Journal of Clinical Oncology, Vol 23, No 15 (May 20), 2005: pp. 3383-3389
© 2005 American Society of Clinical Oncology.
DOI: 10.1200/JCO.2005.08.100
Bendamustine Plus Rituximab Is Effective and Has a Favorable Toxicity Profile in the Treatment of Mantle Cell and Low-Grade Non-Hodgkin's Lymphoma
Mathias J. Rummel,
Salah E. Al-Batran,
Soo-Z. Kim,
Manfred Welslau,
Ralf Hecker,
Dorothea Kofahl-Krause,
Klaus-M. Josten,
Heinz Dürk,
Andreas Rost,
Michael Neise,
Ulrich von Grünhagen,
Kai U. Chow,
Martin-L. Hansmann,
Dieter Hoelzer,
Paris S. Mitrou
From the Med. Klinik II, Johann Wolfgang Goethe-Universitätsklinik, Frankfurt/Main; II. Med. Klinik, Krankenhaus Nordwest, Frankfurt/Main; St.-Marienkrankenhaus, Hamm; Medizinische Hochschule, Hannover; Städtische Kliniken, Darmstadt; Onkologische Schwerpunktpraxen in Aschaffenburg, Wiesbaden, Krefeld, Cottbus, Germany
Address reprint requests to Mathias J. Rummel, MD, PhD, Department of Internal Medicine, Hematology/Oncology, University Hospital, Theodor-Stern-Kai 7, 60590 Frankfurt/Main, Germany; e-mail: rummel{at}em.uni-frankfurt.de
PURPOSE: The aim of this multicenter-study was to evaluate the progression-free survival, response rate and toxicity of the combination of bendamustine and rituximab (BR) in patients with mantle cell or low-grade lymphomas in first to third relapse or refractory to previous treatment.
PATIENTS AND METHODS: A total of 245 courses (median, four courses per patient) were administered to 63 patients. Bendamustine was given at a dose of 90 mg/m2 as a 30-minute infusion on days 1 and 2, combined with 375 mg/m2 rituximab on day 1, for a maximum of four cycles every 4 weeks. Histologies were 24 follicular, 16 mantle cell, 17 lymphoplasmacytoid, and six marginal zone lymphoma.
RESULTS: Fifty-seven of 63 patients responded to BR, corresponding to an overall response rate of 90% (95% CI, 80% to 96%) with a complete remission rate (CR) of 60% (95% CI, 47% to 72%). The median time of progression-free survival was 24 months (range, 5 to 44+ months), and the median duration of overall survival has not yet been reached. In mantle cell lymphomas, BR showed a considerable activity, achieving a response rate of 75% (95% CI, 48% to 93%) with a CR rate of 50%. Myelosuppression was the major toxicity, with 16% grade 3 and 4 leukocytopenia. Thrombocytopenia was rare, with only 3% grade 3 and 4.
CONCLUSION: These results demonstrate that the BR combination is a highly active regimen in the treatment of low-grade lymphomas and mantle cell lymphomas.
Authors' disclosures of potential conflicts of interest are found at the end of this article.

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