Robert Z Orlowski1, Philippe Moreau2, Ruben Niesvizky3, Heinz Ludwig4, Albert Oriol5, Wee Joo Chng6, Hartmut Goldschmidt7, Zhao Yang8, Amy S Kimball9, Meletios Dimopoulos10. 1. Department of Lymphoma and Myeloma, The University of Texas M.D. Anderson Cancer Center, Houston, TX. Electronic address: ROrlowski@mdanderson.org. 2. Department of Hematology, University Hospital Hotel-Dieu, Nantes, France. 3. Department of Medical Oncology, Myeloma Center, New York Presbyterian Hospital-Weill Cornell Medical Center, New York, NY. 4. Department of Medicine I, Wilhelminen Cancer Research Institute, Wilhelminenspital, Vienna, Austria. 5. Department of Clinical Hematology, Institut Catala d'Oncologia and Institut Josep Carreras, Hospital Germans Trias i Pujol, Barcelona, Spain. 6. Department of Hematology Oncology, National University of Singapore, Singapore. 7. Department of Hematology Oncology, Heidelberg University Clinic and the National Center of Tumor Diseases, Heidelberg, Germany. 8. Department of Biostatistics, Amgen, Inc, Thousand Oaks, CA. 9. Department of Clinical Research, Amgen, Inc, Thousand Oaks, CA. 10. Department of Clinical Therapeutics, University Athens School of Medicine, Athens, Greece.
Abstract
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/m2) 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 Kaplan-Meier 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.
RCT Entities:
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/m2) 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 Kaplan-Meier 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.
Authors: Meisam Naeimi Kararoudi; Yuya Nagai; Ezgi Elmas; Marcelo de Souza Fernandes Pereira; Syed Abbas Ali; Philip Hollingsworth Imus; Darren Wethington; Ivan Marques Borrello; Dean Anthony Lee; Gabriel Ghiaur Journal: Blood Date: 2020-11-19 Impact factor: 22.113
Authors: Shaji Kumar; Lawrence Baizer; Natalie S Callander; Sergio A Giralt; Jens Hillengass; Boris Freidlin; Antje Hoering; Paul G Richardson; Elena I Schwartz; Anthony Reiman; Suzanne Lentzsch; Philip L McCarthy; Sundar Jagannath; Andrew J Yee; Richard F Little; Noopur S Raje Journal: Blood Cancer J Date: 2022-06-29 Impact factor: 9.812