Adjuvant gemcitabine plus docetaxel followed by doxorubicin versus observation for high-grade uterine leiomyosarcoma: A phase III NRG Oncology/Gynecologic Oncology Group study Journal Article


Authors: Hensley, M. L.; Enserro, D.; Hatcher, H.; Ottevanger, P. B.; Krarup-Hansen, A.; Blay, J. Y.; Fisher, C.; Moxley, K. M.; Lele, S. B.; Lea, J. S.; Tewari, K. S.; Thaker, P. H.; Zivanovic, O.; O'Malley, D. M.; Robison, K.; Miller, D. S.
Article Title: Adjuvant gemcitabine plus docetaxel followed by doxorubicin versus observation for high-grade uterine leiomyosarcoma: A phase III NRG Oncology/Gynecologic Oncology Group study
Abstract: Purpose: We conducted a randomized phase III trial to determine whether adjuvant chemotherapy improves survival in women with uterine leiomyosarcoma. Methods: Women with uterus-confined, high-grade leiomyosarcoma who were confirmed disease free by imaging were randomly assigned to four cycles of gemcitabine plus docetaxel, followed by four cycles of doxorubicin, or to observation. All were followed for evidence of recurrence. The primary end point was overall survival (OS). Results: With international collaboration, 38 of the targeted accrual of 216 patients were enrolled, after which the study was closed by the National Cancer Institute for accrual futility. Twenty patients were assigned to chemotherapy, 18 to observation. Among the 17 patients treated with at least one cycle of chemotherapy, grade 3 or 4 toxicities were observed in 47%; among the 18 patients assigned to observation, one had grade 3 hypertension. There were six deaths (chemotherapy, n = 5; observation, n = 1), all due to disease. The restricted mean survival time for OS was estimated as 34.3 months (95% CI, 25.3 to 43.3 months) in the chemotherapy arm and as 46.4 months (95% CI, 43.6 to 49.1 months) in the observation arm. There were eight recurrences in each arm. The restricted mean survival time for recurrence-free survival was estimated as 18.1 (95% CI, 14.2 to 22.0) months in the chemotherapy arm and as 14.6 months (95% CI, 10.3 to 19.0 months) in the observation arm. Neither survival outcome comparison was considered statistically robust, due to the small sample size. Conclusion: Despite international collaboration to test the role of adjuvant chemotherapy in uterine-confined leiomyosarcoma, this study was closed for accrual futility. Although the sample size precludes robust statistical comparison, observed OS and recurrence-free survival data do not show superior outcomes with adjuvant chemotherapy. © 2018 by American Society of Clinical Oncology. All rights reserved.
Journal Title: Journal of Clinical Oncology
Volume: 36
Issue: 33
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 2018-11-20
Start Page: 3324
End Page: 3330
Language: English
DOI: 10.1200/jco.18.00454
PROVIDER: scopus
PMCID: PMC6241678
PUBMED: 30289732
DOI/URL:
Notes: Conference Paper -- Export Date: 3 December 2018 -- Source: Scopus
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  1. Martee L Hensley
    212 Hensley