Document 0933
 DOCN  M9440933
 TI    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).
 DT    9404
 AU    Errante D; Tirelli U; Gastaldi R; Milo D; Nosari AM; Rossi G; Fiorentini
       G; Carbone A; Vaccher E; Monfardini S; Division of Medical Oncology,
       Centro di Riferimento Oncologico,; Aviano, Italy.
 SO    Cancer. 1994 Jan 15;73(2):437-44. Unique Identifier : AIDSLINE
       MED/94123248
 AB    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.
 DE    Adult  Antineoplastic Agents, Combined/*ADMINISTRATION & DOSAGE
       Bleomycins/ADMINISTRATION & DOSAGE  Drug Therapy, Combination
       Epirubicin/ADMINISTRATION & DOSAGE  Female  Hodgkin's
       Disease/COMPLICATIONS/*DRUG THERAPY/MORTALITY  Human  HIV
       Infections/COMPLICATIONS/*DRUG THERAPY/MORTALITY  Lymphoma, AIDS-Related
       Male  Middle Age  Prospective Studies  Support, Non-U.S. Gov't
       Vinblastine/ADMINISTRATION & DOSAGE  Zidovudine/*ADMINISTRATION & DOSAGE
       CLINICAL TRIAL  JOURNAL ARTICLE

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