Session 100Poster Presentations HIV/AIDS-Related Lymphoma Session Day and Time: Wednesday 1:30 - 3:30 pm Room: Hall B
804 Rituximab and Infusional Cyclophosphamide, Doxorubicin, and Etoposide: A Safe and Highly Active Regimen in HIV-related Non-Hodgkin's Lymphomas U. Tirelli*1, M. Spina1, D. Bernardi1, E. Vaccher1, C. Simonelli1, U. Jaeger2, J. A. Sparano3 1Ctr di Riferimento Oncologico, Aviano, Italy; 2Univ of Vienna, Austria; and 3Montefiore Med Ctr, Bronx, NY
Background: Recent data suggest that the combination of rituximab plus chemotherapy (CT) is more effective in the treatment of high grade Non-Hodgkin's Lymphomas (NHL).
Methods: With the aim to evaluate the efficacy and activity of combining infusional Cyclophosphamide, Doxorubicin, and Etoposide (CDE) plus rituximab, in June 1998 we started a phase II study using infusional CDE (cyclophosphamide 187.5 mg/m2/day, doxorubicin 12.5 mg/m2/day and etoposide 60 mg/m2/day) administered by continuous intravenous infusion for 4 days every 4 wks for up to 6 cycles and rituximab 375 mg/m2 IV on day 1 prior to each CDE. Highly active antiretroviral therapy (HAART) was given concomitantly with CT, irrespectively of CD4+ cell count and HIV viral load.
Results: From June 1998 to October 2001, 41 patients (pts) have been enrolled and 38 pts are evaluable for response and toxicity. Thirty-five (35) pts (85%) were males and median age was 38 yrs (range 29-65). The median CD4+ cell count was 120 (range 3-578) and the median Performance Status (ECOG) was 1 (range 0-2). Sixty-one percent (61%) of pts had advanced stage (III-IV) disease and 49% had B symptoms. Twenty-nine (29) out of 38 pts (76%) achieved a complete remission (CR), 2/38 (5%) had a partial remission and 7 pts progressed. Only 3 pts out of 29 CRs have relapsed and 32/41 pts are alive. The major cause of death was NHL (8/9 pts). Grade 3-4 neutropenia, anemia, and thrombocytopenia were observed in 80%, 37%, and 29% of pts, respectively. Twenty-nine percent (29%) of pts developed bacterial infections during neutropenia. No toxic death was observed. With a median follow-up of 12 months, the actuarial overall survival and progression-free survival at 2 yrs were 70% and 86%, respectively.
Conclusion: The combination of rituximab and infusional CDE in pts with HIV-associated NHL is safe and feasible, even if there is an increase in bacterial infections. Based on CR rate (76%) and progression-free survival at 2 yrs (86%), this regimen seems highly active as well.
