A randomized phase III trial of docetaxel plus cisplatin or paclitaxel plus carboplatin compared with doxorubicin plus cisplatin as adjuvant chemotherapy for endometrial cancer at high risk of recurrence: Japanese Gynecologic Oncology Group study (JGOG2043).

Authors

null

Hiroyuki Nomura

Keio University School of Medicine, Tokyo, Japan

Hiroyuki Nomura , Daisuke Aoki , Hirofumi Michimae , Mika Mizuno , Hidekatsu Nakai , Masahide Arai , Motoi Sasagawa , Kimio Ushijima , Toru Sugiyama , Motoaki Saito , Hideki Tokunaga , Kohei Omatsu , Toru Nakanishi , Yoh Watanabe , Toshiaki Saito , Nobuo Yaegashi

Organizations

Keio University School of Medicine, Tokyo, Japan, Kitasato University School of Pharmacy, Tokyo, Japan, Aichi Cancer Center Hospital, Aichi, Japan, Department of Obstetrics and Gynecology, Kindai University Faculty of Medicine, Osaka, Japan, Kitasato University School of Medicine, Kanagawa, Japan, Department of Gynecology, Niigata Cancer Center Hospital, Niigata, Japan, Kurume University School of Medicine, Fukuoka, Japan, Department of Obstetrics and Gynecology, Iwate Medical University, Iwate, Japan, The Jikei University School of Medicine, Tokyo, Japan, Tohoku University Hospital, Miyagi, Japan, Cancer Institute Hospital, Tokyo, Japan, Tohoku University, Miyagi, Japan, National Kyushu Cancer Center, Fukuoka, Japan

Research Funding

Other Foundation

Background: The superiority of chemotherapy regimens employing a taxane plus a platinum agent over standard therapy with doxorubicin plus cisplatin (AP) was recently demonstrated for advanced or recurrent endometrial cancer. This multicenter phase III trial evaluated the clinical benefit of taxane plus platinum agent regimens as adjuvant chemotherapy compared with AP for endometrial cancer patients at high risk of recurrence after surgery. Methods: Endometrial cancer patients having a high risk of recurrence and postoperative residual disease < 2 cm were randomly assigned (1:1:1) with stratification by FIGO stage and histologic grade to receive 6 cycles of doxorubicin (60 mg/m2) plus cisplatin (50 mg/m2) on day 1 (AP), docetaxel (70 mg/m2) plus cisplatin (60 mg/m2) on day 1 (DP) or paclitaxel (180 mg/m2) plus carboplatin (AUC 6.0 mg/mL x minute) on day 1 (TC) every 3 weeks as adjuvant chemotherapy. The primary endpoint was progression-free survival (PFS). Secondary endpoints were overall survival (OS), adverse events, and tolerability. Results: From November 2006 to January 2011, 788 patients were enrolled from 118 institutions in Japan and were eligible for evaluation. The proportion of patients receiving 6 cycles was 80% for AP, 83% for DP, and 76% for TC, and tolerability of the regimens showed no significant difference. After a median follow-up period of 7.0 years, there was no statistical difference of PFS (P=0.1246) or OS (P=0.6734) among the 3 groups. The 5-year PFS rate was 74.9% for AP, 80.9% for DP, and 74.7% for TC, while the 5-year OS rates were 84.3%, 89.3%, and 88.4%, respectively. Conclusions: There was no significant difference of survival among patients receiving AP, DP, or TC as adjuvant chemotherapy for endometrial cancer. Since each regimen showed adequate tolerability, taxane plus platinum agent regimens may be a reasonable alternative to AP. Clinical trial information: UMIN000000522.

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Abstract Details

Meeting

2017 ASCO Annual Meeting

Session Type

Oral Abstract Session

Session Title

Gynecologic Cancer

Track

Gynecologic Cancer

Sub Track

Uterine Cancer

Clinical Trial Registration Number

UMIN000000522

Citation

J Clin Oncol 35, 2017 (suppl; abstr 5503)

DOI

10.1200/JCO.2017.35.15_suppl.5503

Abstract #

5503

Abstract Disclosures