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Vinorelbine Is an Effective and Safe Drug for AIDS-Related Kaposi’s Sarcoma: Results of a Phase II Study

From the Division of Medical Oncology A and Epidemiology Unit, Centro di Riferimento Oncologico, Aviano; I and II Divisions of Infectious Diseases, Ospedale L. Sacco, Milano; Division of Medical Oncology, Ospedale Niguarda Cà Granda, Milano; Division of Infectious Diseases, Ospedale di Circolo, Varese; Institute of Infectious Diseases, Policlinico San Matteo, Pavia; and Division of Infectious Diseases B, Ospedale Amedeo di Savoia, Torino, Italy.

Address reprint requests to Umberto Tirelli, MD, Division of Medical Oncology A, Centro di Riferimento Oncologico, via Pedemontana Occ.le 12, 33081 Aviano (PN), Italy; email oma{at}ets.it

PURPOSE: To assess the safety and efficacy of vinorelbine in patients with AIDS-related Kaposi’s sarcoma (KS).

PATIENTS AND METHODS: From December 1994 to May 1997, within the Italian Cooperative Group on AIDS and Tumors, we enrolled 36 patients with AIDS-related KS who experienced disease progression after one or more regimens of systemic chemotherapy. Patients were treated with vinorelbine 30 mg/m² every 2 weeks by intravenous bolus.

RESULTS: Of 35 assessable patients, three (9%) had a clinical complete response and 12 (34%) had a partial remission, for an overall objective response rate of 43% (95% confidence interval, 26% to 61%). For the 15 patients with objective responses, the median duration of response from the beginning of therapy until the development of progression was 176 days, whereas the median progression-free survival and the median survival durations for 35 assessable patients were 151 days and 216 days, respectively. Vinorelbine also induced responses in patients who had become resistant to regimens that included other vinca alkaloids. Overall, vinorelbine was well tolerated. Toxicity, including neurologic toxicity, was mild and reversible. Neutropenia was the most frequent dose-limiting toxicity.

CONCLUSION: Vinorelbine is safe and effective in the treatment of patients with advanced KS who have been previously treated with one or more chemotherapy regimens.

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