- 105: Blood. 2004 Nov 18
Rituximab plus infusional cyclophosphamide, doxorubicin and etoposide (R-CDE) in HIV-associated non-Hodgkin's lymphoma: pooled results from three phase II trials.
Spina M, Jaeger U, Sparano JA, Talamini R, Simonelli C, Michieli M, Rossi G, Nigra E, Berretta M, Cattaneo C, Rieger AC, Vaccher E, Tirelli U.
Division of Medical Oncology A, National Cancer Institute, Aviano, PN, Italy.
Evidence suggests that infusional therapy is a more effective means for administering cytotoxic therapy than intravenous bolus therapy for lymphoma, and offers greater potential for therapeutic synergy with rituximab, which has a long half-life. We pooled the results of three prospective phase II trials evaluating rituximab in combination with a 96 hour infusion of cyclophosphamide (187.5-200 mg/m(2)/day), doxorubicin (12.5 mg/m(2)/day) and etoposide (60 mg/m(2)/day) (called "R-CDE") plus granulocyte colony-stimulating factor (G-CSF) in 74 patients with human immunodeficiency (HIV)-associated B-cell non-Hodgkin's lymphoma, of whom 56 patients (76%) received concurrent highly active antiretroviral therapy (HAART). The complete remission rate was 70% (95% confidence intervals [CI] 59%-81%), and the estimated 2-year failure-free survival and overall survival were 59% (95% CI 47%-71%) and 64% (95% CI 52%-76%), respectively. Ten patients (14%) had an opportunistic infection during or within three months from the end of R-CDE, and 17 (23%) developed non-opportunistic infections. There were six deaths related to infection (8%), including two from bacterial sepsis during R-CDE (3%), and four opportunistic infections that occurred between 2-8 months after completion of R-CDE (5%). R-CDE produced a 70% CR rate and 59% 2-year failure free survival in patients with HIV-associated lymphoma. Consistent with other reports, addition of rituximab to cytotoxic therapy in this population may increase the risk of life-threatening infection. Further studies evaluating rituximab in combination with infusional chemotherapy are warranted, but need to proceed cautiously.