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Clinical Trial
. 2010 Jan 1;116(1):106-14.
doi: 10.1002/cncr.24714.

Bendamustine Is Effective Therapy in Patients With Rituximab-Refractory, Indolent B-cell non-Hodgkin Lymphoma: Results From a Multicenter Study

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Free PMC article
Clinical Trial

Bendamustine Is Effective Therapy in Patients With Rituximab-Refractory, Indolent B-cell non-Hodgkin Lymphoma: Results From a Multicenter Study

Brad S Kahl et al. Cancer. .
Free PMC article

Abstract

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.

Conflict of interest statement

Conflict of Interest Disclosures: Research support was provided by Cephalon, Inc. Drs. Kahl, Bartlett, Leonard, Chen, Ganjoo, Williams, Czuczman, Robinson, Joyce, van der Hagt, and Cheson received research support from Cephalon, Inc. Dr. Chen is an employee of Cephalon, Inc. Dr. Leonard has acted as a consultant for Cephalon, Inc. Drs. Kahl, Leonard, Williams, Czuczman, and Cheson have served on advisory boards for Cephalon, Inc.

Figures

Figure 1
Figure 1
Kaplan-Meier curves for progression-free survival in patients who received bendamustine are shown both (Top) overall (N = 100) and (Bottom) for patients who were sensitive versus those who were refractory to prior chemotherapy. 95% CL indicates 95% confidence limits.

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