10th Conference on Retroviruses and Opportunistic Infections Boston, MA USA - February 10 -14, 2003

Conf Retroviruses Opportunistic Infect 2003 Feb 10-14;10th: abstract no. 804
U. Tirelli¹ , M. Spina¹, D. Bernardi¹, E. Vaccher¹, C. Simonelli¹, U. Jaeger², J. A. Sparano^3
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.

CONCLUSIONS: 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.

030210
804

Copyright © 2003 - Foundation for Retrovirology and Human Health. Reproduction of this abstract (other than one copy for personal reference) must be cleared through the Foundation for Retrovirology and Human Health. Licensed (AIDSLINE) from National Library of Medicine.