Proc Annu Meet Am Soc Clin Oncol; 16:A189 1997. Unique Identifier : AIDSLINE MED/97621061 Gill PS; Wernz J; Myers A; Scadden D; Espina B; Mukwaya G; Sandhaus R; University of Southern California, Los Angeles, CA
Abstract:
An open-label Phase II clinical trial was conducted to evaluate the safety and efficacy of liposomal daunorubicin (DaunoXome) in 53 patients with AIDS-related pulmonary Kaposi's sarcoma (KS). Forty-eight patients (91%) had pulmonary KS diagnosed by bronchoscopy and/or lung biopsy. Each patient received DaunoXome at a dose of 60 mg/m2 intravenously every two weeks. Response to therapy was evaluated in each of three areas: anatomical (chest X-ray, chest CT scan, bronchoscopy); functional (pulmonary function tests, arterial blood gases, carbon monoxide diffusing capacity [Dlinf]) and symptomatology (cough, chest pain, hemoptysis, shortness of breath). Anatomic response (A) was defined as a moderate to marked improvement in chest X-rays or chest CT scans. Functional response (F) was a 10% or more increase in the percent predicted value for Dlinf. Symptomatic response (S) was a 50% or more reduction in the cumulative score of all symptoms. Each response had to be sustained for 4 weeks or more. The median baseline CD4 count was 14 cells/mL (range 0-200). Patients received a median of 6 cycles of DaunoXome range 1-23). Of the evaluable patients, 15/43 (35%) had a complete or partial (A) response, 11/26 (42%) had a partial (F) response and 22/46 (48%) had a complete or partial (s) response. There were 12 patients who had a response in 2 or more areas. Median survival was 154 days with 5 patients living beyond one year. The most common adverse events were fever (53%), fatigue 51%), nausea (49%), vomiting (32%), and diarrhea (32%). The most common laboratory abnormalities were neutropenia (85%), anemia 32%), thrombocytopenia (19%), and increased alkaline phosphatase 19%). No serious allergic reactions were reported. In conclusion, DaunoXome at 60 mg/m2 every 2 weeks is effective in the treatment of patients with HIV-related pulmonary Kaposi's sarcoma with acceptable toxicity. (C) American Society of Clinical Oncology 1997
Keywords: *Antibiotics, Anthracycline/THERAPEUTIC USE *AIDS-Related Opportunistic Infections/DRUG THERAPY *Daunorubicin/THERAPEUTIC USE *Lung Neoplasms/DRUG THERAPY *Sarcoma, Kaposi/DRUG THERAPY 971130
M97B1211
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