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Bendamustine is effective therapy in patients with rituximab‐refractory, indolent B‐cell non‐Hodgkin lymphoma
Author(s) -
Kahl Brad S.,
Bartlett Nancy L.,
Leonard John P.,
Chen Ling,
Ganjoo Kristen,
Williams Michael E.,
Czuczman Myron S.,
Robinson K. Sue,
Joyce Robin,
van der Jagt Richard H.,
Cheson Bruce D.
Publication year - 2009
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.24714
Subject(s) - medicine , bendamustine , neutropenia , rituximab , gastroenterology , regimen , nausea , adverse effect , febrile neutropenia , surgery , chemotherapy , lymphoma
BACKGROUND: Bendamustine hydrochloride is a novel alkylating agent. In this multicenter study, the authors evaluated the efficacy and toxicity of single‐agent bendamustine in patients with rituximab‐refractory, indolent B‐cell lymphoma. METHODS: Eligible patients (N = 100, ages 31‐84 years) received bendamustine at a dose of 120 mg/m 2 by intravenous infusion on Days 1 and 2 every 21 days for 6 to 8 cycles. Histologies included follicular (62%), small lymphocytic (21%), and marginal zone (16%) lymphomas. Patients had received a median of 2 previous regimens (range, 0‐6 previous regimens), and 36%were refractory to their most recent chemotherapy regimen. Primary endpoints included overall response rate (ORR) and duration of response (DOR). Secondary endpoints were safety and progression‐free survival (PFS). RESULTS: An ORR of 75% (a 14% complete response rate, a 3% unconfirmed complete response rate, and a 58% partial response rate) was observed. The median DOR was 9.2 months, and median PFS was 9.3 months. Six deaths were considered to be possibly treatment related. Grade 3 or 4 (determined using National Cancer Institute Common Toxicity Criteria [version 3.0.19]. reversible hematologic toxicities included neutropenia (61%), thrombocytopenia (25%), and anemia (10%). The most frequent nonhematologic adverse events (any grade) included nausea (77%), infection (69%), fatigue (64%), diarrhea (42%), vomiting (40%), pyrexia (36%), constipation (31%), and anorexia (24%). CONCLUSIONS: Single‐agent bendamustine produced a high rate of objective responses with acceptable toxicity in patients with recurrent, rituximab‐refractory indolent B‐cell lymphoma. Cancer 2010. © 2010 American Cancer Society.