AIDS TREATMENT NEWS Issue #208, October 7, 1994
John S. James
DOX-SL has been submitted to the FDA for possible marketing approval, according to a September 7 announcement by Liposome Technology, Inc. (LTI), of Menlo Park, California. According to treatment activists who have closely followed this drug, it is likely to be considered by an FDA advisory committee either in December, or at a special meeting, probably in February.
A recent trial at several U.S. medical centers studied 42 patients with KS who had failed conventional chemotherapy, either because of toxicity, or because it did not work for them. With DOX-SL there were no complete responses, 66.7% partial responses, 31% stable disease, and 2.3% progressive disease.(1)
Another recent trial, reported at Yokohama, treated 247 patients with moderate or severe KS, but who had not necessarily failed other chemotherapy. With these patients, who were probably less seriously ill than those in the trial above, the best response reported for each person was 6.3% complete response, 74.4% partial response, 18.4% stable disease, and 0.8% progression.(2)
Several other trials of liposomal doxorubicin have also been published.
In the U.S., DOX-SL is available in an open-label trial for patients who cannot be treated with conventional chemotherapy. This trial, called protocol 30-12, requires the treatment to be given at one of the trial sites, so that the required data can be collected. LTI hopes to replace this trial with an open-label safety study, which will collect much less data, and therefore could allow patients not near a study site to receive the drug through their regular physician. For more information about protocol 30-12 (or the new safety trial, if and when it begins), call LTI, 415/323- 9011, and ask for the medical department.
Comment
We are continuing to hear good reports about DOX-SL from physicians and patients who have used it.
For background about KS and its treatments, see The KS Project Report: Current Issues in Research and Treatment of Kaposi's Sarcoma, an 85-page report by Michael Marco and Marty Majchrowicz, published in July 1994 by the Treatment Action Group (TAG). Copies are available from TAG, 147 2nd Ave., Suite 601, New York, NY 10003, 212/260-0300. A $10 donation is requested, but no one will be denied the report due to lack of funds.
References
1. Thommes J, Northfelt D, Rios A, and others. Open-label trial of Stealth liposomal doxorubicin in the treatment of moderate to severe AIDS-related Kaposi's sarcoma. Proceedings of the Annual Meeting of the American Society for Clinical Oncology. 1994; volume 13, abstract 24.
2. S Stewart (for the International DOX-SL Study Group). Efficacy and safety of Stealth liposomal doxorubicin in AIDS- related Kaposi's Sarcoma. Tenth International Conference on AIDS, Yokohama, August 7-12, 1994 [abstract #PB 0123; data above from poster at the meeting].
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