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

LIPOSOMAL ANTHRACYCLINE THERAPY OF KAPOSI'S SARCOMA (KS). OVERVIEW OF PILOT AND MULTICENTER PHASE 2 TRIALS.

PROF. C. A. Presant
California Cancer Medical Center and Los Angeles Oncologic Institute, Los Angeles, California, USA

Int Cong Drug Therapy HIV 1994 Nov 18-22;2:Abstract No. 13-4
AIDS 1994, Vol. 8 (Suppl. 4);S11

Prior studies by us indicated that radiolabelled liposomes accumulated preferentially in KS and lymphoma nodules in AIDS patients (Lancet. 1990 Jun 2;335(8701):1307-9.). We performed a study of liposomal daunorubicin (LD) 40 mg/m² every 2 wk. in 25 patients (pts) with KS. There were 2 complete remissions (CR) and 13 partial remissions (PR). 5 of 6 pts refractory to prior doxorubicin (A) and 7 of 10 pts with visceral KS (VKS) had a CR or PR. The median duration of remission was 4.0 mo. Quality of life improved in 74% of pts based on self-assessment scores.

Confirmatory phase 2 studies have been performed in 135 pts with poor risk KS (coordinated by Vestar, Inc., San Dimas, CA, USA), and 123 are evaluable. 65% achieved PR and 1.6% CR (74% of 66 pts with no prior chemotherapy [CT]; 58% of 57 pts with prior CT; 35% of 17 pts with prior A). CR or PR was seen in 64% of pts with CD4 < 200; 75 % of pts with CD4> 200; 59% of 7l pts with VKS. The median duration of treatment was 172 d: 193 d for pts with no prior CT; 158 d for pts with prior CT; 141 d for pts with prior A; 182 d for pts with VKS; 154 d for pts with CD4 < 200; 202 d for pts with CR or PR. Performance status did not decrease with longer duration of therapy. Dose limiting toxicity was myelosuppression: grade 3 or 4 leukopenia in 21.4% of cycles. Left ventricular ejection fractions did not decrease with longer therapy. Grade 2, 3 or 4 toxicity was observed in 10.4% (fatigue), 4.2% (nausea), 1.0% (alopecia), 0.4% (alopecia), and 2.2% (vomiting).

A study with liposomal A (LA) shows confirmatory results; In 16 pts there were II PR, including 5 of 10 with VKS, and 7 of 12 with prior CT (Clin Oncol (R Coll Radiol). 1993;5(6):372-4.).

These results indicate frequent control by LD or LA of KS in poor risk pts with KS, with good quality of life response and little toxicity. Comparative trials of liposomal and nonliposomal chemotherapy are in progress. Liposomal chemotherapy should be considered a standard treatment in pts with drug-resistant KS.

Presenting author: PROF. C. A. Presant

1994-11-18
13.4

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

Copyright © 1994 - Lippincott Williams & Wilkins. All rights reserved. All abstracts from the 2nd International Congress Drug Therapy in HIV Infection, appearing on the AEGiS web site, are protected by United States copyright law and may not be reproduced, distributed, transmitted, displayed, or otherwise published without the prior written permission of Lippincott Williams & Wilkins. You may not alter or remove any trademark, copyright or other notice. However, provided that you maintain all copyright and other notices contained therein, you may download material (one machine readable copy and one print copy per page) for your personal, non-commercial use only.

http://www.aidsonline.com http://www.ovid.com