Abstract | OBJECTIVE: 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.
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Authors | Katherine Y Look, Alan Sandler, John A Blessing, Joseph A Lucci 3rd, Peter G Rose, Gynecologic Oncology Group (GOG) Study |
Journal | Gynecologic oncology
(Gynecol Oncol)
Vol. 92
Issue 2
Pg. 644-7
(Feb 2004)
ISSN: 0090-8258 [Print] United States |
PMID | 14766260
(Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, U.S. Gov't, P.H.S.)
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Chemical References |
- Antimetabolites, Antineoplastic
- Deoxycytidine
- Gemcitabine
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Antimetabolites, Antineoplastic
(adverse effects, therapeutic use)
- Deoxycytidine
(adverse effects, analogs & derivatives, therapeutic use)
- Drug Administration Schedule
- Female
- Humans
- Infusions, Intravenous
- Leiomyosarcoma
(drug therapy)
- Middle Aged
- Neoplasm Recurrence, Local
(drug therapy)
- Uterine Neoplasms
(drug therapy)
- Gemcitabine
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