Description of characteristics, management of care and healthcare direct costs of patients with HR+/HER2- early breast cancer in Italy: a real-world study involving administrative and pathological anatomy databases

ABSTRACT

Background

Healthcare administrative and pathological anatomy data were used to identify Italian patients with early breast cancer (EBC) with HR+/HER2- status at high risk of recurrence, evaluating drug utilization and other healthcare resource use in clinical practice.

Methods

This retrospective analysis, based on 9.4 million of Italian National Health Service beneficiaries, included adult patients with hospitalization discharge diagnosis for EBC in 01/2015–12/2020. Those with HR+/HER2- status were selected; among them, patients that underwent removal of lymph nodes (LN) were analyzed.

Results

Of 24,137 patients with EBC and HR+/HER2- status, 3619 patients (15%) had documented LN removal. Overall, 4.7% of HR+/HER2- patients and 9.9% of patients with LN removal experienced distant relapse over a median follow-up of 33.2 months (Q1-Q3: 17.0–50.6). Local relapse occurred in approximately 9.1–9.3% of patients in each group. Among the 1,175 patients with LN removal that had available pathological anatomy data, 399 (34.0%) had pathological high-risk characteristics and 13.3% experienced distant relapse.

Conclusions

One in ten patients with EBC who underwent LN removal experienced a relapse, highlighting the strong need to prevent early recurrence.

KEYWORDS:

• Breast cancer
• data linkage
• real life
• recurrence
• HR+/HER2-

Article highlights

• The analysis combined administrative and pathological anatomy data to provide insights on early breast cancer in real-world settings in Italy;

• HR+/HER2- patients and, among them, those with lymph node removal were described in terms of characteristics, treatments, recurrence and healthcare resource consumption; a sub- cohort with pathological high-risk characteristics was identified as well.

• Overall, 4.7% of HR+/HER2- patients and 9.9% of patients with LN removal experienced distant relapse over a median follow-up of 33.2 months (Q1-Q3: 17.0-50.6) and reached up to 13% in patients with pathological high-risk characteristics. Local relapse occurred in approximately 9% of patients.

• Our results can support further evidence into the need of therapies for early stages and can help the health decision makers by showing how patients were managed, and their burden for the Italian National Health Service.

• Given the growing interest for real-world data in oncology, the integration between different data sources (administrative and clinical) herein provided could be a useful tool for evidence generation from clinical practice.

Declaration of interest

V Perrone, E Giacomini, D Sangiorgi, L Degli Esposti are employees of CliCon S.r.l. Società Benefit and report no conflicts of interest related to this work. A Tamma and C Buzzoni are employees of Eli Lilly Italy S.p.a., Italy; M Giovannitti is an employee of Eli Lilly S.p.a. & Company Roma, Italy. The agreement signed by Clicon S.r.l. Società Benefit and Eli Lilly does not create any entity, joint venture or any similar relationship between parties. Clicon S.r.l. Società Benefit is an independent company. Neither CliCon S.r.l. Società Benefit nor any of their representatives are employees of Eli Lilly for any purpose. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

Study conception: C Buzzoni, V Perrone, L Degli Esposti. Acquisition/analysis/interpretation of data: V Perrone, E Giacomini, D Sangiorgi, L Degli Esposti. Validation: A Tamma, M Giovannitti, C Buzzoni, L Degli Esposti. Writing first draft: E Giacomini, V Perrone. Revision and editing of the draft: all authors. Final approval of the manuscript for publication: all authors.

Acknowledgments

The present manuscript was edited for proper English language, grammar, punctuation, spelling, and overall style by Courey A. from American Journal Experts (AJE).

Data sharing statement

All data used for the current study are available upon reasonable request next to CliCon s.r.l. which is the body entitled of data treatment and analysis by Local Health Units.

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14737167.2023.2246652.

Additional information

Funding

Eli Lilly purchased the study report that is the basis for this manuscript and provided funding. This manuscript was developed with Eli Lilly and CliCon S.r.l Società Benefit.