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Review
. 2022 Apr 9;14(8):1898.
doi: 10.3390/cancers14081898.

Definition of High-Risk Early Hormone-Positive HER2-Negative Breast Cancer: A Consensus Review

Mattia Garutti  1 , Gaia Griguolo  2   3 , Andrea Botticelli  4 , Giulia Buzzatti  5 , Carmine De Angelis  6 , Lorenzo Gerratana  1 , Chiara Molinelli  5 , Vincenzo Adamo  7 , Giampaolo Bianchini  8   9 , Laura Biganzoli  10 , Giuseppe Curigliano  11   12 , Michelino De Laurentiis  13 , Alessandra Fabi  14 , Antonio Frassoldati  15 , Alessandra Gennari  16   17 , Caterina Marchiò  18   19 , Francesco Perrone  20 , Giuseppe Viale  12   21 , Claudio Zamagni  22 , Alberto Zambelli  23 , Lucia Del Mastro  5   24 , Sabino De Placido  6 , Valentina Guarneri  2   3 , Paolo Marchetti  25 , Fabio Puglisi  1   26
Affiliations
Review

Definition of High-Risk Early Hormone-Positive HER2-Negative Breast Cancer: A Consensus Review

Mattia Garutti et al. Cancers (Basel). .

Abstract

Breast cancer is one of the major causes of cancer-related morbidity and mortality in women worldwide. During the past three decades, several improvements in the adjuvant treatment of hormone receptor-positive/HER2-negative breast cancer have been achieved with the introduction of optimized adjuvant chemotherapy and endocrine treatment. However, estimating the risk of relapse of breast cancer on an individual basis is still challenging. The IRIDE (hIGh Risk DEfinition in breast cancer) working group was established with the aim of reviewing evidence from the literature to synthesize the current relevant features that predict hormone-positive/HER2-negative early breast cancer relapse. A panel of experts in breast cancer was involved in identifying clinical, pathological, morphological, and genetic factors. A RAND consensus method was used to define the relevance of each risk factor. Among the 21 features included, 12 were considered relevant risk factors for relapse. For each of these, we provided a consensus statement and relevant comments on the supporting scientific evidence. This work may guide clinicians in the practical management of hormone-positive/HER2-negative early breast cancers.

Keywords: TNM; adjuvant; breast cancer; chemotherapy; consensus; ctDNA; endocrine therapy; genomic signature; hormone receptors; risk of relapse.

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Conflict of interest statement

L. Del Mastro received personal fees from Roche, Novartis, Pfizer, MSD, Eli Lilly, Eisai, Seagen, Gilead, Daiichi Sannkyo, Exact sciences, Pierre Fabre, Astrazeneca; S. De Placido received personal fees (participation on advisory board and/or speakers bureau) from Novartis, Roche, Celgene, AstraZeneca, Pfizer, Lilly, Eisai, Seagen, Daiichi Sankyo, Clovis, GSK, MSD; V. Guarneri received personal fees from EliLilly, Novartis, Roche, MSD, GSK, Gilead for speaker’s bureau and/or advisory board, outside the submitted work; P. Marchetti received grant to his Institution from Roche, MSD, BMS Astra Zeneca, Boehringer Ingelheim, Novartis, Pfizer. Personal fee: Roche, MSD, BMS, Lilly, Novartis, Pfizer; F. Puglisi declares receipt of grants/research supports from Astrazeneca, Eisai, Roche and receipt of honoraria or consultation fees: Amgen, Astrazeneca, Daichii Sankyo, Celgene, Eisai, Eli Lilly, Gilead, GSK, Ipsen, MSD, Novartis, Pierre-Fabre, Pfizer, Roche, Seagen, Takeda, Viatris; A. Botticelli has nothing to declare; G. Buzzatti declares receipt of honoraria from Pfizer, Lilly, Novartis; C. Molinelli received honoraria from Novartis and Lilly; G. Bianchini declares consultancy/honorarium from Roche, Pfizer, AstraZeneca, Lilly, Novartis, Neopharm Israel, Amgen, MSD, Chugai, Sanofi, Daiichi Sankyo, EISAI, Gilead, Seagen, Exact Science, Gilead, Seagen; V. Adamo during the past three years received honoraria for consultant roles and/or partecipation to advisory board and/or meeting by Amgen, Astra Zeneca, BMS, Lilly, MSD, Novartis, Pfizer, Roche, Sandoz, Sanofi, Sevier, Takeda, outside the submitted work; L. Biganzoli received personal financial interests (honoraria, consulting or advisory role) from AstraZeneca, Daiichi-Sankyo, Eisai, Exaxt Sciences, Genomic Health, Gilead, Lilly, Novartis, Pfizer, Pierre Fabre, Roche, Sanofi, Seattle Genetics. Research Funding: Celgene, Genomic Health, Novartis; G. Curigliano declares consultancy from BMS, Roche, Pfizer, Novartis, Lilly, Seagen, Exact Sciences, Astra Zeneca, Daichii Sankyo; M. De Laurentiis declares consulting Fees (e.g., advisory boards) from Roche; Novartis; Eli Lilly; Pierre Fabre; Astra Zeneca; MSD; Seagen; Gilead; Daiichi-Sankyo; Pfizer; Exact Science; Fees For Non-Cme Services and received directly from commercial interest or their agents (e.g., Speakers’ Bureaus) from Roche; Novartis; Eli Lilly; Pierre Fabre; Astra Zeneca; Msd; Daiichi-Sankyo, Exact Science; Gilead; Ipsen; Pfizer; Seagen; Takeda, Sanofi-Genzyme; A. Fabi declares receipt of grants/research supports: Roche, Lilly, Novartis, Astra Zeneca, Dompè Biotech, Eisai, Novartis, Astra Zeneca Pfizer, MSD; A. Frassoldati grants for advisory boards, lectures or congress participation from Novartis, Astrazeneca, Roche, Eli-Lilly, Pfizer, Daichii, Seagen - None related to the topics of the paper; A. Gennari has nothing to declare outside of the submitted work; C. Marchiò received personal consultancy fees from Roche, Bayer, Astrazeneca, Daiichi Sankyo, MSD Oncology; F. Perrone received honoraria from Incyte, GSK, Ipsen, Astellas, Astra Zeneca, Roche, BMS, Bayer, Clovis, Pierre Fabre and institutional grants for research activity from Roche, Astra Zeneca, Pfizer, MSD, Bayer, INcyte Taiho, Janssen, Exelixis, Aileron, Daiichi Sankyo; G. Viale received grants/research supports from Roche/Genentech, Ventana Medical Systems, Dako/Agilent Technologies; Receipt of honoraria or consultation fees: Ventana, Dako/Agilent, Roche, MSD Oncology, AstraZeneca, Daiichi Sankyo, Pfizer, Eli Lilly; C. Zamagni received fees for advisory board and travel accomodations from Roche, Novartis, Pfizer, PharmaMar, Tesaro and Celgene; Advisory boards from Eisai, AstraZeneca, Amgen, Lilly, QuintilesIMS; L. Gerratana received personal fees from Eli Lilly and Novartis, all outside the submitted work; A. Zambelli has nothing to declare; M. Garutti received personal consultancy fees from Novartis, Eli Lilly, Pierre-Fabre, all outside the submitted work; C. De Angelis has received personal fees (as consultant and/or speaker bureau) from Roche, Eli Lilly, GSK, Novartis, Pfizer and AstraZeneca, unrelated to the current work; G. Griguolo received personal fees from EliLilly, Novartis, all outside the submitted work.

Figures

Figure 1
Figure 1
RAND results (2nd round): 1 = not relevant as prognostic factor for disease relapse; 2–3 = poorly relevant as prognostic factor for disease relapse; 4–6 = moderately relevant as prognostic factor for disease relapse; 7–9 = highly relevant as prognostic factor for disease relapse.
See this image and copyright information in PMC

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