Vinorelbine is an effective and safe drug for AIDS-related Kaposi's sarcoma: results of a phase II study.
OBJECTIVE
To assess the safety and efficacy of vinorelbine in patients with AIDS-related Kaposi's sarcoma (KS).


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/m(2) 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.


CONCLUSIONS
Vinorelbine is safe and effective in the treatment of patients with advanced KS who have been previously treated with one or more chemotherapy regimens.
Nasti
G
G
Division of Medical Oncology A and Epidemiology Unit, Centro di Riferimento Oncologico, Aviano, Italy.
Errante
D
D
Talamini
R
R
Rizzardini
G
G
Fasan
M
M
Landonio
G
G
Zeroli
C
C
Chichino
G
G
Nigra
E
E
Vaccher
E
E
Tirelli
U
U
D000163:Acquired Immunodeficiency Syndrome / Q000150:complications*; D000328:Adult; D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects / Q000627:therapeutic use*; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D012514:Sarcoma, Kaposi / Q000188:drug therapy* / Q000473:pathology; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016896:Treatment Outcome; D014747:Vinblastine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000077235:Vinorelbine
D000972:Antineoplastic Agents, Phytogenic; D014747:Vinblastine; D000077235:Vinorelbine