Phase II trial of topotecan in patients with advanced, persistent, or recurrent uterine leiomyosarcomas: A Gynecologic Oncology Group study

David Scott Miller, John A. Blessing, Larry C. Kilgore, Robert Mannel, Linda Van Le

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48 Scopus citations


From October 1995 to March 1997, a phase II trial of topotecan was carried out in chemotherapy-naive women with advanced, persistent, or recurrent uterine leiomyosarcomas. Thirty-six patients were entered. Median age was 53 years. Performance status was 0 (50%) in 18, 1 (36%) in 13, and 2 (14%) in 5. Most patients, 33 (92%), had undergone prior surgery, and 8 (22%) prior radiation therapy. Topotecan, 1.5 mg/m2, was administered intravenously daily for 5 days, every 3 weeks, until progression of disease or adverse affects prohibited further therapy. Patients received 1 to 13 courses with a median of 3 courses. The most frequent grade 4 adverse effects were neutropenia in 28 (78%), leukopenia in 8 (22%), thrombocytopenia in 3 (8%), and anemia in 3 (8%). Complete response was seen in 1 (3%), partial response in 3 (8%), stable disease in 12 (33%), and increasing tumor in 20 (56%). Thus topotecan at this dose and schedule does not appear to have major activity in uterine leiomyosarcomas.

Original languageEnglish (US)
Pages (from-to)355-357
Number of pages3
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Issue number4
Publication statusPublished - 2000



  • Leiomyosarcomas
  • Topotecan

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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