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Phase II Trial of Infusional Cyclophosphamide, Doxorubicin, and Etoposide in Patients With HIV-Associated Non-Hodgkin’s Lymphoma: An Eastern Cooperative Oncology Group Trial (E1494)

From the Albert Einstein Cancer Center/Montefiore Medical Center, Bronx; Albany Medical College, Albany, NY; Dana-Farber Cancer Institute, Boston; Eastern Cooperative Oncology Group, Brookline, MA; Mayo Clinic, Rochester, MN; Johns Hopkins Oncology Center, Baltimore, MD; University of Pennsylvania Cancer Center, Philadelphia, PA; and Northwestern University Medical Center, Chicago, IL

Address reprint requests to Joseph A. Sparano, MD, Montefiore Medical Center, Weiler Division, 1825 Eastchester Rd,/2 South, Rm 47-48, Bronx, NY 10461; e-mail: jsparano{at}montefiore.org

PURPOSE: To determine the effectiveness of an infusional chemotherapy regimen in patients with HIV-associated lymphoma treated before and after the use of highly active antiretroviral therapy (HAART) in routine clinical practice.

PATIENTS AND METHODS: Ninety-eight assessable patients with HIV-associated intermediate- or high-grade non-Hodgkin’s lymphoma received cyclophosphamide 200 mg/m²/d, doxorubicin 12.5 mg/m²/d, and etoposide 60 mg/m²/d (CDE) given by continuous intravenous infusion for 4 days (96 hours) every 4 weeks plus filgrastim. Concurrent antiretroviral treatment consisted of the nucleoside analog didanosine in the first 43 patients enrolled before December 1996 (pre-HAART group), or HAART in the remaining 55 patients enrolled after that time (HAART group).

RESULTS: Complete response occurred in 44 patients (45%; 95% CI, 35% to 55%). Failure-free survival and overall survival (OS) at 2 years was 36% (95% CI, 26% to 46%) and 43% (95% CI, 33% to 53%), respectively. At the time of the analysis, 30% in the pre-HAART group were alive compared with 47% in the HAART group; when adjusted for varying length of follow-up, patients in the HAART group had improved OS (P = .039). Patients in the HAART group experienced less grade 4 nonhematologic toxicity (22% v 42%; P = .037), thrombocytopenia (31% v 52%; P = .033), and anemia (9% v 27%; P = .021), and had fewer treatment-associated deaths (0% v 10%; P = .013).

CONCLUSION: Infusional CDE is an effective and potentially curative regimen for patients with HIV-associated lymphoma. Patients treated in the HAART era have less chemotherapy-associated toxicity and improved survival.

This study was conducted by the Eastern Cooperative Oncology Group (Robert L. Comis, MD, Chair) and supported in part by Public Health Service grants CA14958, CA23318, CA13650, CA 16116, CA15488, CA17145, CA66636, CA21115 from the National Cancer Institute, National Institutes of Health, and the Department of Health and Human Services. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.

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

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