Paclitaxel is safe and effective in the treatment of advanced AIDS-related Kaposi's sarcoma

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 ta assess safety and antitumor activity. Materials and Methods: A regimen of paclitaxel at a dose of 100 mg/m(2) 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/ mm(3) (range, 0 to 358). A median of 10 cycles (range, 1 ta 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/m(2) 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 far 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. (C) 1999 by American Society of Clinical Oncology.