Randomised phase II trial of mFOLFOX6 plus bevacizumab versus mFOLFOX6 plus cetuximab as first-line treatment for colorectal liver metastasis (ATOM trial)

Eiji Oki, Yasunori Emi, Takeharu Yamanaka, Hiroyuki Uetake, Kei Muro, Takao Takahashi, Takeshi Nagasaka, Etsuro Hatano, Hitoshi Ojima, Dai Manaka, Tetsuya Kusumoto, Yu Katayose, Toshiyoshi Fujiwara, Kazuhiro Yoshida, Michiaki Unno, Ichinosuke Hyodo, Naohiro Tomita, Kenichi Sugihara, Yoshihiko Maehara

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

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).

Original languageEnglish
Pages (from-to)222-229
Number of pages8
JournalBritish journal of cancer
Volume121
Issue number3
DOIs
Publication statusPublished - Jul 30 2019

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Neoplasm Metastasis
Liver
Biological Products
Disease-Free Survival
Therapeutics
Drug Therapy
Bevacizumab
Cetuximab
Registries
Survival Rate
Clinical Trials
Prospective Studies
Safety

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

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Randomised phase II trial of mFOLFOX6 plus bevacizumab versus mFOLFOX6 plus cetuximab as first-line treatment for colorectal liver metastasis (ATOM trial). / 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; Hyodo, Ichinosuke; Tomita, Naohiro; Sugihara, Kenichi; Maehara, Yoshihiko.

In: British journal of cancer, Vol. 121, No. 3, 30.07.2019, p. 222-229.

Research output: Contribution to journalArticle

Oki, E, Emi, Y, Yamanaka, T, Uetake, H, Muro, K, Takahashi, T, Nagasaka, T, Hatano, E, Ojima, H, Manaka, D, Kusumoto, T, Katayose, Y, Fujiwara, T, Yoshida, K, Unno, M, Hyodo, I, Tomita, N, Sugihara, K & Maehara, Y 2019, 'Randomised phase II trial of mFOLFOX6 plus bevacizumab versus mFOLFOX6 plus cetuximab as first-line treatment for colorectal liver metastasis (ATOM trial)', British journal of cancer, vol. 121, no. 3, pp. 222-229. https://doi.org/10.1038/s41416-019-0518-2
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 ; Hyodo, Ichinosuke ; Tomita, Naohiro ; Sugihara, Kenichi ; Maehara, Yoshihiko. / Randomised phase II trial of mFOLFOX6 plus bevacizumab versus mFOLFOX6 plus cetuximab as first-line treatment for colorectal liver metastasis (ATOM trial). In: British journal of cancer. 2019 ; Vol. 121, No. 3. pp. 222-229.
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abstract = "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).",
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T1 - Randomised phase II trial of mFOLFOX6 plus bevacizumab versus mFOLFOX6 plus cetuximab as first-line treatment for colorectal liver metastasis (ATOM trial)

AU - Oki, Eiji

AU - Emi, Yasunori

AU - Yamanaka, Takeharu

AU - Uetake, Hiroyuki

AU - Muro, Kei

AU - Takahashi, Takao

AU - Nagasaka, Takeshi

AU - Hatano, Etsuro

AU - Ojima, Hitoshi

AU - Manaka, Dai

AU - Kusumoto, Tetsuya

AU - Katayose, Yu

AU - Fujiwara, Toshiyoshi

AU - Yoshida, Kazuhiro

AU - Unno, Michiaki

AU - Hyodo, Ichinosuke

AU - Tomita, Naohiro

AU - Sugihara, Kenichi

AU - Maehara, Yoshihiko

PY - 2019/7/30

Y1 - 2019/7/30

N2 - 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).

AB - 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).

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