title: Weekly doxorubicin in the treatment of patients with AIDS-related Kaposi's sarcoma. AIDS Clinical Trials Group.
abstract: Fifty-three patients with AIDS-related Kaposi's sarcoma and no previous treatment with cytotoxic chemotherapy enrolled in a phase II multicenter study to evaluate the safety and efficacy of weekly doxorubicin treatment. Doxorubicin was given intravenously at a dose of 15 mg/m2. Patients were stratified for purposes of analyses by tumor burden and coexistence of HIV-associated signs and symptoms; stratum I included patients with cutaneous disease alone and no symptoms, and stratum II included patients with visceral disease, tumor-associated edema, a previous opportunistic infection, or systemic symptoms. Fifty-one patients were evaluable for toxicity and 50 for tumor response. Five patients had a partial response (10%); 32, a minor response (64%); 12, no change (24%); and one, progression (2%) as the best measurable response. Partial response durations ranged from 4 to 14 weeks. Fifteen patients subsequently showed progression while on treatment. A significantly greater number of patients in stratum I (20.1%) had a partial response compared with those in stratum II (0%, p = 0.009). The major toxicities included nausea (37%), stomatitis (9.8%), mucositis (13.7%), and moderate to severe neutropenia (71%). Neutropenia was dose limiting and resulted in discontinuation of doxorubicin in 18% of the patients. Two patients developed cardiac toxicity. In conclusion, doxorubicin treatment induced relatively few tumor responses and remission durations were short. Treatment was limited by a high rate of toxicity.
authors.affiliation: University of Miami School of Medicine, Department of Medicine, FL 33101.
authors.forename: M A
authors.initials: MA
authors.lastname: Fischl
authors.forename: S E
authors.initials: SE
authors.lastname: Krown
authors.forename: K P
authors.initials: KP
authors.lastname: O'Boyle
authors.forename: R
authors.initials: R
authors.lastname: Mitsuyasu
authors.forename: S
authors.initials: S
authors.lastname: Miles
authors.forename: J C
authors.initials: JC
authors.lastname: Wernz
authors.forename: P A
authors.initials: PA
authors.lastname: Volberding
authors.forename: J
authors.initials: J
authors.lastname: Kahn
authors.forename: J E
authors.initials: JE
authors.lastname: Groopman
authors.forename: J
authors.initials: J
authors.lastname: Feinberg
mesh_terms: D017088:AIDS-Related Opportunistic Infections / Q000150:complications; D000163:Acquired Immunodeficiency Syndrome / Q000150:complications*; D000328:Adult; D004317:Doxorubicin / Q000008:administration & dosage* / Q000009:adverse effects; D004334:Drug Administration Schedule; D006801:Humans; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D012514:Sarcoma, Kaposi / Q000097:blood / Q000188:drug therapy* / Q000209:etiology
chemical_list: D004317:Doxorubicin