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Originally published as JCO Early Release 10.1200/JCO.2005.03.108 on December 21 2004

Journal of Clinical Oncology, Vol 23, No 4 (February 1), 2005: pp. 667-675
© 2005 American Society of Clinical Oncology.
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Phase II Study of Proteasome Inhibitor Bortezomib in Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma

Andre Goy, Anas Younes, Peter McLaughlin, Barbara Pro, Jorge E. Romaguera, Frederick Hagemeister, Luis Fayad, Nam H. Dang, Felipe Samaniego, Michael Wang, Kristine Broglio, Barry Samuels, Frederic Gilles, Andreas H. Sarris, Susan Hart, Elizabeth Trehu, David Schenkein, Fernando Cabanillas, Alma M. Rodriguez

From the Departments of Lymphoma and Myeloma, Molecular Pathology, Biostatistics, and Imaging, The University of Texas M.D. Anderson Cancer Center, Houston TX; Hematology Oncology Department, Hygeia Hospital, Athens, Greece; and Millennium Pharmaceuticals, Inc, Cambridge, MA

Address reprint requests to Andre Goy, MD, Department of Lymphoma and Myeloma, University of Texas M.D. Anderson Cancer Center, 1515 Holcombe Blvd, Box 459, Houston, TX 77030; e-mail: ahgoy{at}mdanderson.org

PURPOSE: Evaluate efficacy and toxicity of bortezomib in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.

PATIENTS AND METHODS: Patients were stratified, based on preclinical data, into arm A (mantle-cell lymphoma) or arm B (other B-cell lymphomas) without limitation in number of prior therapies. Bortezomib was administered as an intravenous push (1.5 mg/m2) on days 1, 4, 8, and 11 every 21 days for a maximum of six cycles.

RESULTS: Sixty patients with a median number of prior therapies of 3.5 (range, one to 12 therapies) were enrolled; 33 patients were in arm A and 27 were in arm B, including 12 diffuse large B-cell lymphomas, five follicular lymphomas (FL), three transformed FLs, four small lymphocytic lymphomas (SLL), two Waldenström's macroglobulinemias (WM), and one marginal zone lymphoma. In arm A, 12 of 29 assessable patients responded (six complete responses [CR] and six partial responses [PR]) for an overall response rate (ORR) of 41% (95% CI, 24% to 61%), and a median time to progression not reached yet, with a median follow-up of 9.3 months (range, 1.7 to 24 months). In arm B, four of 21 assessable patients responded (one SLL patient had a CR, one FL patient had a CR unconfirmed, one diffuse large B-cell lymphoma patient had a PR, and one WM patient had a PR) for an ORR of 19% (95% CI, 5% to 42%). Grade 3 toxicity included thrombocytopenia (47%), gastrointestinal (20%), fatigue (13%), neutropenia (10%), and peripheral neuropathy (5%). Grade 4 toxicity occurred in nine patients (15%), and three deaths from progression of disease occurred within 30 days of withdrawal from study.

CONCLUSION: Bortezomib showed promising activity in relapsed mantle-cell lymphoma and encouraging results in other B-cell lymphomas. Future studies will explore bortezomib in combination with other cytotoxic or biologic agents.

Supported by Millennium Pharmaceuticals Inc, Cambridge, MA.

Presented in part at the 45th Annual Meeting of the American Society of Hematology, San Diego, CA, December 6-9, 2003.

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


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