Three-Year Follow-Up and Response-Survival Relationship of Nivolumab in Previously Treated Patients with Advanced Esophageal Squamous Cell Carcinoma (ATTRACTION-3)

Morihito Okada; Ken Kato; Byoung Chul Cho; Masanobu Takahashi; Chen Yuan Lin; Keisho Chin; Shigenori Kadowaki; Myung Ju Ahn; Yasuo Hamamoto; Yuichiro Doki; Chueh Chuan Yen; Yutaro Kubota; Sung Bae Kim; Chih Hung Hsu; Eva Holtved; Ioannis Xynos; Yasuhiro Matsumura; Akira Takazawa; Yuko Kitagawa

doi:10.1158/1078-0432.CCR-21-0985

Three-Year Follow-Up and Response-Survival Relationship of Nivolumab in Previously Treated Patients with Advanced Esophageal Squamous Cell Carcinoma (ATTRACTION-3)

Morihito Okada, Ken Kato, Byoung Chul Cho, Masanobu Takahashi, Chen Yuan Lin, Keisho Chin, Shigenori Kadowaki, Myung Ju Ahn, Yasuo Hamamoto, Yuichiro Doki, Chueh Chuan Yen, Yutaro Kubota, Sung Bae Kim, Chih Hung Hsu, Eva Holtved, Ioannis Xynos, Yasuhiro Matsumura, Akira Takazawa, Yuko Kitagawa

Department of Internal Medicine

Research output: Contribution to journal › Article › peer-review

8 Citations (Scopus)

Abstract

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.

Original language	English
Pages (from-to)	3277-3286
Number of pages	10
Journal	Clinical Cancer Research
Volume	28
Issue number	15
DOIs	https://doi.org/10.1158/1078-0432.CCR-21-0985
Publication status	Published - 2022 Aug 1

Bibliographical note

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.

All Science Journal Classification (ASJC) codes

Oncology
Cancer Research

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1158/1078-0432.CCR-21-0985

Cite this

Okada, M., Kato, K., Cho, B. C., Takahashi, M., Lin, C. Y., Chin, K., Kadowaki, S., Ahn, M. J., Hamamoto, Y., Doki, Y., Yen, C. C., Kubota, Y., Kim, S. B., Hsu, C. H., Holtved, E., Xynos, I., Matsumura, Y., Takazawa, A., & Kitagawa, Y. (2022). Three-Year Follow-Up and Response-Survival Relationship of Nivolumab in Previously Treated Patients with Advanced Esophageal Squamous Cell Carcinoma (ATTRACTION-3). Clinical Cancer Research, 28(15), 3277-3286. https://doi.org/10.1158/1078-0432.CCR-21-0985

@article{ec743aafbfce4df58419b909df992593,

title = "Three-Year Follow-Up and Response-Survival Relationship of Nivolumab in Previously Treated Patients with Advanced Esophageal Squamous Cell Carcinoma (ATTRACTION-3)",

abstract = "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.",

author = "Morihito Okada and Ken Kato and Cho, {Byoung Chul} and Masanobu Takahashi and Lin, {Chen Yuan} and Keisho Chin and Shigenori Kadowaki and Ahn, {Myung Ju} and Yasuo Hamamoto and Yuichiro Doki and Yen, {Chueh Chuan} and Yutaro Kubota and Kim, {Sung Bae} and Hsu, {Chih Hung} and Eva Holtved and Ioannis Xynos and Yasuhiro Matsumura and Akira Takazawa and Yuko Kitagawa",

note = "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{\textquoteright} 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: {\textcopyright} 2022 TheAuthors.",

year = "2022",

month = aug,

day = "1",

doi = "10.1158/1078-0432.CCR-21-0985",

language = "English",

volume = "28",

pages = "3277--3286",

journal = "Clinical Cancer Research",

issn = "1078-0432",

publisher = "American Association for Cancer Research Inc.",

number = "15",

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Okada, M, Kato, K, Cho, BC, Takahashi, M, Lin, CY, Chin, K, Kadowaki, S, Ahn, MJ, Hamamoto, Y, Doki, Y, Yen, CC, Kubota, Y, Kim, SB, Hsu, CH, Holtved, E, Xynos, I, Matsumura, Y, Takazawa, A & Kitagawa, Y 2022, 'Three-Year Follow-Up and Response-Survival Relationship of Nivolumab in Previously Treated Patients with Advanced Esophageal Squamous Cell Carcinoma (ATTRACTION-3)', Clinical Cancer Research, vol. 28, no. 15, pp. 3277-3286. https://doi.org/10.1158/1078-0432.CCR-21-0985

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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UR - http://www.scopus.com/inward/citedby.url?scp=85133823549&partnerID=8YFLogxK

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 -

Three-Year Follow-Up and Response-Survival Relationship of Nivolumab in Previously Treated Patients with Advanced Esophageal Squamous Cell Carcinoma (ATTRACTION-3)

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