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Phase II trial of gemcitabine as second-line chemotherapy of uterine leiomyosarcoma: a Gynecologic Oncology Group (GOG) Study.

Abstract：

OBJECTIVE:To determine the antitumor activity and toxicity profile of gemcitabine as second-line chemotherapy in patients with recurrent or persistent uterine leiomyosarcoma (LMS). METHODS:Intravenous gemcitabine was administered over 30 min at a dose of 1000 mg/m(2) on days 1, 8, 15, with cycles repeated every 28 days. Eligibility criteria included measurable disease, performance status 0-2, adequate bone marrow function, creatinine <1.5 mg%, bilirubin <1.5x institutional normal, SGOT/alkaline phosphatase <3x institutional normal, and signed informed consent. Standard Gynecologic Oncology Group (GOG) toxicity and response criteria were utilized. RESULTS:Forty-eight patients were enrolled on the study. Three were deemed ineligible upon central pathology review, another received an inadequate course of protocol treatment, and two others were not reassessed for response; thus 44 patients were evaluable for toxicity and 42 for toxicity and response. The median age was 52.5 (range: 31-82) years. Thirty-five patients had received prior chemotherapy and 11 had undergone prior radiotherapy. Sites of measurable disease were pelvic (n = 9) and extrapelvic (n = 35). A median of two (range: 1-13) cycles was received. The schedule was well tolerated; there were no treatment-related deaths. The only grade 4 toxicities included neutropenia (n = 7), nausea and vomiting (n = 2), and dermatologic (n = 1). One (2.3%) patient achieved a complete response and eight (18.2%) experienced a partial response, for an overall response rate of 20.5%. CONCLUSION:Gemcitabine demonstrates activity in patients with persistent or recurrent uterine LMS and should be considered in multiagent regimens treating this patient population.

journal_name

Gynecol Oncol

journal_title

Gynecologic oncology

authors

Look KY,Sandler A,Blessing JA,Lucci JA 3rd,Rose PG,Gynecologic Oncology Group (GOG) Study.

doi

10.1016/j.ygyno.2003.11.023

subject

Has Abstract

pub_date

2004-02-01 00:00:00

pages

644-7

issue

eissn

0090-8258

issn

1095-6859

pii

S0090825803008382

journal_volume

pub_type

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Phase II trial of gemcitabine as second-line chemotherapy of uterine leiomyosarcoma: a Gynecologic Oncology Group (GOG) Study.