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Funding for this research was provided by:
PharmaMar supported the study with an unrestricted grant and provided trabectedin in countries where this drug was not yet reimbursed by the national health system.
Article History
Received: 29 July 2022
Revised: 30 November 2022
Accepted: 6 December 2022
First Online: 9 February 2023
Competing interests
: EB, ER, GF and RF report grants from PharmaMar to their Institution for the conduct of the study. UG reports personal fees from Pfizer, personal fees from Roche, personal fees from Pharmamar, personal fees from GSK, personal fees from Clovis, personal fees from Astrazeneca, personal fees from Ipsen, personal fees from Astellas, personal fees from Janssen, personal fees from MSD, personal fees from BMS, personal fees from Novartis, personal fees from EISAI, outside the submitted work. MPBG reports personal fees from Roche, personal fees from Astrazeneca, personal fees from Clovis, personal fees from Pharmamar, personal fees from GSK outside the submitted work. GTasca reports personal fees from GSK, personal fees from Clovis Oncology, personal fees from Astrazeneca, outside the submitted work. IV reports personal fees from Agenus (2021), personal fees from Akesobio China (2021), grants and other from Amgen (Europe), GmbH (2019), personal fees and other from AstraZeneca (2019–2022), personal fees from Bristil Myers Squibb (2021), other from Clovis Oncology Inc. (2019–2019), other from Carrick Therapeutics (2019), personal fees and other from Deciphera Pharmaceuticals (2020–2021), personal fees from Eisai (2021), personal fees from Elevar Therapeutics (2020), personal fees and other from F. Hoffmann-La Roche Ltd (2019-2021), grants and other from Genmab (2019-2021), personal fees and other from GSK (2019-2021), personal fees and other from Immunogen Inc. (2019–2022), personal fees from Jazzpharma (2021–2022), personal fees from Karyopharm (2021), personal fees from Mersana (2020), other from Millenium Pharmaceuticals (2019), personal fees and other from MSD (2019–2022), personal fees and other from Nocovure (2020–2022), personal fees from Novartis (2021), other from Octimet Oncology NV (2019), grants, personal fees and other from Oncoinvent AS (2019–2022), personal fees from Seagen (2021), personal fees and other from Sotio a.s. (2019–2022), other from Verastem Oncology (2020), personal fees from Zentalis (2020), grants and other from Roche (2019–2020), outside the submitted work. JM reports personal Payment or honoraria for lectures, presentations, speaker’s bureaus, manuscript writing or educational events from GSK, AstraZeneca, Eisai, and MSD. RB reports grants from Istituto di Ricerche Farmacologiche IRCCS, during the conduct of the study; non-financial support from ROCHE, non-financial support from Biocad, outside the submitted work. IT reports speaker’s honorarium from Pharma Mar Austria outside the submitted work. MRM reports grants from Astra Zeneca, grants from GSK, personal fees from Nuvation Bio, personal fees from Merck, personal fees from Karyopharm, personal gees from Sera Prognostic, personal fees from Mersana, outside the submitted work. MD’Incalci reports grants and personal fees from Pharma Mar, s.a. during the conduct of the study. AP reports advisory board, personal financial interest and invited speaker from Astrazeneca, advisory board and personal financial interest from Clovis, advisory board and personal financial interest from GSK, advisory board and personal financial interest from MSD, advisory board and personal financial interest from PharmaMar, advisory board and personal financial interest from Roche, advisory board and personal financial interest from TESARO/GSK, MR reports grants and personal fees from Astrazeneca, grants and personal fees from MSD, grants and personal fees from Clovis, grants and personal fees from GSK, outside the submitted work. PW reports grants and honoraria/advisory board from Amgen, Astrazeneca, Novartis, Pfizer, Roche, Lilly, GSK and MSD outside the submitted work. NC reports fundings from PharmaMar for the submitted work, consulting fees from AstraZeneca, Clovis Oncology, Eisai, GSK, Immunogen, Mersana, MSD/Merck, Nuvation Bio, Onxerna, Pfizer, Pieris, Roche outside the submitted work, personal Payment or honoraria for lectures, presentations, speaker’s bureaus, manuscript writing or educational events from AstraZeneca, Novartis, Clovis Oncology, GSK, MSD/Merck, EISAI outside the submitted work, support for attending meetings and/or travel from Astra Zeneca, GSK outside the submitted work, participation on a Data Safety Monitoring Board or Advisory Board with AstraZeneca, Clovis Oncology, Eisai, GSK, Immunogen, Mersana, MSD/Merck, Nuvation Bio, Onxerna, Pfizer, Pieris, Roche outside the submitted work. CZ reports grants or contracts from Roche, Eisai, Novartis, Astrazeneca, Pfizer, Pharmamar, Tesaro, Pierre Fabre, Ist. Gentili, Teva, Seagen, Eli Lilly, Celgene, MSD, GSK, Amgen, Daichii, support for attending meetings and/or travel from Roche, Novartis, Pfizer, Pharmamar, Tesaro, Pierre Fabre, Ist. Gentili, Celgene, participation on a Data Safety Monitoring Board or Advisory Board with Roche, Eisai, Novartis, Astrazeneca, Pfizer, Pharmamar, Amgen, Tesaro, QuintilesIms, Eli Lilly, Celgene, MSD, GSK, Daichii, other financial or non-financial interests from Roche, Novartis, Astrazeneca, Pfizer, Amgen, Tesaro, QuintilesIms, MSD, GSK, Daichii. JS reports grants or contracts from Roche Pharma, AstraZeneca, Bayer, Clovis, GlaxoSmith, Lilly, Tesaro, consulting fees from Tesaro, Merck, Pfizer, PharmaMar, Clovis Oncology, AstraZeneca, Roche Pharma, GlaxoSmith, MSD, Eisai, Novocure, Oncoinvent, payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Tesaro, GlaxoSmith, PharmaMar, AstraZeneca, Clovis, Bayer, Roche, PharmaMar, Vifor Pharma, Hexal AG, Novartis Pharma. The remaining authors declare no competing interests.
: The trial was approved in each country by the competent authority, a central independent ethics committee and by the independent ethics committees at each trial site. All patients provided written informed consent to participate. The trial was conducted in accordance with the Declaration of Helsinki and the International Conference on Harmonisation (ICH) E6 Guidelines for Good Clinical Practice.
: All authors have read and approved this manuscript.