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Phase II Multicenter Study of Bendamustine Plus Rituximab in Patients With Relapsed Indolent B-Cell and Mantle Cell Non-Hodgkin's Lymphoma

2008; Lippincott Williams & Wilkins; Volume: 26; Issue: 27 Linguagem: Inglês

10.1200/jco.2008.17.0001

1527-7755

Katherine Robinson, Michael E. Williams, Richard H. van der Jagt, Philip Cohen, Jordan A. Herst, Anil Tulpule, Lee S. Schwartzberg, Bernard Lemieux, Bruce D. Cheson,

CNS Lymphoma Diagnosis and Treatment

Bendamustine HCl is a bifunctional mechlorethamine derivative with clinical activity in the treatment of non-Hodgkin's lymphoma. This study evaluated bendamustine plus rituximab in 67 adults with relapsed, indolent B-cell or mantle cell lymphoma without documented resistance to prior rituximab.Patients received rituximab 375 mg/m(2) intravenously on day 1 and bendamustine 90 mg/m(2) intravenously on days 2 and 3 of each 28-day cycle for four to six cycles. An additional dose of rituximab was administered 1 week before the first cycle and 4 weeks after the last cycle. Sixty-six patients (median age, 60 years) received at least one dose of both drugs.Overall response rate was 92% (41% complete response, 14% unconfirmed complete response, and 38% partial response). Median duration of response was 21 months (95% CI, 18 to 24 months). Median progression-free survival time was 23 months (95% CI, 20 to 26 months). Outcomes were similar for patients with indolent or mantle cell histologies. The combination was generally well tolerated; the primary toxicity was myelosuppression (grade 3 or 4 neutropenia, 36%; grade 3 or 4 thrombocytopenia, 9%).Bendamustine plus rituximab is an active combination in patients with relapsed indolent and mantle cell lymphoma.