Adjuvant therapy for high-grade, uterus-limited leiomyosarcoma: Results of a phase 2 trial (SARC 005) Journal Article


Authors: Hensley, M. L.; Wathen, J. K.; Maki, R. G.; Araujo, D. M.; Sutton, G.; Priebat, D. A.; George, S.; Soslow, R. A.; Baker, L. H.
Article Title: Adjuvant therapy for high-grade, uterus-limited leiomyosarcoma: Results of a phase 2 trial (SARC 005)
Abstract: BACKGROUND: Between 30% and 50% of women who have high-grade uterine leiomyosarcoma (uLMS) limited to the uterus at diagnosis remain progression-free at 2 years. Adjuvant pelvic radiation does not improve outcome. The objective of the current study was to determine the 2-year and 3-year progression-free survival (PFS) among a prospective cohort of women who received adjuvant gemcitabine plus docetaxel followed by doxorubicin. METHODS: Women with uterus-limited, high-grade uLMS and adequate organ function were eligible. Within 12 weeks of complete resection and after confirmation that they had no evidence of disease on computed tomography (CT) images, the patients received 4 cycles of fixed-dose-rate gemcitabine plus docetaxel. Those who were confirmed disease-free on CT scans after cycle 4 received 4 cycles of doxorubicin. CT imaging for recurrence was performed every 3 months for 2 years, then every 6 months for 3 years. RESULTS: In total, 47 women were enrolled (46 evaluable) in 3 years. Characteristics included a median age of 53 years; 1988 International Federation of Gynecology and Obstetrics stage I disease in 81% of patients, stage II disease in 15%, and serosa-only stage IIIA disease in 4%; American Joint Committee on Cancer stage II disease in 13% of patients and stage III disease in 87%; a median tumor size of 8 cm (range, 2.5-30 cm); and a median mitotic rate of 18 mitoses per 10 high-power fields (range, 5-83 mitoses per 10 high-power fields). At a median follow-up of 39.8 months, 21 of 46 patients developed recurrent disease (45.7%). The median time to recurrence was 27.4 months (range, 3-40 months). Seventy-eight percent of patients (95% confidence interval, 67%-91%) were progression-free at 2 years, and 57% (95% confidence interval, 44%-74%) were progression-free at 3 years. The median PFS was not reached and exceeded 36 months. CONCLUSIONS: Among women with high-grade, uterus-limited uLMS who received treatment with adjuvant gemcitabine plus docetaxel followed by doxorubicin, 78% remained progression-free at 2 years, and 57% remained progression-free at 3 years. A randomized trial of adjuvant chemotherapy versus observation to determine whether adjuvant chemotherapy can improve survival in women with uterus-limited uLMS is underway. © 2013 American Cancer Society.
Keywords: survival; adult; cancer survival; clinical article; controlled study; treatment outcome; aged; disease-free survival; middle aged; cancer recurrence; doxorubicin; drug dose reduction; drug withdrawal; side effect; liver dysfunction; gemcitabine; cancer adjuvant therapy; disease free survival; chemotherapy, adjuvant; chemotherapy; cancer staging; cancer grading; prospective studies; edema; progression free survival; computer assisted tomography; lung toxicity; multiple cycle treatment; phase 2 clinical trial; cohort studies; neoplasm recurrence, local; bone marrow suppression; bleeding; mucosa inflammation; neuropathy; randomized controlled trial; thrombocytopenia; antineoplastic combined chemotherapy protocols; cohort analysis; dexamethasone; continuous infusion; docetaxel; drug hypersensitivity; febrile neutropenia; survival time; taxoids; leiomyosarcoma; estrogen receptor; progesterone receptor; recombinant granulocyte colony stimulating factor; deoxycytidine; uterine neoplasms; bilirubin blood level; premedication; adjuvant; uterine; uterus surgery; cancer prognosis; neoplasm grading
Journal Title: Cancer
Volume: 119
Issue: 8
ISSN: 0008-543X
Publisher: Wiley Blackwell  
Date Published: 2013-04-15
Start Page: 1555
End Page: 1561
Language: English
PROVIDER: scopus
PUBMED: 23335221
DOI: 10.1002/cncr.27942
DOI/URL:
Notes: --- - "Export Date: 1 May 2013" - "CODEN: CANCA" - ":doi 10.1002/cncr.27942" - "Source: Scopus"
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MSK Authors
  1. Martee L Hensley
    257 Hensley
  2. Robert Soslow
    757 Soslow