Multigene tests for breast cancer: the physician’s perspective

Francesco Cognetti, Laura Biganzoli, Sabino De Placido, Lucia del Mastro, Riccardo Masetti, Giuseppe Naso, Giancarlo Pruneri, Donatella Santini, Carlo Alberto Tondini, Corrado Tinterri, Giuseppe Tonini and Sandro Barni _

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Oncotarget. 2021; 12:936-947. https://doi.org/10.18632/oncotarget.27948

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Francesco Cognetti1, Laura Biganzoli2, Sabino De Placido3, Lucia del Mastro4, Riccardo Masetti5, Giuseppe Naso6, Giancarlo Pruneri7, Donatella Santini8, Carlo Alberto Tondini9, Corrado Tinterri10, Giuseppe Tonini11 and Sandro Barni12

1 Scuola di specializzazione di Oncologia, La Sapienza University, Rome, Italy

2 Sandro Pitigliani Medical Oncology Department, Hospital of Prato, Prato, Italy

3 Università Degli Studi di Napoli Federico II Dipartimento di Medicina clinica e Chirurgia Professore di Oncologia Medica, Napoli, Italy

4 Oncology, IRCCS AOU San Martino - IST Istituto Nazionale per la Ricerca del Cancro, Genova, Italy

5 Breast Center, Catholic University, Rome, Italy

6 Department of Radiology, Pathology and Oncology, La Sapienza University, Rome, Italy

7 Department of Pathology, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy

8 Department of Pathology, IRCCS Azienda Ospedaliera Universitaria di Bologna, Policlinico di Sant’Orsola, Bologna, Italy

9 Medical Oncology, Papa Giovanni XXIII Hospital, Bergamo, Italy

10 Senology Unit, Humanitas Cancer Center, Rozzano, Milan, Italy

11 Medical Oncology, School University Campus Bio-Medico, Rome, Italy

12 Emeritus, Department of Oncology, ASST Bergamo Ovest, Treviglio, Bergamo, Italy

Correspondence to:

Sandro Barni,email: [email protected]

Keywords: genomic tests; breast cancer; adjuvant chemotherapy; adjuvant hormone therapy

Received: November 03, 2020     Accepted: April 01, 2021     Published: April 27, 2021

Copyright: © 2021 Cognetti et al. This is an open access article distributed under the terms of the Creative Commons Attribution License (CC BY 3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.


Breast cancer is the most common tumour in women and the first cause of death for cancer in the female population. Preserving the quality of life has therefore become an important objective in the management of the disease. The benefits of adjuvant chemotherapy in patients with HR+ HER2- early breast cancer should always be balanced against its potential short and long-term adverse effects, and identifying the appropriate patients for whom chemotherapy can offer the highest clinical benefit is critical. Besides clinical and pathological factors, today four multigene tests able to guide the choice of the adjuvant therapy early breast cancer are available in Italy: Oncotype DX®, EndoPredict®, MammaPrint® e Prosigna®. This review evaluates the main characteristics of these diagnostic tests, the studies on clinical utility, their economic impact and their inclusion in international and national guidelines. The Oncotype DX Breast Recurrence Score® test is the only multigene test validated, with level IA evidence, to guide the adjuvant therapy decisions: hormone therapy alone for most patients with RS results 0–25, and chemotherapy for patients with RS results 26–100. Clinical data demonstrate that the Oncotype DX test is able to significantly impact therapeutic decisions, reducing chemotherapy use up to 49% and supporting the use of chemotherapy (up to 12%) in potentially under-treated patients. Based on the level of clinical evidence and established clinical utility, several multigene tests have been included in the main international guidelines, with recommendations ranging from “strong” to “moderate”.

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