Originally published as JCO Early Release 10.1200/JCO.2008.18.7252 on February 17 2009

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Bendamustine: Rebirth of an Old Drug

From the Georgetown University Hospital, Lombardi Comprehensive Cancer Center, Washington, DC; and Justus Liebig University Hospital, Department of Hematology, Giessen, Germany

Corresponding author: Bruce D. Cheson, MD, Georgetown University Hospital, 3800 Reservoir Rd NW, Washington, DC 20007; e-mail: bdc4{at}georgetown.edu.

Bendamustine is a unique cytotoxic agent with structural similarities to alkylating agents and antimetabolites, but which is non–cross-resistant with alkylating agents and other drugs in vitro and in the clinic. Early clinical studies conducted in the German Democratic Republic more than 30 years ago suggested promising activity in indolent non-Hodgkin's lymphoma (NHL). Two North American trials reported responses in more than 70% of patients with chemotherapy- and rituximab-refractory disease, suggesting that bendamustine may be the most effective drug available for this patient population. Response rates of 90% to 92%, with complete remission in 55% to 60%, have been reported in patients with follicular and mantle-cell lymphoma with the combination of bendamustine and rituximab. Superiority over chlorambucil in previously untreated patients with chronic lymphocytic leukemia (CLL) led to its recent approval for this disease in the United States. Bendamustine is approved in Germany for the treatment of patients with indolent NHL, CLL, and multiple myeloma. Activity has also been noted in patients with breast cancer and small-cell lung cancer. Questions related to the optimization of bendamustine therapy, including dose and schedule, role relative to other available agents, and management of toxicities, are being investigated. However, the availability of bendamustine provides another effective treatment option for patients with lymphoid malignancies.

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

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