TY - JOUR
T1 - Adjuvant gemcitabine plus docetaxel followed by doxorubicin versus observation for high-grade uterine leiomyosarcoma
T2 - A phase III NRG oncology/gynecologic oncology group study
AU - Hensley, Martee L.
AU - Enserro, Danielle
AU - Hatcher, Helen
AU - Ottevanger, Petronella B.
AU - Krarup-Hansen, Anders
AU - Blay, Jean Yves
AU - Fisher, Cyril
AU - Moxley, Katherine M.
AU - Lele, Shashikant B.
AU - Lea, Jayanthi S
AU - Tewari, Krishnansu S.
AU - Thaker, Premal H.
AU - Zivanovic, Oliver
AU - O'Malley, David M.
AU - Robison, Katina
AU - Miller, David S
N1 - Funding Information:
The following NRG Oncology/Gynecologic Oncology Group member institutions participated in this study: European Organization for Research and Treatment of Cancer; University of Oklahoma Health Sciences Center; Roswell Park; University of Texas Southwestern Medical Center; University of California Medical Center at Irvine-Orange Campus; Washington University School of Medicine; Memorial Sloan Kettering Cancer Center; Ohio State University Comprehensive Cancer Center; Women and Infants Hospital; Duke University Medical Center; Abington Memorial Hospital; Rush University Medical Center; Fox Chase Cancer Center; Women’s Cancer Center of Nevada; University of Chicago; Froedtert and the Medical College of Wisconsin; University of Michigan Health System Cancer Center; Emory University School of Medicine; Maine Medical Center – Scarborough Campus; Kansas City Clinical Oncology Program; University of New Mexico; and John H. Stroger Jr. Hospital of Cook County.
Publisher Copyright:
© 2018 by American Society of Clinical Oncology. All rights reserved.
PY - 2018/11/20
Y1 - 2018/11/20
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85056783564&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85056783564&partnerID=8YFLogxK
U2 - 10.1200/JCO.18.00454
DO - 10.1200/JCO.18.00454
M3 - Article
C2 - 30289732
AN - SCOPUS:85056783564
SN - 0732-183X
VL - 36
SP - 3324
EP - 3330
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 33
ER -