Multigene signatures for early breast cancer in clinical practice: A report of the Lombardy genomic assays for breast cancer working group.

The increasing understanding of breast cancer biology has provided the basis for the development of multigene signatures aimed to improve the capability of clinicians to assess patients' prognostication and risk stratification. Incorporating these tools in clinical practice has profoundly impacted on the decision-making process for the adjuvant therapy of patients with ER+/HER2- early breast cancer and the results from prospective adjuvant trials have strengthened the clinical utility of multigene signatures in this setting. In July 2019, Lombardy was the first Region in Italy to reimburse genomic testing for patients with ER+/HER2- early breast cancer. Three years later, a group of investigators from six referral Cancer Centers in Lombardy convened to debate the use of multigene signatures in clinical practice and share their own experience with the tests after reimbursement. Here, we reviewed relevant data on the role of multigene signatures in tailoring adjuvant chemotherapy for patients with ER+/HER2- early breast cancer and discussed about the optimal use of these assays in current clinical practice. As the treatment landscape of early breast cancer evolves and novel questions about the possible additional applications of multigene assays arise, we also provide our viewpoint on the potential implementation of the assays in the evolving scenario ER+/HER2- early breast cancer treatment.

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Copyright © 2023 Licata, Cosentini, De Sanctis, Iorfida, Caremoli, Vingiani, Simoncini, Pruneri, Munzone, Bianchini, Zambelli and Tondini.

Déclaration de conflit d'intérêts

LL has served on the advisory boards for: Lilly, Exact Sciences, AstraZeneca and Daiichi Sankyo; has received consulting fee from: Exact Sciences; honoraria for speakers’ bureaus from: Gilead, Exact Sciences and EISAI; support for travel, accommodations, expenses from: Lilly and Gilead. RS has served on the advisory boards for: Novartis, Lilly, Istituto Clinico Gentili, Ipsen, Amgen, EISAI. AV reports honoraria from Roche and Lilly. ES has received consulting fee and served on the advisory boards for: Exact Sciences, Seagen. GP has served on the advisory boards for: ADS Biotec; has received honoraria for speakers’ bureaus and travel funding from: Lilly, AstraZeneca, Exact Sciences, Novartis. EM has received consulting fee and served on the advisory boards for: Exact Sciences, EISAI, MSD Oncology, Daiichi Sankyo/Astra Zeneca, Pfizer, Seagen; support for travel, accommodations, expenses from: Roche, Pfizer, Lilly, Novartis. GB has received consulting fee from Roche, AstraZeneca, Novartis, MSD, Sanofi, Daiichi Sankyo, and Exact Sciences; honoraria for speakers’ bureaus from Roche, Pfizer, Astra- Zeneca, Lilly, Novartis, Neopharm Israel, MSD, Chugai, Daiichi Sankyo, EISAI, and Exact Sciences; support for travel, accommodations, expenses from Roche, Pfizer, and AstraZeneca; is co-inventor of ‘European patent Application N. 12195182.6 and 12196177.5 titled “PDL-1 expression in anti-HER2 therapy” -Roche- Issued no compensation provided; and has served on the advisory boards for Roche, Pfizer, Daiichi Sankyo, Lilly, MSD, Novartis, AstraZeneca, Genomic Health, EISAI, Gilead, and Seagen. AZ has received personal fees and non-financial support from Novartis, AstraZeneca, Lilly, Pfizer, Daiichi Sankyo, MDS Merck Sharp&Dome, Roche, Seagen, Exact Sciences, Gilaed, Istituto Gentili. CT has received consulting fee and served on the advisory boards for: Myriad Genetics, MSD Oncology and Amgen; honoraria for speakers’ bureaus from: Amgen; support for travel, accommodations, expenses from: Takeda, Amgen, MSD, Eli Lilly Italia SPA, Roche, Pfizer. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.