ESMO Clinical Practice Guideline for the diagnosis, staging and treatment of patients with metastatic breast cancer

A Gennari, F André, C H Barrios, J Cortés, E de Azambuja, A DeMichele, R Dent, D Fenlon, J Gligorov, S A Hurvitz, S-A Im, D Krug, W G Kunz, S Loi, F Penault-Llorca, J Ricke, M Robson, H S Rugo, C Saura, P Schmid, C F Singer, T Spanic, S M Tolaney, N C Turner, G Curigliano, S Loibl, S Paluch-Shimon, N Harbeck, ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org, A Gennari, F André, C H Barrios, J Cortés, E de Azambuja, A DeMichele, R Dent, D Fenlon, J Gligorov, S A Hurvitz, S-A Im, D Krug, W G Kunz, S Loi, F Penault-Llorca, J Ricke, M Robson, H S Rugo, C Saura, P Schmid, C F Singer, T Spanic, S M Tolaney, N C Turner, G Curigliano, S Loibl, S Paluch-Shimon, N Harbeck, ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org

No abstract available

Keywords: ESCAT; ESMO Clinical Practice Guideline; ESMO-MCBS; diagnosis; metastatic breast cancer; treatment.

Conflict of interest statement

Disclosure FA reports receipt of research funding and has served as speaker/advisor (compensated to the hospital) for Roche, AstraZeneca, Daiichi Sankyo, Pfizer, Novartis and Eli Lilly. CHB reports grants/research support (to the institution) from Pfizer, Novartis, Amgen, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline (GSK), Roche/Genentech, Eli Lilly, Sanofi, Taiho Pharmaceutical, Mylan, Merrimack, Merck, AbbVie, Astellas Pharma, BioMarin, Bristol-Myers Squibb (BMS), Daiichi Sankyo, Abraxis Biosciences, AB Science, Asana Biosciences, Medivation, Exelixis, ImClone Systems, LEO Pharma, Millennium, Merck KGaA, Shanghai Henlius Biotech, Polyphor and PharmaMar; ownership or stocks in Biomarker, Tummi and MEDSir; and advisory boards and consulting for Boehringer Ingelheim, GSK, Novartis, Pfizer, Roche/Genentech, Eisai, Bayer, Merck Sharp & Dohme (MSD), AstraZeneca, Zodiac, Eli Lilly and Sanofi. JC has served as a consultant/advisor for Roche, Celgene, Cellestia, AstraZeneca, Seattle Genetics, Daiichi Sankyo, Erytech, Athenex, Polyphor, Eli Lilly, MSD, GSK, Leuko, Bioasis, Clovis Oncology, Boehringer Ingelheim, Ellipses, Hibercell, BioInvent, Gemoab and Gilead; received honoraria from Roche, Novartis, Celgene, Eisai, Pfizer, Samsung Bioepis, Eli Lilly, MSD and Daiichi Sankyo; received research funding to the institution from Roche, Ariad Pharmaceuticals, AstraZeneca, Baxalta GmbH/Servier Affaires, Bayer Healthcare, Eisai, Roche, Guardanth Health, MSD, Pfizer, Piqur Therapeutics, Puma C and Queen Mary University of London; owns stock, patents and intellectual property for MedSIR; and received travel, accommodation and expenses from Roche, Novartis, Eisai, Pfizer and Daiichi Sankyo. GC has served as consultant or advisor for Roche, Eli Lilly and BMS; served on a speaker’s bureau for Roche, Pfizer and Eli Lilly; received travel funding from Pfizer and Roche; and received honoraria from Roche, Pfizer, Eli Lilly, Novartis, AstraZeneca and SeaGen, all outside the submitted work. EdA reports honoraria and/or advisory boards for Roche/Genentech, Novartis, Seattle Genetics, Zodiacs, Libbs and Pierre Fabre and Eli Lilly; travel grants from Roche/Genentech and GSK/Novartis; and research grants for his institute from Roche/Genentech, AstraZeneca, Novartis and Servier. AD reports research funding to institute from Genentech, Novartis, Pfizer and Calithera. RD reports research funding from AstraZeneca; and honoraria for consultancy/advisory board participation from AstraZeneca, Eisai, Eli Lilly, Novartis, Pfizer and Roche. DF reports honoraria for participation in symposia from Roche. AG reports honoraria for advisory boards from AstraZeneca, Daiichi Sankyo, Eisai, Eli Lilly, Novartis, Pfizer and Roche; honoraria for lectures from Eisai and Eli Lilly; and honoraria for expert testimony from Gentili. JG has served as a consultant/advisor for AstraZeneca, Daiichi Sankyo, Eisai, Exact Science, Eli Lilly, Merck, Novartis, Pfizer, Pierre Fabre, Roche/Genentech and Seattle Genetics; received honoraria from AGM communication, Amgen, AstraZeneca, Daiichi Sankyo, Decision Santé, Edimark, Eisai, Exact Science, Kephren, Eli Lilly, Merck, Novartis, Pfizer, Pierre Fabre, Roche/Genentech and Seattle Genetics; received research funding to the institution from Eisai, Exact Science and Roche/Genentech; is an ABC Global Alliance member; has a leadership role in AROMe and Nice St Paul de Vence Cours; and is involved in educational programmes for ESO. NH reports honoraria for lectures, advisory boards and/or personal fees from Amgen, AstraZeneca, Daiichi Sankyo, Eli Lilly, MSD, Novartis, Pfizer, Pierre Fabre, Roche, Sandoz and SeaGen; and minority ownership interest in the West German Study Group. SAH reports contracted research paid to institution from Ambrx, Amgen, AstraZeneca, Arvinas, Bayer, Cytomx, Daiichi Sankyo, Dignitana, Genentech/Roche, Gilead, GSK, Immunomedics, Eli Eli Lilly, Macrogenics, Novartis, Pfizer, OBI Pharma, Pieris, PUMA Biotechnologies, Radius, Sanofi, Seattle Genetics/SeaGen, Zymeworks, Phoenix Molecular Designs, Ltd. and Samumed; unpaid steering committee member for Novartis, Eli Lilly, Daiichi Sankyo/AstraZeneca, Genentech/Roche and Sanofi; travel expenses from Eli Lilly (2019); and uncompensated consulting/advisory boards for 4DPharma, Ambrx, Amgen, Artios, Arvinas, Daiichi Sankyo, Dantari, Genentech/Roche, Immunomedics, Macrogenics, Eli Eli Lilly, Novartis, NK Max, Pieris, Pyxis, SeaGen, Biotheranostics and Loxo. SAI reports advisory board participation (uncompensated) for Amgen, AstraZeneca, Daiichi Sankyo, Eisai, GSK, Hanmi, Eli Lilly, MSD, Novartis, Pfizer and Roche; and receipt of research funding/clinical trial budget from AstraZeneca, Dae Woong, Daiichi Sankyo, Eisai, Hanmi, Pfizer and Roche. DK reports honoraria from the European School of Oncology and MSD; non-renumerated membership of American Society for Clinical Oncology, American Society for Radiation Oncology, Arbeitsgemeinschaft Gynäkologische Onkologie, Arbeitsgemeinschaft Radiologische Onkologie, Deutsche Gesellschaft für Radioonkologie, Deutsche Gesellschaft für Senologie, European Society for Radiotherapy and Oncology and The Radiosurgery Society. WGK reports institutional research funding by the German Research Foundation and the medical faculty of LMU Munich; and serves as a non-compensated committee member of the European Organisation for Research and Treatment of Cancer and the European Society of Oncologic Imaging. SLoi reports research funding to her institution from Novartis, BMS, Merck, PUMA Biotechnologies, Eli Eli Lilly, Nektar Therapeutics, AstraZeneca, Roche-Genentech and Seattle Genetics; consultancy (not compensated) to Seattle Genetics, Novartis, BMS, Merck, AstraZeneca and Roche/Genentech; consultancy (paid to institution) to Aduro Biotech, Novartis, GSK, Roche/Genentech, AstraZeneca, Silverback Therapeutics, G1 Therapeutics, PUMA Biotechnologies, Pfizer, Gilead Therapeutics, Seattle Genetics and BMS; and Scientific Advisory Board Member of Akamara Therapeutics. SLoibl reports honoraria for advisory boards (to institute) from Bayer, BMS, Eirgenix, GSK, Eli Lilly and Merck; honoraria for lecture (to institute) from Samsung; honoraria for advisory boards and lectures (to institute) from Pierre Fabre and Prime/Medscape; grants and honoraria for advisory boards (to institute) from AbbVie and Celgene; grants and honoraria for advisory boards and lectures (to institute) from AstraZeneca; grants, non-financial support and honoraria for advisory boards, lectures and medical writing (to institute) from Daiichi Sankyo, Novartis, Pfizer and Roche; grants, non-financial support and honoraria for advisory boards and medical writing (to institute) from Immunomedics/Gilead, non-financial support and honoraria for advisory boards and medical writing (to institute) from PUMA Biotechnologies and SeaGen; and non-financial support and honoraria for advisory boards (to institute) from Amgen, all outside the submitted work. In addition, SLoibl has patents EP14153692.0, EP21152186.9, EP19808852.8 and Digital Ki67 Evaluator pending and patent EP15702464.7 issued, with royalties paid. SP-S reports honoraria and/or advisory board and/or speaker’s bureau and/or travel funding from Roche, Pfizer, Eli Eli Lilly, Novartis, AstraZeneca, MSD, Exact Sciences and Nanostring. Institutional research funding from Sharing Progress in Cancer Care and Pfizer. FP-L has received honoraria and/or advisory board and/or speaker’s bureau and/or travel funding from Roche, Pfizer, Eli Lilly, Novartis, AstraZeneca, MSD, SeaGen, Illumina, Exact Sciences, Myriad and Nanostring; and institutional research funding from AstraZeneca, Roche, MSD and Illumina. JR reports honoraria or research grants (to the institution) from Terumo, Sirtex Medical, Boston Scientific, Roche and AstraZeneca. MR reports honoraria from Research to Practice, Intellisphere and Physicians’ Education Resource; consultant or advisor for Artios Pharma (uncompensated), AstraZeneca (uncompensated), Change Healthcare, Daiichi Sankyo (uncompensated), Epic Sciences (uncompensated), Merck (uncompensated), Pfizer (uncompensated) and Zenith Pharmaceuticals (uncompensated); research funding to institute from AstraZeneca, Merck and Pfizer; and editorial services for AstraZeneca and Pfizer. HSR reports research support for clinical trials through the University of California from Pfizer, Merck, Novartis, Eli Lilly, Roche, Daiichi Sankyo, Seattle Genetics, Macrogenics, Sermonix, Boehringer Ingelheim, Polyphor, AstraZeneca, Ayala and Gilead; and honoraria from PUMA Biotechnologies (grant reviews for the US National Comprehensive Cancer Network 2021, steering committee 2020), Mylan (educational talk 2019), Samsung (educational talk and consultant 2019) and Napo Pharmaceuticals, Inc (consultant). CFS reports institutional research funding from Amgen, AstraZeneca, Daiichi Sanyko and the US Department of Defence; and travel funding and speaker honoraria from Novartis, AstraZeneca, Roche and Amgen. PS reports honoraria for participation in advisory boards and satellite symposia from AstraZeneca, Bayer, Boehringer Ingelheim, Merck, Novartis, Pfizer, PUMA Biotechnologies, Roche, Eisai and Celgene; research funding to institute from Astellas, AstraZeneca, Genentech, Novartis, Oncogenex, Roche and Medivation. CS has served as consultant, participated in advisory boards or received travel grants from AstraZeneca, Byondis B.V., Daiichi Sankyo, Eisai, Exact Sciences, Exeter Pharma, Roche, MediTech, MSD, Novartis, Pfizer, Philips, Pierre Fabre, PintPharma, PUMA Biotechnologies, Sanofi-Aventis, SeaGen and Zymeworks. TS reports receipt of honoraria for advisory board participation for Roche and Pfizer. SMT reports receipt of institutional research funding from AstraZeneca, Eli Lilly, Merck, Nektar, Novartis, Pfizer, Genentech/Roche, Immunomedics/Gilead, Exelixis, BMS, Eisai, Nanostring, Cyclacel, Odonate and Seattle Genetics; and has served as an advisor/consultant (compensated) for AstraZeneca, Eli Lilly, Merck, Nektar, Novartis, Pfizer, Genentech/Roche, Immunomedics/Gilead, BMS, Eisai, Nanostring, PUMA Biotechnologies, Sanofi, Silverback Therapeutics, G1 Therapeutics, Athenex, OncoPep, Kyowa Kirin Pharmaceuticals, Daiichi Sankyo, Ellipsis, Infinity, 4D Pharma, Samsung Bioepsis Inc., Chugai Pharmaceuticals, BeyondSpring Pharmaceuticals, OncXerna, OncoSec Medical Incorporated, Certara, Mersana Therapeutics, CytomX and Seattle Genetics. NCT reports receipt of advisory board honoraria from AstraZeneca, BMS, Eli Lilly, MSD, Novartis, Pfizer, Roche/Genentech, GSK, Zentalis Pharmaceuticals, Repare Therapeutics and Arvinas; and research funding from AstraZeneca, BioRad, Pfizer, Roche/Genentech, MSD, Guardant Health, Invitae, Inivata, Personalis and Natera.