Stanford V and HAART Feasible in HIV Patients With Hodgkin's Disease

ORLANDO—Use of highly active antiretroviral therapy (HAART) has significantly changed the prognosis of human immunodeficiency disease (HIV). However, the outcomes of patients with Hodgkin’s disease (HD) in the HIV setting are still poor. According to Michele Spina, MD, this is mainly due to the short duration of complete response.

Dr. Spina, of the Division of Medical Oncology, National Cancer Institute, Aviano, Italy, was lead author of a study of previously untreated HIV-infected patients with Hodgkin’s disease presented at a poster session of the 43rd Annual Meeting of the American Society of Hematology (ASH abstract 573).

Intensive Regimen

Patients received an intensive 12-week chemotherapy protocol (Stanford V) with adjuvant radiotherapy and concomitant HAART. Patients had bulky limited disease or stage III/IV disease. Of the original 49 patients enrolled in the study, 46 were evaluable for toxicity and 45 for response.

The chemotherapy regimen included doxorubicin 25 mg/m² and vinblastine 6 mg/m² on weeks 1, 3, 5, 7, 9, and 11; mechlorethamine (Mustargen) 6 mg/m² on weeks 1, 5, and 9; etoposide (VePesid) 60 mg/m² on days 1 and 2 on weeks 3, 7, and 11; vincristine 1.4 mg/m² with a maximum dose of 2 mg and bleomycin (Blenoxane) 5 mg/m² on weeks 2, 4, 6, 8, 10, and 12. Prednisone was administered every other day.

The median age of the patients was 36 years (range, 28 to 63 years). "All patients but five were males," Dr. Spina said. "Twenty patients were intravenous drug users, and there were 14 homosexuals and 12 heterosexuals among the cohort." The median CD4+ cell count at time of entry to the study was 225/mm³ (range, 32 to 1,008); 27 the patients had a detectable HIV viral load (median, 3,600 copies/mm³). Stage III and IV disease was present in 33 patients (72%).

Study Results

Dr. Spina and his colleagues found reasonable activity in the chemotherapy and HAART combination. They observed a complete response in 37 patients (82%) and a partial response in 4 patients (9%). Seven of the complete response patients later relapsed. The actuarial overall survival and disease-free survival rates at 2 years are 57% and 66%, respectively.

Although there were no toxic deaths, other significant events were associated with the regimen, Dr. Spina said. An absolute neutrophil count less than 500 was noted in 37 patients (80%). Grade 4 anemia was seen in 20 (43%). More problematic events were seen among 8 patients (17%) who presented with severe thrombocytopenia. Also, 13 patients (28%) had febrile neutropenia with three documented cases of bacterial sepsis.

"Our preliminary data demonstrate that the abbreviated chemotherapy regimen (Stanford V) in combination with HAART is a feasible and active treatment in HIV-infected patients with Hodgkin’s disease. This study also demonstrates that further examination of this approach is warranted," Dr. Spina concluded.