Adjuvant chemotherapy plus radiation for locally advanced endometrial cancer

Daniela Elena Matei*, Virginia Filiaci, Marcus E. Randall, David Mutch, Margaret M. Steinhoff, Paul A. DiSilvestro, Katherine M. Moxley, Yong M. Kim, Matthew A. Powell, David M. O’Malley, Nick M. Spirtos, William Small, Krishnansu S. Tewari, William E. Richards, John Nakayama, Ursula A. Matulonis, Helen Q. Huang, David S. Miller

*Corresponding author for this work

Research output: Contribution to journalArticle

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Abstract

BACKGROUND Stage III or IVA endometrial cancer carries a significant risk of systemic and locoregional recurrence. METHODS In this randomized phase 3 trial, we tested whether 6 months of platinumbased chemotherapy plus radiation therapy (chemoradiotherapy) is associated with longer relapsefree survival (primary end point) than six cycles of combination chemotherapy alone in patients with stage III or IVA endometrial carcinoma. Secondary end points included overall survival, acute and chronic toxic effects, and quality of life. RESULTS Of the 813 patients enrolled, 736 were eligible and were included in the analysis of relapsefree survival; of those patients, 707 received the randomly assigned intervention (346 received chemoradiotherapy and 361 received chemotherapy only). The median followup period was 47 months. At 60 months, the Kaplan–Meier estimate of the percentage of patients alive and relapsefree was 59% (95% confidence interval [CI], 53 to 65) in the chemoradiotherapy group and 58% (95% CI, 53 to 64) in the chemotherapyonly group (hazard ratio, 0.90; 90% CI, 0.74 to 1.10). Chemoradiotherapy was associated with a lower 5year incidence of vaginal recurrence (2% vs. 7%; hazard ratio, 0.36; 95% CI, 0.16 to 0.82) and pelvic and paraaortic lymphnode recurrence (11% vs. 20%; hazard ratio, 0.43; 95% CI, 0.28 to 0.66) than chemotherapy alone, but distant recurrence was more common in association with chemoradiotherapy (27% vs. 21%; hazard ratio, 1.36; 95% CI, 1.00 to 1.86). Grade 3, 4, or 5 adverse events were reported in 202 patients (58%) in the chemoradiotherapy group and 227 patients (63%) in the chemotherapyonly group. CONCLUSIONS Chemotherapy plus radiation was not associated with longer relapsefree survival than chemotherapy alone in patients with stage III or IVA endometrial carcinoma.

Original languageEnglish (US)
Pages (from-to)2317-2326
Number of pages10
JournalNew England Journal of Medicine
Volume380
Issue number24
DOIs
StatePublished - Jun 13 2019

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Adjuvant Chemotherapy
Endometrial Neoplasms
Radiation
Drug Therapy
Confidence Intervals
Radiotherapy
Recurrence
Survival
Poisons
Chemoradiotherapy
Survival Analysis
Combination Drug Therapy
Quality of Life
Incidence

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Matei, D. E., Filiaci, V., Randall, M. E., Mutch, D., Steinhoff, M. M., DiSilvestro, P. A., ... Miller, D. S. (2019). Adjuvant chemotherapy plus radiation for locally advanced endometrial cancer. New England Journal of Medicine, 380(24), 2317-2326. https://doi.org/10.1056/NEJMoa1813181
Matei, Daniela Elena ; Filiaci, Virginia ; Randall, Marcus E. ; Mutch, David ; Steinhoff, Margaret M. ; DiSilvestro, Paul A. ; Moxley, Katherine M. ; Kim, Yong M. ; Powell, Matthew A. ; O’Malley, David M. ; Spirtos, Nick M. ; Small, William ; Tewari, Krishnansu S. ; Richards, William E. ; Nakayama, John ; Matulonis, Ursula A. ; Huang, Helen Q. ; Miller, David S. / Adjuvant chemotherapy plus radiation for locally advanced endometrial cancer. In: New England Journal of Medicine. 2019 ; Vol. 380, No. 24. pp. 2317-2326.
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abstract = "BACKGROUND Stage III or IVA endometrial cancer carries a significant risk of systemic and locoregional recurrence. METHODS In this randomized phase 3 trial, we tested whether 6 months of platinumbased chemotherapy plus radiation therapy (chemoradiotherapy) is associated with longer relapsefree survival (primary end point) than six cycles of combination chemotherapy alone in patients with stage III or IVA endometrial carcinoma. Secondary end points included overall survival, acute and chronic toxic effects, and quality of life. RESULTS Of the 813 patients enrolled, 736 were eligible and were included in the analysis of relapsefree survival; of those patients, 707 received the randomly assigned intervention (346 received chemoradiotherapy and 361 received chemotherapy only). The median followup period was 47 months. At 60 months, the Kaplan–Meier estimate of the percentage of patients alive and relapsefree was 59{\%} (95{\%} confidence interval [CI], 53 to 65) in the chemoradiotherapy group and 58{\%} (95{\%} CI, 53 to 64) in the chemotherapyonly group (hazard ratio, 0.90; 90{\%} CI, 0.74 to 1.10). Chemoradiotherapy was associated with a lower 5year incidence of vaginal recurrence (2{\%} vs. 7{\%}; hazard ratio, 0.36; 95{\%} CI, 0.16 to 0.82) and pelvic and paraaortic lymphnode recurrence (11{\%} vs. 20{\%}; hazard ratio, 0.43; 95{\%} CI, 0.28 to 0.66) than chemotherapy alone, but distant recurrence was more common in association with chemoradiotherapy (27{\%} vs. 21{\%}; hazard ratio, 1.36; 95{\%} CI, 1.00 to 1.86). Grade 3, 4, or 5 adverse events were reported in 202 patients (58{\%}) in the chemoradiotherapy group and 227 patients (63{\%}) in the chemotherapyonly group. CONCLUSIONS Chemotherapy plus radiation was not associated with longer relapsefree survival than chemotherapy alone in patients with stage III or IVA endometrial carcinoma.",
author = "Matei, {Daniela Elena} and Virginia Filiaci and Randall, {Marcus E.} and David Mutch and Steinhoff, {Margaret M.} and DiSilvestro, {Paul A.} and Moxley, {Katherine M.} and Kim, {Yong M.} and Powell, {Matthew A.} and O’Malley, {David M.} and Spirtos, {Nick M.} and William Small and Tewari, {Krishnansu S.} and Richards, {William E.} and John Nakayama and Matulonis, {Ursula A.} and Huang, {Helen Q.} and Miller, {David S.}",
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Matei, DE, Filiaci, V, Randall, ME, Mutch, D, Steinhoff, MM, DiSilvestro, PA, Moxley, KM, Kim, YM, Powell, MA, O’Malley, DM, Spirtos, NM, Small, W, Tewari, KS, Richards, WE, Nakayama, J, Matulonis, UA, Huang, HQ & Miller, DS 2019, 'Adjuvant chemotherapy plus radiation for locally advanced endometrial cancer', New England Journal of Medicine, vol. 380, no. 24, pp. 2317-2326. https://doi.org/10.1056/NEJMoa1813181

Adjuvant chemotherapy plus radiation for locally advanced endometrial cancer. / Matei, Daniela Elena; Filiaci, Virginia; Randall, Marcus E.; Mutch, David; Steinhoff, Margaret M.; DiSilvestro, Paul A.; Moxley, Katherine M.; Kim, Yong M.; Powell, Matthew A.; O’Malley, David M.; Spirtos, Nick M.; Small, William; Tewari, Krishnansu S.; Richards, William E.; Nakayama, John; Matulonis, Ursula A.; Huang, Helen Q.; Miller, David S.

In: New England Journal of Medicine, Vol. 380, No. 24, 13.06.2019, p. 2317-2326.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Adjuvant chemotherapy plus radiation for locally advanced endometrial cancer

AU - Matei, Daniela Elena

AU - Filiaci, Virginia

AU - Randall, Marcus E.

AU - Mutch, David

AU - Steinhoff, Margaret M.

AU - DiSilvestro, Paul A.

AU - Moxley, Katherine M.

AU - Kim, Yong M.

AU - Powell, Matthew A.

AU - O’Malley, David M.

AU - Spirtos, Nick M.

AU - Small, William

AU - Tewari, Krishnansu S.

AU - Richards, William E.

AU - Nakayama, John

AU - Matulonis, Ursula A.

AU - Huang, Helen Q.

AU - Miller, David S.

PY - 2019/6/13

Y1 - 2019/6/13

N2 - BACKGROUND Stage III or IVA endometrial cancer carries a significant risk of systemic and locoregional recurrence. METHODS In this randomized phase 3 trial, we tested whether 6 months of platinumbased chemotherapy plus radiation therapy (chemoradiotherapy) is associated with longer relapsefree survival (primary end point) than six cycles of combination chemotherapy alone in patients with stage III or IVA endometrial carcinoma. Secondary end points included overall survival, acute and chronic toxic effects, and quality of life. RESULTS Of the 813 patients enrolled, 736 were eligible and were included in the analysis of relapsefree survival; of those patients, 707 received the randomly assigned intervention (346 received chemoradiotherapy and 361 received chemotherapy only). The median followup period was 47 months. At 60 months, the Kaplan–Meier estimate of the percentage of patients alive and relapsefree was 59% (95% confidence interval [CI], 53 to 65) in the chemoradiotherapy group and 58% (95% CI, 53 to 64) in the chemotherapyonly group (hazard ratio, 0.90; 90% CI, 0.74 to 1.10). Chemoradiotherapy was associated with a lower 5year incidence of vaginal recurrence (2% vs. 7%; hazard ratio, 0.36; 95% CI, 0.16 to 0.82) and pelvic and paraaortic lymphnode recurrence (11% vs. 20%; hazard ratio, 0.43; 95% CI, 0.28 to 0.66) than chemotherapy alone, but distant recurrence was more common in association with chemoradiotherapy (27% vs. 21%; hazard ratio, 1.36; 95% CI, 1.00 to 1.86). Grade 3, 4, or 5 adverse events were reported in 202 patients (58%) in the chemoradiotherapy group and 227 patients (63%) in the chemotherapyonly group. CONCLUSIONS Chemotherapy plus radiation was not associated with longer relapsefree survival than chemotherapy alone in patients with stage III or IVA endometrial carcinoma.

AB - BACKGROUND Stage III or IVA endometrial cancer carries a significant risk of systemic and locoregional recurrence. METHODS In this randomized phase 3 trial, we tested whether 6 months of platinumbased chemotherapy plus radiation therapy (chemoradiotherapy) is associated with longer relapsefree survival (primary end point) than six cycles of combination chemotherapy alone in patients with stage III or IVA endometrial carcinoma. Secondary end points included overall survival, acute and chronic toxic effects, and quality of life. RESULTS Of the 813 patients enrolled, 736 were eligible and were included in the analysis of relapsefree survival; of those patients, 707 received the randomly assigned intervention (346 received chemoradiotherapy and 361 received chemotherapy only). The median followup period was 47 months. At 60 months, the Kaplan–Meier estimate of the percentage of patients alive and relapsefree was 59% (95% confidence interval [CI], 53 to 65) in the chemoradiotherapy group and 58% (95% CI, 53 to 64) in the chemotherapyonly group (hazard ratio, 0.90; 90% CI, 0.74 to 1.10). Chemoradiotherapy was associated with a lower 5year incidence of vaginal recurrence (2% vs. 7%; hazard ratio, 0.36; 95% CI, 0.16 to 0.82) and pelvic and paraaortic lymphnode recurrence (11% vs. 20%; hazard ratio, 0.43; 95% CI, 0.28 to 0.66) than chemotherapy alone, but distant recurrence was more common in association with chemoradiotherapy (27% vs. 21%; hazard ratio, 1.36; 95% CI, 1.00 to 1.86). Grade 3, 4, or 5 adverse events were reported in 202 patients (58%) in the chemoradiotherapy group and 227 patients (63%) in the chemotherapyonly group. CONCLUSIONS Chemotherapy plus radiation was not associated with longer relapsefree survival than chemotherapy alone in patients with stage III or IVA endometrial carcinoma.

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DO - 10.1056/NEJMoa1813181

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Matei DE, Filiaci V, Randall ME, Mutch D, Steinhoff MM, DiSilvestro PA et al. Adjuvant chemotherapy plus radiation for locally advanced endometrial cancer. New England Journal of Medicine. 2019 Jun 13;380(24):2317-2326. https://doi.org/10.1056/NEJMoa1813181