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Lenalidomide plus rituximab (R 2 ) in previously untreated marginal zone lymphoma: subgroup analysis and long‐term follow‐up of an open‐label phase 2 trial
Author(s) -
Becnel Melody R.,
Nastoupil Loretta J.,
Samaniego Felipe,
Davis Richard E.,
You M. J.,
Green Michael,
Hagemeister Fredrick B.,
Fanale Michelle A.,
Fayad Luis E.,
Westin Jason R.,
Wang Michael,
Oki Yasuhiro,
Forbes Sheryl G.,
Feng Lei,
Neelapu Sattva S.,
Fowler Nathan H.
Publication year - 2019
Publication title -
british journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.907
H-Index - 186
eISSN - 1365-2141
pISSN - 0007-1048
DOI - 10.1111/bjh.15843
Subject(s) - lenalidomide , medicine , neutropenia , rituximab , tolerability , clinical endpoint , gastroenterology , adverse effect , follicular lymphoma , progression free survival , febrile neutropenia , phases of clinical research , lymphoma , oncology , surgery , clinical trial , chemotherapy , multiple myeloma
Summary Lack of consensus for first‐line marginal zone lymphoma ( MZL ) treatment and toxicities associated with currently available systemic therapies have inspired evaluation of immunotherapeutic agents yielding robust outcomes with improved tolerability. We previously reported durable efficacy with first‐line lenalidomide and rituximab (R 2 ) in follicular lymphoma, MZL and small lymphocytic lymphoma with a subsequent long‐term follow‐up shown here in MZL patients. This phase 2 investigator‐initiated study included previously untreated, stage III / IV MZL patients treated with lenalidomide 20 mg/day on days 1–21 and rituximab 375 mg/m 2 on day 1 of each 28‐day cycle, continuing in responders for ≥6–12 cycles. The primary endpoint was overall response rate ( ORR ); secondary endpoints were complete and partial response ( CR , PR ), safety, and progression‐free survival ( PFS ). The ORR was 93% with 70% attaining CR / CR unconfirmed. At median follow‐up of 75·1 months, median PFS was 59·8 months and 5‐year OS was 96%. Most non‐haematological adverse events ( AE ) were grade 1/2. Grade 3 haematological AE s were neutropenia (33%) and leucopenia (7%), and grade 4 were leucopenia (3%) and thrombocytopenia (3%). Two patients died of secondary malignancies; no treatment‐related fatalities occurred. With extended follow‐up, outcomes for MZL patients receiving R 2 were robust with no unexpected late or delayed toxicities.