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Article History

Received: 1 October 2024

Revised: 4 February 2025

Accepted: 10 March 2025

First Online: 20 March 2025

Competing interests

: MA discloses consultancy, advisory roles, honoraria from Amgen, AstraZeneca, Beigene, Drangofly Therapeutics, Jazz Pharmaceuticals, BMS, Lilly, Novartis and MSD. Institutional research funding from Merck. FL reports institutional grants from: Astra Zeneca, Beigene, BMS, Daiichi Sankyo and Gilead, and personal fees from: Amgen, ArtTempi. Astellas, Astra Zeneca, Bayer, Biontech, BMS, Boehringer Ingelheim, Daiichi Sankyo, Eli Lilly, Gilead, Elsevier, Incyte, Medscape, MedUpdate, Merck Serono, MSD, PAGE, Roche, Servier, StreamedUp!, VJ Oncology, all outside the submitted work. TF discloses advisory roles honoraria from Amgen, AstraZeneca, Beigene, BMS and MSD. Institutional research funding from Gilead. Speaker honoraria from Amgen, Servier, BMS, MSD, Lilly, Roche, Bayer. JF was full-time employee at Anaxomics Biotech at the time of the study. RD declares advisory role for Roche, Foundation Medicine, AstraZeneca received a speaker’s fee from Roche, Ipsen, Amgen, Servier, Sanofi, Libbs, Merck Sharp & Dohme, Lilly, AstraZeneca, Janssen, Takeda, Bristol Myers Squibb, GlaxoSmithKline, Gilead, research grants from Merck, Novartis, Daiichi-Sankyo, GlaxoSmithKline and AstraZeneca, and is investor in Trialing Health, S.L. AC declares institutional grants from Actuate Therapeutic Adaptimmune, Affimed, Amgen, Astellas Pharma, Astra Zeneca, Bayer, F. STAR Therapeutics, Genentech, Gilead, Janssen, Lilly, MedImmune, Merck Serono, MSD, Natera, Novartis, Ribon Therapeutics, Roche, Takeda. Speaker honoraria from Amgen, Foundation Medicine, Merck Serono, Roche. Advisory role for Abbvie, AnHeart Therapeutics, GSK, Merck Serono, Roche, Transgene, Amgen. Leadership role as ESMO president, ESMO OPEN Associate Editor, Annals of Oncology Associate Editor, and Cancer & treatment reviews, editor in chief. RMF and CF declares their own patent WO/2018/169423 on microbiome markers for gastric cancer. SD reports: a consultant or advisory role for BMS (related to checkpoint inhibitors); research funding, medication supply, or both from Incyte (related to checkpoint inhibitors); and speaker roles for Servier, BMS, and Benecke. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

: The study has been conducted according to the principles of the Declaration of Helsinki (Fortaleza, Brazil, October 2013), following the Medical Research Involving Human Subjects Act and Good Clinical Practice standards. The study can be found under ClinicalTrials.gov Identifier: NCT04015466, and NCT03957031, July 11, 2019. The study protocol has been approved by the ethics committee of all patient-recruiting centres: the ethics committee of University Clinical Hospital of Valencia, Spain (reference number 2018/205), the institutional review board of VU University Medical Center Amsterdam (reference number 2019.355. NL 69480.02919), the ethics committee of Instituto de Previsión Social, Asuncion-Paraguay (reference number CA N°11-020/19), the ethical research committee of Instituto Alexander Fleming, Buenos Aires Argentina (Resolution July 25th, 2019, for LEGACy study 1 and 2 and October 3rd, 2019 for LEGACy study 3); the ethical committee of Instituto Nacional de Cancerología (INCAN, México (reference number INCAN/CEI/0486/19). The ethics committee of the University Center of Sao Joao and Medicine Faculty of Porto University, Portugal (reference 100/019), the scientific ethical Committee Pontificia University of Chili, reference 180806007, and the Drug research ethics committee of Valld’Hebron University Hospital, Barcelona, Spain with references PR (AG)387/2019 approved on October 29th, 2019 for LEGACy study 1, PR (AG)388/2019 approved in December 13th 2019 for LEGACy study 2 and PR (AG)419/2019 approved in January 30th, respectively. All participants provided written informed consent before study enrolment. Each data-contributing partner has undergone online ethical and data training before the beginning of data collection and has managed access to the data of their centre through this security system. Inside this system, a patient ID generator has generated a unique code for each participating patient to maintain data privacy.