Phase II trial of paclitaxel in leiomyosarcoma of the uterus: a gynecologic oncology group study.
OBJECTIVE
The aim of this study was to determine the activity of paclitaxel in chemotherapy-naive patients with advanced or recurrent uterine leiomyosarcoma.


METHODS
Patients received 175 mg/m(2) of paclitaxel iv over 3 h. Courses were repeated every 3 weeks until disease progression or adverse side effects supervened.


RESULTS
Thirty-four women were entered, but 1 patient was ineligible because of wrong cell type. Median age was 55 years (range: 35-84 years). GOG performance status was 2 in 2 instances, 1 in 9 cases, and 0 in 22 others. Eight patients (23.4%) had received radiotherapy. A median of 2.5 courses was given (range: 1-18). Eleven patients (33.3%) experienced grade 3 or 4 neutropenia, 1 (2.9%) had grade 4 thrombocytopenia, and 1 had grade 3 anemia. There were no cases of grade 3 or 4 gastrointestinal or dermatologic toxicity. One patient each developed deep venous thrombosis and a grade 3 allergic reaction. Eight patients (24.2%) had stable disease for at least 2 courses of therapy. Three complete responses were reported (9.1%).


CONCLUSIONS
With the dose and schedule tested, paclitaxel has limited activity in patients with uterine leiomyosarcoma. Modest toxicity suggests that a higher dose of paclitaxel might be evaluated.
Sutton
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Division of Gynecologic Oncology, Indiana University Medical School, Indianapolis, Indiana, 46202, USA.
Blessing
J A
JA
Ball
H
H
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000972:Antineoplastic Agents, Phytogenic / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007890:Leiomyosarcoma / Q000188:drug therapy*; D008875:Middle Aged; D017239:Paclitaxel / Q000627:therapeutic use*; D014594:Uterine Neoplasms / Q000188:drug therapy*
D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel