Carfilzomib-Dexamethasone Versus Bortezomib-Dexamethasone in Relapsed or Refractory Multiple Myeloma: Updated Overall Survival, Safety, and Subgroups
| Autor: | Orlowski, R. Z., Moreau, P., Niesvizky, R., Ludwig, H., Oriol, Albert, Chng, W. J., Goldschmidt, H., Yang, Z., Kimball, A. S., Dimopoulos, M., Universitat Autònoma de Barcelona |
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| Rok vydání: | 2019 |
| Předmět: |
Male
0301 basic medicine Oncology Cancer Research medicine.medical_specialty Efficacy Phases of clinical research Dexamethasone Bortezomib 03 medical and health sciences chemistry.chemical_compound Phase III 0302 clinical medicine Clinical outcomes Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans Proteasome inhibitor Multiple myeloma Aged Lenalidomide Salvage Therapy Proportional hazards model business.industry Hazard ratio Hematology Prognosis medicine.disease Carfilzomib Survival Rate 030104 developmental biology chemistry Drug Resistance Neoplasm 030220 oncology & carcinogenesis Female Patient Safety Neoplasm Recurrence Local Multiple Myeloma business Oligopeptides Follow-Up Studies medicine.drug |
| Zdroj: | Dipòsit Digital de Documents de la UAB Universitat Autònoma de Barcelona Clinical Lymphoma Myeloma & Leukemia r-IGTP. Repositorio Institucional de Producción Científica del Instituto de Investigación Germans Trias i Pujol instname |
| ISSN: | 2152-2650 |
| DOI: | 10.1016/j.clml.2019.04.018 |
| Popis: | In this updated analysis of patients with relapsed/refractory multiple myeloma (RRMM) from the RandomizEd, OpeN Label, Phase 3 Study of Carfilzomib Plus DExamethAsone Vs Bortezomib Plus DexamethasOne in Patients With Relapsed Multiple Myeloma (ENDEAVOR) trial, clinically meaningful overall survival improvements continue to be observed with carfilzomib 56 mg/m(2) and dexamethasone (Kd56; n = 464) versus bortezomib and dexamethasone (n = 465), including in key patient subgroups. With longer-term data, the favorable benefit-risk profile of Kd56 continues to support its use as a standard-of-care in RRMM. Introduction: The phase III RandomizEd, OpeN Label, Phase 3 Study of Carfilzomib Plus DExamethAsone Vs Bortezomib Plus DexamethasOne in Patients With Relapsed Multiple Myeloma (ENDEAVOR) trial showed significantly improved progression-free survival and overall survival (OS) with carfilzomib (56 mg/m(2)) and dexamethasone (Kd56) versus bortezomib and Kd56 (Vd) in patients with relapsed or refractory multiple myeloma (RRMM). We report updated OS and safety data after 6 months of additional follow-up. Patients and Methods: Patients with RRMM (1-3 previous lines of therapy) were randomized 1:1 to Kd56 or Vd. Median OS was estimated using the KaplaneMeier method; OS was compared between treatment groups using Cox proportional hazards models. Results: As of July 19, 2017, median follow-up was 44.3 months for Kd56 and 43.7 months for Vd. Median OS was 47.8 months (Kd56) versus 38.8 months (Vd; hazard ratio, 0.76; 95% confidence interval, 0.633-0.915). OS was longer with Kd56 versus Vd within age and cytogenetic subgroups, and according to number of previous lines of therapy, previous bortezomib exposure, previous lenalidomide exposure, and lenalidomide-refractory status. Exposure-adjusted incidences per 100 patient-years of adverse events (AEs) were 1352.07 for Kd56 and 1754.86 for Vd; for Grade >= 3 AEs, these values were 162.31 and 175.90. Conclusion: With median follow-up of approximately 44 months, clinically meaningful improvements in OS were observed with Kd56 versus Vd, including in all subgroups examined. The Kd56 safety profile was consistent with previous analyses. |
| Databáze: | OpenAIRE |
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