TY - JOUR
TI - Elotuzumab plus lenalidomide and dexamethasone in relapsed/refractory multiple myeloma: Extended 4-year follow-up and analysis of relative progression-free survival from the randomized ELOQUENT-2 trial
AU - Dimopoulos, M.A.
AU - Lonial, S.
AU - Betts, K.A.
AU - Chen, C.
AU - Zichlin, M.L.
AU - Brun, A.
AU - Signorovitch, J.E.
AU - Makenbaeva, D.
AU - Mekan, S.
AU - Sy, O.
AU - Weisel, K.
AU - Richardson, P.G.
JO - JMIR Cancer
PY - 2018
VL - 124
TODO - 20
SP - 4032-4043
PB - John Wiley and Sons Inc
SN - null
TODO - 10.1002/cncr.31680
TODO - dexamethasone;  elotuzumab;  lenalidomide;  antineoplastic agent;  dexamethasone;  elotuzumab;  lenalidomide;  monoclonal antibody, adult;  anemia;  Article;  backache;  cancer mortality;  cancer registry;  cancer risk;  cancer staging;  cardiovascular disease;  constipation;  controlled study;  coughing;  diarrhea;  disease course;  drug efficacy;  drug safety;  fatigue;  fever;  follow up;  gastrointestinal disease;  hazard ratio;  herpes zoster;  human;  infection;  long term care;  lymphocytopenia;  multiple myeloma;  muscle spasm;  neutropenia;  pneumonia;  priority journal;  progression free survival;  randomized controlled trial;  relapsed refractory multiple myeloma;  relapsed refractory multiple myeloma;  risk reduction;  sepsis;  thrombocytopenia;  treatment outcome;  vascular disease;  aged;  clinical trial;  disease exacerbation;  drug effect;  drug resistance;  female;  male;  middle aged;  mortality;  multicenter study;  multiple myeloma;  pathology;  survival analysis;  time factor;  tumor recurrence;  very elderly, Adult;  Aged;  Aged, 80 and over;  Antibodies, Monoclonal, Humanized;  Antineoplastic Combined Chemotherapy Protocols;  Dexamethasone;  Disease Progression;  Drug Resistance, Neoplasm;  Female;  Follow-Up Studies;  Humans;  Lenalidomide;  Male;  Middle Aged;  Multiple Myeloma;  Neoplasm Recurrence, Local;  Progression-Free Survival;  Survival Analysis;  Time Factors;  Treatment Outcome
TODO - Background: The randomized phase 3 ELOQUENT-2 study (NCT01239797) evaluated the efficacy and safety of elotuzumab plus lenalidomide and dexamethasone (ELd) versus lenalidomide and dexamethasone (Ld) in relapsed/refractory multiple myeloma (RRMM), and to date, has the longest follow-up of any monoclonal antibody in patients with RRMM. Methods: In this extended 4-year follow-up of the ELOQUENT-2 trial, the coprimary endpoints of progression-free survival (PFS) and overall response rate as well as the secondary endpoint of overall survival were assessed. In the absence of head-to-head trials comparing Ld-based triplet regimens to guide treatment selection, 4 randomized controlled trials—ELOQUENT-2, ASPIRE, TOURMALINE-MM1, and POLLUX—were indirectly compared to provide insight into the relative efficacy of these regimens in RRMM. Results: Data at 4 years were consistent with 2- and 3-year follow-up data: ELd reduced the risk of disease progression/death by 29% versus Ld (hazard ratio, 0.71) while maintaining safety. The greatest PFS benefit among the assessed subgroups was observed in patients at the median time or further from diagnosis (≥3.5 years) with 1 prior line of therapy, who had a 44% reduction in the risk of progression/death, and in patients in the high-risk category, who had a 36% reduction in favor of ELd. This regimen also showed a relative PFS benefit that was maintained beyond 50 months. Conclusions: The sustained PFS benefit and long-term safety of ELd at 4 years, similar to those observed at 2 and 3 years, support ELd as a valuable therapeutic option for the long-term treatment of patients with RRMM. © 2018 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society
ER -