Περίληψη:
This FIRST trial final analysis examined survival outcomes in patients with transplant-ineligible newly diagnosed multiple myeloma (NDMM) treated with lenalidomide and low-dose dexamethasone until disease progression (Rd continuous), Rd for 72 weeks (18 cycles; Rd18), or melphalan, prednisone, and thalidomide (MPT; 72 weeks). The primary endpoint was progression-free survival (PFS; primary comparison: Rd continuous vs MPT). Overall survival (OS) was a key secondary endpoint (final analysis prespecified ‡60 months’ follow-up). Patients were randomized to Rd continuous (n 5 535), Rd18 (n 5 541), or MPT (n 5 547). At a median follow-up of 67 months, PFS was significantly longer with Rd continuous vs MPT (hazard ratio [HR], 0.69; 95% confidence interval [CI], 0.59-0.79; P < .00001) and was similarly extended vs Rd18. Median OS was 10 months longer with Rd continuous vs MPT (59.1 vs 49.1 months; HR, 0.78; 95% CI, 0.67-0.92; P 5 .0023), and similar with Rd18 (62.3 months). In patients achieving complete or very good partial responses, Rd continuous had an 30-month longer median time to next treatment vs Rd18 (69.5 vs 39.9 months). Over half of all patients who received second-line treatment were given a bortezomib-based therapy. Second-line outcomes were improved in patients receiving bortezomib after Rd continuous and Rd18 vs after MPT. No new safety concerns, including risk for secondary malignancies, were observed. Treatment with Rd continuous significantly improved survival outcomes vs MPT, supporting Rd continuous as a standard of care for patients with transplant-ineligible NDMM. This trial was registered at www.clinicaltrials.gov as #NCT00689936 and EudraCT as 2007-004823-39. © 2018 by The American Society of Hematology.
Συγγραφείς:
Facon, T.
Dimopoulos, M.A.
Dispenzieri, A.
Catalano, J.V.
Belch, A.
Cavo, M.
Pinto, A.
Weisel, K.
Ludwig, H.
Bahlis, N.J.
Banos, A.
Tiab, M.
Delforge, M.
Cavenagh, J.D.
Geraldes, C.
Lee, J.-J.
Chen, C.
Oriol, A.
De La Rubia, J.
White, D.
Binder, D.
Lu, J.
Anderson, K.C.
Moreau, P.
Attal, M.
Perrot, A.
Arnulf, B.
Qiu, L.
Roussel, M.
Boyle, E.
Manier, S.
Mohty, M.
Avet-Loiseau, H.
Leleu, X.
Ervin-Haynes, A.
Chen, G.
Houck, V.
Benboubker, L.
Hulin, C.
Λέξεις-κλειδιά:
bortezomib; carfilzomib; cyclophosphamide; dexamethasone; lactate dehydrogenase; lenalidomide; melphalan; prednisone; thalidomide; antineoplastic agent, adult; aged; anemia; Article; cancer growth; cancer regression; cancer survival; cataract; comparative study; constipation; controlled study; deep vein thrombosis; diarrhea; febrile neutropenia; human; infection; low drug dose; lung embolism; major clinical study; multicenter study; multiple cycle treatment; multiple myeloma; neutropenia; outcome assessment; overall survival; peripheral neuropathy; phase 3 clinical trial; pneumonia; priority journal; progression free survival; randomized controlled trial; second cancer; sensory neuropathy; survival analysis; thrombocytopenia; treatment response; clinical trial; multiple myeloma; treatment outcome, Antineoplastic Agents; Humans; Multiple Myeloma; Progression-Free Survival; Survival Analysis; Treatment Outcome
