AEGiS-CATIE: A warning about a KS drug

A warning about a KS drug

TreatmentUpdate83 - Vol. 9, No. 9 - pp. 4-5; November 1997
Sean Hosein

Daunorubicin is a drug used to treat leukemia. Recently it has been reformulated--the drug has been packed into tiny balls of "fatty material" called liposomes. In its new liposomal form, daunorubicin is called DaunoXome. Recently, the drug appeared to have activity in PHAs with less than 20 KS lesions. Although the drug clearly delays the growth and spread of KS lesions by at least 90 days, it may reduce survival compared to PHAs with KS who did not receive the drug. The Food and Drug Administration in the USA recommends that DaunoXome not be used in people who have "early" KS.

Study Details

The study reported data on PHAs with "early" KS. By that term doctors meant people with fewer than 20 lesions on their skin and none in their abdomen. Subjects were divided into 2 groups; the first group received early treatment with DaunoXome and the second group initially received no treatment. This latter group was observed for 3 months before being offered DaunoXome.

Results

Researchers planned to enrol 40 subjects but stopped the study after 29 had entered. Subjects who were given early treatment experienced a delay of at least 90 days before their lesions grew or spread. Those subjects not given the drug usually had their lesions resume growth or spread after about 30 days.

Unfortunately, 50% of volunteers given early treatment lived for 359 days while for those that "initially received no treatment" the figure was 586 days. As well, 50% of subjects given early treatment developed life-threatening infections within 145 days. The equivalent figure for those who "initially received no treatment" was 371 days. Because of the likelihood that DaunoXome could have had some "immunosuppressive" effects, it may be best to reserve the drug for people with extensive KS lesions.

REFERENCES:

1. White RM. Liposomal daunorubicin is not recommended in patients with less than advanced HIV-related Kaposi's sarcoma. AIDS 1997;11(11):1412-1413.

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