Carfilzomib-Dexamethasone Versus Bortezomib-Dexamethasone in Relapsed or Refractory Multiple Myeloma : Updated Overall Survival, Safety, and Subgroups
Orlowski, Robert Z. (Department of Lymphoma and Myeloma. The University of Texas M.D. Anderson Cancer Center)
Moreau, Philippe (Department of Hematology. University Hospital Hotel-Dieu)
Niesvizky, Ruben (Department of Medical Oncology. Myeloma Center. New York Presbyterian Hospital-Weill Cornell Medical Center)
Ludwig, Heinz (Wilhelminen Cancer Research Institute (Viena, Àustria))
Oriol, Albert (Institut Germans Trias i Pujol. Institut de Recerca contra la Leucèmia Josep Carreras)
Chng, Wee Joo (Department of Hematology Oncology. National University of Singapore)
Goldschmidt, Hartmut (Department of Hematology Oncology. Heidelberg University Clinic and the National Center of Tumor Diseases)
Yang, Zhao (Department of Biostatistics. Amgen. Inc)
Kimball, Amy S. (Department of Clinical Research. Amgen. Inc)
Dimopoulos, Meletios (Department of Clinical Therapeutics. University Athens School of Medicine)
Universitat Autònoma de Barcelona

Fecha:	2019
Resumen:	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) 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. 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 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.
Derechos:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Lengua:	Anglès
Documento:	Article ; recerca ; Versió publicada
Materia:	Clinical outcomes ; Efficacy ; Phase III ; Proteasome inhibitor
Publicado en:	Clinical Lymphoma, Myeloma & Leukemia, Vol. 19 Núm. 8 (august 2019) , p. 522-530.e1, ISSN 2152-2669

DOI: 10.1016/j.clml.2019.04.018
PMID: 31160237

10 p, 1.8 MB

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Documentos de investigación > Documentos de los grupos de investigación de la UAB > Centros y grupos de investigación (producción científica) > Ciencias de la salud y biociencias > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP) > Instituto de Investigación contra la Leucemia Josep Carreras
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