Article Information
Accepted for Publication: October 1, 2020.
Published Online: January 7, 2021. doi:10.1001/jamaoncol.2020.6758
Open Access: This is an open access article distributed under the terms of the
CC-BY-NC-ND License. © 2021 Akamatsu H et al.
JAMA Oncology.
Corresponding Author: Hiroaki Akamatsu, MD, PhD, Internal Medicine III, Wakayama Medical University, 811-1,
Kimiidera, Wakayama, Japan (
hiroakiakamatsu@
123456gmail.com
).
Author Contributions: Dr Akamatsu (principal investigator) had full access to all of the data in the study
and takes responsibility for the integrity of the data and the accuracy of the data
analysis.
Concept and design: Akamatsu, Furuya, Nishino, Morita, Nakagawa, Yamamoto.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Akamatsu, Hayashi, Fujimoto, Furuya, Otani, Shimizu, Nishino, Hara, Morita, Yamamoto.
Critical revision of the manuscript for important intellectual content: Akamatsu, Toi, Tachihara, Furuya, Shimizu, Katakami, Azuma, Miura, Nishino, Teraoka,
Nakagawa, Yamamoto.
Statistical analysis: Akamatsu, Katakami, Morita.
Obtained funding: Akamatsu.
Administrative, technical, or material support: Akamatsu, Hayashi, Fujimoto, Tachihara, Furuya, Otani, Shimizu, Hara, Yamamoto.
Supervision: Nakagawa, Yamamoto.
Conflict of Interest Disclosures: Dr Akamatsu reported receiving grants and personal fees from Chugai Pharmaceutical
and MSD KK and personal fees from AstraZeneca KK, Boehringer Ingelheim Japan Inc,
Bristol Myers Squibb, Eli Lilly Japan KK, Novartis Pharma KK, Ono Pharmaceutical,
and Taiho Pharmaceutical outside the submitted work. Dr Toi reported receiving personal
fees from AstraZeneca, Bristol Myers Squibb, MSD, and Ono Pharmaceutical during the
conduct of the study. Dr Hayashi reported receiving grants and personal fees from
AstraZeneca KK and Chugai Pharmaceutical during the conduct of the study; and grants
and personal fees from Boehringer Ingelheim Japan, Ono Pharmaceutical, and Bristol
Myers Squibb and personal fees from Eli Lilly Japan KK, Kyorin Pharmaceutical, Merck
Biopharma, MSD KK, Novartis Pharmaceuticals KK, Pfizer Japan Inc, Shanghai HaiHe Biopharma,
and Taiho Pharmaceutical outside the submitted work. Dr Fujimoto reported receiving
grants and personal fees from AstraZeneca KK and personal fees from Boehringer Ingelheim
Japan Inc, Bristol Myers Squibb, Chugai Pharmaceutical, Eli Lilly Japan KK, MSD KK,
Novartis Pharma KK, Ono Pharmaceutical, and Taiho Pharmaceutical outside the submitted
work. Dr Tachihara reported receiving grants and personal fees from AstraZeneca KK
and personal fees from Boehringer Ingelheim Japan Inc, Chugai Pharmaceutical, Eli
Lilly Japan KK, MSD KK, and Olympus outside the submitted work. Dr Furuya reported
receiving personal fees from Eli Lilly Japan, Chugai, AstraZeneca, Bristol Myers Squibb,
Boehringer Ingelheim Japan, Taiho, Ono Pharmaceutical, and Pfizer Japan outside the
submitted work. Dr Shimizu reported receiving honoraria from AstraZeneca KK, MSD KK,
Ono Pharmaceutical, Taiho Pharmaceutical, and Chugai Pharmaceutical outside the submitted
work. Dr Katakami reported receiving grants and personal fees from AstraZeneca KK,
Bristol Myers Squibb, Chugai Pharmaceutical, Eli Lilly Japan KK, MSD KK, and Ono Pharmaceutical,
and personal fees from Boehringer Ingelheim Japan, Novartis Pharma KK, and Taiho Pharmaceutical
outside the submitted work. Dr Azuma reported receiving personal fees from Chugai
Pharma, AstraZeneca, MSD, Bristol Myers Squibb, and Ono Pharmaceutical outside the
submitted work. Dr Nishino reported receiving personal fees from Nippon Boehringer
Ingelheim, AstraZeneca KK, Novartis Pharma KK, Eli Lilly Japan KK, Roche Diagnostics
KK, Chugai Pharma, and Ono Pharmaceutical outside the submitted work. Dr Teraoka reported
receiving personal fees from AstraZeneca and Chugai Pharmabody Research outside the
submitted work. Dr Morita reported receiving personal fees from AstraZeneca KK, Bristol
Myers Squibb, Chugai Pharmaceutical, Eli Lilly Japan KK, MSD KK, Pfizer Japan, Taiho
Pharmaceutical, and Ono Pharmaceutical outside the submitted work. Dr Nakagawa reported
receiving grants and personal fees from AstraZeneca KK, Astellas Pharma, MSD KK, Nippon
Boehringer Ingelheim, Novartis Pharma KK, Bristol Myers Squibb, Chugai Pharmaceutical,
Daiichi Sankyo, and Merck Serono/Merck Biopharma and grants, personal fees, and other
from Ono Pharmaceutical, Pfizer Japan, and Eli Lilly Japan KK, during the conduct
of the study; grants from inVentiv Health Japan, ICON Japan KK, Gritstone Oncology,
Parexel International, Kissei Pharmaceutical, EPS Corporation, Syneos Health, Pfizer
R&D Japan GK, A2 Healthcare, Quintiles/IQVIA Services JAPAN KK, EP-CRSU, Linical,
Eisai, CMIC Shift Zero KK, Kyowa Hakko Kirin, Bayer Yakuhin, EPS International, and
Otsuka Pharmaceutical; grants and personal fees from Takeda Pharmaceutical, Taiho
Pharmaceutical, and SymBio Pharmaceuticals; personal fees from Clinical Trial Co,
Medicus Shuppan Publishers, Care Net, Reno Medical KK, Medical Review, Roche Diagnostics
KK, Bayer Yakuhin, Medical Mobile Communications, 3H Clinical Trial, Nichi-Iko Pharmaceutical,
Nanzando, Yodosha, Nikkei Business Publications, Thermo Fisher Scientific KK, Yomiuri
Telecasting Corporation, and Nippon Kayaku; personal fees and other from Kyorin Pharmaceutical;
and grants and personal fees from AbbVie outside the submitted work. Dr Yamamoto reported
receiving grants from AstraZeneca during the conduct of the study; grants from Astellas,
Shionogi, Tumura, AbbVie GK, Amgen, Kyorin, Eisai, Terumo, Toppan Printing, and Tosoh;
grants and personal fees from Eli Lilly, AstraZeneca, Ono Pharmaceutical, Daiichi
Sankyo, Taiho, Takeda, Chugai, MSD, Novartis, Pfizer, and Boehringer Ingelheim; personal
fees from Bristol Myers Squibb, Thermo Fisher Scientific, Life Technologies Japan,
Nippon Kayaku, and Merck Biopharma, outside the submitted work. No other disclosures
were reported.
Funding/Support: This work was supported by
AstraZeneca Japan.
Role of the Funder/Sponsor: AstraZeneca Japan was involved with review of the manuscript and its approval but
was not involved with design and conduct of the study (collection, management, analysis,
and interpretation of the data and decision to submit the manuscript for publication).
Meeting Presentation: This study was presented at the European Society for Medical Oncology Virtual Congress
2020; September 19-21, 2020.
Additional Contributions: We are grateful to data managers and other support staff of the West Japan Oncology
Group, especially Koji Takeda, MD, and Shinichiro Nakamura, MD, PhD. The present study
was conducted with support from the West Japan Oncology Group Data Center, Osaka,
Japan. We acknowledge proofreading and editing by Benjamin Phillis, BA, at the Clinical
Study Support Center, Wakayama Medical University. These individuals did not receive
compensation for their contributions.