Skip to main content
SpringerLink
Log in

HR+/HER2− Metastatic Breast Cancer: Epidemiology, Prescription Patterns, Healthcare Resource Utilisation and Costs from a Large Italian Real-World Database

  • Original Research Article
  • Published:
Clinical Drug Investigation Aims and scope Submit manuscript

Abstract

Background and Objective

Breast cancer is the second leading cause of cancer death worldwide. The economic burden of breast cancer is crucial for the sustainability of healthcare systems. The objective of this study was to estimate the burden of HR+/HER2− metastatic breast cancer (MBC) in Italy, in terms of incidence, prescription patterns, healthcare resource utilisation and costs for the National Health System (NHS).

Methods

A cohort study based on healthcare administrative data (ReS database), covering > 10 million Italians, was performed. Incident cases of HR+/HER2− MBC were identified among adult women in 2013. The cohort was followed-up for 2 years to describe healthcare utilisation and integrated costs (pharmaceuticals, hospitalisations and outpatient services) for NHS. Prescription patterns were described as first-line choice and therapeutic changes. Specific therapeutic changes were used as proxies of disease progression. A survival analysis was performed to estimate the time from diagnosis to first disease progression.

Results

Of 5174,723 women, 355 cases of de novo HR+/HER2− MBC were selected (incidence: 6.9 per 100,000). During the 1st follow-up year, they generated an average cost of €7543, whereas €4834 in the 2nd year. The 85.9% received a monotherapy, while the 14.1% received a combination therapy. The most used monotherapy was nonsteroidal-aromatase-inhibitors (45.9%), while the most prescribed combination was tamoxifen + luteinizing hormone releasing hormone (LHRH) analogues (6.2%). Therapeutic changes occurred in 45.4% of patients, especially from chemotherapy to nonsteroidal-aromatase-inhibitors, after an average of 276.8 days from the first treatment. Disease progression was identified in 22.5% of patients occurring after a mean 13 ± 6 months from diagnosis.

Conclusions

This detailed picture of HR+/HER2− MBC, based on real-world data, could be helpful in health technology assessment and expenditure forecasts of future therapeutic strategies for this condition in Italy.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1

Similar content being viewed by others

References

  1. International Agency for Research on Cancer (IARC). Cancer fact sheets: Breast, Source: Globocan 2018. https://gco.iarc.fr/today/data/factsheets/cancers/20-Breast-fact-sheet.pdf. Accessed 24 July 2019.

  2. Perou CM, Sorlie T, Eisen MB, van de Rijn M, Jeffrey SS, Rees CA, et al. Molecular portraits of human breast tumours. Nature. 2000;406(6797):747–52.

    Article  CAS  Google Scholar 

  3. van ‘t Veer LJ, Dai H, van de Vijver MJ, He YD, Hart AA, Mao M, et al. Gene expression profiling predicts clinical outcome of breast cancer. Nature. 2002;415(6871):530–6.

    Article  Google Scholar 

  4. van de Vijver MJ, He YD, van ‘t Veer LJ, Dai H, Hart AA, Voskuil DW, et al. A gene-expression signature as a predictor of survival in breast cancer. N Engl J Med. 2002;347(25):1999–2009.

    Article  CAS  Google Scholar 

  5. Rivenbark AG, O’Connor SM, Coleman WB. Molecular and cellular heterogeneity in breast cancer: challenges for personalized medicine. Am J Pathol. 2013;183(4):1113–24.

    Article  CAS  Google Scholar 

  6. Luengo-Fernandez R, Leal J, Gray A, Sullivan R. Economic burden of cancer across the European Union: a population-based cost analysis. Lancet Oncol. 2013;14(12):1165–74.

    Article  Google Scholar 

  7. Parisi M, Pelletier C, Cherepanov D, Broder MS. Outcomes research examining treatments, quality of life and costs in HER2− negative and triple-negative metastatic breast cancer: a systematic literature review. J Comp Eff Res. 2018;7(1):67–83.

    Article  Google Scholar 

  8. Piccinni C, Ronconi G, Calabria S, Dondi L, Forcesi E, Rossi E, et al. Healthcare resources utilisation in primary progressive multiple sclerosis. Neurol Sci. 2018;39(7):1169–74.

    Article  Google Scholar 

  9. Calabria S, Forcesi E, Dondi L, Pedrini A, Maggioni AP, Martini N. Target population of non-deferrable surgery and uncontrolled severe bleeding related to dabigatran. Cardiovasc Drugs Ther. 2018;32(3):281–6.

    Article  CAS  Google Scholar 

  10. Schifano P, Papini P, Agabiti N, Scarinci M, Borgia P, Perucci CA. Indicators of breast cancer severity and appropriateness of surgery based on hospital administrative data in the Lazio Region, Italy. BMC Public Health. 2006;6:25.

    Article  Google Scholar 

  11. Nordstrom BL, Whyte JL, Stolar M, Mercaldi C, Kallich JD. Identification of metastatic cancer in claims data. Pharmacoepidemiol Drug Saf. 2012;21(Suppl 2):21–8.

    Article  Google Scholar 

  12. Kahn LH, Blustein J, Arons RR, Yee R, Shea S. The validity of hospital administrative data in monitoring variations in breast cancer surgery. Am J Public Health. 1996;86(2):243–5.

    Article  CAS  Google Scholar 

  13. Hao Y, Li N, Fang AP, Koo V, Peeples M, Kageleiry A, et al. Real-world analysis of medical costs and healthcare resource utilization in elderly women with HR+/HER2− metastatic breast cancer receiving everolimus-based therapy or chemotherapy. Adv Ther. 2016;33(6):983–97.

    Article  Google Scholar 

  14. Vaz-Luis I, Lin NU, Keating NL, Barry WT, Lii H, Winer EP, et al. Racial differences in outcomes for patients with metastatic breast cancer by disease subtype. Breast Cancer Res Treat. 2015;151(3):697–707.

    Article  Google Scholar 

  15. Jacquet E, Lardy-Cleaud A, Pistilli B, Franck S, Cottu P, Delaloge S, et al. Endocrine therapy or chemotherapy as first-line therapy in hormone receptor-positive HER2− negative metastatic breast cancer patients. Eur J Cancer (Oxford, England: 1990). 2018;95:93–101.

    Article  CAS  Google Scholar 

  16. Ciruelos E, Perez-Garcia JM, Gavila J, Rodriguez A, de la Haba-Rodriguez J. Maintenance therapy in HER2− negative metastatic breast cancer: a new approach for an old concept. Clin Drug Investig. 2019;39(7):595–606.

    Article  Google Scholar 

  17. Crocetti E, Gori S, Falcini F. Metastatic breast cancers: Estimates for Italy. Tumori. 2018;104(2):116–20.

    Article  Google Scholar 

  18. Mariotto AB, Etzioni R, Hurlbert M, Penberthy L, Mayer M. Estimation of the number of women living with metastatic breast cancer in the United States. Cancer Epidemiol Biomark Prev. 2017;26(6):809–15.

    Article  Google Scholar 

  19. Bertaut A, Mounier M, Desmoulins I, Guiu S, Beltjens F, Darut-Jouve A, et al. Stage IV breast cancer: a population-based study about prognostic factors according to HER2 and HR status. Eur J Cancer Care. 2015;24(6):920–8.

    Article  CAS  Google Scholar 

  20. Tao L, Chu L, Wang LI, Moy L, Brammer M, Song C, et al. Occurrence and outcome of de novo metastatic breast cancer by subtype in a large, diverse population. Cancer Causes Control. 2016;27(9):1127–38.

    Article  Google Scholar 

  21. Gobbini E, Ezzalfani M, Dieras V, Bachelot T, Brain E, Debled M, et al. Time trends of overall survival among metastatic breast cancer patients in the real-life ESME cohort. Eur J Cancer (Oxford, England: 1990). 2018;96:17–24.

    Article  Google Scholar 

  22. Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Paluch-Shimon S, et al. Ribociclib as first-line therapy for HR-Positive, advanced breast cancer. N Engl J Med. 2016;375(18):1738–48.

    Article  CAS  Google Scholar 

  23. Cristofanilli M, Turner NC, Bondarenko I, Ro J, Im SA, Masuda N, et al. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2− negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial. Lancet Oncol. 2016;17(4):425–39.

    Article  CAS  Google Scholar 

  24. Capri S, Russo A. Cost of breast cancer based on real-world data: a cancer registry study in Italy. BMC Health Serv Res. 2017;17(1):84.

    Article  Google Scholar 

  25. Pawaskar M, Karve S, Dalvi T, Davis KL, Deeter R, editors. Health care utilization and costs among HER2− negative, HR-positive, elderly women with metastatic breast cancer in the United States. In: 2013 ASCO annual meeting; 2013 31 May–4 June 2013; Chicago, IL, USA.

  26. van Walraven C, Austin P. Administrative database research has unique characteristics that can risk biased results. J Clin Epidemiol. 2012;65(2):126–31.

    Article  Google Scholar 

  27. Gini R, Schuemie MJ, Pasqua A, Carlini E, Profili F, Cricelli I, et al. Monitoring compliance with standards of care for chronic diseases using healthcare administrative databases in Italy: strengths and limitations. PLoS One. 2017;12(12):e0188377.

    Article  CAS  Google Scholar 

  28. Broekx S, Den Hond E, Torfs R, Remacle A, Mertens R, D’Hooghe T, et al. The costs of breast cancer prior to and following diagnosis. Eur J Health Econ. 2011;12(4):311–7.

    Article  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Fondazione ReS (Ricerca e Salute)-Research and Health Foundation, Via Magnanelli 6/3, Casalecchio di Reno, 40033, Bologna, Italy

    Carlo Piccinni, Letizia Dondi, Giulia Ronconi, Silvia Calabria, Antonella Pedrini, Nello Martini & Maurizio Marangolo

  2. Drugs and Health, Rome, Italy

    Immacolata Esposito

Authors
  1. Carlo Piccinni
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Letizia Dondi
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Giulia Ronconi
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Silvia Calabria
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Antonella Pedrini
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Immacolata Esposito
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Nello Martini
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Maurizio Marangolo
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Nello Martini.

Ethics declarations

Funding

No funding was received for the study.

Conflict of interest

CP, LD, GR, SC, AP, IE, NM and MM declare that they have no conflict of interest.

Ethical approval

This is an observational, non-interventional database study, re-utilising administrative data, primary collected for governance purposes. The study was conducted under specific agreements between Fondazione ReS and Italian Regional/Local Health Facilities, participating with anonymous data to the ReS database. All these institutions have general legal and ethical frameworks that allow them for conducting analyses, aimed to address governance and research questions, by making secondary use of anonymous administrative data.

Informed consent

No informed consent is required to use anonymous patient data which is analysed retrospectively.

Additional information

Part of results of this study has been submitted as abstracts to the Italian Society of Pharmacology 39th annual national meeting (20–23 November 2019, Firenze) and to AIOM (Italian Association of Medical Oncology) 21st annual national meeting (25–27 October 2019, Roma).

Electronic supplementary material

Below is the link to the electronic supplementary material.

Supplementary material 1 (PDF 136 kb)

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Piccinni, C., Dondi, L., Ronconi, G. et al. HR+/HER2− Metastatic Breast Cancer: Epidemiology, Prescription Patterns, Healthcare Resource Utilisation and Costs from a Large Italian Real-World Database. Clin Drug Investig 39, 945–951 (2019). https://doi.org/10.1007/s40261-019-00822-4

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40261-019-00822-4

Search

Navigation