Journal of Clinical Oncology, Vol 13, 914-920, Copyright © 1995 by American Society of Clinical Oncology
Liposomal-entrapped doxorubicin: an active agent in AIDS-related Kaposi's sarcoma
M Harrison, D Tomlinson and S Stewart
Department of Oncology, St Mary's Hospital, London, United Kingdom.
PURPOSE: A phase II study was performed of single-agent liposomally
entrapped doxorubicin ([LED] Doxil; Liposome Technology Inc, Menlo Park,
CA) against locally advanced cutaneous/systemic AIDS-related Kaposi's
sarcoma (KS). PATIENTS AND METHODS: Thirty-four patients with AIDS-related
advanced cutaneous/systemic KS were treated with 20 mg/m2 of LED every 3
weeks on an outpatient basis. The median age was 39 years and the median
Karnofsky score was 70. All patients had poor prognostic disease as judged
by AIDS Clinical Trials Group (ACTG) criteria. Nineteen of 34 patients had
received prior chemotherapy for KS, although no patient had received prior
anthracyclines. RESULTS: An overall response rate of 73.5% (25 of 34) was
observed. Partial responses (PRs) occurred in 67.7% (23 of 34) and complete
responses (CRs) in 5.8% (two of 34). In patients who had received previous
chemotherapy, the response rate was 68.4% (13 of 19), and all responses
were PRs. The median time to response was 6 weeks. The median duration of
response was 9 weeks. Toxicity according to World Health Organization (WHO)
criteria was as follows: neutropenia (grade > or = 3), 34%; alopecia
(grade 1 only), 9%; and nausea and vomiting (grade 1), 18%. One patient
died of heart failure, which was not considered to be
anthracycline-induced. CONCLUSION: LED appears to be highly active against
AIDS-related KS. The major toxicity is neutropenia, which seems to be
progressive in patients who receive several cycles of therapy. Comparative
studies of LED versus conventional chemotherapy are needed.

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