Journal of Clinical Oncology, Vol 16, 3369-3374, Copyright © 1998 by American Society of Clinical Oncology
Phase II trial of liposomal daunorubicin in the treatment of AIDS- related pulmonary Kaposi's sarcoma
A Tulpule, RC Yung, J Wernz, BM Espina, A Myers, DT Scadden, S Cabriales, M Ilaw, W Boswell and PS Gill
Department of Medicine, Kenneth Norris Cancer Hospital and Research Institute, University of Southern California School of Medicine, Los Angeles 90033, USA.
PURPOSE: Kaposi's sarcoma (KS) is the most common tumor in patients with
AIDS and can be fatal in patients with lung involvement. Systemic
chemotherapy is the most effective treatment for pulmonary KS. We thus
conducted this study to determine the efficacy of liposomal daunorubicin in
the treatment of patients with pulmonary KS. METHODS: Patients with
biopsy-proven, symptomatic pulmonary KS were accrued. Liposomal
daunorubicin was given at a dose of 60 mg/m2 intravenously every 2 weeks.
Response was monitored by chest radiographs, pulmonary function tests,
arterial blood gases, and grading of pulmonary symptoms. RESULTS:
Fifty-three male patients were accrued. The median CD4+ lymphocyte count
was 13/microL (range, 0 to 200); 70% reported a prior AIDS-defining
opportunistic infection. All patients were symptomatic, with cough reported
in all patients, shortness of breath in 94%, and hemoptysis in 55%. The
mean study entry diffusing capacity of carbon monoxide (DLCO) was 58.5%
(percent of predicted). The median dose of liposomal daunorubicin delivered
was 360 mg/m2 (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 reported in 32%. The most common
treatment-related toxicity was neutropenia, which occurred in 85%. There
were no instances of cardiac toxicity observed, even at high cumulative
doses. CONCLUSION: Liposomal daunorubicin at 60 mg/m2 is safe and active in
patients with pulmonary KS. Trials combining liposomal daunorubicin with
other active agents in KS should be considered.
