Adjuvant Chemotherapy for Endometrial Cancer (ACE) trial: A randomized phase II study for advanced endometrial carcinoma.

Abstract

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 (UMIN000008911).

• Authors: Tomomi Egawa-Takata, Yutaka Ueda, Kimihiko Ito, Kensuke Hori, Shoji Tadahiro, Takayuki Nagasawa, Shin Nishio, Kimio Ushijima, Nishino Koji, Takayuki Enomoto, Akira Kikuchi, Shigeru Honma, Tetsuro Oishi, Muneaki Shimada, Yuji Takei, Hiroyuki Fujiwara, Hiroshi Tanabe, Aikou Okamoto, Yukihiro Nishio, Tomomi Yamada, Tadashi Kimura
• Journal: Cancer science (Cancer Sci) Vol. 113 Issue 5 Pg. 1693-1701 (May 2022) ISSN: 1349-7006 [Electronic] England
• PMID: 35218673 (Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial)
• Copyright: © 2022 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association.

Chemical References

• Carboplatin
• Paclitaxel

Topics

• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Carboplatin (adverse effects)
• Chemotherapy, Adjuvant
• Endometrial Neoplasms (drug therapy)
• Female
• Humans
• Neoplasm Staging
• Paclitaxel (therapeutic use)