TreatmentUpdate79 - Vol. 7, No. 9;- July 1997
Sean Hosein
On June 23, an advisory panel of the American Food and Drug Administration voted 8-0 for approving Taxol« (paclitaxel) as a treatment for Kaposi's sarcoma (KS), a cancer that can occur in some people with HIV/AIDS. The panel recommended that Taxol not be used as the therapy of choice for treating KS, but rather as a second option. Currently there is no effective therapy for KS, although interferon-alpha together with AZT, Doxil« (liposomal doxorubicin) and HCG (human chorionic gonadotropin), among others, can provide benefit for some people.
Toxicity
There are concerns both among the advisory panel and some AIDS activists about the toxicity of Taxol which tends to affect the bone marrow, reducing levels of disease-fighting cells called neutrophils. The activists suggest that Taxol only be used together with the bone marrow stimulant G-CSF (Granulocyte-Colony Stimulating Factor), which is also called Neupogen.
Clinical Trials
In reviewing data from clinical trials the FDA's advisory panel felt that improvement occurred in 60% of volunteers, half of whom had about 15 CD4+ cells. This improvement lasted for just over 10 months in 50% of study subjects. The best dose/schedule tested was 135 mg/square metre of skin for "three hours, every three weeks."
Clearly, Taxol is not a cure but can help bring KS under control in some people. Perhaps the next step is to test combinations of Taxol with other drugs such as Doxil«. Taxol is licensed in North America for the treatment of cancer of the breasts and ovaries.
REFERENCE:
1. Anonymous. FDA panel backs KS drug, votes down Non-Hodgkin's drug. Press Release 24 June, 1997.
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