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Peer-reviewedCC BY 4.0Cancers

Chemotherapy Use, Healthcare Resource Utilisation, and Direct Costs in High-Risk Early-Stage ER+/HER2– Breast Cancer in Italy: A Real-World Study Linking Administrative and Pathology Data

4 affiliations
  1. 1Humanitas Research Hospital, 20072 Milan, Italy
  2. 2Division of Early Drug Development, European Institute of Oncology, IRCCS, 20141 Milan, Italy
  3. 3CliCon S.r.l. Società Benefit, Health, Economics & Outcomes Research, 40137 Bologna, Italy
  4. 4Merck & Co., Inc., Rahway, NJ 00765, USA

Abstract

Background/Objectives: Patients with high-risk early-stage oestrogen receptor-positive/human epidermal growth factor receptor 2-negative early breast cancer (ER+/HER2– eBC) remain at high risk of recurrence despite standard endocrine therapy. Given the limited real-world data in Italy, this analysis evaluated treatments, economic burden and clinical outcomes in routine practice. Methods: Administrative healthcare databases linked with pathology data were used to identify patients with ER+/HER2– eBC undergoing surgery. The overall population (Cohort #1) comprised patients identified between January 2010 and June 2024. A subset meeting high-risk criteria constituted Cohort #2 (Grade 3 tumours AND clinical stage T1c–T2/N1–N2 or T3–T4/N0–N2; when TNM components were unavailable, clinical stage II–III patients were included). Healthcare resource utilisation and direct costs were assessed during neoadjuvant, adjuvant, and follow-up phases. Recurrence rate, real-world event-free survival and overall survival were evaluated during the 4 years post-surgery using Kaplan–Meier curves. Results: Among 17,731 patients identified as ER+/HER2– eBC (Cohort #1), 366 were classified as high-risk (Cohort #2). The descriptive analysis documented substantial healthcare resource utilisation and direct costs in the high-risk subgroup during both neoadjuvant and adjuvant phases, together with a considerable recurrence burden and reduced survival probabilities. Conclusions: This descriptive real-world analysis provides estimates of the clinical and economic burden of ER+/HER2– eBC in the real Italian practice, with a focus on the high-risk subgroup. Post-surgery cost estimates reflect healthcare expenditure during recurrence-free follow-up and do not capture the costs of recurrent or metastatic disease. These findings highlight the healthcare resources required for the management of high-risk eBC and the need for continued efforts to improve clinical outcomes.

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BibTeX
@article{criscitiello2026chemotherapy,
  title = {{Chemotherapy Use, Healthcare Resource Utilisation, and Direct Costs in High-Risk Early-Stage ER+/HER2– Breast Cancer in Italy: A Real-World Study Linking Administrative and Pathology Data}},
  author = {Carmen Criscitiello and Valentina Perrone and Luca Degli Esposti and Stefania Mazzoni and Kaushal Desai and Kim M. Hirshfield and Jagadeswara Rao Earla},
  journal = {Cancers},
  year = {2026},
  month = oct,
  doi = {10.3390/cancers18213467},
  url = {https://www.mdpi.com/2072-6694/18/21/3467},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Chemotherapy Use, Healthcare Resource Utilisation, and Direct Costs in High-Risk Early-Stage ER+/HER2– Breast Cancer in Italy: A Real-World Study Linking Administrative and Pathology Data
AU  - Carmen Criscitiello
AU  - Valentina Perrone
AU  - Luca Degli Esposti
AU  - Stefania Mazzoni
AU  - Kaushal Desai
AU  - Kim M. Hirshfield
AU  - Jagadeswara Rao Earla
PY  - 2026
DA  - 2026/10/27
JO  - Cancers
DO  - 10.3390/cancers18213467
UR  - https://www.mdpi.com/2072-6694/18/21/3467
AB  - Background/Objectives: Patients with high-risk early-stage oestrogen receptor-positive/human epidermal growth factor receptor 2-negative early breast cancer (ER+/HER2– eBC) remain at high risk of recurrence despite standard endocrine therapy. Given the limited real-world data in Italy, this analysis evaluated treatments, economic burden and clinical outcomes in routine practice. Methods: Administrative healthcare databases linked with pathology data were used to identify patients with ER+/HER2– eBC undergoing surgery. The overall population (Cohort #1) comprised patients identified between January 2010 and June 2024. A subset meeting high-risk criteria constituted Cohort #2 (Grade 3 tumours AND clinical stage T1c–T2/N1–N2 or T3–T4/N0–N2; when TNM components were unavailable, clinical stage II–III patients were included). Healthcare resource utilisation and direct costs were assessed during neoadjuvant, adjuvant, and follow-up phases. Recurrence rate, real-world event-free survival and overall survival were evaluated during the 4 years post-surgery using Kaplan–Meier curves. Results: Among 17,731 patients identified as ER+/HER2– eBC (Cohort #1), 366 were classified as high-risk (Cohort #2). The descriptive analysis documented substantial healthcare resource utilisation and direct costs in the high-risk subgroup during both neoadjuvant and adjuvant phases, together with a considerable recurrence burden and reduced survival probabilities. Conclusions: This descriptive real-world analysis provides estimates of the clinical and economic burden of ER+/HER2– eBC in the real Italian practice, with a focus on the high-risk subgroup. Post-surgery cost estimates reflect healthcare expenditure during recurrence-free follow-up and do not capture the costs of recurrent or metastatic disease. These findings highlight the healthcare resources required for the management of high-risk eBC and the need for continued efforts to improve clinical outcomes.
SN  - 2072-6694
ER  -