Benefit of continuous treatment for responders with newly diagnosed multiple myeloma in the randomized FIRST trial
Journal
Leukemia
Journal Volume
31
Journal Issue
11
Pages
2435-2442
Date Issued
2017
Author(s)
Bahlis N.J.
Corso A.
Mugge L.-O.
Shen Z.-X.
Desjardins P.
Stoppa A.-M.
Decaux O.
De Revel T.
Granell M.
Marit G.
Nahi H.
Demuynck H.
Basu S.
Guthrie T.H.
Ervin-Haynes A.
Marek J.
Chen G.
Facon T.
Abstract
The phase 3, randomized Frontline Investigation of Revlimid and Dexamethasone Versus Standard Thalidomide (FIRST) trial investigating lenalidomide plus low-dose dexamethasone until disease progression (Rd continuous) vs melphalan, prednisone and thalidomide for 12 cycles (MPT) and Rd for 18 cycles (Rd18) in transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM) showed that Rd continuous prolonged progression-free survival and overall survival compared with MPT. A subanalysis of the FIRST trial was conducted to determine the benefits of Rd continuous in patients with NDMM based on depth of response. Patients randomized 1:1:1 to Rd continuous, Rd18 or MPT were divided into subgroups based on best response: complete response (CR; n=290), ? very good partial response (VGPR; n=679), ? partial response (PR; n=1 225) or ? stable disease (n=299). Over 13% of patients receiving Rd continuous who achieved ? VGPR as best response did so beyond 18 months of treatment. Rd continuous reduced the risk of progression or death by 67%, 51% and 35% vs MPT in patients with CR, ? VGPR and ? PR, respectively. Similarly, Rd continuous reduced the risk of progression or death by 61%, 54% and 38% vs Rd18 in patients with CR, ? VGPR and ? PR, respectively. In patients with CR, ? VGPR or ? PR, 4-year survival rates in the Rd continuous arm (81.1%, 73.1% or 64.6%, respectively) were higher vs MPT (70.8%, 59.8% or 57.2%, respectively) and similar vs Rd18 (76.5%, 67.7% and 62.5%, respectively). Rd continuous improved efficacy outcomes in all responding patients, including those with CR, compared with fixed duration treatment. ? 2017 Macmillan Publishers Limited, part of Springer Nature. All rights reserved.
SDGs
Other Subjects
dexamethasone; lenalidomide; melphalan; prednisone; thalidomide; antineoplastic agent; dexamethasone; lenalidomide; melphalan; prednisone; thalidomide; adult; adverse outcome; aged; anemia; Article; cancer growth; cancer survival; cardiovascular disease; cataract; controlled study; death; deep vein thrombosis; drug effect; drug efficacy; drug response; drug safety; female; human; infection; major clinical study; male; multicenter study; multiple cycle treatment; multiple myeloma; neutropenia; open study; overall survival; patient risk; phase 3 clinical trial; priority journal; progression free survival; randomized controlled trial; risk reduction; sensory neuropathy; survival rate; thrombocytopenia; treatment duration; treatment outcome; analogs and derivatives; clinical trial; middle aged; multiple myeloma; pathology; very elderly; Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Female; Humans; Male; Melphalan; Middle Aged; Multiple Myeloma; Prednisone; Thalidomide
Publisher
Nature Publishing Group
Type
journal article