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Erschienen in: Clinical Drug Investigation 10/2019

01.10.2019 | Original Research Article

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

verfasst von: Carlo Piccinni, Letizia Dondi, Giulia Ronconi, Silvia Calabria, Antonella Pedrini, Immacolata Esposito, Nello Martini, Maurizio Marangolo

Erschienen in: Clinical Drug Investigation | Ausgabe 10/2019

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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.
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Literatur
2.
Zurück zum Zitat 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.CrossRef 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.CrossRef
3.
Zurück zum Zitat 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.CrossRef 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.CrossRef
4.
Zurück zum Zitat 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.CrossRef 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.CrossRef
5.
Zurück zum Zitat 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.CrossRef 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.CrossRef
6.
Zurück zum Zitat 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.CrossRef 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.CrossRef
7.
Zurück zum Zitat 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.CrossRef 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.CrossRef
8.
Zurück zum Zitat 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.CrossRef 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.CrossRef
9.
Zurück zum Zitat 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.CrossRef 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.CrossRef
10.
Zurück zum Zitat 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.CrossRef 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.CrossRef
11.
Zurück zum Zitat 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.CrossRef 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.CrossRef
12.
Zurück zum Zitat 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.CrossRef 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.CrossRef
13.
Zurück zum Zitat 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.CrossRef 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.CrossRef
14.
Zurück zum Zitat 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.CrossRef 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.CrossRef
15.
Zurück zum Zitat 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.CrossRef 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.CrossRef
16.
Zurück zum Zitat 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.CrossRef 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.CrossRef
17.
Zurück zum Zitat Crocetti E, Gori S, Falcini F. Metastatic breast cancers: Estimates for Italy. Tumori. 2018;104(2):116–20.CrossRef Crocetti E, Gori S, Falcini F. Metastatic breast cancers: Estimates for Italy. Tumori. 2018;104(2):116–20.CrossRef
18.
Zurück zum Zitat 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.CrossRef 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.CrossRef
19.
Zurück zum Zitat 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.CrossRef 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.CrossRef
20.
Zurück zum Zitat 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.CrossRef 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.CrossRef
21.
Zurück zum Zitat 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.CrossRef 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.CrossRef
22.
Zurück zum Zitat 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.CrossRef 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.CrossRef
23.
Zurück zum Zitat 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.CrossRef 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.CrossRef
24.
Zurück zum Zitat 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.CrossRef 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.CrossRef
25.
Zurück zum Zitat 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. 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.
Zurück zum Zitat van Walraven C, Austin P. Administrative database research has unique characteristics that can risk biased results. J Clin Epidemiol. 2012;65(2):126–31.CrossRef van Walraven C, Austin P. Administrative database research has unique characteristics that can risk biased results. J Clin Epidemiol. 2012;65(2):126–31.CrossRef
27.
Zurück zum Zitat 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.CrossRef 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.CrossRef
28.
Zurück zum Zitat 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.CrossRef 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.CrossRef
Metadaten
Titel
HR+/HER2− Metastatic Breast Cancer: Epidemiology, Prescription Patterns, Healthcare Resource Utilisation and Costs from a Large Italian Real-World Database
verfasst von
Carlo Piccinni
Letizia Dondi
Giulia Ronconi
Silvia Calabria
Antonella Pedrini
Immacolata Esposito
Nello Martini
Maurizio Marangolo
Publikationsdatum
01.10.2019
Verlag
Springer International Publishing
Erschienen in
Clinical Drug Investigation / Ausgabe 10/2019
Print ISSN: 1173-2563
Elektronische ISSN: 1179-1918
DOI
https://doi.org/10.1007/s40261-019-00822-4

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