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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.
 Previous Article | Next Article 
Submitted April 8, 2005
Accepted May 10, 2005
Rituximab does not improve clinical outcome in a randomized phase III trial of CHOP with or without rituximab in patients with HIV-associated non-Hodgkin's lymphoma: AIDS-malignancies consortium trial 010
Lawrence D Kaplan*, Jeanette Y Lee, Richard F Ambinder, Joseph A Sparano, Ethel Cesarman, Amy Chadburn, Alexandra M Levine, and David T Scadden
Division of Hematology/Oncology, University of California, San Francisco, CA, USA
Division of Hematology/Oncology, Medical Statistics Section, University of Alabama Birmingham, Birmingham, AL, USA
Department of Oncology, Johns Hopkins University, Baltimore, MD, USA
Montefiore Medical Center, Albert Einstein Cancer Center, New York, NY, USA
Department of Pathology, Weill Medical College of Cornell University, New York, NY, USA
Department of Medicine, University of Southern California, Los Angeles, CA, USA
Center for Regenerative Medicine and Technology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA
* Corresponding author; email: lkaplan{at}medicine.ucsf.edu.
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. In order to assess the potential risks and benefits of this agent administered with concurrent chemotherapy in HIV-infected individuals with aggressive B-cell lymphoma (HIV-NHL) 150 patients receiving CHOP chemotherapy for HIV-NHL were randomized (2:1) to receive 375mg/m2 rituximab with each chemotherapy cycle (n=99) or no immunotherapy (n=50) in a multicenter phase III trial. The primary endpoint was complete response rate. Secondary endpoints included time to progression, progression-free survival (PFS), overall survival (OS) and treatment-related toxicity.
The complete response rate (CR + CRu) was 57.6% for R-CHOP and 47% for CHOP (p=.147). With a median followup of 137 weeks, time to progression, progression-free and overall survival times were 125, 45, and 139 weeks respectively for R-CHOP and 85, 38 and 110 weeks respectively for CHOP (p=ns, 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% were in patients with baseline CD4 < 50/mm3. PFS was significantly influenced by CD4+ count (p< .001) and IPI score (p=022), but not bcl-2 status.
The addition of rituximab to CHOP chemotherapy in patients with AIDS lymphoma 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 < 50/mm3.
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