Literature DB >> 23335221

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

Martee L Hensley1, J Kyle Wathen, Robert G Maki, Dejka M Araujo, Gregory Sutton, Dennis A Priebat, Suzanne George, Robert A Soslow, Laurence H Baker.   

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.
Copyright © 2013 American Cancer Society.

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Year:  2013        PMID: 23335221     DOI: 10.1002/cncr.27942

Source DB:  PubMed          Journal:  Cancer        ISSN: 0008-543X            Impact factor:   6.860


  53 in total

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6.  Systemic Treatment of Metastatic/Recurrent Uterine Leiomyosarcoma: A Changing Paradigm.

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Review 7.  Gynecologic Cancer InterGroup (GCIG) consensus review: uterine and ovarian leiomyosarcomas.

Authors:  Martee L Hensley; Brigitte A Barrette; Klaus Baumann; David Gaffney; Anne L Hamilton; Jae-Weon Kim; Johanna U Maenpaa; Patricia Pautier; Nadeem Ahmad Siddiqui; Anneke M Westermann; Isabelle Ray-Coquard
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8.  A Phase II evaluation of ixabepilone (IND #59699, NSC #710428) in the treatment of recurrent or persistent leiomyosarcoma of the uterus: an NRG Oncology/Gynecologic Oncology Group Study.

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Journal:  Gynecol Oncol       Date:  2014-08-01       Impact factor: 5.482

9.  Adjuvant Gemcitabine Plus Docetaxel Followed by Doxorubicin Versus Observation for High-Grade Uterine Leiomyosarcoma: A Phase III NRG Oncology/Gynecologic Oncology Group Study.

Authors:  Martee L Hensley; Danielle Enserro; Helen Hatcher; Petronella B Ottevanger; Anders Krarup-Hansen; Jean-Yves Blay; Cyril Fisher; Katherine M Moxley; Shashikant B Lele; Jayanthi S Lea; Krishnansu S Tewari; Premal H Thaker; Oliver Zivanovic; David M O'Malley; Katina Robison; David S Miller
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10.  Adjuvant therapy for high-risk soft tissue sarcoma in the adult.

Authors:  Alessandro Gronchi; Paolo G Casali
Journal:  Curr Treat Options Oncol       Date:  2013-09
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