title: Combined antineoplastic and antiretroviral therapy for patients with Hodgkin's disease and human immunodeficiency virus infection. A prospective study of 17 patients. The Italian Cooperative Group on AIDS and Tumors (GICAT).
abstract: BACKGROUND
  The optimal therapeutic approach for patients with Hodgkin's disease (HD) and human immunodeficiency virus (HIV) infection is unknown. In an attempt to improve the results obtained with standard chemotherapy and to decrease the occurrence of opportunistic infections (OI) during chemotherapy and follow-up observed in a previous experience, the authors designed a prospective combined antineoplastic and antiretroviral approach.
  
  
  METHODS
  Between March 1989 and March 1992, 17 consecutive previously untreated patients (median age, 30 years) with HD and HIV infection were enrolled. They had Stage III and IV or Stage I and II disease with adverse prognostic factors. The median CD4+ cell count was 184/microliters. Patients were stratified in two groups and treated accordingly. Group A was made up of patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of less than 3 and without OI. These patients received epirubicin 70 mg/m2 intravenously on day 1, bleomycin 10 mg/m2 IV on day 1, and vinblastine 6 mg/m2 IV on day 1 (regimen EBV). Group B was made up of patients with PS of 3 or greater or previous OI who had received a 50% reduced dose of epirubicin and vinblastine and a full dose of bleomycin. Courses were repeated every 21 days for six cycles. Zidovudine was given at the dose of 500 mg/day from the beginning of chemotherapy in Group B and after the third cycle in Group A.
  
  
  RESULTS
  Overall, 14 of 17 (82%) patients had an objective response and 9 of 17 (53%) achieved a complete remission (CR) of disease for a median duration of 20 months. Toxicity was moderate with Grade 3-4 leukopenia in eight patients and Grade 3 thrombocytopenia in one patient. Thirteen of 17 patients received zidovudine as planned with a median duration of 9 months. Only one patient had OI during or after chemotherapy (median follow-up, 11 months). No worsening of HIV markers during the combined therapy was seen, with the median CD4+ cell count before and after therapy being 184/microliters and 203/microliters, respectively. The median survival time was 11 months, with an actuarial survival rate of 48% at 36 months. The median survival time for the nine patients with CR has not been reached at the time of this analysis.
  
  
  CONCLUSIONS
  These results revealed the feasibility and the activity of the combination of EBV regimen and zidovudine. Objective response rate seems similar to those previously observed in patients receiving standard chemotherapy, but only one patient had OI, and this compares favorably with the 16 OI observed in 28 patients treated with standard chemotherapy (6% versus 57%) in the authors' previous experience. Thus, it seems that the addition of antiretroviral therapy to the EBV regimen decreased the occurrence of OI during chemotherapy or follow-up.
authors.affiliation: Division of Medical Oncology, Centro di Riferimento Oncologico, Aviano, Italy.
authors.forename: D
authors.initials: D
authors.lastname: Errante
authors.forename: U
authors.initials: U
authors.lastname: Tirelli
authors.forename: R
authors.initials: R
authors.lastname: Gastaldi
authors.forename: D
authors.initials: D
authors.lastname: Milo
authors.forename: A M
authors.initials: AM
authors.lastname: Nosari
authors.forename: G
authors.initials: G
authors.lastname: Rossi
authors.forename: G
authors.initials: G
authors.lastname: Fiorentini
authors.forename: A
authors.initials: A
authors.lastname: Carbone
authors.forename: E
authors.initials: E
authors.lastname: Vaccher
authors.forename: S
authors.initials: S
authors.lastname: Monfardini
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D001761:Bleomycin / Q000008:administration & dosage; D004359:Drug Therapy, Combination; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy* / Q000401:mortality; D006689:Hodgkin Disease / Q000150:complications / Q000188:drug therapy* / Q000401:mortality; D006801:Humans; D016483:Lymphoma, AIDS-Related; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D014747:Vinblastine / Q000008:administration & dosage; D015215:Zidovudine / Q000008:administration & dosage*
chemical_list: D001761:Bleomycin; D015251:Epirubicin; D015215:Zidovudine; D014747:Vinblastine