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Review

Real-world effectiveness of palbociclib in HR+/HER2- metastatic breast cancer: a literature review

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Article: 2340329 | Received 25 Apr 2023, Accepted 01 Dec 2023, Published online: 31 Jan 2024

References

  • Sung H, Ferlay J, Siegel RL et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J. Clin. 71(3), 209–249 (2021).
  • National Cancer Institute. Cancer stat facts: female breast cancer subtypes. https://seer.cancer.gov/statfacts/html/breast-subtypes.html
  • National Cancer Institute. Institute. Cancer stat facts: female breast cancer. https://seer.cancer.gov/statfacts/html/breast.html
  • Ballinger TJ, Meier JB, Jansen VM. Current landscape of targeted therapies for hormone-receptor positive, HER2 negative metastatic breast cancer. Front. Oncol. 8, 308 (2018).
  • Finn RS, Aleshin A, Slamon DJ. Targeting the cyclin-dependent kinases (CDK) 4/6 in estrogen receptor-positive breast cancers. Breast Cancer Res. 18(1), 17 (2016).
  • Gennari A, Andre F, Barrios CH et al. ESMO Clinical Practice Guideline for the diagnosis, staging and treatment of patients with metastatic breast cancer. Ann. Oncol. 32(12), 1475–1495 (2021).
  • 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. 16(1), 25–35 (2015).
  • Finn RS, Martin M, Rugo HS et al. palbociclib and letrozole in advanced breast cancer. N. Engl. J. Med. 375(20), 1925–1936 (2016).
  • Cristofanilli M, Turner NC, Bondarenko I 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. 17(4), 425–439 (2016).
  • U.S. FDA. palbociclib (IBRANCE). https://www.fda.gov/drugs/resources-information-approved-drugs/palbociclib-ibrance
  • 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. 174(3), 719–729 (2019).
  • Cristofanilli M, Rugo HS, Im SA et al. Overall Survival with palbociclib and Fulvestrant in Women with HR+/HER2- ABC: Updated Exploratory Analyses of PALOMA-3, a Double-blind, Phase III Randomized Study. Clin. Cancer Res. 28(16), 3433–3442 (2022).
  • 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. 183(2), 419–428 (2020).
  • 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(Suppl. 17), LBA1003–LBA1003 (2022).
  • Turner NC, Slamon DJ, Ro J et al. Overall survival with palbociclib and fulvestrant in advanced breast cancer. N. Engl. J. Med. 379(20), 1926–1936 (2018).
  • Chen D. Real-world studies: bridging the gap between trial-assessed efficacy and routine care. J. Biomed. Res. 36(3), 147–154 (2022).
  • Chodankar D. Introduction to real-world evidence studies. Perspect. Clin. Res. 12(3), 171–174 (2021).
  • Gyawali B, Parsad S, Feinberg BA, Nabhan C. Real-world evidence and randomized studies in the precision oncology era: the right balance. JCO Precis Oncol. 1, 1–5 (2017).
  • Harbeck N, Bartlett M, Spurden D et al. CDK4/6 inhibitors in HR+/HER2- advanced/metastatic breast cancer: a systematic literature review of real-world evidence studies. Future Oncol. 17(16), 2107–2122 (2021).
  • Rugo HS, Brufsky A, Liu X et al. Real-world study of overall survival with palbociclib plus aromatase inhibitor in HR+/HER2- metastatic breast cancer. NPJ Breast Cancer 8(1), 114 (2022).
  • Demichele A, Cristofanilli M, Brufsky A et al. Comparative effectiveness of first-line palbociclib plus letrozole versus letrozole alone for HR+/HER2- metastatic breast cancer in US real-world clinical practice. Breast Cancer Res. 23(1), 37 (2021).
  • Brufsky A, Liu X, Li B, Mcroy L, Layman RM. Real-world effectiveness of palbociclib plus letrozole vs letrozole alone for metastatic breast cancer with lung or liver metastases: flatiron database analysis. Front. Oncol. 12, 865292 (2022).
  • Ha MJ, Singareeka Raghavendra A, Kettner NM et al. Palbociclib plus endocrine therapy significantly enhances overall survival of HR+/HER2- metastatic breast cancer patients compared to endocrine therapy alone in the second-line setting: a large institutional study. Int. J. Cancer 150(12), 2025–2037 (2022).
  • Porte B, Carton M, Lerebours F et al. Real life efficacy of palbociclib and endocrine therapy in HR positive, HER2 negative advanced breast cancer. Breast 54, 303–310 (2020).
  • Law JW, Mitra D, Kaplan HG et al. Real-world treatment patterns and clinical effectiveness of palbociclib plus an aromatase inhibitor as first-line therapy in advanced/metastatic breast cancer: analysis from the US syapse Learning health network. Curr. Oncol. 29(2), 1047–1061 (2022).
  • Ali MS, Prieto-Alhambra D, Lopes LC et al. Propensity Score methods in health technology assessment: principles, extended applications, and recent advances. Front. Pharmacol. 10, 973 (2019).
  • Neven P, Fasching PA, Chia S et al. Updated overall survival from the MONALEESA-3 trial in postmenopausal women with HR+/HER2- advanced breast cancer receiving first-line ribociclib plus fulvestrant. Breast Cancer Res. 25(1), 103 (2023).
  • Goetz MP. MONARCH 3: interim overall survival results of abemaciclib plus a nonsteroidal aromatase inhibitor in patients with HR+, HER2- advanced breast cancer. Presented at: ESMO Congress. Paris, France (9-13 september 2022).
  • Grinshpun A, Tolaney SM, Burstein HJ, Jeselsohn R, Mayer EL. The dilemma of selecting a first line CDK4/6 inhibitor for hormone receptor-positive/HER2-negative metastatic breast cancer. NPJ Breast Cancer 9(1), 15 (2023).
  • Medicinrådet. Behandlingsvejledning vedrørende CDK4/6-hæmmere til ER+/HER2- lokalt fremskreden eller metastatisk brystkræft (2023). https://medicinraadet.dk/anbefalinger-og-vejledninger/behandlingsvejledninger-og-laegemiddelrekommandationer/brystkraeft
  • Onesti CE, Jerusalem G. CDK4/6 inhibitors in breast cancer: differences in toxicity profiles and impact on agent choice. A systematic review and meta-analysis. Expert Rev. Anticancer Ther. 21(3), 283–298 (2021).
  • Cejuela M, Gil-Torralvo A, Castilla M et al. abemaciclib, palbociclib, and ribociclib in Real-World Data: A Direct Comparison of First-Line Treatment for Endocrine-Receptor-Positive Metastatic Breast Cancer. Int. J. Mol. Sci. 24(10), (2023).