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Clinical Trial
. 2021 Oct;18(4):835-843.
doi: 10.1007/s10388-021-00850-0. Epub 2021 May 16.

Five-year follow-up of nivolumab treatment in Japanese patients with esophageal squamous-cell carcinoma (ATTRACTION-1/ONO-4538-07)

Taroh Satoh  1 , Ken Kato  2 , Takashi Ura  3   4 , Yasuo Hamamoto  5 , Takashi Kojima  6 , Takahiro Tsushima  7 , Shuichi Hironaka  8   9 , Hiroki Hara  10 , Satoru Iwasa  2 , Kei Muro  3 , Hirofumi Yasui  7 , Keiko Minashi  8 , Kensei Yamaguchi  10   11 , Atsushi Ohtsu  12 , Yuichiro Doki  13 , Yasuhiro Matsumura  14 , Yuko Kitagawa  15
Affiliations
Clinical Trial

Five-year follow-up of nivolumab treatment in Japanese patients with esophageal squamous-cell carcinoma (ATTRACTION-1/ONO-4538-07)

Taroh Satoh et al. Esophagus. 2021 Oct.

Abstract

Background: In the phase II ATTRACTION-1 study, nivolumab demonstrated a promising antitumor activity among Japanese patients with treatment-refractory advanced esophageal cancer. Here, we report the follow-up results of ATTRACTION-1 of > 5 years.

Methods: We enrolled patients with esophageal cancer that was refractory or intolerant to a standard chemotherapy. Then, nivolumab (3 mg/kg) was administered every 2 weeks. The primary endpoint was a centrally assessed objective response rate.

Results: Nivolumab was administered to 65 patients with esophageal squamous-cell carcinoma (ESCC). The centrally assessed objective response rate was 17.2%. The overall survival rates at 3 and 5 years were 10.9% and 6.3%, respectively. Three-year survivors tended to have more reduced target lesions. A total of 63.1% of the patients exhibited treatment-related adverse events, and no new safety signal was observed. Patients with select adverse events tended to have better overall survival than those without. No apparent chronological order was observed between the first response and the onset of select adverse events.

Conclusion: Our follow-up analysis of more than 5 years is currently the longest and is the first to demonstrate that nivolumab has long-term efficacy and safety for advanced ESCC.

Keywords: Clinical trial; Esophageal squamous cell carcinoma; Immunotherapy; Nivolumab.

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Conflict of interest statement

Taroh Satoh received research funding from Ono and Bristol-Myers Squibb during the conduct of the study; and grants from Ono, Chugai, Yakult Honsha, Eli Lilly, Bristol-Myers Squibb, MSD, Gilead Sciences, Parexel, Daiichi Sankyo, and Astellas; honoraria from Ono, Chugai, Yakult Honsha, Eli Lilly, Bristol-Myers Squibb, and Daiichi Sankyo; and travel fee from Ono outside the submitted work. Ken Kato received research funding from Ono and Bristol-Myers Squibb during the conduct of the study; and grants from Ono, MSD, AstraZeneca, Bayer, Chugai, BeiGene, and Shionogi; honoraria from Ono and Bristol-Myers Squibb outside the submitted work. Takashi Ura, Yasuo Hamamoto, Hirofumi Yasui, and Yuichiro Doki received research funding from Ono and Bristol-Myers Squibb during the conduct of the study. Takashi Kojima received research funding from Ono and Bristol-Myers Squibb during the conduct of the study; and research funding from MSD, Astellas Amgen BioPharma, Taiho, Chugai, and Shionogi; and honoraria from Ono, Bristol-Myers Squibb, MSD, Astellas, Merck, and Oncolys BioPharma outside the submitted work. Takahiro Tsushima received research funding from Ono and Bristol-Myers Squibb during the conduct of the study; and honorarium from Ono outside the submitted work. Shuichi Hironaka received research funding from Ono and Bristol-Myers Squibb during the conduct of the study; and honoraria from Bristol-Myers Squibb, Ono, Taiho, Daiichi Sankyo, Eli Lilly, Chugai, Nippon kayaku, Tsumura, Sanofi, Merck, and AstraZeneca outside the submitted work. Hiroki Hara received research funding from Ono and Bristol-Myers Squibb during the conduct of the study; and research funding from Astellas, AstraZeneca, Bayer, BeiGene, Boehringer Ingelheim, Chugai, Daiichi Sankyo, Dainippon Sumitomo, Eisai, Elevar Therapeutics, GSK, Incyte, Merck Biopharma, MSD, Ono, Pfizer, and Taiho; consulting fees from Boehringer Ingelheim, Daiichi Sankyo, Dainippon Sumitomo, Eli Lilly, MSD, and Ono; and honoraria from Bayer, Bristol-Myers Squibb, Chugai, Daiichi Sankyo, Kyowa Hakko Kirin, Eli Lilly, Merck Biopharma, MSD, Ono, Sanofi, Taiho, Takeda, and Yakult outside the submitted work. Satoru Iwasa received research funding from Ono, Bristol-Myers Squibb, and Pfizer during the conduct of the study; and honoraria from Ono and Bristol-Myers Squibb outside the submitted work. Kei Muro received research funding from Ono and Bristol-Myers Squibb during the conduct of the study; and research funding from Solasia, Merck Serono, Daiichi Sankyo, Parexel International, Pfizer, MSD, Amgen, Ono, Sanofi, and Taiho; consulting fees from Amgen, Ono, and AstraZeneca; and honoraria from Ono, Sanofi, Taiho, Chugai, Takeda, Eli Lilly, Bristol-Myers Squibb, and Bayer outside the submitted work. Keiko Minashi received research funding from Ono and Bristol-Myers Squibb during the conduct of the study; and research funding from MSD, Mediscience Planning, Merck Biopharma, Astellas, Taiho, and Daiichi Sankyo outside the submitted work. Kensei Yamaguchi received research funding from Ono and Bristol-Myers Squibb during the conduct of the study; and grants from Taiho, Yakult Honsha, Sanofi, Ono, and Elli Lilly; and honoraria Taiho, Chugai, Bristol-Myers Squibb, Merck Serono, Takeda, Ono, and Elli Lilly outside the submitted work. Atsushi Ohtsu received research funding from Ono and Bristol-Myers Squibb during the conduct of the study; and honorarium from Bristol-Myers Squibb outside the submitted work. Yasuhiro Matsumura is an employee and a stockholder of Ono. Yuko Kitagawa received research funding from Ono and Bristol-Myers Squibb during the conduct of the study; and grants from Takeda, Chugai, Taiho, Yakult Honsha, Asahi Kasei, Otsuka, Ono, Tsumura, EA, Astellas, Toyama Chemical, Medicon, Kaken, Eisai, Otsuka, Teijin, Nihon, and Nippon Covidien; and honoraria from Chugai, Taiho, Asahi Kasei, Otsuka, Shionogi, and Nippon Covidien outside the submitted work.

Figures

Fig. 1
Fig. 1
Change of target lesion sizes. The waterfall plot highlights maximum percent change in the sum of target lesion size from baseline that were assessed by each investigator. Each color represents patients surviving for < 1 (navy blue), 1 (blue), 2 (cyan), 3 (pink), 4 (orange), and 5 (green) years
Fig. 2
Fig. 2
Probability of survival. The Kaplan–Meier curves show the a overall survival (OS) and b progression-free survival (PFS). Circles represent censors. CI, Confidence interval
Fig. 3
Fig. 3
Relationships between select AEs and overall survival or response. a The Kaplan–Meier curves shows the overall survival (OS) in patients with and without select adverse events (AEs) are shown. b The swimmer plot shows the timing of the response and the first onsets of each category of the treatment-related adverse events in patients with complete response (CR) or partial response (PR) in the nivolumab group
See this image and copyright information in PMC

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