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Blood, 1 September 2005, Vol. 106, No. 5, pp. 1538-1543.
Prepublished online as a Blood First Edition Paper on May 24, 2005; DOI 10.1182/blood-2005-04-1437.


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CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS

Rituximab does not improve clinical outcome in a randomized phase 3 trial of CHOP with or without rituximab in patients with HIV-associated non-Hodgkin lymphoma: AIDS-Malignancies Consortium Trial 010

Lawrence D. Kaplan, Jeannette Y. Lee, Richard F. Ambinder, Joseph A. Sparano, Ethel Cesarman, Amy Chadburn, Alexandra M. Levine, and David T. Scadden

From the Division of Hematology/Oncology, University of California San Francisco; Division of Hematology/Oncology, Medical Statistics Section, University of Alabama Birmingham; Department of Oncology, Johns Hopkins University, Baltimore, MD; Albert Einstein Cancer Center, Montefiore Medical Center, New York, NY; Department of Pathology, Weill Medical College of Cornell University, New York, NY; Department of Medicine, University of Southern California, Los Angeles; Center for Regenerative Medicine and Technology, Massachusetts General Hospital, Harvard Medical School, Boston.

The addition of rituximab to cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy results in significant improvement in clinical outcome for individuals with non–HIV-associated aggressive B-cell lymphoma. To assess the potential risks and benefits of the addition of rituximab to CHOP for HIV-associated non-Hodgkin lymphoma (HIV-NHL) 150 patients receiving CHOP for HIV-NHL were randomized (2:1) to receive 375 mg/m2 rituximab with each chemotherapy cycle (n = 99) or no immunotherapy (n = 50) in a multicenter phase 3 trial. The complete response rate (CR + CRu) was 57.6% for R-CHOP and 47% for CHOP (P = .147). With a median follow-up of 137 weeks, time to progression, progression-free survival, and overall survival times were 125, 45, and 139 weeks, respectively, for R-CHOP and 85, 38, and 110 weeks, respectively, for CHOP (P = not significant, all comparisons). Treatment-related infectious deaths occurred in 14% of patients receiving R-CHOP compared with 2% in the chemotherapy-alone group (P = .035). Of these deaths, 60% occurred in patients with CD4 counts less than 50/mm3. Progression-free survival was significantly influenced by CD4+ count (P < .001) and International Prognostic Index score (P = .022), but not bcl-2 status. The addition of rituximab to CHOP in patients with HIV-NHL may be associated with improved tumor responses. However, these benefits may be offset by an increase in infectious deaths, particularly in those individuals with CD4+ lymphocyte counts less than 50/mm3.


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