title: Phase I AIDS Clinical Trials Group (075) study of adriamycin, bleomycin and vincristine chemotherapy with zidovudine in the treatment of AIDS-related Kaposi's sarcoma.
abstract: OBJECTIVE
  To determine the toxicity and maximum tolerated dose of doxorubicin (adriamycin) in combination with fixed doses of bleomycin, vincristine (ABV) and zidovudine in patients with advanced AIDS-related Kaposi's sarcoma.
  
  
  METHODS
  Twenty-six HIV-seropositive men with Kaposi's sarcoma were treated daily with 100 mg zidovudine orally every 4 h, along with combination chemotherapy using bleomycin 10 U/m2 and vincristine 1.4 mg/m2 (maximum, 2 mg) given intravenously in 2-week cycles. In addition, three successive cohorts of eight patients received escalating doses of doxorubicin each beginning with no doxorubicin (level I), doses of 10 mg/m2 (level II), and 15 mg/m2 (level III).
  
  
  RESULTS
  The major dose-limiting toxicity experienced with the combination therapy was severe neutropenia in eight patients, four of whom received level III doxorubicin (15 mg/m2). Therefore, 10 mg/m2 of doxorubicin in combination with zidovudine and BV chemotherapy was defined as the maximum tolerated dose. Other dose-limiting toxicities included neuropathy (n = 2), cutaneous toxicity associated with bleomycin (n = 1), and diarrhea (n = 1). Seventeen patients (71%; 95% confidence interval, 46-85) experienced either partial (n = 13) or clinical complete remission (n = 4) to therapy after a median of five cycles (range, 2-9).
  
  
  CONCLUSIONS
  The maximum tolerated dose of doxorubicin is 10 mg/m2 when given in combination with zidovudine and BV chemotherapy. Response rates observed with the combined antiretroviral and chemotherapy regimen are similar to those previously reported with ABV chemotherapy alone.
authors.affiliation: Department of Internal Medicine, University of Southern California School of Medicine, Los Angeles.
authors.forename: P S
authors.initials: PS
authors.lastname: Gill
authors.forename: S A
authors.initials: SA
authors.lastname: Miles
authors.forename: R T
authors.initials: RT
authors.lastname: Mitsuyasu
authors.forename: T
authors.initials: T
authors.lastname: Montgomery
authors.forename: S
authors.initials: S
authors.lastname: McCarthy
authors.forename: B M
authors.initials: BM
authors.lastname: Espina
authors.forename: M
authors.initials: M
authors.lastname: Feldstein
authors.forename: A M
authors.initials: AM
authors.lastname: Levine
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000150:complications* / Q000276:immunology; D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D001761:Bleomycin / Q000008:administration & dosage; D001853:Bone Marrow / Q000187:drug effects; D018791:CD4 Lymphocyte Count; D015331:Cohort Studies; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects; D004361:Drug Tolerance; D006801:Humans; D008297:Male; D009503:Neutropenia / Q000139:chemically induced; D010292:Paresthesia / Q000139:chemically induced; D012514:Sarcoma, Kaposi / Q000188:drug therapy* / Q000209:etiology*; D014750:Vincristine / Q000008:administration & dosage; D015215:Zidovudine / Q000008:administration & dosage*
chemical_list: D001761:Bleomycin; D015215:Zidovudine; D014750:Vincristine; D004317:Doxorubicin