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Originally published as JCO Early Release 10.1200/JCO.2005.13.821 on June 13 2005

Journal of Clinical Oncology, Vol 23, No 22 (August 1), 2005: pp. 5044-5051
© 2005 American Society of Clinical Oncology.

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Combination Antibody Therapy With Epratuzumab and Rituximab in Relapsed or Refractory Non-Hodgkin's Lymphoma

John P. Leonard, Morton Coleman, Jamie Ketas, Michelle Ashe, Jennifer M. Fiore, Richard R. Furman, Ruben Niesvizky, Tsiporah Shore, Amy Chadburn, Heather Horne, Jacqueline Kovacs, Cliff L. Ding, William A. Wegener, Ivan D. Horak, David M. Goldenberg

From the Center for Lymphoma and Myeloma, Division of Hematology and Medical Oncology, and Department of Pathology, Weill Medical College of Cornell University and New York Presbyterian Hospital, New York, NY; Immunomedics Inc, Morris Plains, NJ; and Garden State Cancer Center, Center for Molecular Medicine and Immunology, Belleville, NJ

Address reprint requests to John P. Leonard, Center for Lymphoma and Myeloma, and Division of Hematology and Oncology, Weill Medical College of Cornell University and New York Presbyterian Hospital, 520 E 70th St, New York, NY 10021; e-mail: jpleonar{at}med.cornell.edu

PURPOSE: To explore the safety and therapeutic activity of combination anti–B-cell monoclonal antibody therapy in non-Hodgkin's lymphoma (NHL).

PATIENTS AND METHODS: Twenty-three patients with recurrent B-cell lymphoma received anti-CD22 epratuzumab 360 mg/m2 and anti-CD20 rituximab 375 mg/m2 monoclonal antibodies weekly for four doses each. Sixteen patients had indolent histologies (15 with follicular lymphoma) and seven had aggressive NHL (all diffuse large B-cell lymphoma [DLBCL]). Indolent patients had received a median of one (range, one to six) prior treatment, with 31% refractory to their last therapy and 81% with high-risk Follicular Lymphoma International Prognostic Index scores. Patients with DLBCL had a median of three (range, one to eight) prior regimens (14% resistant to last treatment) and 71% had high intermediate–risk or high-risk International Prognostic Index scores. All patients were rituximab naïve.

RESULTS: Treatment was well tolerated, with toxicities principally infusion-related and predominantly grade 1 or 2. Ten (67%) patients with follicular NHL achieved an objective response (OR), including nine of 15 (60%) with complete responses (CRs and unconfirmed CRs). Four of six assessable patients (67%) with DLBCL achieved an OR, including three (50%) CRs. Median time to progression for all indolent NHL patients was 17.8 months.

CONCLUSION: The full-dose combination of epratuzumab with rituximab was well tolerated and had significant clinical activity in NHL, suggesting that this combination should be tested in comparison with single-agent treatment.

Supported by a K23 award from the National Institutes of Health (RR16814), and grants from the Cornell Center for Aging Research and Clinical Care, the Lymphoma Research Foundation, the Dorothy Rodbell Cohen Foundation, and the Brian Rooney Fund of the Lymphoma Foundation, as well as research grants from Immunomedics Inc.

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




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