PMID- 31160237
OWN - NLM
STAT- MEDLINE
DCOM- 20200806
LR  - 20200806
IS  - 2152-2669 (Electronic)
IS  - 2152-2669 (Linking)
VI  - 19
IP  - 8
DP  - 2019 Aug
TI  - Carfilzomib-Dexamethasone Versus Bortezomib-Dexamethasone in Relapsed or 
      Refractory Multiple Myeloma: Updated Overall Survival, Safety, and Subgroups.
PG  - 522-530.e1
LID - S2152-2650(19)30028-X [pii]
LID - 10.1016/j.clml.2019.04.018 [doi]
AB  - 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 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.
CI  - Copyright (c) 2019 The Authors. Published by Elsevier Inc. All rights reserved.
FAU - Orlowski, Robert Z
AU  - Orlowski RZ
AD  - Department of Lymphoma and Myeloma, The University of Texas M.D. Anderson Cancer 
      Center, Houston, TX. Electronic address: ROrlowski@mdanderson.org.
FAU - Moreau, Philippe
AU  - Moreau P
AD  - Department of Hematology, University Hospital Hotel-Dieu, Nantes, France.
FAU - Niesvizky, Ruben
AU  - Niesvizky R
AD  - Department of Medical Oncology, Myeloma Center, New York Presbyterian 
      Hospital-Weill Cornell Medical Center, New York, NY.
FAU - Ludwig, Heinz
AU  - Ludwig H
AD  - Department of Medicine I, Wilhelminen Cancer Research Institute, 
      Wilhelminenspital, Vienna, Austria.
FAU - Oriol, Albert
AU  - Oriol A
AD  - Department of Clinical Hematology, Institut Catala d'Oncologia and Institut Josep 
      Carreras, Hospital Germans Trias i Pujol, Barcelona, Spain.
FAU - Chng, Wee Joo
AU  - Chng WJ
AD  - Department of Hematology Oncology, National University of Singapore, Singapore.
FAU - Goldschmidt, Hartmut
AU  - Goldschmidt H
AD  - Department of Hematology Oncology, Heidelberg University Clinic and the National 
      Center of Tumor Diseases, Heidelberg, Germany.
FAU - Yang, Zhao
AU  - Yang Z
AD  - Department of Biostatistics, Amgen, Inc, Thousand Oaks, CA.
FAU - Kimball, Amy S
AU  - Kimball AS
AD  - Department of Clinical Research, Amgen, Inc, Thousand Oaks, CA.
FAU - Dimopoulos, Meletios
AU  - Dimopoulos M
AD  - Department of Clinical Therapeutics, University Athens School of Medicine, 
      Athens, Greece.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20190502
PL  - United States
TA  - Clin Lymphoma Myeloma Leuk
JT  - Clinical lymphoma, myeloma & leukemia
JID - 101525386
RN  - 0 (Oligopeptides)
RN  - 69G8BD63PP (Bortezomib)
RN  - 72X6E3J5AR (carfilzomib)
RN  - 7S5I7G3JQL (Dexamethasone)
SB  - IM
MH  - Aged
MH  - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use
MH  - Bortezomib/administration & dosage
MH  - Dexamethasone/administration & dosage
MH  - Drug Resistance, Neoplasm/*drug effects
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Male
MH  - Multiple Myeloma/drug therapy/*mortality/pathology
MH  - Neoplasm Recurrence, Local/drug therapy/*mortality/pathology
MH  - Oligopeptides/administration & dosage
MH  - Patient Safety
MH  - Prognosis
MH  - *Salvage Therapy
MH  - Survival Rate
OTO - NOTNLM
OT  - Clinical outcomes
OT  - Efficacy
OT  - Phase III
OT  - Proteasome inhibitor
EDAT- 2019/06/05 06:00
MHDA- 2020/08/07 06:00
CRDT- 2019/06/05 06:00
PHST- 2019/01/10 00:00 [received]
PHST- 2019/04/11 00:00 [revised]
PHST- 2019/04/29 00:00 [accepted]
PHST- 2019/06/05 06:00 [pubmed]
PHST- 2020/08/07 06:00 [medline]
PHST- 2019/06/05 06:00 [entrez]
AID - S2152-2650(19)30028-X [pii]
AID - 10.1016/j.clml.2019.04.018 [doi]
PST - ppublish
SO  - Clin Lymphoma Myeloma Leuk. 2019 Aug;19(8):522-530.e1. doi: 
      10.1016/j.clml.2019.04.018. Epub 2019 May 2.