DOCSLIB.ORG

Thiotepa, Busulfan and Cyclophosphamide As a Preparative Regimen for Allogeneic Transplantation for Advanced Chronic Myelogenous Leukemia

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Thiotepa, Busulfan and Cyclophosphamide As a Preparative Regimen for Allogeneic Transplantation for Advanced Chronic Myelogenous Leukemia Bone Marrow Transplantation, (1999) 23, 977–981 1999 Stockton Press All rights reserved 0268–3369/99 $12.00 http://www.stockton-press.co.uk/bmt Thiotepa, busulfan and cyclophosphamide as a preparative regimen for allogeneic transplantation for advanced chronic myelogenous leukemia D Przepiorka1, I Khouri1, P Thall2, R Mehra1, M-S Lee3, C Ippoliti1, S Giralt1, J Gajewski1, K van Besien1, B Andersson1,MKo¨rbling1, AB Deisseroth1 and R Champlin1 Departments of 1Blood and Marrow Transplantation, 2Biomathematics and 3Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA Summary: blast crisis and 15–40% for transplantation in accelerated or second chronic phase.1–7 Busulfan-based preparative Thirty-six adults with chronic myelogenous leukemia regimens have been favored by some for CML as a result (CML) in second or greater chronic phase, accelerated of the potent anti-myeloid activity and ease of adminis- phase, or blast crisis underwent marrow or blood stem tration of busulfan, and results with the busulfan–cyclopho- cell transplantation from an HLA-matched sibling using sphamide regimen are similar to those achieved with cyclo- high-dose thiotepa, busulfan and cyclophosphamide phosphamide and total body irradiation for patients with (TBC) as the preparative regimen. All evaluable advanced CML.8 N,NЈ,NЈ-triethylenethiophosphoramide patients engrafted and had complete donor chimerism. (thiotepa) is a highly myelosuppressive alkylating agent One patient failed to clear meningeal leukemia, and one that lacks overlapping toxicities with busulfan or cyclopho- patient had one of 30 metaphases positive for the Phila- sphamide.9 We evaluated the combination of thiotepa with delphia chromosome at 2 months post transplant. The busulfan and cyclophosphamide as a preparative regimen remainder of the patients studied had eradication of to determine if addition of a third alkylating agent would CML documented by cytogenetics and/or Southern blot improve outcome without increased toxicity. The maximal for BCR gene rearrangement, and 13 of 15 patients tolerated dose of this combination was previously identified studied became negative for the BCR gene rearrange- in a phase I study.10 Here we report the results using this ment by polymerase chain reaction. Three-year relapse novel regimen for transplantation of patients with advanced rate is 42% (95% CI, 19–64%). The relapse rate was CML from HLA-identical donors. significantly lower for patients transplanted without blast crisis (9% vs 100%, P Ͻ 0.001). Eight (22%, 95% CI, 10–39%) patients had severe or fatal veno-occlusive Materials and methods disease (VOD). Elevated liver enzymes within 1 month prior to transplantation and transplantation using mar- Eligibility criteria row were significantly associated with the occurrence of VOD. Three-year survival is 28% (95% CI, 13–43%). From May 1991 to January 1996, patients with CML past Survival was significantly higher for patients trans- first chronic phase having a t(9;22) documented by cyto- planted without blast crisis (45% vs 0%, P = 0.01). TBC genetics or Southern blot for rearrangement of the BCR is an effective preparative regimen for CML in acceler- gene were eligible for treatment on consecutive phase I– ated phase but not refractory blast crisis, and it should II studies of thiotepa, busulfan and cyclophosphamide as be used with caution in patients with prior hepatopathy preparative regimen. Other requirements included age 15– who have an increased risk of severe VOD. 55 years, Zubrod performance status 0–2, adequate organ Keywords: allogeneic bone marrow transplantation; function, and an HLA-matched related donor.10,11 Protocols chronic myelogenous leukemia; thiotepa; busulfan were approved by the institutional review board of the MD Anderson Cancer Center, and written informed consent was obtained from all patients and donors. Advanced phase of disease is a strong predictor of poor outcome after HLA-identical marrow transplantation for Treatment 1 chronic myelogenous leukemia (CML). Long-term sur- The preparative regimen consisted of thiotepa 150– vival is reported to be 0–25% for patients transplanted in 250 mg/m2/day i.v. on days Ϫ9, Ϫ8 and Ϫ7, busulfan 1 mg/kg orally every 6 h on days Ϫ6, Ϫ5 and Ϫ4 (for a total of 12 doses), and cyclophosphamide 60 mg/kg/day i.v. on Correspondence: Dr D Przepiorka, Baylor College of Medicine, Center Ϫ Ϫ for Cell and Gene Therapy, 1102 Bates St, Suite 1100, Houston, TX days 3 and 2 (TBC) with precautions and dose adjust- 10,11 77030, USA ments as described previously. Marrow or blood stem Received 15 July 1998; accepted 19 December 1998 cells were collected as reported,10,11 and T cell depletion TBC for advanced CML D Przepiorka et al 978 was not used. Graft-versus-host disease (GVHD) prophy- intervals for proportions were based on the binomial laxis consisted of tacrolimus (FK506) or cyclosporine distribution. (CsA) with methylprednisolone, methotrexate, or immuno- toxin.10,11 Standard post-transplant care was provided. Thirty-four patients received filgrastim post transplant to Results accelerate neutrophil recovery. Patient characteristics Monitoring post transplant Thirty-six adults were transplanted (Table 1). Twenty had clinical signs of accelerated disease, two were in у2nd Patients were reviewed by one of the study collaborators chronic phase, five were in lymphoid blast crisis, and nine at least weekly to day 100 and less frequently thereafter. were in myeloid blast crisis. Thirteen of 15 patients treated Regimen-related toxicity was scored using the system of with induction chemotherapy were refractory, and two had Bearman et al12 except that death occurring after day 28 relapsed after allogeneic transplantation using a TBI-based due to regimen-related toxicity was still considered grade preparative regimen. 4. Monitoring for idiopathic interstitial pneumonitis, hemorrhagic cystitis and VOD continued to day 100. GVHD was graded according to the consensus criteria.13 Engraftment and GVHD Marrow biopsies and aspirates were examined at 1, 3, 6, All patients who survived at least 28 days engrafted. The 12, 18 and 24 months after transplantation and annually neutrophil count exceeded 0.5 × 109/l and 1.0 × 109/l at a thereafter. Hematopoietic chimerism was evaluated by median of 10 (range, 8–24) days and 11 (range, 9–27) days restriction fragment length polymorphisms (RFLP). post transplant, respectively. The platelet count exceeded Residual disease was evaluated by conventional cytogen- 20 × 109/l and 50 × 109/l at a median of 19 (9–100+) days etics, Southern blot hybridization for a BCR gene and 24 (10–100+) days post transplant, respectively. Com- rearrangement, and, in some cases, by polymerase chain plete chimerism was found by RFLP analysis in 17 of 20 reaction (PCR) for the bcr-abl transcript.14 patients tested. One patient had mixed chimerism transi- Definitions Table 1 Patient and donor characteristics The criteria for blast crisis were у30% blasts in the marrow or blood, or any extramedullary collections of blasts, and Number of patients 36 the criteria for accelerated phase included у10% blasts in Median age 44 years (range) (20–55 years) marrow or blood; Ն20% basophils and eosinophils in mar- Patient sex row or blood; cytopenia unrelated to therapy; and leuko- Male/female 21/15 cytosis, thrombocytosis, adenopathy, splenomegaly or bone Disease status pain unresponsive to therapy. Patients with cytogenetic CP у 2, AP/BC 22/14 clonal evolution and no clinical evidence of accelerated Cytogenetics phase were not eligible for these protocols. Neutrophil High risk/Standard risk 16/20 recovery was defined as the first of 3 consecutive days that Prior treatment the absolute neutrophil count exceeded the target value, and Busulfan 6 platelet recovery was defined as the day that the platelet Hydroxyurea 28 count exceeded the target value with no platelet trans- Interferon 13 Interferon + other 11 fusions the following week. After transplantation, obser- Homoharringtonine 6 vation of the Philadelphia chromosome in two or more con- Induction chemotherapy 15 secutive studies without abnormalities in the blood counts Allogeneic transplantation 2 was considered a cytogenetic relapse. A white blood cell Resistant to therapy 12 9 count greater than 10 × 10 /l with cytogenetic or molecular Thiotepa dose level evidence of the Philadelphia chromosome but less than 5% 150 mg/m2 day 3 blasts and no extramedullary disease was considered a hem- 200 mg/m2 day 4 2 atologic relapse in chronic phase. High-risk cytogenetics 250 mg/m day 29 include variant Ph, double Ph, +8, and 3p abnormalities.15 Transplant Marrow/Blood stem cells 22/14 GVHD prophylaxis Statistical analyses Tacrolimus-based 8 Cyclosporine-based 28 At time of analysis, median time from transplantation for Median donor age 44 years all patients was 4.8 years (range, 2.4–7.1 years). Minimum (range) (14–65 years) follow-up for survivors was 3 years. Categorical data were Donor sex compared using the Fisher exact test. The actuarial risks Male/Female 20/16 of GVHD, relapse, survival and treatment-related mortality Patient–donor pair sex-mismatched 11 were estimated according to Kaplan and Meier, and the Patient–donor pair CMV-seronegative 0 logrank test was used to make comparisons. Confidence TBC for advanced CML D Przepiorka et al 979 ently at 3 months post transplant and remains in remission 42% (95% CI, 19–64%), and there were no cytogenetic 40 months post transplant, and two patients had mixed relapses without clinical evidence of recurrence. The risk chimerism within 3 months prior to hematologic relapse. of relapse correlated with phase of disease but not with type Grades 2–4 GVHD occurred in 49% (95%CI, 31–67%), of transplant, age or cytogenetic risk group (Table 3). and grades 3–4 GVHD in 21% (95% CI, 7–35%). Seventy- five percent of the patients survived at least 100 days, and Survival the incidence of chronic GVHD in these patients was 83% (95% CI, 63–100%).
Load more

Recommended publications
  • ASHP Guidelines on Handling Hazardous Drugs
    132 Drug Distribution and Control: Preparation and Handling–Guidelines ASHP Guidelines on Handling Hazardous Drugs ASHP published its first guidance on hazardous drugs (HDs) Because newer studies have shown that contamination in 1983 as part of the 1983–84 ASHP Practice Spotlight: Safe is widespread in healthcare settings and that more workers Handling of Cytotoxic Drugs.1,2 This was followed by tech- than previously thought are exposed, these guidelines should nical assistance bulletins in 1985 and 1990 and the ASHP be implemented wherever HDs are received, stored, pre- Guidelines on Handling Hazardous Drugs in 2006.3-5 The pared, transported, administered, or disposed.8-11 2006 guidelines were created to harmonize with the National Comprehensive reviews of the literature covering an- Institute for Occupational Safety and Health (NIOSH) Alert: ecdotal and case reports of surface contamination, worker ex- 6,9,12 Preventing Occupational Exposure to Antineoplastic and posure, and risk assessment are available from NIOSH, Other Hazardous Drugs in Health Care Settings issued in the Occupational Safety and Health Administration 13,14 15-20 2004.6 The ASHP 2006 HD guidelines were current to 2005. (OSHA), and individual authors. The primary goal In 2007, the United States Pharmacopeial Convention of this document is to provide recommendations for the safe revised United States Pharmacopeia (USP) chapter 797 handling of HDs. These guidelines represent the research (Pharmaceutical Compounding—Sterile Preparations)7 to and recommendations of many groups and individuals who harmonize with the NIOSH 2004 Alert. It became effective have worked tirelessly over decades to reduce the potential May 1, 2008, establishing many of the NIOSH recommenda harmful effects of HDs on healthcare workers.
    [Show full text]
  • NOV 1 72010 1.0 Submitter
    510(k) SUMMARY NOV 1 72010 1.0 Submitter Name Shen Wei (USA) Inc. Street Address 33278 Central Ave., Suite 102 Union City, CA. 94587 Phone No. (510)429-8692 Fax No. (510)487-5347 Date of Summary Prepared: 08/12/10 Prepared by: Albert Li 2.0 Name of the device: Glove Proprietary or Trade Name: Blue and Red with Pearlescent® Pigment, Powder Free Nitrile Examination Gloves with Aloe Vera, Tested for use with Chemotherapy Drugs Common Name: Exam gloves Classification Name: Patient examination glove, Specialty Chemotherapy'(per 21 CFR 880.6250 product code LZC) Classification Information: Class I Nitrile patient examination glove 8OLZC, powder-free and meeting all the requirements of ASTM D 631 9-O0a-05 and is tested with chemotherapy drugs according to ASTM D 6978-05. 3.0 Identification of the Legally Marketed Device: Blue and Red with Pearlescent® Pigment, Powder Free Nitrile Examination Gloves with Aloe Vera Regulatory Class I Nitrile patient examination Product code: 8OLZA 5 10(k): K092411 4.0 Description of the Device: Blue and Red with Pearlescent® Pigment, Powder Free Nitrite Examination Gloves with Aloe Vera, Tested for use with Chemotherapy Drugs meets all the requirements of ASTM D 6978-05, ASTM D63 19-00a(2005) and FDA 21 CFT 880.6250. 5.0 Intended Use of Device: Product: Red with Pearlescent® Pigment, Powder Free Nitrile Examination Gloves with Aloe Vera, Tested for use with Chemotherapy Drugs A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only.
    [Show full text]
  • Wear the Battle Gear That Protects Against 52 Chemotherapy Drugs!
    YOU’RE FIGHTING CANCER. Wear the Battle Gear That Protects Against 52 Chemotherapy Drugs! PURPLE NITRILE-XTRA* Gloves and HALYARD* Procedure Gowns for Chemotherapy Use have been tested It’s 52 vs. You. for resistance to 52 chemotherapy drugs.† Arsenic Trioxide (1 mg/ml) Cyclophosphamide (20 mg/ml) Fludarabine (25 mg/ml) Mitomycin (0.5 mg/ml) Temsirolimus (25 mg/ml) Azacitidine (Vidaza) (25 mg/ml) Cytarabine HCl (100 mg/ml) Fluorouracil (50 mg/ml) Mitoxantrone (2 mg/ml) Trastuzumab (21 mg/ml) Bendamustine (5 mg/ml) Cytovene (10 mg/ml) Fulvestrant (50 mg/ml) Oxaliplatin (2 mg/ml) ThioTEPA (10 mg/ml) Bleomycin Sulfate (15 mg/ml) Dacarbazine (10 mg/ml) Gemcitabine (38 mg/ml) Paclitaxel (6 mg/ml) Topotecan HCl (1 mg/ml) Bortezomib (Velcade) (1 mg/ml) Daunorubicin HCl (5 mg/ml) Idarubicin (1 mg/ml) Paraplatin (10 mg/ml) Triclosan (1 mg/ml) Busulfan (6 mg/ml) Decitabine (5 mg/ml) Ifosfamide (50 mg/ml) Pemetrexed (25 mg/ml) Trisenox (0.1 mg/ml) Carboplatin (10 mg/ml) Docetaxel (10 mg/ml) Irinotecan (20 mg/ml) Pertuzumab (30 mg/ml) Vincrinstine Sulfate (1 mg/ml) Carfilzomib (2 mg/ml) Doxorubicin HCl (2 mg/ml) Mechlorethamine HCl (1 mg/ml) Raltitrexed (0.5 mg/ml) Vinblastine (1 mg/ml) Carmustine (3.3 mg/ml)† Ellence (2 mg/ml) Melphalan (5 mg/ml) Retrovir (10 mg/ml) Vinorelbine (10 mg/ml) Cetuximab (Erbitux) (2 mg/ml) Eribulin Mesylate (0.5 mg/ml) Methotrexate (25 mg/ml) Rituximab (10 mg/ml) Zoledronic Acid (0.8 mg/ml) Cisplatin (1 mg/ml) Etoposide (20 mg/ml) † Testing measured no breakthrough at the Standard Breakthrough Rate of 0.1ug/cm2/minute, up to 240 minutes for gloves and 480 minutes for gowns, except for carmustine.
    [Show full text]
  • 1 Contents of Online Supporting Information Etable 1. Study
    Contents of Online Supporting Information eTable 1. Study characteristics for trials of intravesical therapy vs. TURBT alone eTable 2. Study characteristics of head to head trials of intravesical therapy eTable 3. Study characteristics of trials comparing dose or duration of a single drug eTable 4. Summary of the evidence eFigure 1. Literature flow diagram eFigure 2. Meta-analysis of doxorubicin versus no intravesical therapy: Risk of recurrence eFigure 3. Meta-analysis of epirubicin versus no intravesical therapy: Risk of recurrence References for the Supplement 1 eTable 1. Study characteristics for trials of intravesical therapy vs. TURBT alone Author, Year Risk of Bias Inclusion Criteria Population Characteristics Intervention Followup Duration Abrams, 19811 Histologically confirmed All characteristics reported for A: Doxorubicin, 50 mg (in 50 6 months for all patients. High superficial bladder tumor; all randomized patients, not mL saline). Single instillation, Recurrent only, with presence the groups analyzed: within 24 hours of TURBT of tumors at both of two Age, mean (years): 72 vs. 68 (n=30). previous endoscopies 12 Male: 70% vs. 79% months and 6 months before Recurrent bladder cancer: B: No adjuvant treatment. entry into trial; Stages Ta or 100% vs. 100% TURBT alone (n=30). T1; Included grades not Ta: 73% vs. 77% specified, but "well" and T1: 27% vs. 23%; "moderate" differentiation included. Akaza, 19872 Histologically proven Age, mean (years): 62.3 vs. A: Doxorubicin, 30 mg (in 30 Maximum (years): 5; Not [Study One] superficial bladder cancer 62.9 vs. 62.9 vs. 62.9 mL saline). Total 8 instillations: reported as median/mean, nor (followup of Niijima, (primary or recurrent).
    [Show full text]
  • The Cost Burden of Blood Cancer Care a Longitudinal Analysis of Commercially Insured Patients Diagnosed with Blood Cancer
    MILLIMAN RESEARCH REPORT The cost burden of blood cancer care A longitudinal analysis of commercially insured patients diagnosed with blood cancer October 2018 Gabriela Dieguez, FSA, MAAA Christine Ferro, CHFP David Rotter, PhD Commissioned by The Leukemia & Lymphoma Society Table of Contents EXECUTIVE SUMMARY ............................................................................................................................................... 2 BACKGROUND ............................................................................................................................................................. 1 FINDINGS ...................................................................................................................................................................... 2 PREVALENCE AND COST OF BLOOD CANCER BY AGE GROUP ....................................................................... 2 INCIDENCE OF BLOOD CANCER ........................................................................................................................... 4 BLOOD CANCER CARE SPENDING FOLLOWING INITIAL DIAGNOSIS ............................................................... 5 PATIENT OUT-OF-POCKET COSTS FOLLOWING A BLOOD CANCER DIAGNOSIS ........................................... 9 The impact of insurance plan design on patient OOP costs .......................................................................... 10 CONSIDERATIONS FOR PAYERS ...........................................................................................................................
    [Show full text]
  • Thiotepa Stable in Light and in Acidic Solution, but Stable in Alkaline Solutions (IARC 1990)
    Report on Carcinogens, Fourteenth Edition For Table of Contents, see home page: http://ntp.niehs.nih.gov/go/roc Thiotepa stable in light and in acidic solution, but stable in alkaline solutions (IARC 1990). Physical and chemical properties of thiotepa are listed CAS No. 52-24-4 in the following table. Known to be a human carcinogen Property Information a First listed in the Second Annual Report on Carcinogens (1981) Molecular weight 189.2 Melting point 51.5°Ca Also known as tris(1-aziridinyl)phosphine sulfide b Log Kow 0.53 Water solubility 190 g/L at 25°Cb Vapor pressure 0.00845 mm Hg at 25°Cb N Sources: aHSDB 2009, bChemIDplus 2009. NNP Use S Carcinogenicity Thiotepa suppresses cell growth and division and was introduced in 1953 for use in cancer chemotherapy to treat lymphoma and a vari- Thiotepa is known to be a human carcinogen based on sufficient ev- ety of solid and soft-tissue tumors. It was commonly used in cancer idence from studies in humans. Thiotepa was first listed in the Sec- therapy until the early 1970s (only 3 kg of thiotepa was used in 1973). ond Annual Report on Carcinogens in 1981 as reasonably anticipated Although thiotepa has largely been replaced by the nitrogen mustards, to be a human carcinogen based on sufficient evidence of carcinoge- it still has specific uses, particularly as a component of experimen- nicity from studies in experimental animals and insufficient evidence tal high-dose chemotherapy regimens. Thiotepa was most effective of carcinogenicity from studies in humans. Thiotepa was reclassified in treating adenocarcinoma of the breast, ovary, and bladder, malig- as known to be a human carcinogen in the Eighth Report on Carcin- nant lymphoma, bronchogenic carcinoma, and Wilms tumor.
    [Show full text]
  • All-Trans Retinoic Acid and Arsenic Trioxide Resistance of Acute Promyelocytic Leukemia with the Variant STAT5B-RARA Fusion Gene
    Letters to the Editor 1606 leukemia mouse model. This effect was proposed to be due, at REFERENCES least in part, to inhibition of FBXW7, a negative regulator of Notch 1 Ferrando AA, Neuberg DS, Staunton J, Loh ML, Huard C, Raimondi SC et al. Gene 8 signaling. However, FBXW7 targets the degradation of other expression signatures define novel oncogenic pathways in T cell acute lympho- oncogenic proteins, such as c-Myc and mTOR, and the expression blastic leukemia. Cancer Cell 2002; 1: 75–87. of miR-223 is significantly elevated in TAL1-positive T-ALL cases 2 Cardoso BA, de Almeida SF, Laranjeira AB, Carmo-Fonseca M, Yunes JA, (Supplementary Figure 2), suggesting that the oncogenic function Coffer PJ et al. TAL1/SCL is downregulated upon histone deacetylase of this microRNA may extend beyond mere collaboration in Notch- inhibition in T-cell acute lymphoblastic leukemia cells. Leukemia 2011; 25: induced leukemia. Moreover, the proleukemic role of mir-223 may 1578–1586. 3 O’Neil J, Shank J, Cusson N, Murre C, Kelliher M. TAL1/SCL induces leukemia be also achieved by downregulating targets such as E2F1, FOXO1, by inhibiting the transcriptional activity of E47/HEB. Cancer Cell 2004; 5: RHOB or EPB41L3, which have been associated with induction of 587–596. apoptosis and/or have tumor-suppressive roles (Supplementary 4 Sanda T, Lawton LN, Barrasa MI, Fan ZP, Kohlhammer H, Gutierrez A et al. Table 5). Interestingly, the intriguing possibility that miR-223 may Core transcriptional regulatory circuit controlled by the TAL1 complex potentially act downstream of TAL1 to negatively regulate MEF2C, in human T cell acute lymphoblastic leukemia.
    [Show full text]
  • Systematic Review and Individual Patient Data Meta-Analysis Of
    EUROPEAN UROLOGY 69 (2016) 231–244 available at www.sciencedirect.com journal homepage: www.europeanurology.com Platinum Priority – Guidelines Editorial by J. Alfred Witjes on pp. 245–246 of this issue Systematic Review and Individual Patient Data Meta-analysis of Randomized Trials Comparing a Single Immediate Instillation of Chemotherapy After Transurethral Resection with Transurethral Resection Alone in Patients with Stage pTa–pT1 Urothelial Carcinoma of the Bladder: Which Patients Benefit from the Instillation? Richard J. Sylvester a,*, Willem Oosterlinck b, Sten Holmang c, Matthew R. Sydes d, Alison Birtle e, Sigurdur Gudjonsson f, Cosimo De Nunzio g, Kikuo Okamura h, Eero Kaasinen i, Eduardo Solsona j, Bedeir Ali-El-Dein k, Can Ali Tatar l, Brant A. Inman m, James N’Dow n, Jorg R. Oddens o, Marek Babjuk p a EORTC Headquarters, Department of Biostatistics, Brussels, Belgium; b Ghent University Hospital, Department of Urology, Ghent, Belgium; c University of Gothenburg, Department of Urology, Gothenburg, Sweden; d Medical Research Council Clinical Trials Unit at University College London, Department of Cancer and Other Non-Infectious Diseases, London, UK; e Royal Preston Hospital, Rosemere Cancer Centre, Preston, UK; f Skane University Hospital, Department of Urology, Malmo, Sweden; g Ospedale Sant’Andrea, University ‘‘La Sapienza,’’ Department of Urology, Rome, Italy; h Higashi Nagoya Hospital, Department of Urology, Nagoya, Japan; i Hyvinkaa Hospital, Department of Urology, Hyvinkaa, Finland; j Valencia Oncology Institute, Department
    [Show full text]
  • North Carolina Medicaid Division of Health Benefits Abbreviated
    North Carolina Medicaid Division of Health Benefits Abbreviated Physician Administered Drug Program Catalog •Unless otherwise indicated, the catalog contains procedure codes representing drugs, biologics, devices and vaccines which are only covered for FDA approved indications. •11 digit National Drug Codes (NDCs) are required to be billed along with their corresponding procedure code. Drugs and biologics must be classified as CMS covered outpatient drugs from a labeler/manufacturer participating in the Medicaid Drug Rebate Program (MDRP). •Procedure codes for covered devices and vaccines are not required to be from a rebating labeler/manufacturer as they are not classified as covered outpatient drugs. HCPCS HCPCS Code Description Brand Name Generic Name Code 90291 Cytomegalovirus immune globulin (CMV-IgIV), human, for intravenous use Cytogam® cytomegalovirus immune globulin intravenous, human 90371 Hepatitis B Immune Globulin (Hbig), human, for intramuscular use HyperHep, Nabi-HB hepatitis b immune globulin (human) rabies immune globulin, (human) treated with solvent/detergent, for infiltration and intramuscular 90375 Rabies Immune Globulin (RIg), human, for intramuscular and/or subcutaneous use HyperRAB® S/D, HyperRAB® administration rabies immune globulin, (human) solution for infiltration and intramuscular injection Rabies Immune Globulin, heat-treated (RIg-HT), human, for intramuscular and/or 90376 Imogam® Rabies-HT rabies immune globulin (human), heat treated subcutaneous use 90389 Tetanus Immune Globulin (TIg), human, for intramuscular
    [Show full text]
  • Inflammatory High-Risk Breast Cancer
    Bone Marrow Transplantation (2000) 26, 51–59 2000 Macmillan Publishers Ltd All rights reserved 0268–3369/00 $15.00 www.nature.com/bmt High-dose busulfan, melphalan and thiotepa as consolidation for non- inflammatory high-risk breast cancer F Gutierrez-Delgado, LA Holmberg, H Hooper, FR Appelbaum, RB Livingston, RT Maziarz, P Weiden, S Rivkin, P Montgomery, K Kawahara and W Bensinger Fred Hutchinson Cancer Research, University of Washington and Puget Sound Oncology Consortium, Seattle, WA, USA Summary: disease,3–7 and stage III disease8,9 have a probability of disease-free survival (DFS) at 5 years of 13 to 45% which The purpose of this study was to evaluate the toxicity falls to 10 to 30% at 10 years. and efficacy of high-dose busulfan, melphalan and thi- The experimental and clinical observations suggesting a otepa (Bu/Mel/TT) in patients with high-risk non- significant dose–response relationship in metastatic and pri- inflammatory breast cancer defined as stage II disease mary breast cancer10–14 have encouraged the evaluation of у10 lymph nodes (n = 52) or stage III (n = 69), and high-dose chemotherapy supported with autologous stem prognostic factors for treatment outcome. One hundred cell infusion (HDC/ASCI) as treatment for breast cancer. and twenty-one patients (median age, 46 years) were While a wide range of regimens and trials have evaluated treated with high-dose Bu (12 mg/kg), Mel (100 mg/m2) this approach in metastatic disease, relatively few trials and TT (500 mg/m2) (HDC) followed by autologous stem have investigated the therapeutic potential of HDC/ASCI cell infusion (ASCI).
    [Show full text]
  • Brand Generic Guide
    Table Of Contents Section 1 .................................................2-6 Introduction Section 2 ................................................7-14 Dr. Reddy’s Product Portfolio Section 3 ............................................. 15-52 Generic Names To Brand Names Section 4 ......................................... 53-90 Brand Names To Generic Names Section 5 ..........................................91-110 Clinical Resources 1 Dear Healthcare Professional, At Dr. Reddy’s North American Generics, we strive every day to do what matters most to patients –accelerating access to the affordable medicines they need, because Good Health Can't Wait. Each of us is driven by the urgency for good health and committed to providing you with the most affordable products at the best value every day. The medicines we provide to patients and our customers are among the more than 1000 products listed in the Dr. Reddy’s Brand-to-Generic-to-Brand Conversion Guide. The complimentary pocket guide features an easy-to-use conversion guide and other clinical resources to assist you with conversions, calculations, assessments and more. It includes: • Generic-to-Brand Conversion Guide An alphabetical listing of generic products, cross-referenced to the corresponding brand names • Brand-to-Generic Conversion Guide An alphabetical listing of brand products, cross-referenced to the corresponding generic names • Clinical Resource Section Resources such as charts on liver function assessment, equi-analgesic doses, and high-alert drugs • Product Portfolio The complete Dr. Reddy’s product portfolio is presented in Section 2 of the guide. Throughout the guide, Dr. Reddy’s products are printed in color. As the Brand-to-Generic-to-Brand Conversion Guide earns 1 its place as a valuable tool in your clinical setting, know that all of us at Dr.
    [Show full text]
  • Safe Handling of Hazardous Chemotherapy Drugs in Limited-Resource Settings
    Safe Handling of Hazardous Chemotherapy Drugs in Limited-Resource Settings Safe Handling of Hazardous Chemotherapy Drugs in Limited-Resource Settings Special Program on Sustainable Development and Health Equity Washington, D.C. 2013 JJtttSafe Handling Of Hazardous Chemotherapy Drugs In Limited-Resource Settings PAHO HQ Library Cataloguing-in-Publication Data ************************************************************************ Pan American Health Organization. Safe Handling of Hazardous Chemotherapy Drugs in Limited-Resource Settings. Washington, DC : PAHO, 2013. 1. Hazardous Substances. 2. Drug Therapy. 3. Hazardous Waste. 4. Substances, Products and Materials Transportation. I. Title. ISBN 978-92-75-11801-6 (NLM Classification: W330) The Pan American Health Organization welcomes requests for permission to reproduce or translate its publications, in part or in full. Applications and inquiries should be addressed to the Department of Knowledge Management and Communications (KMC), Pan American Health Organization, Washington, D.C., U.S.A. ([email protected]). The Special Program on Sustainable Development and Health Equity will be glad to provide the latest information on any changes made to the text, plans for new editions, and reprints and translations already available. © Pan American Health Organization, 2013. All rights reserved. Publications of the Pan American Health Organization enjoy copyright protection in accordance with the provisions of Protocol 2 of the Universal Copyright Convention. All rights are reserved. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the Secretariat of the Pan American Health Organization concerning the status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries.
    [Show full text]