TY - JOUR
T1 - Three-Year Follow-Up and Response-Survival Relationship of Nivolumab in Previously Treated Patients with Advanced Esophageal Squamous Cell Carcinoma (ATTRACTION-3)
AU - Okada, Morihito
AU - Kato, Ken
AU - Cho, Byoung Chul
AU - Takahashi, Masanobu
AU - Lin, Chen Yuan
AU - Chin, Keisho
AU - Kadowaki, Shigenori
AU - Ahn, Myung Ju
AU - Hamamoto, Yasuo
AU - Doki, Yuichiro
AU - Yen, Chueh Chuan
AU - Kubota, Yutaro
AU - Kim, Sung Bae
AU - Hsu, Chih Hung
AU - Holtved, Eva
AU - Xynos, Ioannis
AU - Matsumura, Yasuhiro
AU - Takazawa, Akira
AU - Kitagawa, Yuko
N1 - Funding Information:
K. Kato reports other support from Ono Pharmaceutical during the conduct of the study as well as other support from MSD, BMS, Bayer, Shionogi, Taiho, AstraZeneca, Chugai, and Janssen outside the submitted work. B.C. Cho reports grants from Novartis, Bayer, AstraZeneca, MOGAM Institute, Dong-A ST, Champions Oncology, Janssen, Yuhan, Ono, Dizal Pharma, MSD, AbbVie, Medpacto, GI Innovation, Eli Lilly, Blueprint Medicines, and Interpark Bio Convergence Corp.; personal fees from Novartis, AstraZeneca, Boehringer-Ingelheim, Roche, BMS, Ono, Yuhan, Pfizer, Eli Lilly, Janssen, Takeda, MSD, Medpacto, Blueprint Medicines, TheraCanVac Inc, Gencurix Inc, Bridgebio Therapeutics, Kanaph Therapeutics Inc, Cyrus Therapeutics, Interpark Bio Convergence Corp., Guardant Health, Joseah BIO, and Champions Oncology; and other support from DAAN Biotherapeutics outside the submitted work. M. Takahashi reports grants from Ono Pharmaceutical Co. during the conduct of the study as well as grants and personal fees from Ono Pharmaceutical Co.; personal fees from Daiichi Sankyo Co., Bristol-Myers Squibb, and Taiho Pharmaceutical Co.; and grants from Chugai Pharmaceutical Co. outside the submitted work. K. Chin reports personal fees from Ono Pharmaceutical Co. Ltd. and Bristol-Myers Squibb during the conduct of the study as well as personal fees from Chugai Pharmaceutical Co., Ltd. and Taiho Pharma outside the submitted work. S. Kadowaki reports grants and personal fees from Ono Pharmaceutical and Bristol-Myers Squibb during the conduct of the study as well as grants and personal fees from Taiho Pharmaceutical, Eli Lilly, MSD, and Chugai Pharma; grants from Nobel Pharma; and personal fees from Bayer, Merck Serono, and Eisai outside the submitted work. M.-J. Ahn reports personal fees from AstraZeneca, Alpha Pharmaceuticals, Merck, Takeda, Lilly, Yuhan, MSD, and Ono outside the submitted work. Y. Hamamoto reports other support from Ono Pharmaceutical during the conduct of the study as well as other support from Ono Pharmaceutical outside the submitted work. Y. Doki reports personal fees from Ono Pharmaceutical during the conduct of the study. C.-C. Yen reports grants from Ono Pharmaceutical and Bristol-Myers Squibb during the conduct of the study as well as grants from TLC, EffPha, Athenex, Deciphera, Eisai, and BioAtla and other support from Deciphera, TTY Biopharm, CStone, Daiichi Sankyo, and Merck Sharp & Dohme outside the submitted work. S.-B. Kim reports research funding from Novartis, Sanofi-Aventis, and DongKook PharmCo.; has served on advisory boards for Novartis, AstraZeneca, Lilly, Dae Hwa Pharmaceutical Co. Ltd, ISU Abxis, and Daiichi-Sankyo; and owns shares in Genopeaks and NeogeneTC. C.-H. Hsu reports grants from Bristol-Myers Squibb, Merck Sharp & Dohme, AstraZeneca, Roche, Ono Pharmaceutical, and EMD Serono and personal fees from Bristol-Myers Squibb and Ono Pharmaceutical during the conduct of the study as well as personal fees from Merck Sharp & Dohme, Roche, and EMD Serono and grants from BeiGene outside the submitted work. I. Xynos is an employee and stock owner of Bristol-Myers Squibb. Y. Matsumura reports other support from Ono Pharmaceutical during the conduct of the study. A. Takazawa reports personal fees from Ono Pharmaceutical outside the submitted work. Y. Kitagawa reports grants from Takeda Pharmaceutical, Yakult Honsha, Otsuka Pharmaceutical, Tsumura & Co., Kyouwa Hakkou Kirin, Dainippon Sumitomo Pharma, EA Pharma, Astellas Pharma, Toyama Chemical Co., Medicon, Eisai, Kaken Pharmaceutical, Teijin Pharma Limited, and Nihon Pharmaceutical; grants and personal fees from Chugai Pharmaceuticals, Taiho Pharmaceuticals, Asahi Kasei Pharma Corporation, Ono Pharmaceutical, Otsuka, and Nippon Covidien; and personal fees from Shionogi & Co., Ethicon, Olympus Corporation, Bristol-Myers Squibb K.K., AstraZeneca K.K., MSD K.K., and Smith & Nephew K.K. outside the submitted work. No disclosures were reported by the other authors.
Funding Information:
This study was funded by Ono Pharmaceutical Co., Ltd and Bristol-Myers Squibb. We thank the patients, their families, and the investigators. Editorial support, in the form of medical writing, assembling tables and creating high-resolution images based on authors’ detailed directions, collating author comments, copyediting, fact checking, and referencing, was provided by Amit Garg of Enago Life Sciences, and was funded by Ono Pharmaceutical Co., Ltd., and Bristol-Myers Squibb.
Publisher Copyright:
© 2022 TheAuthors.
PY - 2022/8/1
Y1 - 2022/8/1
N2 - Purpose: Limited long-term data are available on immune checkpoint inhibitor use in patients with advanced esophageal squamous cell carcinoma (ESCC). We report 3-year follow-up data from our study of nivolumab versus chemotherapy (paclitaxel or docetaxel) in patients with previously treated ESCC. Patients and Methods: ATTRACTION-3 was a randomized, multicenter, open-label, phase III trial. Overall survival (OS), time from randomization to death from any cause, was the primary endpoint. An exploratory subanalysis assessed OS according to the best overall response (BOR) with and without landmark at 4 months. Results: Of the enrolled patients, 210 received nivolumab and 209 received chemotherapy. With a minimum follow-up of 36.0 months, OS was longer in the nivolumab versus the chemotherapy group (median, 10.9 vs. 8.5 months; HR, 0.79; P = 0.0264), with 3-year OS rates of 15.3% and 8.7%, respectively. The median OS was longer with nivolumab versus chemotherapy irrespective of the BOR (complete response/partial response: 19.9 vs. 15.4 months; stable disease: 17.4 vs. 8.8 months; and progressive disease: 7.6 vs. 4.2 months). Grade 3 or higher treatment-related adverse events were reported in 40 patients (19.1%) in the nivolumab group and 133 patients (63.9%) in the chemotherapy group. Conclusions: Nivolumab as second-line therapy demonstrated clinically meaningful long-term improvement in OS compared with chemotherapy in previously treated patients with advanced ESCC. The OS was consistently improved in the nivolumab group compared with the chemotherapy group regardless of BOR. Nivolumab was well tolerated over the 3-year follow-up.
AB - Purpose: Limited long-term data are available on immune checkpoint inhibitor use in patients with advanced esophageal squamous cell carcinoma (ESCC). We report 3-year follow-up data from our study of nivolumab versus chemotherapy (paclitaxel or docetaxel) in patients with previously treated ESCC. Patients and Methods: ATTRACTION-3 was a randomized, multicenter, open-label, phase III trial. Overall survival (OS), time from randomization to death from any cause, was the primary endpoint. An exploratory subanalysis assessed OS according to the best overall response (BOR) with and without landmark at 4 months. Results: Of the enrolled patients, 210 received nivolumab and 209 received chemotherapy. With a minimum follow-up of 36.0 months, OS was longer in the nivolumab versus the chemotherapy group (median, 10.9 vs. 8.5 months; HR, 0.79; P = 0.0264), with 3-year OS rates of 15.3% and 8.7%, respectively. The median OS was longer with nivolumab versus chemotherapy irrespective of the BOR (complete response/partial response: 19.9 vs. 15.4 months; stable disease: 17.4 vs. 8.8 months; and progressive disease: 7.6 vs. 4.2 months). Grade 3 or higher treatment-related adverse events were reported in 40 patients (19.1%) in the nivolumab group and 133 patients (63.9%) in the chemotherapy group. Conclusions: Nivolumab as second-line therapy demonstrated clinically meaningful long-term improvement in OS compared with chemotherapy in previously treated patients with advanced ESCC. The OS was consistently improved in the nivolumab group compared with the chemotherapy group regardless of BOR. Nivolumab was well tolerated over the 3-year follow-up.
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U2 - 10.1158/1078-0432.CCR-21-0985
DO - 10.1158/1078-0432.CCR-21-0985
M3 - Article
C2 - 35294546
AN - SCOPUS:85133823549
SN - 1078-0432
VL - 28
SP - 3277
EP - 3286
JO - Clinical Cancer Research
JF - Clinical Cancer Research
IS - 15
ER -
