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Bendamustine in Patients With Rituximab-Refractory Indolent and Transformed Non-Hodgkin's Lymphoma: Results From a Phase II Multicenter, Single-Agent Study

Jonathan W. Friedberg, Philip Cohen, Ling Chen, K. Sue Robinson, Andres Forero-Torres, Ann S. La Casce, Luis E. Fayad, Alberto Bessudo, Elber S. Camacho, Michael E. Williams, Richard H. van der Jagt, Jennifer W. Oliver, Bruce D. Cheson

From the Wilmot Cancer Center, University of Rochester, Rochester, NY; Georgetown University Hospital, Washington, DC; Cephalon Inc, Frazer, PA; QE II Health Sciences Centre, Halifax, Nova Scotia; Ottawa Hospital, Ottawa, Ontario, Canada; University of Alabama, Birmingham, AL; Dana-Farber Cancer Institute, Boston, MA; The University of Texas M.D. Anderson Cancer Center, Houston, TX; San Diego Cancer Center, San Diego; Desert Regional Med Center, Palm Springs, CA; and University of Virginia, Charlottesville, VA

Corresponding author: Jonathan W. Friedberg, MD, James P. Wilmot Cancer Center, University of Rochester, 601 Elmwood Ave, Box 704, Rochester, NY, 14642; e-mail: Jonathan_Friedberg{at}URMC.Rochester.edu

Purpose Bendamustine hydrochloride is an alkylating agent with novel mechanisms of action. This phase II multicenter study evaluated the efficacy and toxicity of bendamustine in patients with B-cell non-Hodgkin's lymphoma (NHL) refractory to rituximab.

Patients and Methods Patients received bendamustine 120 mg/m² intravenously on days 1 and 2 of each 21-day cycle. Outcomes included response, duration of response, progression-free survival, and safety.

Results Seventy-six patients, ages 38 to 84 years, with predominantly stage III/IV indolent (80%) or transformed (20%) disease were treated; 74 were assessable for response. Twenty-four (32%) were refractory to chemotherapy. Patients received a median of two prior unique regimens. An overall response rate of 77% (15% complete response, 19% unconfirmed complete response, and 43% partial) was observed. The median duration of response was 6.7 months (95% CI, 5.1 to 9.9 months), 9.0 months (95% CI, 5.8 to 16.7) for patients with indolent disease, and 2.3 months (95% CI, 1.7 to 5.1) for those with transformed disease. Thirty-six percent of these responses exceeded 1 year. The most frequent nonhematologic adverse events included nausea and vomiting, fatigue, constipation, anorexia, fever, cough, and diarrhea. Grade 3 or 4 reversible hematologic toxicities included neutropenia (54%), thrombocytopenia (25%), and anemia (12%).

Conclusion Single-agent bendamustine produced durable objective responses with acceptable toxicity in heavily pretreated patients with rituximab-refractory, indolent NHL. These findings are promising and will serve as a benchmark for future clinical trials in this novel patient population.

Research support was provided by Cephalon Inc. J.W.F. is supported in part by Grant No. CA-102216 from the National Cancer Institute.

Presented in part at the 48th Annual Meeting of the American Society of Hematology, December 9-12, 2006, Orlando, Florida.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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