Maroto, José Pablo
Puente, Javier
Conde Moreno, Antonio
Juárez, Álvaro
Garcillán, Beatriz
Calderón, José Miguel
del Toro, Jacobo Muñoz
Valdivieso, Juan Luis
López-Menduiña, María
Sarró, Eduard
Alcaraz, Antonio
Funding for this research was provided by:
Janssen-Cilag S.A. a Johnson & Johnson company
Article History
Received: 10 February 2025
Accepted: 7 August 2025
First Online: 21 October 2025
Declarations
:
: The study was classified as a non-post authorization study by the Spanish Agency of Medicines and Health Products (AEMPS code: JAN-CPR-2018–01) and was approved by the corresponding Institutional Review Boards of the participating centers (ethics committee for drug research at the Hospital Universitario y Politécnico la Fe, Spain, CEIm-F-PE-01–14 Ed.01-ACTA 433). All local ethics committees approved the project in 2019, authorizing the use of retrospective clinical data corresponding to the period 2014–2018, in accordance with the study protocol. Patient consent was waived because aggregated and anonymized data were analysed from deidentified EHRs. This study was designed, implemented, and reported in accordance with the Guidelines for Good Pharmacoepidemiology Practices (GPP) of the International Society for Pharmacoepidemiology, the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines, with additional consideration of the RECORD (REporting of studies Conducted using Observational Routinely-collected Data) extension for studies using routinely collected health data, and with the ethical principles laid down in the Declaration of Helsinki by the World Medical Association.
: All authors have approved the manuscript and agree with its submission to BMC Cancer.
: PM has received fees for lectures, consulting, and other support such as logistic support from Astellas, Janssen, Bayer, MSD, Novartis, Astra Zeneca y Pfizer. JP has received honoraria for speaker engagements, advisory roles or funding of continuous medical education from Astellas, Astra Zeneca, Bayer, Bristol Myers Squibb, Eisai, Eusa Pharma, IPSEN, Janssen, Merck KGaA, MSD, Novartis, Pfizer, Roche and Gilead; and research grants from Pfizer, Astellas, and Merck. ACM has received consulting fees, honoraria for lectures, and support for attending meetings from Janssen, Astellas, Bayer, Recordation and Ipsen. None stock ownership or options, expert testimony, royalties, or patents filed, received, or pending. AJS reports consultancy/advisory and meeting participation/being a lecturer for Astellas, Bayer, and Janssen; investigator activities for Bayer and Janssen; and research funding from Janssen. BM, JMC, and JMT are Janssen employees and shareholders from Janssen. BG, JMC, and JMT are full time employees at Janssen-Cilag, S.JV, ML, and ES are full time employees at Savana Research, S.L.