A Three-Arm Randomized Phase II Study of Bendamustine/Rituximab with Bortezomib Induction or Lenalidomide Continuation in Untreated Follicular Lymphoma: ECOG-ACRIN E2408.

Autor:	Evens AM; Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey. ae378@cinj.rutgers.edu., Hong F; Dana Farber Cancer Institute, ECOG-ACRIN Biostatistics Center, Boston, Massachusetts., Habermann TM; Mayo Clinic, Rochester, Minnesota., Advani RH; Stanford Cancer Institute, Stanford, California., Gascoyne RD; British Columbia Cancer Agency, Vancouver, Canada., Witzig TE; Mayo Clinic, Rochester, Minnesota., Quon A; University of California at Los Angeles, California., Ranheim EA; University of Wisconsin, Madison, Wisconsin., Ansell SM; Mayo Clinic, Rochester, Minnesota., Cheema PS; Saint John's Hospital Health East Care System, Maplewood, Minnesota., Dy PA; Decatur Memorial Hospital, Effingham, Illinois., O'Brien TE; Case Western Reserve University, Cleveland, Ohio., Winter JN; Northwestern University, Chicago, Illinois., Cescon TP; Reading Hospital, West Reading, Pennsylvania., Chang JE; University of Wisconsin, Madison, Wisconsin., Kahl BS; Washington University, St. Louis, Missouri.
Jazyk:	angličtina
Zdroj:	Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2020 Sep 01; Vol. 26 (17), pp. 4468-4477. Date of Electronic Publication: 2020 Jun 12.
DOI:	10.1158/1078-0432.CCR-20-1345
Abstrakt:	Purpose: We sought to improve upon frontline bendamustine/rituximab (BR) induction therapy followed by rituximab maintenance in untreated high-risk follicular lymphoma (FL). Patients and Methods: Patients were randomized to BR induction followed by 2-year rituximab maintenance (BR-R), BR with bortezomib and rituximab maintenance (BVR-R), or BR followed by lenalidomide (1 year) with rituximab maintenance (BR-LR). Dual primary objectives were complete remission (CR) rate and 1-year disease-free survival (DFS); 289 patients enrolled (NCT01216683). Results: For induction, 92%, 87%, and 86% of patients randomized to BR-R, BVR-R, or BR-LR received six cycles, respectively. CR rate with BR versus BVR induction was 62% versus 75%, respectively ( P = 0.04). One-year DFS rates with BR-R versus BR-LR were 85% versus 67%, respectively ( P = 0.0009). This was due to an imbalance in CR rates post-BR induction and discontinuation due to adverse events (AEs). The most common grade 3-4 AEs for BVR versus BR were neutropenia and sensory neuropathy (12% vs <1%); 83% of the latter occurred with intravenous bortezomib. The most common grade 3-4 AEs related to LR versus rituximab maintenance were neutropenia 66% versus 21%, respectively ( P < 0.0001), and febrile neutropenia 10% versus 2%, respectively ( P = 0.05). The overall treatment-related mortality was 1.4%. With 5-year median follow-up, 3-year PFS rates for BR-R, BVR-R, and BR-LR were 77%, 82%, and 76%, respectively ( P = 0.36) with OS rates of 87%, 90%, and 84%, respectively ( P = 0.79). For prognostication, CR rate and POD-24 were associated with survival. Conclusions: Altogether, neither bortezomib added to BR induction nor lenalidomide added to rituximab maintenance immediately post-BR induction is recommended in untreated FL. (©2020 American Association for Cancer Research.)
Databáze:	MEDLINE
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