Second International Congress Drug Therapy in HIV Infection 18-22 November 1994 Glasgow, UK

EFFICACY AND SAFETY OF STEALTH® LIPOSOMAL DOXORUBICIN (DOX-SL™) IN AIDS-RELATED KAPOSI'S SARCOMA

JSW Stewart*, F Antunes, JCC Borleffts, W Brockhaus, D Cooper, JTh Fischer, FD Goebel, M Goos, H Jablonowski, P Kern, H Knechten, M L'Age, R Luethy, BK Mandal, WN Meigel, F Milazzo, PS Mitrou, I Schedel, N Spannbrucker, MF Spittle, HJ Stellbrink
The International DOX-SL Study Group, *St Mary'sHospital,London,UK

Int Cong Drug Therapy HIV 1994 Nov 18-22;2:Abstract No. 10.1
AIDS 1994, Vol. 8 (Suppl. 4);S8

OBJECTIVE: The utility of current chemotherapeutic regimens in the treatment of AIDS-related Kaposi's sarcoma (AIDS-KS) is often compromised by both limited efficacy and substantial toxicity. DOX-SL, a long-circulating, liposomally encapsulated doxorubicin, has been demonstrated to specifically deliver high concentrations of doxorubicin to KS lesions. This phase II study was therefore performed to evaluate the efficacy and safety of DOX-SL in the treatment of moderate to severe AIDS-KS.

METHODS: Patients were treated biweekly with DOX-SL, in almost all cases at 10 or 20mg/m². Lesion response was assessed according to ACTG criteria prior to each cycle.

RESULTS: Best response was determined for 196 patients and was achieved after a mean of 2.5 cycles (range 1-20). Thirteen patients (6.6%) had a complete response (CR) to DOX-SL, 143 (73.0%) had a partial response (PR), 38 (19.4%) had stable disease while 2 (1.0%) had disease progression. The degree of response to DOX-SL did not appear to correlate with dose. Mean response duration (measured from the time of best response) was 95.6 days (range 4-451) for PRs and/or CRs and 53.9 (range: 25-77) for CRs. DOX-SL was well-tolerated: only 6 patients discontinued therapy because of adverse events during the first 6 cycles.

CONCLUSIONS: 1) DOX-SL has substantial activity in AIDS-KS; 2) DOX-SL is well-tolerated, and may lack much of the toxicity of free doxorubicin; 3) Further study of DOX-SL in AIDS-KS is justified.

Presenting author: JSW Stewart*

1994-11-18
10.1

Originally published in AIDS Volume 8, Supplement 4 and hosted with permission of the publisher Lippincott Williams & Wilkins, 250 Waterloo Road, London, SE1 8RD, UK. Tel: +44 (0)20 7981 0700 Fax: +44 (0) 7981 0701

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