Abstract

BackgroundSeveral Breast Cancer Multigene Signatures (BCMS) are available to profile early breast cancer (eBC) but knowledge regarding their use in clinical practice is scarce. Results from the European PROCURE Project on the use of BCMS in current daily clinical practice are presented.MethodsA Delphi questionnaire drafted by the Scientific Committee was administered twice to 133 European experts from 11 countries. The questionnaire included 5 sections: 1) Panellists’ profile and experience with BCMS, 2) Current clinical practice in eBC and use of BCMS, 3) Panellists’ opinion on the utility of the BCMS in eBC according to patient profiles, 4) Agreement with a set of recommendations on the use of BCMS in clinical practice and 5) Identification of unmet needs and future applications of BCMS.Results85.0% panellists reported the existence of hospital/country policies to regulate the use of BCMS being the nodal status (92.0%), the HER2 negative by ICH/FISH/CISH (87.6%) and the tumour size (77.87%) the most important criteria defined in those guidelines for the use of BCMS. When guidelines are not available, the main criterion is still the nodal status (80.0%), but they also give great importance to menopausal status and the percentage of Ki67 expression (70.0%). Also, the two main reasons for using BCMS in patients with eBC were to assess the risk of distant recurrence within 10 years in order to avoid chemotherapy (60.2%) and to predict the benefit from chemotherapy (46.6%). Finally, to define prognosis and treatment needs, BCMS were used routinely or in selected patients by more than 60% of the participants, regardless of the patient’s gender or age, with similar results when asked by menopausal status; lack of lymph node involvement (97.0%) or involvement of 1–3 lymph nodes (88.0%); HR-positive status (98.5%); and HER2-negative status (96.2%).ConclusionsThe main reason for using BCMS was to predict chemotherapy benefit. This, along with the fact that some experts reported the use of BCMS in 4 positive lymph node, triple negative or HER2+ patients, suggests that there is a need of education on how to correctly interpreting BCMS results.Editorial acknowledgementEditorial and writing assistance has been provided by Adelphi Targis, S.L.Legal entity responsible for the studyVeracyte Inc.FundingVeracyte Inc.DisclosureG. Curigliano: Financial Interests, Personal, Invited Speaker: Roche , AstraZeneca , Daiichi Sankyo, Novartis , Pfizer , Pfizer; Financial Interests, Personal, Advisory Board: Ellipsis, Roche , AstraZeneca , Daiichi Sankyo, Lilly , Pfizer , Veracyte, BMS , Merck , Exact Sciences; Financial Interests, Personal, Advisory Board, Advisory Board: Exact Science, Celcuity; Financial Interests, Institutional, Research Grant, Investigator Initiated Trial: Merck; Financial Interests, Institutional, Funding, Phase I studies: BMS , Novartis , AstraZeneca , Daiichi Sankyo, Roche , Blueprint Medicine, Kymab, Astellas , Sanofi , Philogen; Financial Interests, Institutional, Invited Speaker, Phase I clinical basket trial: Relay Therapeutics; Non-Financial Interests, Officer, Italian National Health Council as Advisor for Ministry of Health: Consiglio Superiore di Sanità; Non-Financial Interests, Advisory Role, Member of the Scientific Council. Patient advocacy association: Europa Donna; Non-Financial Interests, Advisory Role, Cancer Research Foundation: Fondazione Beretta; Non-Financial Interests, Invited Speaker, No compensation for this role. This a public national company for cancer prevention: Lega Italiana Lotta ai Tumori; Non-Financial Interests, Officer, Member of the Advisory Council: EUSOMA. F. Cardoso: Financial Interests, Personal, Other, Consultancy: Amgen, Astellas/Medivation, AstraZeneca, Celgene, Daiichi Sankyo, Eisai, GE Oncology, Genentech, GlaxoSmithKline, Macrogenics, Medscape, Merck-Sharp, Merus BV, Mylan, Mundipharma, Novartis, Pfizer, Pierre-Fabre, Prime Oncology, Roche, Sanofi, Samsung Bioepis, Seagen, Teva; Financial Interests, Institutional, Invited Speaker: Amgen, AstraZeneca, Boehringer-Ingelheim, Bristol-Myers-Squibb, Bayer, Daiichi, Eisai, Fresenius GmbH, Genentech, GlaxoSmithKline, Ipsen, Incyte, Nektar Therapeutics, Nerviano, Novartis, Macrogenics, Medigene, MedImmune, Merck, Millenium, Pfizer, Pierre-Fabre, Roche, Sanofi-Aventis, Sonus, Taiho Oncology, Tesaro, Tigris, Wilex, Wyeth; Non-Financial Interests, Leadership Role, President: ABC Global Alliance and ABC Consensus Conference and Guidelines; Non-Financial Interests, Member: ESMO, ESO, EORTC, BCG, IBCSG, SOLTI, ASCO, AACR, EACR, SIS, ASPIC. M.I. Gnant: Financial Interests, Personal, Invited Speaker: Amgen, AstraZeneca, Novartis, PierreFabre; Financial Interests, Personal, Advisory Board: DaiichiSankyo, EliLilly; Financial Interests, Personal, Other, Consulting on scientific matters: LifeBrain; Financial Interests, Personal, Expert Testimony: Veracyte; Financial Interests, Personal, Full or part-time Employment: ABCSG GmbH; Financial Interests, Invited Speaker: Pfizer; Other, Spouse is employed by Sandoz: Sandoz. N. Harbeck: Financial Interests, Personal, Invited Speaker: AstraZeneca , Daiichi Sankyo, Lilly , MSD , Novartis , Pierre Fabre , Roche , Seagen, Medscape, Art Tempi, Onkowissen, Gilead , Sanofi , Exact Sciences; Financial Interests, Personal, Advisory Board: AstraZeneca , Daiichi Sankyo, Novartis , Pfizer , Roche , Sandoz-Hexal, Seagen, Aptitude Health, Gilead , Sanofi; Financial Interests, Personal, Other, Husband: WSG (Husband); Financial Interests, Personal, Ownership Interest: West German Study Group; Financial Interests, Institutional, Funding: AstraZeneca , BMS , Daiichi Sankyo, Lilly , MSD , Novartis , Pierre Fabre , Roche , Palleos, Seagen, TRIO, WSG; Non-Financial Interests, Member, Member German AGO Breast Guideline Committee: AGO Breast Committee; Non-Financial Interests, Member, Breast Cancer Educational Programs: ESO /ESCO; Other, Founding Editor: BreastCare Journal. J. King: Financial Interests, Personal, Advisory Role: Roche, Pfizer, AstraZeneca, Gilead, Lilly; Financial Interests, Personal, Speaker’s Bureau: Pfizer, Roche, Seagen, Novartis. A. Laenkholm: Financial Interests, Personal, Leadership Role, Scientific Commttee member: Veracyte; Financial Interests, Personal, Advisory Board: AstraZeneca , Novartis , MSD; Financial Interests, Institutional, Funding: Novartis , AstraZeneca . F. Penault-Llorca: Financial Interests, Personal, Other: AbbVie, Agendia, Astellas, AstraZeneca, Bayer, BMS, Eisai, Exact Sciences, GSK, Janssen, Lilly, Merck Life, MSD, Myriad, Novartis, Pfizer, Pierre-Fabre, Roche, Sanofi, Servier, Veracyte. A. Prat: Financial Interests, Personal, Other, Lecture fees: Roche , Pfizer , Novartis , Amgen , BMS , Nanostring Technologies, Daiichi Sankyo; Financial Interests, Personal, Advisory Role: Roche , Pfizer , Novartis , Amgen , BMS , Puma, Oncolytics Biotech , MSD , Guardan Health, Peptomyc, Lilly; Financial Interests, Personal, Leadership Role: Reveal Genomics, SL; Financial Interests, Institutional, Other, Contracted research: Boehringer, Novartis , Roche , Nanostring, Sysmex Europa GmbH, Medica Scientia inno. Research, SL, Celgene , Astellas , Pzifer; Financial Interests, Institutional, Other, Lecture fees: Nanostring technologies; Financial Interests, Institutional, Other, Clinical trials: Boehringer, Lilly , Roche , Novartis , Amgen , Daiichi Sankyo; Financial Interests, Personal, Leadership Role, Executive boards: Reveal Genomics, SL, SOLTI cooperative group; Financial Interests, Personal, Leadership Role, Patronage committee: SOLTI Foundation, Actitud Frente al Cáncer Foundation; Financial Interests, Personal, Leadership Role, Scientific Committee member: Veracyte. BackgroundSeveral Breast Cancer Multigene Signatures (BCMS) are available to profile early breast cancer (eBC) but knowledge regarding their use in clinical practice is scarce. Results from the European PROCURE Project on the use of BCMS in current daily clinical practice are presented. Several Breast Cancer Multigene Signatures (BCMS) are available to profile early breast cancer (eBC) but knowledge regarding their use in clinical practice is scarce. Results from the European PROCURE Project on the use of BCMS in current daily clinical practice are presented. MethodsA Delphi questionnaire drafted by the Scientific Committee was administered twice to 133 European experts from 11 countries. The questionnaire included 5 sections: 1) Panellists’ profile and experience with BCMS, 2) Current clinical practice in eBC and use of BCMS, 3) Panellists’ opinion on the utility of the BCMS in eBC according to patient profiles, 4) Agreement with a set of recommendations on the use of BCMS in clinical practice and 5) Identification of unmet needs and future applications of BCMS. A Delphi questionnaire drafted by the Scientific Committee was administered twice to 133 European experts from 11 countries. The questionnaire included 5 sections: 1) Panellists’ profile and experience with BCMS, 2) Current clinical practice in eBC and use of BCMS, 3) Panellists’ opinion on the utility of the BCMS in eBC according to patient profiles, 4) Agreement with a set of recommendations on the use of BCMS in clinical practice and 5) Identification of unmet needs and future applications of BCMS. Results85.0% panellists reported the existence of hospital/country policies to regulate the use of BCMS being the nodal status (92.0%), the HER2 negative by ICH/FISH/CISH (87.6%) and the tumour size (77.87%) the most important criteria defined in those guidelines for the use of BCMS. When guidelines are not available, the main criterion is still the nodal status (80.0%), but they also give great importance to menopausal status and the percentage of Ki67 expression (70.0%). Also, the two main reasons for using BCMS in patients with eBC were to assess the risk of distant recurrence within 10 years in order to avoid chemotherapy (60.2%) and to predict the benefit from chemotherapy (46.6%). Finally, to define prognosis and treatment needs, BCMS were used routinely or in selected patients by more than 60% of the participants, regardless of the patient’s gender or age, with similar results when asked by menopausal status; lack of lymph node involvement (97.0%) or involvement of 1–3 lymph nodes (88.0%); HR-positive status (98.5%); and HER2-negative status (96.2%). 85.0% panellists reported the existence of hospital/country policies to regulate the use of BCMS being the nodal status (92.0%), the HER2 negative by ICH/FISH/CISH (87.6%) and the tumour size (77.87%) the most important criteria defined in those guidelines for the use of BCMS. When guidelines are not available, the main criterion is still the nodal status (80.0%), but they also give great importance to menopausal status and the percentage of Ki67 expression (70.0%). Also, the two main reasons for using BCMS in patients with eBC were to assess the risk of distant recurrence within 10 years in order to avoid chemotherapy (60.2%) and to predict the benefit from chemotherapy (46.6%). Finally, to define prognosis and treatment needs, BCMS were used routinely or in selected patients by more than 60% of the participants, regardless of the patient’s gender or age, with similar results when asked by menopausal status; lack of lymph node involvement (97.0%) or involvement of 1–3 lymph nodes (88.0%); HR-positive status (98.5%); and HER2-negative status (96.2%). ConclusionsThe main reason for using BCMS was to predict chemotherapy benefit. This, along with the fact that some experts reported the use of BCMS in 4 positive lymph node, triple negative or HER2+ patients, suggests that there is a need of education on how to correctly interpreting BCMS results. The main reason for using BCMS was to predict chemotherapy benefit. This, along with the fact that some experts reported the use of BCMS in 4 positive lymph node, triple negative or HER2+ patients, suggests that there is a need of education on how to correctly interpreting BCMS results.

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