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 radiotherapy and concomitant HAART was started in previously untreated HD-HIV pts.
Methods: 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, 28 pts have been enrolled. The median age was 39 yrs. The median CD4+ cell count at entry was 256/mm3 (range 44–589) and 15 pts had a detectable HIV viral load (median 9402 copies/mm3, range 89->500000). Stage III and IV disease was present in 19/28 (68%) pts. Histologic subtypes were: MC 75%, NS 14%, not determined 7%, LP 4%. One toxic death, due to hepatic failure in a HCV positive pt was observed. An absolute neutrophil count <500 was noted in 12/28 pts (43%). Grade 3–4 anemia was observed in 8/28 pts (29%) and severe thrombocytopenia in 5/28 pts (18%). Nine pts (32%) had febrile neutropenia with 6 documented infections in 5 pts (one PCP, one cerebral toxoplasmosis, one bacterial sepsis, one bacterial pneumonia, one salmonellosis, one varicella). A grade 2–3 mucositis was observed in 6/28 pts (21%). CR was obtained in 21/28 pts (75%) and PR in 2/28 pts (7%). With a median follow up of 24 months, only 2 pts have relapsed (9%). OS and TTF at 2 years are 86% and 68%, 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.