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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

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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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