1. "Positioning of tucatinib in the new clinical scenario of HER2-positive metastatic breast cancer: An Italian and Spanish consensus paper".
- Author
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Conte P, Ciruelos E, Curigliano G, De Laurentiis M, Del Mastro L, Gennari A, Llombart A, Martìn M, Poggio F, Prat A, Puglisi F, and Saura C
- Subjects
- Humans, Female, Italy, Spain, Oxazoles therapeutic use, Antineoplastic Agents therapeutic use, Protein Kinase Inhibitors therapeutic use, Triazoles therapeutic use, Breast Neoplasms drug therapy, Breast Neoplasms pathology, Receptor, ErbB-2 metabolism, Pyridines therapeutic use, Quinazolines therapeutic use, Delphi Technique, Consensus, Brain Neoplasms secondary, Brain Neoplasms drug therapy
- Abstract
Introduction: Advancements in monoclonal antibodies, tyrosine kinase inhibitors, and antibody drug conjugates (ADCs) have notably enhanced outcomes for metastatic HER2-positive breast cancer patients. Despite the expanding treatment options and clinical complexities, determining the optimal sequence of HER2-targeted therapies remains partly uncertain, influenced by various factors., Methods: To refine HER2-positive metastatic breast cancer management, particularly regarding tucatinib's position, a Steering Committee of leading oncologists in breast cancer care devised a panel of statements via a Delphi approach, focusing on five key topics: general clinical management, therapeutic approaches for patients with HER2-positive breast cancer and brain metastases, treatment sequence, and tucatinib's safety and efficacy., Results: A total of 29 statements were deliberated, with strong consensus achieved for most. However, no consensus emerged regarding the management of brain progression alongside stable extracranial disease: 48 % advocated for switching to tucatinib, while 53 % favored a stereotactic brain radiotherapy (SBRT) approach if feasible., Conclusion: The unanimous consensus attained in this Delphi panel, particularly regarding tucatinib's efficacy and safety, underscores oncologists' recognition of its clinical significance based on existing trial data. These findings align closely with current literature, shedding light on areas necessitating further investigation, not thoroughly explored in prior studies. Moreover, the results underscore the scarcity of data on managing brain progression alongside stable extracranial disease, emphasizing the imperative for dedicated research to address these gaps and yield definitive insights., Competing Interests: Declaration of competing interest PC: Consulting or Advisory Role: Daiichi Sankyo/Lilly, Reveal Genomics, Gilead Sciences; Speakers' Bureau: Roche/Genentech, Novartis, AstraZeneca, Lilly, BMS; Research Funding: Merck KGaA (Inst); Patents, Royalties, Other Intellectual Property: HER2Dx patent; Expert Testimony: AstraZeneca. EC: reports consulting fees from Novartis, Lilly, Pfizer, Roche, AstraZeneca, and Daiichi Sankyo; speaker's bureau from Lilly, Pfizer, AstraZeneca, and Daiichi Sankyo; and travel and accommodations from Pfizer and Roche. GC: received honoraria for speaker's engagement: Roche, Seattle Genetics, Novartis, Lilly, Pfizer, Foundation Medicine, NanoString, Samsung, Celltrion, BMS, MSD; Honoraria for providing consultancy: Roche, Seattle Genetics, NanoString; Honoraria for participating in Advisory Board: Roche, Lilly, Pfizer, Foundation Medi-cine, Samsung, Celltrion, Mylan; Honoraria for writing engagement: Novartis, BMS; Honoraria for participation in Ellipsis Scientific Affairs Group; Institutional research funding for conducting phase I and II clinical trials: Pfizer, Roche, Novartis, Sanofi, Celgene, Servier, Orion, AstraZeneca, Seattle Genetics, AbbVie, Tesaro, BMS, Merck Serono, Merck Sharp Dome, Janssen-Cilag, Philogen, Bayer, Medivation, MedI- mmune MDL: advisory boards, activities as a speaker, travel grants, consultancy: Eli Lilly, Novartis, Seagen, Takeda, Roche, Daiichi Sankyo, Tomalab, Gilead, Genetic, Menarini, Sophos, AstraZeneca, Pfizer, Sanofi, Ipsen, Pierre Fabre, GSK. AG: research funding to the Institution: AstraZeneca, Pfizer, Janssen, Roche, MSD, Daichii-Sankyo, GSK/Tesaro, HiFiBio, Merck, Boehringer-Ingelheim, Exelixis, Bayer, Incyte, Bayer, Aileron; travel, accommodation, expenses: Gentili. LDM: advisory role for Agendia, Amgen, AstraZeneca, Collage SpA, Daiichi Sankyo, Eli Lilly, Exact Sciences, Gilead, GSK, Havas Life, Pfizer, Pierre Fabre, Roche, Seagen Int, Stemline Menarini and Uvet; personal fees as an invited speaker for Accademia Nazionale Medicina, Andromeda E20, Aristea, Delphi international, Editree, Eli Lilly, Ipsen, Meeting SrL, MSD, Novartis, Over Srl, Prex Srl, Symposia and Vyvamed Srl; personal fees for writing engagements for Edizioni Minerva Medica, Pensiero Scientifico Editore and Roche; personal consultancy fees from Eli Lilly, Gilead, Kardo Srl and Sharing Progress in Cancer Care (SPCC)—Switzerland; personal fees for author slide kits from Forum service and Think2it; personal fees for interviews from Infomedica Srl and Think2it; institutional funding as a local PI from AstraZeneca, Daiichi Sankyo, Eli Lilly, Gilead, Novartis, Novella Clinical, Roche and Seagen; institutional funding as a national coordinating PI from Roche; institutional research grant from Pfizer; and non-remunerated product samples from FoundationOne. AG: received advisory role from AstraZeneca, Daiichi, Eisai, Lilly, Novartis, Pfizer, Roche, Seagen, Gilead, Teva, and Gentili; lecture honoraria from Novartis, Pfizer, Gilead, Roche, Eisai, Seagen, Teva, and Gentili; and research support from Roche, Eisai, Gilead, and Pharmanutra AL: Research support: Roche, Agendia, Lilly, Pfizer, Novartis, Merck Sharp&Dhome, Gilead, Daiichi Sankyo; Consulting/advisor: Lilly, Roche, Pfizer, Novartis; Speaker's Bureaus: Lilly, Astrazeneca, Merck Sharp&Dhome, Pfizer, Novartis; Travel support: Roche, Pfizer, Astrazeneca, Merck Sharp&Dhome. MM: Honoraria: Roche/Genentech, Lilly, Pfizer, Novartis, Pierre Fabre, Seagen; Consulting or Advisory Role: Roche/Genentech, Novartis, Pfizer, Lilly, AstraZeneca, Daiichi-Sankyo; Speakers' Bureau: Lilly/ImClone, Lilly/ImClone, Roche/Genentech, Pierre Fabre; Research Funding: Novartis (Inst), Roche (Inst), Puma Biotechnology (Inst); Travel, Accommodations, Expenses: Daiichi-Sankyo; Other Relationship: Roche, Novartis. FPo: advisory board from AstraZeneca; speaking honoraria and travel grants from Eli Lilly, Novartis, Seagen, Daichii Sankyo, and Gilead. AP: reports grants and personal fees from NanoString Technologies, Veracyte, Novartis, AstraZeneca, DaiichiSankyo, and Roche; in addition, A. Prat has a patent for DNADX pending. FPu: reports honoraria for advisory boards, activities as a speaker, travel grants, research grants from Amgen - Astrazeneca - Daiichi Sankyo - Celgene - Eisai - Eli Lilly- Exact Sciences- Gilead - Ipsen – Menarini- MSD - Novartis - Pierre Fabre - Pfizer - Roche - Seagen - Takeda – Viatris; Research funding from Astrazeneca – Eisai – Roche. CS: consultancy or advisory role for AstraZeneca, Ax's Consulting, Byondis, Daiichi Sankyo, Eisai, Exact Sciences, Exeter, F. Hoffmann-La Roche Ltd., International Society for the Study and Exchange of evidence from Clinical research And Medical experience (ISSECAM), Medical Statistics Consulting, MediTech, Merck Sharp and Dohme Corp, Novartis, Pfizer, Philips, Pierre Fabre, PintPharma, Puma, Roche, Sanofi, Seagen, Zymeworks, and research funding from Aragon, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Byondis, CytomX, Daiichi Sankyo, F. Hoffmann-La Roche Ltd., Genentech, German Breast Group Forchungs, GlaxoSmithKline, Immunomedics, Innoup, International Breast Cancer Study Group (IBCSG), Lilly, Macrogenics, Medica Scientia Innovation Research, Menarini Ricerche, Merck Sharp and Dohme Corp, Merus, Millennium, Novartis, Pfizer, Piqur, Puma, Roche, Sanofi, Seagen, Synthon, and Zenith., (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)
- Published
- 2024
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