Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2025 Sep 5:12:198-204.
doi: 10.33393/grhta.2025.3568. eCollection 2025 Jan-Dec.

RWE in oncologia: uso dei database per identificare i sottotipi molecolari del cancro mammario metastatico in Italia

[Article in Italian]
Valentina Perrone  1 , Maria Cappuccilli  1 , Melania Leogrande  1 , Stefania Saragoni  1 , Andrea Cinti Luciani  1 , Sandro Barni  2 , Luca Degli Esposti  1
Affiliations

RWE in oncologia: uso dei database per identificare i sottotipi molecolari del cancro mammario metastatico in Italia

[Article in Italian]
Valentina Perrone et al. Glob Reg Health Technol Assess. .

Abstract

Introduction:: The use of Real-World Evidence (RWE) is gaining increasing relevance in oncology, offering a complementary perspective to randomised clinical trials (RCTs). In Italy, administrative databases represent a promising source to explore treatment patterns and distribution of molecular subtypes in metastatic breast cancer (mBC). This study was aimed at evaluating the feasibility and accuracy of using administrative data to identify and characterise molecular subtypes of mBC in a setting of real clinical practice in Italy.

Methods:: Retrospective observational study conducted on a sample of about 4 million assisted patients. Data from different administrative flows were used to identify patients with mBC and to assign them to one of the three main molecular subtypes (HR+/HER2-, HER2+, TNBC) through the use of proxies based on prescriptions of drugs and diagnostic codes.

Results:: Between January 2019 and June 2023, the observed distribution of subtypes was HR+/HER2- (74%), HER2+ (15%), and TNBC (11%), in line with the ranges reported in the literature. The model demonstrated a high concordance with pre-existing epidemiological data.

Conclusions:: Administrative data are confirmed as a valid resource to describe the molecular landscape of mBC in Italy. The RWE emerges as a crucial tool to support clinical and regulatory decisions, promoting the approach of personalised medicine and the optimisation of healthcare resources.

PubMed Disclaimer

Conflict of interest statement

Conflict of interest: The Authors declare no conflict of interest.

Figures

Figura 1 -
Figura 1 -
Distribuzione dei sottotipi molecolari identificata mediante database amministrativi nella popolazione con mBC in analisi.
See this image and copyright information in PMC

References

    1. Pellat A et al. Comprehensive mapping review of real-world evidence publications focusing on targeted therapies in solid tumors: A collaborative work from ESMO real-world data and Digital Health Working Group. Abstract 1689O. ESMO Congress 2023. Annals of Oncology, 34:S925. doi: 10.1016/j.annonc.2023.09.2643. Volume. https://doi.org/10.1016/j.annonc.2023.09.2643. - DOI
    1. Tannock IF, Amir E, Booth CM et al. Relevance of randomised controlled trials in oncology. Lancet Oncol. 2016;17(12):e560–e567. doi: 10.1016/S1470-2045(16)30572-1. https://doi.org/10.1016/S1470-2045(16)30572-1. https://pubmed.ncbi.nlm.nih.gov/27924754. - DOI - PubMed
    1. Mahajan R. Real world data: additional source for making clinical decisions. Int J Appl Basic Med Res. 2015;5(2):82. doi: 10.4103/2229-516X.157148. https://doi.org/10.4103/2229-516X.157148. https://pubmed.ncbi.nlm.nih.gov/26097811. - DOI - PMC - PubMed
    1. Tsukita Y, Tozuka T, Kushiro K et al. Immunotherapy or Chemoimmunotherapy in Older Adults With Advanced Non-Small Cell Lung Cancer. JAMA Oncol. 2024;10(4):439–447. doi: 10.1001/jamaoncol.2023.6277. https://doi.org/10.1001/jamaoncol.2023.6277. https://pubmed.ncbi.nlm.nih.gov/38451530. - DOI - PMC - PubMed
    1. AIFA. Sviluppo scientifico dei dati dei registri di monitoraggio AIFA. [(Accessed April; 2025 )]; Online

LinkOut - more resources