References
- World Health Organization. Breast cancer. 2021. https://www.who.int/news-room/fact-sheets/detail/breast-cancer
- Cancer Research UK. Breast cancer incidence (invasive) statistics. 2021. https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/breast-cancer/incidence-invasive
- O'Shaughnessy J. Extending survival with chemotherapy in metastatic breast cancer. Oncologist. 2005;10(S3):20–29.
- Metastatic Breast Cancer Network. Incidence and incidence rates. 2022. http://mbcn.org/incidence-and-incidence-rates/
- DeKoven M, Bonthapally V, Jiao X, et al. Treatment pattern by hormone receptors and HER2 status in patients with metastatic breast cancer in the UK, Germany, France, Spain and Italy (EU-5): results from a physician survey. J Comp Eff Res. 2012;1(5):453–463.
- Howlader N, Altekruse SF, Li CI, et al. US incidence of breast cancer subtypes defined by joint hormone receptor and HER2 status. J Natl Cancer Inst. 2014;106(5):dju055.
- NCI. Surveillance, epidemiology, and end results program. cancer stat facts: female breast cancer subtypes. 2023. https://seer.cancer.gov/statfacts/html/breast-subtypes.html
- Elfgen C, Bjelic-Radisic V. Targeted therapy in HR + HER2- Metastatic breast cancer: current clinical trials and their implications for CDK4/6 inhibitor therapy and beyond treatment options. Cancers. 2021;13(23):5994.
- Spring LM, Wander SA, Zangardi M, et al. CDK 4/6 inhibitors in breast cancer: current controversies and future directions. Curr Oncol Rep. 2019;21(3):25.
- Finn RS, Boer K, Bondarenko I, et al. Overall survival results from the randomized phase 2 study of palbociclib in combination with letrozole versus letrozole alone for first-line treatment of ER+/HER2- advanced breast cancer (PALOMA-1, TRIO-18). Breast Cancer Res Treat. 2020;183(2):419–428.
- Finn RS, Crown JP, Lang I, et al. The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 study. Lancet Oncol. 2015;16(1):25–35.
- Finn RS, Martin M, Rugo HS, et al. Palbociclib and letrozole in advanced breast cancer. N Engl J Med. 2016;375(20):1925–1936.
- Hortobagyi GN, Stemmer S, Burris HA, et al. LBA17 overall survival (OS) results from the phase III MONALEESA-2 (ML-2) trial of postmenopausal patients (pts) with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2−) advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib (RIB). Ann Oncol. 2021;32: s1290–S1291.
- Hortobagyi GN, Stemmer SM, Burris HA, et al. Ribociclib as First-Line therapy for HR-Positive, advanced breast cancer. N Engl J Med. 2016;375(18):1738–1748.
- Xu B, Hu X, Li W, et al. 228MO PALOMA-4: primary results from a phase III trial of palbociclib (PAL) + letrozole (LET) vs placebo (PBO) + LET in asian postmenopausal women with estrogen receptor-positive/human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced breast cancer (ABC). Ann Oncol. 2021;32:s457.
- European Medicines Agency (EMA). Kisqali: summary of Product Characteristics. 2022. https://www.ema.europa.eu/en/documents/product-information/kisqali-epar-product-information_en.pdf
- European Medicines Agency (EMA). Ibrance: summary of Product Characteristics. 2022. https://www.ema.europa.eu/en/documents/product-information/ibrance-epar-product-information_en.pdf
- Slamon DJ, Neven P, Chia S, et al. Overall survival with ribociclib plus fulvestrant in advanced breast cancer. N Engl J Med. 2020;382(6):514–524.
- Turner NC, Slamon DJ, Ro J, et al. Overall survival with palbociclib and fulvestrant in advanced breast cancer. N Engl J Med. 2018;379(20):1926–1936.
- Suri G, Chandiwana D, Lee A, et al. Cost-effectiveness analysis of ribociclib plus letrozole versus palbociclib plus letrozole in the United Kingdom. J Health Econ Outcomes Res. 2019;6(2):20–31.
- European Medicines Agency (EMA). Verzenios: summary of Product Characteristics. 2022. https://www.ema.europa.eu/en/documents/product-information/verzenios-epar-product-information_en.pdf
- Cameron D, Sharma V, Biswas C, et al. EE361 Cost-Effectiveness analysis of ribociclib Versus abemaciclib in the First-Line (1L) treatment of postmenopausal women With HR+/HER2- Advanced breast cancer (ABC). Value in Health. 2022;25(12S): s126.
- Study of Efficacy and Safety of LEE011 in postmenopausal women with advanced breast cancer (MONALEESA-2). 2022. https://clinicaltrials.gov/ct2/show/NCT01958021.
- Hortobagyi GN, Stemmer SM, Burris HA, et al. Overall survival with ribociclib plus letrozole in advanced breast cancer. N Engl J Med. 2022;386(10):942–950.
- Hortobagyi GN, Stemmer SM, Burris HA, et al. Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer. Ann Oncol. 2018;29(7):1541–1547.
- Study of letrozole with or without palbociclib (PD-0332991) for the first-line treatment of hormone-receptor positive advanced breast cancer. 2022. https://clinicaltrials.gov/ct2/show/NCT00721409
- A study of palbociclib (PD-0332991) + Letrozole vs. Letrozole for 1st line treatment of postmenopausal women with ER+/HER2- advanced breast cancer (PALOMA-2). 2022. https://clinicaltrials.gov/ct2/show/NCT01740427
- A Study Of Palbociclib (PD-0332991) + Letrozole VS. Placebo + Letrozole for 1st line treatment of asian postmenopausal women with ER+/HER2- advanced breast cancer [PALOMA-4]. 2022. https://clinicaltrials.gov/ct2/show/NCT02297438
- Finn RS, Rugo HS, Dieras VC, et al. Overall survival (OS) with first-line palbociclib plus letrozole (PAL + LET) versus placebo plus letrozole (PBO + LET) in women with estrogen receptor–positive/human epidermal growth factor receptor 2–negative advanced breast cancer (ER+/HER2− ABC): analyses from PALOMA-2. J Clin Oncol. 40(17_suppl):LBA1003–LBA1003.
- Jhaveri K, O'Shaughnessy J, Fasching PA, et al. Matching adjusted indirect comparison of PFS & OS comparing ribociclib + letrozole vs palbociclib + letrozole as first-line treatment of HR+/HER2− ABC: analysis based on updated PFS & final OS results of MONALEESA-2 & PALOMA-2. Eur J Cancer. 2022;175:S2–S3.
- Latimer NR. Survival analysis For economic evaluations alongside clinical Trials - Extrapolation with Patient-Level data. NICE DSU technical support document 14. London: national Institute for Health and Care Excellence (NICE); 2013. https://www.ncbi.nlm.nih.gov/books/NBK395885/
- Rugo HS, Finn RS, Diéras V, et al. Palbociclib plus letrozole as first-line therapy in estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer with extended follow-up. Breast Cancer Res Treat. 2019;174(3):719–729.
- Devlin NJ, Shah KK, Feng Y, et al. Valuing health-related quality of life: an EQ-5D-5L value set for England. Health Econ. 2018;27(1):7–22.
- Hudgens S, Briggs A, Tremblay G, et al. Comparison of methods to estimate health state utilities in metastatic breast cancer (MBC). Value Health. 2014;17(7):A557.
- Lloyd A, Nafees B, Narewska J, et al. Health state utilities for metastatic breast cancer. Br J Cancer. 2006;95(6):683–690.
- National Institute for Health and Care Excellence. British National Formulary (BNF). 2022. https://bnf.nice.org.uk/
- National Health Service. 2019-20 reference costs. 2022. https://digital.nhs.uk/data-and-information/data-collections-and-data-sets/data-collections/reference-costs
- Brufsky AM. Delaying chemotherapy in the treatment of hormone Receptor-Positive, human epidermal growth factor receptor 2-Negative advanced breast cancer. Clin Med Insights Oncol. 2015;9:137–147.
- Das R, Cope S, Ouwens M, et al. Economic evaluation of fulvestrant 500 mg versus generic nonsteroidal aromatase inhibitors in patients with advanced breast cancer in the United Kingdom. Clin Ther. 2013;35(3):246–260.e5.
- Lin PL, Hao Y, Xie J, et al. Physician experiences and preferences in the treatment of HR+/HER2- metastatic breast cancer in the United States: a physician survey. Cancer Med. 2016;5(2):209–220.
- Macalalad AR, Hao Y, Lin PL, et al. Treatment patterns and duration in post-menopausal women with HR+/HER2- metastatic breast cancer in the US: a retrospective chart review in community oncology practices (2004-2010). Curr Med Res Opin. 2015;31(2):263–273.
- Saad ED, Katz A, Buyse M. Overall survival and post-progression survival in advanced breast cancer: a review of recent randomized clinical trials. J Clin Oncol. 2010;28(11):1958–1962.
- Round J, Jones L, Morris S. Estimating the cost of caring for people with cancer at the end of life: a modelling study. Palliat Med. 2015;29(10):899–907.
- Signorovitch JE, Sikirica V, Erder MH, et al. Matching-adjusted indirect comparisons: a new tool for timely comparative effectiveness research. Value Health. 2012;15(6):940–947.
- National Institute for Health and Care Excellence. Abemaciclib with an aromatase inhibitor for previously untreated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer [TA563]. 2019. https://www.nice.org.uk/guidance/ta563