Precision medicine in breast cancer: From clinical trials to clinical practice

Crimini, Edoardo; Repetto, Matteo; Aftimos, Philippe; Botticelli, Andrea; Marchetti, Paolo; Curigliano, Giuseppe

doi:10.1016/j.ctrv.2021.102223

Cited by 46 publications

(39 citation statements)

References 116 publications

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“…On the whole, ADCs permit the target of HER2 independently from the cell and even the tumor addiction to HER2 pathway provided that a cleavable linker and a potent chemotherapeutic agent seem to be necessary to exert a sufficient bystander effect. Based on these findings, as T-Dxd and trastuzumab-duocarmazine demonstrated promising activity in HER2-low breast cancer but no data are currently available on survival endpoints, HER2-low expression in breast cancer can be classified as a tier IIb according to ESMO Scale for Clinical Actionability of molecular Targets (ESCAT), hoping that this evidence could reach a tier I in the future when more solid data on survival endpoints will be available ( Mateo et al, 2018 ; Crimini et al, 2021 ). Focusing on HER2-negative breast cancer, the most promising therapeutical strategies are probably HER2 vaccines, as they assume that breast cancer cells express HER2 at a higher level than healthy tissues, even in cases of HER2-low and ultra-low breast cancers by IHC ( You et al, 2021 ).…”

Section: Discussionmentioning

confidence: 99%

HER2 Low, Ultra-low, and Novel Complementary Biomarkers: Expanding the Spectrum of HER2 Positivity in Breast Cancer

Venetis

Crimini

Sajjadi

et al. 2022

Front. Mol. Biosci.

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HER2 status in breast cancer is assessed to select patients eligible for targeted therapy with anti-HER2 therapies. According to the American Society of Clinical Oncology (ASCO) and College of American Pathologists (CAP), the HER2 test positivity is defined by protein overexpression (score 3+) at immunohistochemistry (IHC) and/or gene amplification at in situ hybridization (ISH). The introduction of novel anti-HER2 compounds, however, is changing this paradigm because some breast cancers with lower levels of protein expression (i.e. score 1+/2+ with no gene amplification) benefited from HER2 antibody-drug conjugates (ADC). Recently, a potential for HER2 targeting in HER2 “ultra-low” (i.e. score 0 with incomplete and faint staining in ≤10% of tumor cells) and MutL-deficient estrogen receptor (estrogen receptor)-positive/HER2-negative breast cancers has been highlighted. All these novel findings are transforming the traditional dichotomy of HER2 status and have dramatically raised the expectations in this field. Still, a more aware HER2 status assessment coupled with the comprehensive characterization of the clinical and molecular features of these tumors is required. Here, we seek to provide an overview of the current state of HER2 targeting in breast cancers beyond the canonical HER2 positivity and to discuss the practical implications for pathologists and oncologists.

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Section: Discussionmentioning

confidence: 99%

HER2 Low, Ultra-low, and Novel Complementary Biomarkers: Expanding the Spectrum of HER2 Positivity in Breast Cancer

Venetis

Crimini

Sajjadi

et al. 2022

Front. Mol. Biosci.

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“…Oncology is where personalized medicine was first applied, and targeted therapies and diagnostics have been mainly focused on. Moreover, several applications of biomarkers for the successful stratification of patients with a given type of cancer exist, most of them based on molecular data, especially genomics [ 13 , 14 ]. AD research in personalized therapies and diagnostics nowadays is showing its firsts results, based on imaging, cognitive and molecular data [ 15 ].…”

Section: Methodsmentioning

confidence: 99%

Methods for Stratification and Validation Cohorts: A Scoping Review

Moral

Sánchez-Niubò²,

Monistrol-Mula³

et al. 2022

JPM

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Personalized medicine requires large cohorts for patient stratification and validation of patient clustering. However, standards and harmonized practices on the methods and tools to be used for the design and management of cohorts in personalized medicine remain to be defined. This study aims to describe the current state-of-the-art in this area. A scoping review was conducted searching in PubMed, EMBASE, Web of Science, Psycinfo and Cochrane Library for reviews about tools and methods related to cohorts used in personalized medicine. The search focused on cancer, stroke and Alzheimer’s disease and was limited to reports in English, French, German, Italian and Spanish published from 2005 to April 2020. The screening process was reported through a PRISMA flowchart. Fifty reviews were included, mostly including information about how data were generated (25/50) and about tools used for data management and analysis (24/50). No direct information was found about the quality of data and the requirements to monitor associated clinical data. A scarcity of information and standards was found in specific areas such as sample size calculation. With this information, comprehensive guidelines could be developed in the future to improve the reproducibility and robustness in the design and management of cohorts in personalized medicine studies.

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“…Precision medicine represents one of the frontiers in oncological treatments as it allows, mainly through the study of patients' genetic profiles, to build a treatment path that is as personalized as possible ( 1 ).…”

Section: Introductionmentioning

confidence: 99%