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
Top Cited Papers
- 1 September 2005
- journal article
- clinical trial
- Published by American Society of Hematology in Blood
- Vol. 106 (5) , 1538-1543
- https://doi.org/10.1182/blood-2005-04-1437
Abstract
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.Keywords
This publication has 26 references indexed in Scilit:
- Rituximab plus infusional cyclophosphamide, doxorubicin, and etoposide in HIV-associated non-Hodgkin lymphoma: pooled results from 3 phase 2 trialsBlood, 2005
- Protease inhibitors potentiate chemotherapy-induced neutropeniaBlood, 2004
- CD4 lymphopenia as a risk factor for febrile neutropenia and early death after cytotoxic chemotherapy in adult patients with cancerCancer, 2004
- Rituximab: Expanding Role in Therapy for Lymphomas and Autoimmune DiseasesAnnual Review of Medicine, 2004
- Highly effective treatment of acquired immunodeficiency syndrome–related lymphoma with dose-adjusted EPOCH: impact of antiretroviral therapy suspension and tumor biologyBlood, 2003
- Rituximab plus CHOP (R-CHOP) overcomes bcl-2--associated resistance to chemotherapy in elderly patients with diffuse large B-cell lymphoma (DLBCL)Blood, 2003
- Randomized phase 2 study of fludarabine with concurrent versus sequential treatment with rituximab in symptomatic, untreated patients with B-cell chronic lymphocytic leukemia: results from Cancer and Leukemia Group B 9712 (CALGB 9712)Blood, 2002
- CHOP Chemotherapy plus Rituximab Compared with CHOP Alone in Elderly Patients with Diffuse Large-B-Cell LymphomaNew England Journal of Medicine, 2002
- Etiology and Natural History of Neutropenia in Human Immunodeficiency Virus Disease: A Prospective StudyClinical Infectious Diseases, 2001
- Highly Active Antiretroviral Therapy and Incidence of Cancer in Human Immunodeficiency Virus-Infected AdultsJNCI Journal of the National Cancer Institute, 2000