycles that controled the uveitis and achieved inactive retinal vasculitis. The mean IOP in both eyes was 13.7 mmHg, 18 mmHg at baseline to 12 mmHg after 6 cycles. Visual acuity remained value of 1 during treatment without observing eye in no Tyndall effect, whereas the activity observed in vascular fundus and bleeding decreased with each cycle until inactive vascular lesions, so the treatment was discontinued. During these six months remained oral methotrexate at the same dose but decreased oral prednisone dose from 30 mg to 5 mg. Subsequently, the patient was maintained on oral immunosuppressive presenting a relapse 6 months after stopping treatment with infliximab, so it was decided to restart this treatment every 8 weeks. In a marked improvement in the patient, treatment administration spaced every 9 weeks. Visual acuity was maintained throughout the treatment, the mean IOP was 11.5 mmHg having little variability in each of the measures. However, vascular activity fluctuated in both eyes after each treatment cycle.
Infectious complications were the main side effects that the patient presented. Because molluscum contagiosum infection and bacterial tonsillitis, it was necessary to delay the housing management of two cycles of infliximab. Currently, there has been a reduction of infliximab efficacy due to a possible development of autoantibodies.
Conclusions
Infliximab use is safe and effective for the treatment of uveitis, as described in the literature. The short-term improvement was evident, however, the long-term efficacy can be influenced by the possible development of antibodies to infliximab.
No conflict of interest
Keywords Uveitis;Infliximab;Efficacy;
Authors letter There is a diversity of treatment for uveitis, but, when a patient doesn´t tolerate what is usual, which options can we offer? Is there efficacy and safety with them?
Score: 80 Remarks all reviewers: Gouveia, Antonio Melo: Conclusion warranted Conflict of interest clear Rejected 4. Reason for reject: ; one case, from 2007 (up to now?). Described in literature.
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Bonnabry, Pascal: Conclusion warranted Conflict of interest clear Rejected 4. Reason for reject: ;
BAR14-0806 Off label uses for peginterferon a-2a in a third level Hospital Co-authors
S. Ruiz-Fuentes1, S. Belda-Rustarazo1, C. Medarde-Caballero1, C. Fernández-López1, C. García- Fernández1, C. Gómez-Peña1, A. Caballero-Romero1, D. Blánquez-Martínez1, L. González- García1, V. Molina-García1. 1Hospital Universitario San Cecilio, Pharmacy, Granada, Spain.
Background
In spite of the indications for peginterferon α-2a are chronic hepatitis C and B, among the last two years it has been requested to the pharmacy service five times for different uses.
Purpose
To know some off label uses for peginterferon α-2a and find out whether they have been effective.
Materials and Methods
The off label uses requested were: polycythaemia vera for 3 patients, Ergheim-Chester disease for 1 patient and essential thrombocythemia for 1 patient. After studying them carefully, reviewing the evidences in the main sources of clinical and scientific information (Uptodate®, Pubmed® and Medline®) they were all authorized as long as the results were regularly reported and they were satisfactory.
Results
For polycythaemia vera, both patients treated showed complete hematologic and molecular responses with low toxicity. The response started before the fourth month in the two patients. So far they have been treated for 9 and 15 months and continue with it.
For Erdheim-Chester disease, the patient has been on peginterferon α-2a for 8 months having a partial response. The dermatological symptoms have improve whereas the neurological and cardiac ones have not.
The essencial thrombocythemia patient has showed a complete response from the seventh week. The patient is currently in his fourth month of treatment.
Conclusions
Our short experience (just 5 patients) supports what bibliography suggest: peginterferon α-2a seems to be a good alternative for patients suffering from polycythaemia vera, Erdheim-Chester disease and essencial thrombocythemia when the indicated treatments to treat them are not effective. Nevertheless, further studies must be performed to confirm this findings.
No conflict of interest
Keywords peginterferon;polycythaemia vera;thrombocythemia;
Authors letter Polycythaemia vera, Erdheim-Chester disease and essencial thrombocythemia are really serious illness which some times do not respond to their indicated treatments. That is why is so hopeful to know an alternative like peginterferon a-2a which has shown to be effective in many studies and in our experience.
Score: 100 Remarks all reviewers: Gouveia, Antonio Melo: Conclusion warranted Conflict of interest clear Rejected 2.4. Reason for reject: ; ; number of patients is too low to add to a relevant series, results already in literature. Bonnabry, Pascal: Conclusion warranted Conflict of interest clear Rejected 4. Reason for reject: ;
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BAR14-0817 Vandetanib in the medullary thyroid cancer Co-authors
T. Pérez Robles1, E. Rodriguez Martín1, L. González Del Valle1, M. De Sebastian Rueda1, T. Roldán Sevilla1, M. Ruiz de Hoyos1, C. Rueda Pérez1, H.A. Varela Fernández1, M. Bravo Lázaro1, A. Herrero Ambrosio1. 1Hospital Universitario La Paz, Pharmacy, Madrid, Spain.
Background Vandetanib is the first tyrosine kinase inhibitor approved in Europe for medullary thyroid cancer (MTC) aggressive and symptomatic in patients with unresectable locally advanced or metastatic disease.
Purpose To evaluate the effectiveness and safety of vandetanib for the treatment of patients with MTC in a tertiary hospital.
Materials and Methods Observational, descriptive and retrospective study that included all patients treated with vandetanib until April 2013. The following data were collected: sex, age, stage of disease, previous treatment received, presence of mutation in the RET proto-oncogene, dose and duration of treatment with vandetanib. The effectiveness was classified as treatment partial response, complete response or disease stabilization . The biochemical parameters such as the calcitonin levels and the presence of the carcinoembryonic antigen (CEA) were also collected. To evaluate the safety, all adverse effects related to the drug were recorded.
Results Three patients with a median age of 49 years were included in the study. Two patients received sunitinib prior to the study. The RET mutation was negative in one patient and unknown in two of them. One patient discontinued the treatment with vandetanib after two months due to lack of tolerance. The other two patients are currently under treatment with vandetanib and achieved stable disease status after 23 and 24 months respectively . Both of them showed a decrease in the biochemical parameters and the most common adverse events observed were gastrointestinal disorders, skin problems, mild infections and asthenia. None of patients showed a QTc interval prolongation in the ECG.
Conclusions Vandetanib is an alternative drug in patients with MTC. However, futher data are required to evaluate safety the effectiveness and in a long-term
No conflict of interest
Keywords vandetanib;thyroid;cancer;
Authors letter Vandetanib is the first treatment approved in Europe for medullary thyroid cancer aggressive and symptomatic patients with unresectable locally advanced or metastatic disease. It is a tyrosine kinase inhibitor that employs several mechanisms action: blocking the receptor for vascular endothelial growth factor receptor, epidermal growth factor and also acts on the proto-oncogene RET. Studies are needed to evaluate the effectiveness and safety of this new drug in routine clinical practice
Score: 160 Remarks all reviewers: Gouveia, Antonio Melo: Conclusion warranted Conflict of interest clear Rejected 4. Reason for reject: ; only 3 patients for a drug approved by EMA, no comparison with clinical trial data Bonnabry, Pascal: Conclusion warranted Conflict of interest clear Rejected 4. Reason for reject: ;
BAR14-0836 Description of annual incidence of neoplasms in intravenous therapy Co-authors
M. Candela1, E. Blanquer1, A. Burgos1, M.L. Boquera1, G. Riera1, J. Selva1. 1HOSPITAL GENERAL UNIVERSITARIO DE ALICANTE, Pharmacy, Alicante, Spain.
Background
In the area of oncology in pharmacy services daily are validated a high number of treatments and we want study the distribution of type of cancer in our new patients.
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Purpose
To estimate the percentage of diagnoses of patients that start with intravenous antineoplastic treatment in 2012 in a tertiary referral hospital.
Materials and Methods Retrospective observational study of diagnoses associated to patients who iniciated intravenous therapy, validated and prepared by pharmacy service in 2012. To obtain the data we used Oncofarm ® software application (version 2009.0.52.2) and a manual register developed in the pharmacy. Results
The total number of patients who started treatment in 2012 was 557 (529 adults, 26 children). Children 's diagnoses were acute lymphoblastic leukemia ( 5, 19.2 % ) , Wilms tumor or nephroblastoma ( 4 , 15.4 % ), Ewing´s sarcoma ( 3, 11.5 % ) , neuroblastoma ( 3, 11.5 % ) , central nervous system tumors ( 3, 11.5% ) , osteosarcoma (2 , 7.7 % ) , Hodgkin´s lymphoma ( 2 , 7.7 % ) , non-Hodgkin lymphoma (1 , 3.8 %) , retinoblastoma ( 1, 3.8%), hepatoblastoma ( 1, 3.8%), hemophagocytic syndrome (1, 3.8%). In adult population, the distribution of diagnoses was: lung ( 109, 20.6 % ), breast ( 99, 18.7 % ) , colorectal ( 75, 14.2%) , lymphoma ( 50, 9,4 % ) , leukemia ( 39, 7.4 % ) , gynecologic tumors ( 30, 5,7 % ), stomach ( 25, 4.7%) , pancreas (18, 3.4 % ) , otorhinolaryngology ( 16, 3% ) , multiple myeloma ( 15, 2.8 % ) , bladder ( 12, 2.3 % ) , testicular ( 7, 1.3 % ) , prostate (5, 0.9 %), melanoma (5, 0.9 % ) , glioblastoma (4, 0.7 %) , sarcomas (4, 0.7 %) , myelodysplastic syndrome (4, 0.7 %) , metastases of unknown origin ( 3, 0.5%), esophagus (2, 0.4%) , thymoma (2, 0.4%) , biliary tract (2, 0.4%) , neuroendocrine (2, 0.4%) , kidney (1, 0.2%).
Conclusions
The percentage of pediatric hematologic and solid tumors in our center ( 64 % , 36% ) is similar as described in most studies .
No conflict of interest
Keywords neoplasm;intravenous therapy;tumor;
Authors letter When we made this study we observed the high number of patients and we account that is required a high degree of dedication and expertise by pharmacists.
Score: 80 Remarks all reviewers: Gouveia, Antonio Melo: Conclusion NOT warranted Conflict of interest clear Rejected 2.3.5.6.9. Reason for reject: ; ; ; ; ; it is understable, but barely, and clearly not useful. Bonnabry, Pascal: Conclusion warranted Conflict of interest clear Rejected 2. Reason for reject: ;
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