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Page 1 of 32 Scores: 4/11/2013 Scores: Page 1 of 32 ABSTRACT REVIEW Close window Print 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 http://events.eahp.eu/cm.net.webui/cm.net.webui.AS/AScoringAbstract.aspx?confID=0... 4/11/2013 Scores: Page 2 of 32 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 http://events.eahp.eu/cm.net.webui/cm.net.webui.AS/AScoringAbstract.aspx?confID=0... 4/11/2013 Scores: Page 3 of 32 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.
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