Long-Term Follow-up of Rituximab and Infusional Cyclophosphamide, Doxorubicin, and Etoposide (cde) in Combination with HAART in HIVRelated Non-Hodgkin’s Lymphomas (NHL).

Background: The combination of Rituximab plus chemotherapy (CT) is more effective than CT alone in the treatment of high grade NHL.

Objective: To report the long-term follow-up of CDE plus Rituximab in HIV-NHL.

Methods: 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 weeks and Rituximab 375 mg/m² i.v. on day 1. HAART was given concomitantly with CT.

Results: Seventy-four patients (pts) have been enrolled. The median CD4+ cell count was 161 (range 3–691) and the median Performance Status was 1 (range 0–3). Diffuse large B-cell NHL was diagnosed in 72% of pts and Burkitt in 28%. Seventy per cent of pts had advanced stage (III–IV) disease and 57% of pts had an age-adjusted international prognostic index ³2. Fifty-two out of 74 pts (70%) achieved a complete remission (cr), 4/74 (5%) had a partial remission and 18 pts progressed. With a median follow-up of 61 months, only 17% of CRs have relapsed and 41/74 pts are alive. The overall survival, disease free survival and time to treatment failure (TTF) at 5 years were 56%, 81% and 52%, respectively. Only one secondary tumor (acute leukemia) has been observed. No case of late pulmonary or cardiac toxicity has been reported.

Conclusions: The combination of Rituximab and CDE in HIV-NHL treated concomitantly with HAART is very active. CR rate (70%) and TTF at 5 years (52%) are comparable to those observed in high grade NHL of the general population. Our data confirm that in HAART era a high proportion of HIV-NHL can be cured. This study was supported by ISS grants.