Open AccessAdjuvant Chemotherapy for Endometrial Cancer (ACE) trial: A randomized phase II study for advanced endometrial carcinoma
Author(s) -
EgawaTakata Tomomi,
Ueda Yutaka,
Ito Kimihiko,
Hori Kensuke,
Tadahiro Shoji,
Nagasawa Takayuki,
Nishio Shin,
Ushijima Kimio,
Koji Nishino,
Enomoto Takayuki,
Kikuchi Akira,
Honma Shigeru,
Oishi Tetsuro,
Shimada Muneaki,
Takei Yuji,
Fujiwara Hiroyuki,
Tanabe Hiroshi,
Okamoto Aikou,
Nishio Yukihiro,
Yamada Tomomi,
Kimura Tadashi
Publication year - 2022
Publication title -
cancer science
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.035
H-Index - 141
eISSN - 1349-7006
pISSN - 1347-9032
DOI - 10.1111/cas.15310
Subject(s) - medicine , carboplatin , endometrial cancer , epirubicin , paclitaxel , oncology , clinical endpoint , adjuvant , chemotherapy , cancer , urology , randomized controlled trial , breast cancer , cisplatin
This study evaluated the feasibility and efficacy of three postoperative adjuvant chemotherapy regimens for endometrial cancer. Endometrioid cancer patients with intermediate‐risk stage I and II or high‐risk stage III and IV disease were randomly assigned to receive six cycles of either paclitaxel‐epirubicin‐carboplatin (TEC), paclitaxel‐anthracycline (doxorubicin)‐carboplatin (TAC), or dose‐dense paclitaxel‐carboplatin (ddTC). The primary end‐point was the completion rate (CRate) of six cycles of treatment. The secondary end‐points were progression‐free survival (PFS) and overall survival (OS). One hundred and one patients were treated as follows: 33 received TEC, 33 TAC, and 35 ddTC. The CRates for TEC, TAC, and ddTC were 94%, 64%, and 69%, respectively ( P = .005). The TEC CRate was significantly higher than for the other two groups. However, the PFS and OS outcomes were not statistically different between the three groups. The 2‐year survival rates were 94%, 97%, and 97% for TEC, TAC, and ddTC, respectively. When compared to the current standard treatments for endometrial cancer, TEC is a promising candidate for a phase III trial based on its significantly superior CRate and equivalent PFS and OS. This study is registered with UMIN Clinical Trials Registry (UMIN8911).