Randomized phase III trial of pelvic radiotherapy versus cisplatin-based combined chemotherapy in patients with intermediate- and high-risk endometrial cancer: A Japanese Gynecologic Oncology Group study

Nobuyuki Susumu, Satoru Sagae, Yasuhiro Udagawa, Kenji Niwa, Hiroyuki Kuramoto, Shinji Satoh, Ryuichi Kudo

Research output: Contribution to journalArticle

324 Citations (Scopus)

Abstract

Objective.: To establish an optimal adjuvant therapy for intermediate- and high-risk endometrial cancer patients, we conducted a multi-center randomized phase III trial of adjuvant pelvic radiation therapy (PRT) versus cyclophosphamide-doxorubicin-cisplatin (CAP) chemotherapy in women with endometrioid adenocarcinoma with deeper than 50% myometrial invasion. Methods.: Among 385 evaluated patients, 193 patients received PRT and 192 received CAP. The PRT group received at least 40 Gy. The CAP group received cyclophosphamide (333 mg/m 2), doxorubicin (40 mg/m 2) and cisplatin (50 mg/m 2) every 4 weeks for 3 or more courses. Results.: No statistically significant differences in progression-free survival (PFS) and overall survival (OS) were observed. The 5-year PFS rates in the PRT and CAP groups were 83.5% and 81.8% respectively, while the 5-year OS rates were 85.3% and 86.7% respectively. These rates were also not significantly different in a low- to intermediate-risk group defined as stage IC patients under 70 years old with G1/2 endometrioid adenocarcinoma. However, among 120 patients in a high- to intermediate-risk group defined as (1) stage IC in patients over 70 years old or with G3 endometrioid adenocarcinoma or (2) stage II or IIIA (positive cytology), the CAP group had a significantly higher PFS rate (83.8% vs. 66.2%, log-rank test P = 0.024, hazard ratio 0.44) and higher OS rate (89.7% vs. 73.6%, log-rank test P = 0.006, hazard ratio 0.24). Adverse effects were not significantly increased in the CAP group versus the PRT group. Conclusion.: Adjuvant chemotherapy may be a useful alternative to radiotherapy for intermediate-risk endometrial cancer.

Original languageEnglish
Pages (from-to)226-233
Number of pages8
JournalGynecologic Oncology
Volume108
Issue number1
DOIs
Publication statusPublished - 2008 Jan

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Endometrial Neoplasms
Cisplatin
Radiotherapy
Endometrioid Carcinoma
Drug Therapy
Survival Rate
Disease-Free Survival
Doxorubicin
Cyclophosphamide
Adjuvant Chemotherapy
Cell Biology
Survival

Keywords

  • Adjuvant chemotherapy
  • Adjuvant radiotherapy
  • Cisplatin-based chemotherapy
  • Endometrial cancer
  • Intermediate risk

ASJC Scopus subject areas

  • Obstetrics and Gynaecology
  • Oncology

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Randomized phase III trial of pelvic radiotherapy versus cisplatin-based combined chemotherapy in patients with intermediate- and high-risk endometrial cancer : A Japanese Gynecologic Oncology Group study. / Susumu, Nobuyuki; Sagae, Satoru; Udagawa, Yasuhiro; Niwa, Kenji; Kuramoto, Hiroyuki; Satoh, Shinji; Kudo, Ryuichi.

In: Gynecologic Oncology, Vol. 108, No. 1, 01.2008, p. 226-233.

Research output: Contribution to journalArticle

Susumu, Nobuyuki ; Sagae, Satoru ; Udagawa, Yasuhiro ; Niwa, Kenji ; Kuramoto, Hiroyuki ; Satoh, Shinji ; Kudo, Ryuichi. / Randomized phase III trial of pelvic radiotherapy versus cisplatin-based combined chemotherapy in patients with intermediate- and high-risk endometrial cancer : A Japanese Gynecologic Oncology Group study. In: Gynecologic Oncology. 2008 ; Vol. 108, No. 1. pp. 226-233.
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abstract = "Objective.: To establish an optimal adjuvant therapy for intermediate- and high-risk endometrial cancer patients, we conducted a multi-center randomized phase III trial of adjuvant pelvic radiation therapy (PRT) versus cyclophosphamide-doxorubicin-cisplatin (CAP) chemotherapy in women with endometrioid adenocarcinoma with deeper than 50{\%} myometrial invasion. Methods.: Among 385 evaluated patients, 193 patients received PRT and 192 received CAP. The PRT group received at least 40 Gy. The CAP group received cyclophosphamide (333 mg/m 2), doxorubicin (40 mg/m 2) and cisplatin (50 mg/m 2) every 4 weeks for 3 or more courses. Results.: No statistically significant differences in progression-free survival (PFS) and overall survival (OS) were observed. The 5-year PFS rates in the PRT and CAP groups were 83.5{\%} and 81.8{\%} respectively, while the 5-year OS rates were 85.3{\%} and 86.7{\%} respectively. These rates were also not significantly different in a low- to intermediate-risk group defined as stage IC patients under 70 years old with G1/2 endometrioid adenocarcinoma. However, among 120 patients in a high- to intermediate-risk group defined as (1) stage IC in patients over 70 years old or with G3 endometrioid adenocarcinoma or (2) stage II or IIIA (positive cytology), the CAP group had a significantly higher PFS rate (83.8{\%} vs. 66.2{\%}, log-rank test P = 0.024, hazard ratio 0.44) and higher OS rate (89.7{\%} vs. 73.6{\%}, log-rank test P = 0.006, hazard ratio 0.24). Adverse effects were not significantly increased in the CAP group versus the PRT group. Conclusion.: Adjuvant chemotherapy may be a useful alternative to radiotherapy for intermediate-risk endometrial cancer.",
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T1 - Randomized phase III trial of pelvic radiotherapy versus cisplatin-based combined chemotherapy in patients with intermediate- and high-risk endometrial cancer

T2 - A Japanese Gynecologic Oncology Group study

AU - Susumu, Nobuyuki

AU - Sagae, Satoru

AU - Udagawa, Yasuhiro

AU - Niwa, Kenji

AU - Kuramoto, Hiroyuki

AU - Satoh, Shinji

AU - Kudo, Ryuichi

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N2 - Objective.: To establish an optimal adjuvant therapy for intermediate- and high-risk endometrial cancer patients, we conducted a multi-center randomized phase III trial of adjuvant pelvic radiation therapy (PRT) versus cyclophosphamide-doxorubicin-cisplatin (CAP) chemotherapy in women with endometrioid adenocarcinoma with deeper than 50% myometrial invasion. Methods.: Among 385 evaluated patients, 193 patients received PRT and 192 received CAP. The PRT group received at least 40 Gy. The CAP group received cyclophosphamide (333 mg/m 2), doxorubicin (40 mg/m 2) and cisplatin (50 mg/m 2) every 4 weeks for 3 or more courses. Results.: No statistically significant differences in progression-free survival (PFS) and overall survival (OS) were observed. The 5-year PFS rates in the PRT and CAP groups were 83.5% and 81.8% respectively, while the 5-year OS rates were 85.3% and 86.7% respectively. These rates were also not significantly different in a low- to intermediate-risk group defined as stage IC patients under 70 years old with G1/2 endometrioid adenocarcinoma. However, among 120 patients in a high- to intermediate-risk group defined as (1) stage IC in patients over 70 years old or with G3 endometrioid adenocarcinoma or (2) stage II or IIIA (positive cytology), the CAP group had a significantly higher PFS rate (83.8% vs. 66.2%, log-rank test P = 0.024, hazard ratio 0.44) and higher OS rate (89.7% vs. 73.6%, log-rank test P = 0.006, hazard ratio 0.24). Adverse effects were not significantly increased in the CAP group versus the PRT group. Conclusion.: Adjuvant chemotherapy may be a useful alternative to radiotherapy for intermediate-risk endometrial cancer.

AB - Objective.: To establish an optimal adjuvant therapy for intermediate- and high-risk endometrial cancer patients, we conducted a multi-center randomized phase III trial of adjuvant pelvic radiation therapy (PRT) versus cyclophosphamide-doxorubicin-cisplatin (CAP) chemotherapy in women with endometrioid adenocarcinoma with deeper than 50% myometrial invasion. Methods.: Among 385 evaluated patients, 193 patients received PRT and 192 received CAP. The PRT group received at least 40 Gy. The CAP group received cyclophosphamide (333 mg/m 2), doxorubicin (40 mg/m 2) and cisplatin (50 mg/m 2) every 4 weeks for 3 or more courses. Results.: No statistically significant differences in progression-free survival (PFS) and overall survival (OS) were observed. The 5-year PFS rates in the PRT and CAP groups were 83.5% and 81.8% respectively, while the 5-year OS rates were 85.3% and 86.7% respectively. These rates were also not significantly different in a low- to intermediate-risk group defined as stage IC patients under 70 years old with G1/2 endometrioid adenocarcinoma. However, among 120 patients in a high- to intermediate-risk group defined as (1) stage IC in patients over 70 years old or with G3 endometrioid adenocarcinoma or (2) stage II or IIIA (positive cytology), the CAP group had a significantly higher PFS rate (83.8% vs. 66.2%, log-rank test P = 0.024, hazard ratio 0.44) and higher OS rate (89.7% vs. 73.6%, log-rank test P = 0.006, hazard ratio 0.24). Adverse effects were not significantly increased in the CAP group versus the PRT group. Conclusion.: Adjuvant chemotherapy may be a useful alternative to radiotherapy for intermediate-risk endometrial cancer.

KW - Adjuvant chemotherapy

KW - Adjuvant radiotherapy

KW - Cisplatin-based chemotherapy

KW - Endometrial cancer

KW - Intermediate risk

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