Adjuvant gemcitabine plus docetaxel for completely resected stages I-IV high grade uterine leiomyosarcoma: Results of a prospective study Journal Article
| Authors: | Hensley, M. L.; Ishill, N.; Soslow, R.; Larkin, J.; Abu Rustum, N.; Sabbatini, P.; Konner, J.; Tew, W.; Spriggs, D.; Aghajanian, C. A. |
| Article Title: | Adjuvant gemcitabine plus docetaxel for completely resected stages I-IV high grade uterine leiomyosarcoma: Results of a prospective study |
| Abstract: | Objective: Patients with completely resected stages I-IV high grade uterine leiomyosarcoma are at high risk for recurrence. No adjuvant treatment has been shown to improve survival, although prospective data are limited. We sought to determine whether adjuvant gemcitabine-docetaxel would yield a 2-year progression-free survival of at least 50% in this leiomyosarcoma population. Methods: Eligible patients were treated with gemcitabine 900 mg/m<sup>2</sup> over 90 min days 1 and 8 plus docetaxel 75 mg/m<sup>2</sup> day 8, every 3 weeks for 4 cycles. CT imaging was performed at baseline, after cycle 4, and every 3 months. Progression was defined as evidence of new disease on CT. Results: Twenty-five patients (median age 49; range, 37-73) enrolled; 23 were evaluable (1-never treated, 1-ineligible). With median follow-up of 49 months for all patients, 10 (45%) of the 23 evaluable patients remained progression free at 2 years, with a median progression-free survival of 13 months. The median overall survival is not yet reached. Among the 18 patients with stages I or II uterine leiomyosarcoma, 59% remain progression-free at 2 years, with a median progression-free survival of 39 months. Median overall survival for stages I and II patients is not yet reached with median follow-up duration of 49 months. Sites of first recurrence were: lung only - 3/23 (13%); pelvis only - 5/23 (22%); both - 5 (22%). Conclusions: Post-resection gemcitabine-docetaxel for stages I-IV high-grade uterine leiomyosarcoma yields 2-year progression-free survival rates that appear superior to historical rates. Gemcitabine-docetaxel merits further study as part of an adjuvant strategy for patients with completely resected, early-stage uterine leiomyosarcoma. © 2008 Elsevier Inc. All rights reserved. |
| Keywords: | adult; cancer survival; clinical article; aged; disease-free survival; middle aged; unclassified drug; overall survival; clinical trial; disease course; neutropenia; cancer recurrence; cancer risk; treatment duration; liver dysfunction; gemcitabine; adjuvant therapy; cancer adjuvant therapy; disease free survival; chemotherapy, adjuvant; follow up; neoplasm staging; pelvis; prospective study; prospective studies; progression free survival; computer assisted tomography; stomatitis; antineoplastic combined chemotherapy protocols; peripheral neuropathy; dexamethasone; docetaxel; survival time; population research; disease severity; early diagnosis; peripheral edema; lung carcinoma; taxoids; leiomyosarcoma; recombinant granulocyte colony stimulating factor; deoxycytidine; uterine neoplasms; resected stage i-iv; uterine leiomyosarcoma; diuretic agent; pegylated filgrastim; hypersensitivity reaction; pelvis cancer; uterus; uterus leiomyosarcoma |
| Journal Title: | Gynecologic Oncology |
| Volume: | 112 |
| Issue: | 3 |
| ISSN: | 0090-8258 |
| Publisher: | Elsevier Inc. |
| Date Published: | 2009-03-01 |
| Start Page: | 563 |
| End Page: | 567 |
| Language: | English |
| DOI: | 10.1016/j.ygyno.2008.11.027 |
| PUBMED: | 19135708 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | --- - "Cited By (since 1996): 9" - "Export Date: 30 November 2010" - "CODEN: GYNOA" - "Source: Scopus" |
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156Konner -
888Abu-Rustum -
262Sabbatini -
290Hensley -
797Soslow -
609Aghajanian -
247Tew -
325Spriggs -
86Leoce -
8
Larkin
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