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

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

doi:10.1200/jco.18.00454

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

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

Institut for Klinisk Medicin

33 Citationer (Scopus)

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.

Originalsprog	Engelsk
Artikelnummer	JCO1800454
Tidsskrift	Journal of Clinical Oncology
Vol/bind	36
Udgave nummer	33
Sider (fra-til)	1-9
ISSN	0732-183X
DOI	https://doi.org/10.1200/jco.18.00454
Status	Udgivet - 20 nov. 2018

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https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6241678/Licens: Andet

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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. (2018). Adjuvant Gemcitabine Plus Docetaxel Followed by Doxorubicin Versus Observation for High-Grade Uterine Leiomyosarcoma: A Phase III NRG Oncology/Gynecologic Oncology Group Study. Journal of Clinical Oncology, 36(33), 1-9. [JCO1800454]. https://doi.org/10.1200/jco.18.00454

Adjuvant Gemcitabine Plus Docetaxel Followed by Doxorubicin Versus Observation for High-Grade Uterine Leiomyosarcoma : A Phase III NRG Oncology/Gynecologic Oncology Group Study. / Hensley, Martee L; Enserro, Danielle; Hatcher, Helen et al.

I: Journal of Clinical Oncology, Bind 36, Nr. 33, JCO1800454, 20.11.2018, s. 1-9.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

Hensley, ML, Enserro, D, Hatcher, H, Ottevanger, PB, Krarup-Hansen, A, Blay, J-Y, Fisher, C, Moxley, KM, Lele, SB, Lea, JS, Tewari, KS, Thaker, PH, Zivanovic, O, O'Malley, DM, Robison, K & Miller, DS 2018, 'Adjuvant Gemcitabine Plus Docetaxel Followed by Doxorubicin Versus Observation for High-Grade Uterine Leiomyosarcoma: A Phase III NRG Oncology/Gynecologic Oncology Group Study', Journal of Clinical Oncology, bind 36, nr. 33, JCO1800454, s. 1-9. https://doi.org/10.1200/jco.18.00454

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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.",

author = "Hensley, {Martee L} and Danielle Enserro and Helen Hatcher and Ottevanger, {Petronella B} and Anders Krarup-Hansen and Jean-Yves Blay and Cyril Fisher and Moxley, {Katherine M} and Lele, {Shashikant B} and Lea, {Jayanthi S} and Tewari, {Krishnansu S} and Thaker, {Premal H} and Oliver Zivanovic and O'Malley, {David M} and Katina Robison and Miller, {David S}",

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language = "English",

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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

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.

U2 - 10.1200/jco.18.00454

DO - 10.1200/jco.18.00454

M3 - Journal article

C2 - 30289732

SN - 0732-183X

VL - 36

SP - 1

EP - 9

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

IS - 33

M1 - JCO1800454

ER -

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

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