Availability of data and materials
On reasonable request, the data generated and analysed during the current study are available from the corresponding author in accordance with institutional policies.
Ethics approval and consent to participate
The study was conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice Guidelines of the Internal Conference on Harmonisation. The protocol and any accompanying material provided to patients was prospectively approved by the local independent ethics committee at each of the 15 participating sites.
Consent for publication
Not applicable.
Competing interests
DB has received honoraria from Pfizer, Daiichi Sankyo and MDM and research funding from Daiichi Sankyo. RB has undertaken a consulting or advisory role with Otsuka and Boeringher. LBi has received honoraria from Lilly, Novartis and Pfizer, has undertaken a consulting or advisory role with AstraZeneca, Celgene, Eisai, Genomic Health, Ipsen, Lilly, Novartis, Pfizer, Pierre Fabre and Roche; has received research funding (institutional) from Celgene, Genomic Health and Novartis; and has received travel, accommodation or expenses from Celgene, Pfizer, Ipsen and Roche.
AB has undertaken a consulting or advisory role with Eisai, Roche and Eli Lilly, has received research funding from Roche and travel, accommodations or expenses from Eli Lilly and Pharmamar. SC has undertaken a consulting or advisory role with Lilly. MC has received honoraria from Novartis and has undertaken a consulting or advisory role with Pierre Fabre, Pfizer, OBI Pharma, Puma Biotechnology, Celldex and AstraZeneca. SDP has received honoraria from Roche, Celgene, GSK, Novartis, Ipsen and AstraZeneca, has undertaken a consulting or advisory role with Roche, Celgene, GSK, Novartis, Ipsen, Lilly, Pfizer and AstraZeneca, has served on speaker’s bureau with Roche, Novartis, Lilly, Pfizer, AstraZeneca, Celgene, Eisai and Istituto Gentili, has received research funding from Eisai, Novartis, Roche and AstraZeneca, and travel, accommodation and expenses from Roche, GSK, Novartis, Liilly, Pfizer, Eisai, and AstraZeneca. SD has received travel, accommodation or expenses from Roche, Novartis and Takeda. AMM has undertaken a consulting or advisory role with Novartis, Merck Sharp & Dohme and Pierre Fabre. MP has received honoraria from Celgene, Novartis, Pfizer and Istituto Gentili; has undertaken a consulting or advisory role with Novartis and Sandoz; and received travel, accommodation or expenses from Celgene and Istituto Gentili. FP has received honoraria from Amgen, Eli Lilly, Ipsen, Merck Sharp & Dohme, Roche and Takeda; has undertaken a consulting or advisory role with Eisai, Eli Lilly, Novartis, Pfizer, Pierre Fabre and Roche; has received research funding from AstraZeneca, Eisai and Roche; and received travel, accommodation or expenses from Celgene and Roche. ER has received travel, accommodation or expenses from Pfizer. GS has received honoraria from Novartis; has undertaken a consulting or advisory role with Roche; and has received travel, accommodation or expenses from Eisai, Novartis, Pfizer, Pierre Fabre and Roche. SS has received honoraria from Pfizer and Novartis; has undertaken a consulting or advisory role with Novartis; has received research funding (institution) from Roche, Novartis and Abbott; and travel, accommodations or expenses from Pfizer, Istituto Gentili and Tesaro. All remaining authors declare that they have no competing interests.
Funding
The trial was an academic study sponsored by the not-for-profit foundation “Sandro Pitigliani per la lotta contro i Tumori ONLUS”, and was funded by Celgene through an investigator-initiated research grant. Celgene had no influence on the design or conduct of the trial, and was not involved in the reporting of the data and its interpretation.
Contributions
LBi, GM, FP and LBo were involved in the conception and design of the study. LBi, SC, RB, RPe, AMM, REC, SS, EM, AB, ER, RPa, SL, MC, SD, SDP, LO, MP, VP, DB, FP, GS, EZ and GM were involved in acquisition of the data (recruited and managed patients, provided facilities). LBo, AMc, AMi and LBi were involved in collection, assembly, analysis and interpretation of data (eg statistical analysis, biostatistics, computational analysis). All authors were involved in the writing, review and revision of this manuscript. All authors read and approved the final manuscript.
Acknowledgements
The authors would like to thank our patients and their families for their invaluable contributions to the EFFECT study. We thank Daniela Baldari for her role in coordinating study data management.