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Originally published as JCO Early Release 10.1200/JCO.2005.02.050 on December 21 2004

Journal of Clinical Oncology, Vol 23, No 4 (February 1), 2005: pp. 676-684
© 2005 American Society of Clinical Oncology.
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Phase II Clinical Experience With the Novel Proteasome Inhibitor Bortezomib in Patients With Indolent Non-Hodgkin's Lymphoma and Mantle Cell Lymphoma

Owen A. O'Connor, John Wright, Craig Moskowitz, Jamie Muzzy, Barbara MacGregor-Cortelli, Michael Stubblefield, David Straus, Carol Portlock, Paul Hamlin, Elizabeth Choi, Otila Dumetrescu, Dixie Esseltine, Elizabeth Trehu, Julian Adams, David Schenkein, Andrew D. Zelenetz

From the Memorial Sloan-Kettering Cancer Center, Department of Medicine, Division of Hematologic Oncology, Lymphoma and Developmental Chemotherapy Services, Departments of Rehabilitation Medicine and Radiology, New York, NY; Millennium Pharmaceutical, Cambridge, MA; and Drug Development Branch, National Cancer Institute, Bethesda, MD

Address reprint requests to Owen A. O'Connor, MD, PhD, Memorial Sloan-Kettering Cancer Center, Department of Medicine, Box 329, Lymphoma and Developmental Chemotherapy Services, 1275 York Ave, New York, NY 10021; e-mail: oconnoro{at}mskcc.org

PURPOSE: To determine the antitumor activity of the novel proteasome inhibitor bortezomib in patients with indolent and mantle-cell lymphoma (MCL).

PATIENTS AND METHODS: Patients with indolent and MCL were eligible. Bortezomib was given at a dose of 1.5 mg/m2 on days 1, 4, 8, and 11. Patients were required to have received no more than three prior chemotherapy regimens, with at least 1 month since the prior treatment, 3 months from prior rituximab, and 7 days from prior corticosteroids; absolute neutrophil count more than 1,500/µL (500/µL if documented bone marrow involvement); and platelet count more than 50,000/µL.

RESULTS: Twenty-six patients were registered, of whom 24 were assessable. Ten patients had follicular lymphoma, 11 had MCL, three had small lymphocytic lymphoma (SLL) or chronic lymphocytic leukemia (CLL), and two had marginal zone lymphoma. The overall response rate was 58%, with one complete remission (CR), one unconfirmed CR (CRu), and four partial remissions (PR) among patients with follicular non-Hodgkin's lymphoma (NHL). All responses were durable, lasting from 3 to 24+ months. One patient with MCL achieved a CRu, four achieved a PR, and four had stable disease. One patient with MCL maintained his remission for 19 months. Both patients with marginal zone lymphoma achieved PR lasting 8+ and 11+ months, respectively. Patients with SLL or CLL have yet to respond. Overall, the drug was well tolerated, with only one grade 4 toxicity (hyponatremia). The most common grade 3 toxicities were lymphopenia (n = 14) and thrombocytopenia (n = 7).

CONCLUSION: These data suggest that bortezomib was well tolerated and has significant single-agent activity in patients with certain subtypes of NHL.

Supported under an NCI Phase II grant (UO1 CA 69913). O.A.O. is the recipient of the Leukemia and Lymphoma Society Scholar in Research Award and is supported generously by the Werner and Elaine Dannheisser Fund for Research on the Biology of Aging of the Lymphoma Foundation.

O.A.O. is on the Speakers Bureau for Millenium Pharmaceuticals.

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


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Copyright © 2005 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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