Peripheral blood lymphocytes predict clinical outcomes in hormone receptor-positive HER2-negative advanced breast cancer patients treated with CDK4/6 inhibitors.

"Declarations Ethics approval and consent to participate: The study protocol was approved by the Ethics Committee of the coordinating center (internal registration number: INT 138/20), and, subsequently, by Ethics Committees of each participating site. Enrolled patients signed an informed consent for inclusion in the study and for the use of clinical data for research purposes.Consent for publication: Not applicable.Author contributions:Emma Zattarin: Data curation; Formal analysis; Writing – original draft.Luigi Mariani: Formal analysis.Alice Menichetti: Data curation; Writing – review & editing.Rita Leporati: Data curation; Writing – review & editing.Leonardo Provenzano: Writing – review & editing.Francesca Ligorio: Writing – review & editing.Giovanni Fucà: Writing – review & editing.Riccardo Lobefaro: Writing – review & editing.Luca Lalli: Writing – review & editing.Andrea Vingiani: Writing – review & editing.Federico Nichetti: Writing – review & editing.Gaia Griguolo: Data curation; Writing – review & editing.Marianna Sirico: Data curation; Writing – review & editing.Ottavia Bernocchi: Data curation; Writing – review & editing.Antonio Marra: Data curation; Writing – review & editing.Chiara Corti: Data curation; Writing – review & editing.Paola Zagami: Data curation; Writing – review & editing.Elisa Agostinetto: Data curation; Writing – review & editing.Flavia Jacobs: Data curation; Writing – review & editing.Pierluigi Di Mauro: Data curation; Writing – review & editing.Daniele Presti: Writing – review & editing.Caterina Sposetti: Writing – review & editing.Carlo Alberto Giorgi: Writing – review & editing.Valentina Guarneri: Data curation; Writing – review & editing.Rebecca Pedersini: Data curation; Writing – review & editing.Agnese Losurdo: Data curation; Writing – review & editing.Daniele Generali: Data curation; Writing – review & editing.Giuseppe Curigliano: Data curation; Writing – review & editing.Giancarlo Pruneri: Writing – review & editing.Filippo de Braud: Supervision; Writing – review & editing.Maria Vittoria Dieci: Supervision; Writing – review & editing.Claudio Vernieri: Conceptualization; Investigation; Supervision; Writing – original draft; Writing – review & editing.Funding: The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: AIRC, ‘Associazione Italiana per la Ricerca sul Cancro’ (MFAG 2019. Id. 22977. PI: Claudio Vernieri; IG 2021. PI: Giancarlo Pruneri; 5 per Mille 2019 – ID. 22759 program-G.L. Valentina Guarneri) and the Scientific Directorate of Fondazione IRCCS Istituto Nazionale dei Tumori.Competing interests: Dr. GG reports personal fees from Novartis, Eli Lilly. Dr. EA reports consultancy fees or honoraria from Eli Lilly, Sandoz; support to attend medical conferences from Roche, Novartis, Eli Lilly, Genetic, Istituto Gentili. Prof. VG reports personal fees from Eli Lilly, Novartis, Roche, and MSD outside the submitted work. Prof. DG reports consultancy fees or honoraria from Eli Lilly, Novartis, Pfizer, Roche, Istituto Gentili, Eisai. Prof. GC reports funding from Astra Zeneca, Daichii Sankyo, Merck; consulting fees from BMS, Roche, Pfizer, Novartis, Lilly, Astra Zeneca, Daichii Sankyo, Merck, Seagen, Ellipsis; honoraria from Pfizer, Lilly; support for attending meetings from Roche, Pfizer. Prof. GP reports personal fees from Roche Foundation One, Bayer, Novartis, and personal fees from Lilly outside the submitted work. Prof. FdeB reports an advisory role at Roche, EMD Serono, NMS Nerviano Medical Science, Sanofi, MSD, Novartis, Incyte, BMS, Menarini; speaker role for BMS, Healthcare Research & Pharmacoepidemiology, Merck Group, ACCMED, Nadirex, MSD, Pfizer, Servier, Sanofi, Roche, AMGEN, Incyte, Dephaforum; Principal Investigator for Novartis, F.Hoffmann-LaRoche Ltd, BMS, Ignyta Operating INC, Merck Sharp & Dohme Spa, Kymab, Pfizer, Tesaro, MSD, MedImmune LCC, Exelixis Inc., LOXO Oncology Incorporated, DAICHI SANKIO Dev. Limited, Basilea Pharmaceutica International AG, Janssen-Cilag International NV, Merck KGAA. Prof. MVD reports personal fees from Eli Lilly, MSD, Exact Sciences, Novartis, Pfizer, Seagen, Dr. CV reports an advisory role for Novartis, Eli Lilly, Pfizer and Daiichi Sankyo; honoraria as a speaker: Eli Lilly, Novartis, Istituto Gentili, Roche, Pfizer; research grants: Roche. All other authors report no competing interests.Availability of data and materials: The datasets and materials used and/or analyzed during the current study are available from the corresponding author on reasonable request. Competing interests: Dr. GG reports personal fees from Novartis, Eli Lilly. Dr. EA reports consultancy fees or honoraria from Eli Lilly, Sandoz; support to attend medical conferences from Roche, Novartis, Eli Lilly, Genetic, Istituto Gentili. Prof. VG reports personal fees from Eli Lilly, Novartis, Roche, and MSD outside the submitted work. Prof. DG reports consultancy fees or honoraria from Eli Lilly, Novartis, Pfizer, Roche, Istituto Gentili, Eisai. Prof. GC reports funding from Astra Zeneca, Daichii Sankyo, Merck; consulting fees from BMS, Roche, Pfizer, Novartis, Lilly, Astra Zeneca, Daichii Sankyo, Merck, Seagen, Ellipsis; honoraria from Pfizer, Lilly; support for attending meetings from Roche, Pfizer. Prof. GP reports personal fees from Roche Foundation One, Bayer, Novartis, and personal fees from Lilly outside the submitted work. Prof. FdeB reports an advisory role at Roche, EMD Serono, NMS Nerviano Medical Science, Sanofi, MSD, Novartis, Incyte, BMS, Menarini; speaker role for BMS, Healthcare Research & Pharmacoepidemiology, Merck Group, ACCMED, Nadirex, MSD, Pfizer, Servier, Sanofi, Roche, AMGEN, Incyte, Dephaforum; Principal Investigator for Novartis, F.Hoffmann-LaRoche Ltd, BMS, Ignyta Operating INC, Merck Sharp & Dohme Spa, Kymab, Pfizer, Tesaro, MSD, MedImmune LCC, Exelixis Inc., LOXO Oncology Incorporated, DAICHI SANKIO Dev. Limited, Basilea Pharmaceutica International AG, Janssen-Cilag International NV, Merck KGAA. Prof. MVD reports personal fees from Eli Lilly, MSD, Exact Sciences, Novartis, Pfizer, Seagen, Dr. CV reports an advisory role for Novartis, Eli Lilly, Pfizer and Daiichi Sankyo; honoraria as a speaker: Eli Lilly, Novartis, Istituto Gentili, Roche, Pfizer; research grants: Roche. All other authors report no competing interests."

"Funding: The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: AIRC, ‘Associazione Italiana per la Ricerca sul Cancro’ (MFAG 2019. Id. 22977. PI: Claudio Vernieri; IG 2021. PI: Giancarlo Pruneri; 5 per Mille 2019 – ID. 22759 program-G.L. Valentina Guarneri) and the Scientific Directorate of Fondazione IRCCS Istituto Nazionale dei Tumori."

"Ethics approval and consent to participate: The study protocol was approved by the Ethics Committee of the coordinating center (internal registration number: INT 138/20), and, subsequently, by Ethics Committees of each participating site. Enrolled patients signed an informed consent for inclusion in the study and for the use of clinical data for research purposes."