Phase II trial of paclitaxel in leiomyosarcoma of the uterus: a gynecologic oncology group study.

Abstract

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%).

CONCLUSION:

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.

• Authors: G Sutton, J A Blessing, H Ball
• Journal: Gynecologic oncology (Gynecol Oncol) Vol. 74 Issue 3 Pg. 346-9 (Sep 1999) ISSN: 0090-8258 [Print] United States
• PMID: 10479491 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Research Support, U.S. Gov't, P.H.S.)
• Copyright: Copyright 1999 Academic Press.

Chemical References

• Antineoplastic Agents, Phytogenic
• Paclitaxel

Topics

• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Agents, Phytogenic (therapeutic use)
• Female
• Humans
• Leiomyosarcoma (drug therapy)
• Middle Aged
• Paclitaxel (therapeutic use)
• Uterine Neoplasms (drug therapy)