TY - JOUR
TI - Updated outcomes and impact of age with lenalidomide and low-dose dexamethasone or melphalan, prednisone, and thalidomide in the randomized, phase III FIRST trial
AU - Hulin, C.
AU - Belch, A.
AU - Shustik, C.
AU - Petrucci, M.T.
AU - Dührsen, U.
AU - Lu, J.
AU - Song, K.
AU - Rodon, P.
AU - Pégourié, B.
AU - Garderet, L.
AU - Hunter, H.
AU - Azais, I.
AU - Eek, R.
AU - Gisslinger, H.
AU - Macro, M.
AU - Dakhil, S.
AU - Goncalves, C.
AU - Leblanc, R.
AU - Romeril, K.
AU - Royer, B.
AU - Doyen, C.
AU - Leleu, X.
AU - Offner, F.
AU - Leupin, N.
AU - Houck, V.
AU - Chen, G.
AU - Ervin-Haynes, A.
AU - Dimopoulos, M.A.
AU - Facon, T.
JO - Journal of Clinical Oncology
PY - 2016
VL - 34
TODO - 30
SP - 3609-3617
PB - American Society of Clinical Oncology
SN - 0732-183X, 1527-7755
TODO - 10.1200/JCO.2016.66.7295
TODO - dexamethasone;  lenalidomide;  melphalan;  prednisone;  thalidomide;  antineoplastic agent;  dexamethasone;  lenalidomide;  melphalan;  prednisone;  thalidomide, adult;  age;  aged;  cancer survival;  Conference Paper;  controlled study;  death;  disease course;  drug dose reduction;  female;  human;  low drug dose;  major clinical study;  male;  multicenter study;  multiple myeloma;  overall survival;  phase 3 clinical trial;  priority journal;  progression free survival;  randomized controlled trial;  treatment outcome;  age;  analogs and derivatives;  cancer staging;  clinical trial;  disease exacerbation;  disease free survival;  middle aged;  pathology;  survival rate;  very elderly, Adult;  Age Factors;  Aged;  Aged, 80 and over;  Antineoplastic Combined Chemotherapy Protocols;  Dexamethasone;  Disease Progression;  Disease-Free Survival;  Female;  Humans;  Male;  Melphalan;  Middle Aged;  Multiple Myeloma;  Neoplasm Staging;  Prednisone;  Survival Rate;  Thalidomide
TODO - Purpose: This analysis of the FIRST trial in patients with newly diagnosed multiple myeloma (MM) ineligible for stem-cell transplantation examined updated outcomes and impact of patient age. Patients and Methods: Patients with untreated symptomatic MM were randomly assigned at a one-to-one-to-one ratio to lenalidomide plus low-dose dexamethasone until disease progression (Rd continuous), Rd for 72 weeks (18 cycles; Rd18), or melphalan, prednisone, and thalidomide (MPT; 72 weeks), stratified by age (≤ 75 v > 75 years), disease stage (International Staging System stage I/II v III), and country. The primary end point was progression-free survival. Rd continuous and MPT were primary comparators. Results: Between August 21, 2008, and March 7, 2011, 1,623 patients were enrolled (Rd continuous, n = 535; Rd18, n = 541; MPT, n = 547), including 567 (35%) age older than 75 years. Higher rates of advanced-stage disease and renal impairment were observed in patients older than 75 versus 75 years of age or younger. Rd continuous reduced the risk of progression or death compared with MPT by 31% (hazard ratio [HR], 0.69; 95% CI, 0.59 to 0.80; P <.001) overall, 36% (HR, 0.64; 95% CI, 0.53 to 0.77; P <.001) in patients age 75 years or younger, and 20% (HR, 0.80; 95% CI, 0.62 to 1.03; P =.084) in those age older than 75 years. Median overall survival was longer with Rd continuous than with MPT, including a 14-month difference in patients age older than 75 years. Progression-free survival with Rd18 was similar to that with MPT, and overall survival with Rd18 was marginally inferior to that with Rd continuous. Rates of grade 3 to 4 treatment-emergent adverse events were similar for Rd continuous-treated patients age 75 years or older and those age older than 75 years; however, older patients had more frequent lenalidomide dose reductions. Conclusion: Results support Rd continuous treatment as a new standard of care for stem-cell transplantation-ineligible patients with newly diagnosed MM of all ages. © 2016 by American Society of Clinical Oncology.
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