The evolving landscape of hormone receptor-positive/HER2-negative metastatic breast cancer (EVOLVE): An Italian Delphi consensus report

Federica Miglietta(Istituto Oncologico Veneto), Maria Grazia Razeti(Ospedale Policlinico San Martino), Aldo Caltavituro(Scuola Superiore Meridionale), Arianna Dri(National Cancer Institute), Carmine Valenza(European Institute of Oncology), Giampaolo Bianchini(Vita-Salute San Raffaele University), Laura Biganzoli(Azienda Usl Toscana Centro), Andrea Botticelli(Policlinico Umberto I), Michele Caruso(Humanitas Mater Domini), Saverio Cinieri(Ospedale A. Perrino), Carmen Criscitiello(European Institute of Oncology), Carmine De Angelis(Scuola Superiore Meridionale), M. De Laurentis(Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"), Lucia Del Mastro(Ospedale Policlinico San Martino), Sabino De Placido(Federico II University Hospital), Marzia Del Re(Agostino Gemelli University Polyclinic), Maria Vittoria Dieci(Istituto Oncologico Veneto), Alessandra Fabi(Agostino Gemelli University Polyclinic), Daniele Generali(Istituti Ospitalieri di Cremona), Alessandra Gennari(Università degli Studi del Piemonte Orientale “Amedeo Avogadro”), Lorenzo Gerratana(National Cancer Institute), Mario Giuliano(Federico II University Hospital), Matteo Lambertini(Ospedale Policlinico San Martino), Umberto Malapelle, Luca Malorni(Azienda Usl Toscana Centro), Icro Meattini(Azienda Ospedaliero-Universitaria Careggi), Ida Paris(Agostino Gemelli University Polyclinic), Giancarlo Pruneri(IRCCS Ospedale San Raffaele), Claudio Zamagni(Azienda USL di Bologna), Alberto Zambelli(Ospedale Papa Giovanni XXIII), François‐Clément Bidard(Université de Versailles Saint-Quentin-en-Yvelines), Valentina Guarneri(Istituto Oncologico Veneto), Fabio Puglisi(National Cancer Institute), Giuseppe Curigliano(European Institute of Oncology), Grazia Arpino(Federico II University Hospital)
Critical Reviews in Oncology/Hematology
June 6, 2025
Cited by 4Open Access
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Abstract

BACKGROUND: The expanding treatment landscape for patients with hormone receptor-positive, HER2-negative (HR+/HER2-) metastatic breast cancer (mBC) has led to the emergence of new "grey areas" not covered by international guidelines, where treatment decision making is particularly challenging. METHODS: Sixteen relevant statements regarding the management of HR+ /HER2- mBC were formulated by an Executive Board and validated by a Scientific Board, composed by internationally recognized experts in the field of BC. Subsequently, 50 Italian oncologists were surveyed between May 2024 and June 2024 through the modified Delphi method, in order to capture their rate of agreement and disagreement on the proposed statements. RESULTS: The consensus was reached for all 16 statements: 4 were related to resistance and sensitivity to CDK4/6 inhibitors and endocrine therapy, 6 to biomarkers for HR+ /HER2- mBC, and 6 to treatment algorithm of HR+ /HER2- mBC. The Panel critically and comprehensively discussed the most relevant results, especially regarding the statements with lower level of agreement (which ranged from 85.4 % to 100 %). CONCLUSIONS: The treatment of HR+ /HER2- mBC is currently being reshaped due to the expansion of its pharmacopoeia, the better understanding of its molecular determinants and the validation of biomarkers for patient selection. This consensus addressed the most controversial questions related to treatment decision and reached the agreement in all statements.


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