2024-03-29T00:16:59Z
https://tsukuba.repo.nii.ac.jp/oai
oai:tsukuba.repo.nii.ac.jp:00054328
2022-04-27T09:28:40Z
2780:2180
3:62:5297:5193
Randomised phase II trial of mFOLFOX6 plus bevacizumab versus mFOLFOX6 plus cetuximab as first-line treatment for colorectal liver metastasis (ATOM trial)
兵頭, 一之介
ヒョウドウ, イチノスケ
HYODO, Ichinosuke
Oki, Eiji
Emi, Yasunori
Yamanaka, Takeharu
Uetake, Hiroyuki
Muro, Kei
Takahashi, Takao
Nagasaka, Takeshi
Hatano, Etsuro
Ojima, Hitoshi
Manaka, Dai
Kusumoto, Tetsuya
Katayose, Yu
Fujiwara, Toshiyoshi
Yoshida, Kazuhiro
Unno, Michiaki
Tomita, Naohiro
Sugihara, Kenichi
Maehara, Yoshihiko
Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/.
© The Author(s) 2019
Background
Chemotherapy with biologics followed by liver surgery improves the resection rate and survival of patients with colorectal liver metastasis (CRLM). However, no prospective study has compared the outcomes of chemotherapy with bevacizumab (BEV) versus cetuximab (CET).
Methods
The ATOM study is the first randomised trial comparing BEV and CET for initially unresectable CRLM. Patients were randomly assigned in a 1:1 ratio to receive mFOLFOX6 plus either BEV or CET. The primary endpoint was progression-free survival (PFS).
Results
Between May 2013 and April 2016, 122 patients were enrolled. Median PFS was 11.5 months (95% CI 9.2–13.3 months) in the BEV group and 14.8 months (95% CI 9.7–17.3 months) in the CET group (hazard ratio 0.803; P = 0.33). Patients with a smaller-number but larger-sized metastases did better in the CET group. In the BEV and CET groups, the response rates were 68.4% and 84.7% and the resection rates were 56.1% and 49.2%, respectively.
Conclusion
Although CET achieved a better response rate than BEV for patients with a small number of large liver metastases, both biologics had similar efficacy regarding liver resection and acceptable safety profiles. To achieve optimal PFS, biologics should be selected in accordance with patient conditions.
Trial registration
This trial is registered at ClinicalTrials.gov (number NCT01836653), and UMIN Clinical Trials Registry (UMIN-CTR number UMIN000010209).
Springer Nature on behalf of Cancer Research UK
2019-07
eng
journal article
http://hdl.handle.net/2241/00159751
https://tsukuba.repo.nii.ac.jp/records/54328
31285591
10.1038/s41416-019-0518-2
0007-0920
AA00574355
British journal of cancer
121
3
222
229
https://tsukuba.repo.nii.ac.jp/record/54328/files/BJC_121-3.pdf
application/pdf
679.3 kB
2020-03-17