Briggs, Andrew
Daniele, Bruno
Dick, Katherine
Evans, Thomas R. Jeffry
Galle, Peter R.
Hubner, Richard A.
Lopez, Carlos
Siebert, Uwe
Tremblay, Gabriel
Article History
Received: 18 September 2019
Revised: 27 February 2020
Accepted: 11 March 2020
First Online: 8 April 2020
Ethics approval and consent to participate
: This is a reanalysis of existing data from the REFLECT study. All patients provided written informed consent to participate in the study as detailed in the original clinical trial manuscript (Kudo 2018). This study was conducted in accordance with the Declaration of Helsinki.
: No individual person’s data are used in this manuscript in any form, so no consent for publication was required.
: Data are held by the sponsors: Eisai Inc., and Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., to whom all requests for data access should be addressed.
: Sponsorship for the study and analysis were funded by Eisai Inc., and Merck Sharp & Dohme Corporation, a subsidiary of Merck & Co., Inc., and study results were not contingent on the sponsors’ approvals nor did they conduct any censorship of the manuscript. A.B. is a director and shareholder of Avalon Health Economics and received compensation from Eisai as a consultant for this work. He has also been contracted by Bayer, Merck, Janssen, Novartis, Sword Health, Amgen, and Daichii Sankyo and received compensation outside of the submitted work. B.D. reports no conflicts of interest regarding the work at hand but has received personal fees and non-financial support for consultation for Ispen, Sanofi, and Bayer, and personal fees from Eisai, Eli Lilly, Astra Zeneca, and Incyte outside of the submitted work. K.D. is an employee of Avalon Health Economics. T.R.J.E. has received honoraria for advisory boards and/or speaker’s fees from Eisai, Celgene, Bristol-Myers Squibb, Bayer, Roche, Merck (MSD), Nucana, Karus Therapeutics, Modulate Therapeutics (all payable to the employing institution), research funding for clinical trials from multiple pharmaceutical and biotechnology companies including Eisai (all payable to the employing institution), and support to attend international scientific conferences from Bristol-Myers Squibb, Merck, Eisai, Bayer, Roche, Pierre Fabre, and Celgene. He is co-editor of the clinical study section of the British Journal of Cancer (honorarium payable to the employing institution). P.R.G. has received compensation from Eisai for this work and for adboards and lectures from Bayer, AstraZeneca, BMS, MSD, Roche, Sirtex, Ispen, and Lilly outside of the submitted work. R.A.H. received consultancy fees from Eisai for this work. He has also received compensation from Roche and Ispen and attended conferences for both Roche and BMS outside of the submitted work. C.L. has been paid honoraria for consultancy on this work. He has also received compensation for work from Ispen, Bayer, BMS, and Astra Zeneca, and has participated in a speaker’s bureau for Eisai, Ispen, Bayer, and BMS. Further, he has received research funding from Eisai, Ispen, BMS, MSD, Astra Zeneca, and Roche. U.S. has received honorarium for participating in an advisory board of Eisai and reports no other conflicts of interest. G.T. reports no conflicts of interest regarding the submitted work.
: This study was funded by Eisai Inc., Woodcliff Lake, NJ, USA, and Merck Sharp & Dohme Corporation, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.