PHASE-II TRIAL OF LIPOSOMAL DAUNORUBICIN IN THE TREATMENT OF AIDS-RELATED PULMONARY KAPOSIS-SARCOMA

Purpose: Kaposi's sarcoma (KS) is the most common tumor in patients wi th AIDS and can be fatal in patients with lung involvement. Systemic c hemotherapy is the most effective treatment for pulmonary KS. We thus conducted this study to determine the efficacy of liposomal daunorubic in in the treatment of patients with pulmonary KS. Methods: Patients w ith biopsy-proven, symptomatic pulmonary KS were accrued. Liposomal da unorubicin was given at a dose of 60 mg/m(2) intravenously every 2 wee ks. Response wets monitored by chest radiographs, pulmonary function t ests, arterial blood gases, and grading of pulmonary symptoms. Results : Fifty-three male patients were accrued. The median CD4(+) lymphocyte count was 13/mu L (range, 0 to 200); 70% reported a prior AIDS-defini ng opportunistic infection. All patients were symptomatic, with cough reported in all patients, shortness of breath in 94%, and hemoptysis i n 55%. The mean study entry diffusing capacity of carbon monoxide (DLC O) was 58.5% (percent of predicted). The median dose of liposomal daun orubicin delivered was 360 mg/m(2) (range, 60 to 1,380). More than 75% of patients had complete or partial resolution of baseline pulmonary symptoms. Complete or partial improvement in DLCO was observed in 22%; complete or partial resolution of radiographic abnormalities was repo rted in 32%. The most common treatment-related toxicity was neutropeni a, which occurred in 85%. There were no instances of cardiac toxicity observed, even at high cumulative doses. Conclusion: Liposomal daunoru bicin at 60 mg/m(2) is safe and active in patients with pulmonary KS. Trials combining liposomal daunorubicin with other active agents in KS should be considered. (C) 1998 by American Society of Clinical Oncolo gy.