EFFICACY OF PEGYLATED-LIPOSOMAL DOXORUBICIN IN THE TREATMENT OF AIDS-RELATED KAPOSIS-SARCOMA AFTER FAILURE OF STANDARD CHEMOTHERAPY

Purpose: To determine the efficacy and safety of pegylated-liposomal d oxorubicin in patients with AIDS and Kaposi's sarcoma (AIDS-KS) who ex perienced failure of standard chemotherapy. Methods: Fifty-three patie nts with advanced AIDS-KS who experienced disease progression or intol erable toxicities white receiving standard doxorubicin/bleomycin/vincr istine (ABV) or bleomycin/vincristine (BV) chemotherapy were identifie d from a cohort of patients who were then treated with pegylated-lipos omal doxorubicin. Patients received 20 mg/m(2) pegylated-liposomal dox orubicin (Doxil; Sequus Pharmaceuticals, inc, Menlo Park, CA) every 3 weeks. Results: Nineteen patients (36%) had a partial response (PR) an d one patient herd a clinical complete response (CCR). The median dura tion of response and time (from study entry) to treatment failure were 128 and 134 days, respectively. Of 28 patients who experienced diseas e progression while receiving combination regimens that contained stan dard doxorubicin, the PR rate was 32%, which suggests that the pegylat ed-liposomal encapsulation increases the therapeutic effect of doxorub icin. Patients obtained clinical benefits such as flattening of lesion s (48%), improved lesion color (56%), relief of pain (45%), and loss o f edema (83%). Forty-nine percent of patients had more than one clinic al benefit. The most common adverse effect was leukopenia, which occur red in 40% of patients. Only 15% of patients had nausea and/or vomitin g, none of which was severe; 9% experienced alopecia, also generally m ild. Conclusion: Pegylated-liposomal doxorubicin offers a new alternat ive for treatment of patients who have experienced failure of standard chemotherapy for AIDS-KS. (C) 1996 by American Society of Clinical On cology.