VEBEP Regimen and Highly Active Antiretroviral Therapy (HAART) in Patients (pts) with HD and HIV Infection (HD-HIV): Final Results of the Italian Cooperative Group on AIDS and Tumors (GICAT) Study.

Background: The outcome of pts with HD-HIV is still poor, because the duration of complete remission (CR) is short. To improve the prognosis of HD-HIV, a feasibility study with the VEBEP regimen and HAART was started in previously untreated HD-HIV pts.

Methods: Chemotherapy (CT) included epirubicin 30 mg/m²/day (days 1–3), cyclophosphamide 1000 mg/m² (day 1), vinorelbine 25 mg/m² (day 1), bleomycin 10 mg/m² (day 3) and prednisone 100 mg/m²/day (days 1–3).

Results: Since September 2001, 71 pts have been enrolled. The median age was 41 yrs. The median CD4⁺ cell count was 248/mm³ and 51% of pts had a detectable HIV viral load. Stage III–IV was present in 50/71 (70%) pts. Histologic subtypes were: MC 70%, NS 20%, LD 4%, LP 2%, unknown 4%. Four toxic deaths were observed (septic shock, PCP, hepatic failure and pneumonia during neutropenia). An absolute neutrophil count <500 was noted in 60% of pts. Grade 3–4 anemia was observed in 38% of pts and severe thrombocytopenia in 22% of pts. Twenty-two per cent of pts had febrile neutropenia with 19 documented infections in 16 pts (4 varicella, 4 bacterial pneumonia, 3 bacterial sepsis, 2 PCP, 1 cerebral toxoplasmosis, 1 esophageal candidiasis, 1 HBV reactivation, 1 HCV reactivation, 1 prostatitis, 1 salmonellosis). CR was obtained in 47/71 pts (66%) and PR in 9/71 pts (13%). With a median follow up of 22 months, only 4 pts have relapsed. OS and TTF at 24 months are 69% and 59%, respectively.

Conclusions: Our preliminary data demonstrate that VEBEP regimen in combination with HAART is feasible and active in pts with HD-HIV. This study was supported by ISS grants.