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Journal of Clinical Oncology, Vol 17, Issue 6 (June), 1999: 1876
© 1999 American Society for Clinical Oncology

Paclitaxel Is Safe and Effective in the Treatment of Advanced AIDS-Related Kaposi's Sarcoma

Parkash S. Gill, Anil Tulpule, Byron M. Espina, Suzanne Cabriales, Jocelyn Bresnahan, Miki Ilaw, Stan Louie, Nancy F. Gustafson, Marilyn A. Brown, Christopher Orcutt, Benjamin Winograd, David T. Scadden

From the Departments of Medicine and Pharmacy, University of Southern California, Kenneth Norris Cancer Hospital and Research Institute, Los Angeles, CA; Bristol-Myers Squibb Pharmaceutical Research Institute, Wallingford, CT; Department of Medicine, Harvard University, New England Deaconess Hospital, Boston; and Massachusetts General Hospital, Boston, MA.

Address reprint requests to Parkash S. Gill, MD, Kenneth Norris Cancer Hospital and Research Institute, 1441 Eastlake Ave, MS-34, Los Angeles, CA 90033; email parkashg{at}hsc.usc.edu

PURPOSE: Liposomal anthracyclines are the present standard treatment for advanced AIDS-related Kaposi's sarcoma (KS). No effective therapies have been defined for use after treatment failure of these agents. A phase II trial was thus conducted with paclitaxel in patients with advanced KS to assess safety and antitumor activity.

MATERIALS AND METHODS: A regimen of paclitaxel at a dose of 100 mg/m2 was given every 2 weeks to patients with advanced AIDS-related KS. Patients were treated until complete remission, disease progression, or unacceptable toxicity occurred.

RESULTS: Fifty-six patients with advanced AIDS-related KS were accrued. Tumor-associated edema was present in 70% of patients and visceral involvement in 45%. Forty patients (71%) had received prior systemic therapy; 31 of these were resistant to an anthracycline. The median entry CD4+ lymphocyte count was 20 cells/mm3 (range, 0 to 358). A median of 10 cycles (range, 1 to 54+) of paclitaxel was administered. Fifty-nine percent of patients showed complete (n = 1) or partial response (n = 32) to paclitaxel. The median duration of response was 10.4 months (range, 2.8 to 26.7+ months) and the median survival was 15.4 months. The main side effects of therapy were grade 3 or 4 neutropenia in 61% of patients and mild-to-moderate alopecia in 87%.

CONCLUSION: Paclitaxel at 100 mg/m2 given every 2 weeks is active and well tolerated in the treatment of advanced and previously treated AIDS-related KS. The median duration of response is among the longest observed for any regimen or single agent reported for AIDS-related KS. Paclitaxel at this dosage and schedule is a treatment option for patients with advanced AIDS-related KS, including those who have experienced treatment failure of prior systemic therapy.


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