Thursday, November 28, 2024
No menu items!
HomeNatureEarly versus deferred use of CDK4/6 inhibitors in advanced breast cancer

Early versus deferred use of CDK4/6 inhibitors in advanced breast cancer

  • Finn, R. S. et al. Palbociclib and letrozole in advanced breast cancer. N. Engl. J. Med. 375, 1925–1936 (2016).

    Article 
    CAS 
    PubMed 

    Google Scholar
     

  • Hortobagyi, G. N. 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. 29, 1541–1547 (2018).

    Article 
    CAS 
    PubMed 

    Google Scholar
     

  • Johnston, S. et al. MONARCH 3 final PFS: a randomized study of abemaciclib as initial therapy for advanced breast cancer. NPJ Breast Cancer 5, 5 (2019).

    Article 
    PubMed 
    PubMed Central 

    Google Scholar
     

  • Tripathy, D. et al. Ribociclib plus endocrine therapy for premenopausal women with hormone-receptor-positive, advanced breast cancer (MONALEESA-7): a randomised phase 3 trial. Lancet Oncol. 19, 904–915 (2018).

    Article 
    CAS 
    PubMed 

    Google Scholar
     

  • Cristofanilli, M. 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, 425–439 (2016).

    Article 
    CAS 
    PubMed 

    Google Scholar
     

  • Slamon, D. J. et al. Phase III randomized study of ribociclib and fulvestrant in hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: MONALEESA-3. J. Clin. Oncol. 36, 2465–2472 (2018).

    Article 
    CAS 
    PubMed 

    Google Scholar
     

  • Sledge, G. W. et al. MONARCH 2: abemaciclib in combination with fulvestrant in women with HR+/HER2− advanced breast cancer who had progressed while receiving endocrine therapy. J. Clin. Oncol. 35, 2875–2884 (2017).

    Article 
    CAS 
    PubMed 

    Google Scholar
     

  • van Ommen-Nijhof, A. et al. Selecting the optimal position of CDK4/6 inhibitors in hormone receptor-positive advanced breast cancer—the SONIA study: study protocol for a randomized controlled trial. BMC Cancer 18, 1146 (2018).

    Article 
    PubMed 
    PubMed Central 

    Google Scholar
     

  • Sledge, G. W. et al. The effect of abemaciclib plus fulvestrant on overall survival in hormone receptor-positive, ERBB2-negative breast cancer that progressed on endocrine therapy-MONARCH 2: a randomized clinical trial. JAMA Oncol. 6, 116–124 (2020).

    Article 
    PubMed 

    Google Scholar
     

  • Hortobagyi, G. N. et al. Overall survival with ribociclib plus letrozole in advanced breast cancer. N. Engl. J. Med. 386, 942–950 (2022).

    Article 
    CAS 
    PubMed 

    Google Scholar
     

  • Slamon, D. J. et al. Overall survival with ribociclib plus fulvestrant in advanced breast cancer. N. Engl. J. Med. 382, 514–524 (2020).

    Article 
    CAS 
    PubMed 

    Google Scholar
     

  • Lu, Y. S. et al. Updated overall survival of ribociclib plus endocrine therapy versus endocrine therapy alone in pre- and perimenopausal patients with HR+/HER2− advanced breast cancer in MONALEESA-7: a phase III randomized clinical trial. Clin. Cancer Res. 28, 851–859 (2022).

    Article 
    ADS 
    CAS 
    PubMed 

    Google Scholar
     

  • Gradishar, W. J. et al. NCCN Guidelines Insights: Breast cancer, Version 4.2023. J. Natl Compr. Cancer Netw.21, 594–608 (2023).

  • Kümler, I., Knoop, A. S., Jessing, C. A., Ejlertsen, B. & Nielsen, D. L. Review of hormone-based treatments in postmenopausal patients with advanced breast cancer focusing on aromatase inhibitors and fulvestrant. ESMO Open 1, e000062 (2016).

    Article 
    PubMed 
    PubMed Central 

    Google Scholar
     

  • Yang, C. et al. Acquired CDK6 amplification promotes breast cancer resistance to CDK4/6 inhibitors and loss of ER signaling and dependence. Oncogene 36, 2255–2264 (2017).

    Article 
    CAS 
    PubMed 

    Google Scholar
     

  • Park, Y. H. et al. Longitudinal multi-omics study of palbociclib resistance in HR-positive/HER2-negative metastatic breast cancer. Genome Med. 15, 55 (2023).

    Article 
    CAS 
    PubMed 
    PubMed Central 

    Google Scholar
     

  • Gyawali, B. et al. Problematic crossovers in cancer drug trials. Nat. Rev. Clin. Oncol. 20, 815–816 (2023).

    Article 
    PubMed 

    Google Scholar
     

  • Spring, L. M. et al. Cyclin-dependent kinase 4 and 6 inhibitors for hormone receptor-positive breast cancer: past, present, and future. Lancet 395, 817–827 (2020). A.

    Article 
    CAS 
    PubMed 

    Google Scholar
     

  • Cherny, N. I. et al. A standardised, generic, validated approach to stratify the magnitude of clinical benefit that can be anticipated from anti-cancer therapies: the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS). Ann. Oncol. 26, 1547–1573 (2015).

    Article 
    CAS 
    PubMed 

    Google Scholar
     

  • G-standaard, Tarieven Januari (Z-index, 2023).

  • G-standaard, Tarieven Januari (Z-index, 2019).

  • Centers for Medicare & Medicaid Services. Medicare Part D Spending by Drug (Centers for Medicare & Medicaid Services, accessed 8 May 2024); data.cms.gov/summary-statistics-on-use-and-payments/medicare-medicaid-spending-by-drug/medicaid-spending-by-drug.

  • Johnston, S. et al. Abemaciclib as initial therapy for advanced breast cancer: MONARCH 3 updated results in prognostic subgroups. NPJ Breast Cancer 7, 80 (2021).

    Article 
    CAS 
    PubMed 
    PubMed Central 

    Google Scholar
     

  • Rugo, H. S. 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, 719–729 (2019).

    Article 
    CAS 
    PubMed 
    PubMed Central 

    Google Scholar
     

  • Di Lauro, V. et al. Health-related quality of life in breast cancer patients treated with CDK4/6 inhibitors: a systematic review. ESMO Open 7, 100629 (2022).

    Article 
    PubMed 
    PubMed Central 

    Google Scholar
     

  • Turner, N. C. et al. Overall survival with palbociclib and fulvestrant in advanced breast cancer. N. Engl. J. Med. 379, 1926–1936 (2018).

    Article 
    CAS 
    PubMed 

    Google Scholar
     

  • Finn, S. R. 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, LBA1003 (2022).

    Article 

    Google Scholar
     

  • André, F. et al. Alpelisib for PIK3CA-mutated, hormone receptor-positive advanced breast cancer. N. Engl. J. Med. 380, 1929–1940 (2019).

    Article 
    PubMed 

    Google Scholar
     

  • Turner, N. C. et al. Capivasertib in hormone receptor-positive advanced breast cancer. N. Engl. J. Med. 388, 2058–2070 (2023).

    Article 
    CAS 
    PubMed 
    PubMed Central 

    Google Scholar
     

  • Bidard, F. C. et al. Elacestrant (oral selective estrogen receptor degrader) versus standard endocrine therapy for estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: results from the randomized phase III EMERALD trial. J. Clin. Oncol. 40, 3246–3256 (2022).

    Article 
    CAS 
    PubMed 
    PubMed Central 

    Google Scholar
     

  • Garcia-Fructuoso, I., Gomez-Bravo, R. & Schettini, F. Integrating new oral selective oestrogen receptor degraders in the breast cancer treatment. Curr. Opin. Oncol. 34, 635–642 (2022).

    Article 
    CAS 
    PubMed 

    Google Scholar
     

  • Woodford, R. et al. Validity and efficiency of progression-free survival-2 as a surrogate end point for overall survival in advanced cancer randomized trials. JCO Precis. Oncol. 8, e2300296 (2024).

    Article 
    PubMed 

    Google Scholar
     

  • European Medicines Agency. Appendix 1 to the Guideline on the Evaluation of Anticancer Medicinal Products in Man (EMA, 2012).

  • Fojo, T. & Simon, R. M. Inappropriate censoring in Kaplan-Meier analyses. Lancet Oncol. 22, 1358–1360 (2021).

    Article 
    PubMed 

    Google Scholar
     

  • Gyawali, B. et al. Biases in study design, implementation, and data analysis that distort the appraisal of clinical benefit and ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCBS) scoring. ESMO Open 6, 100117 (2021).

    Article 
    CAS 
    PubMed 
    PubMed Central 

    Google Scholar
     

  • Committee for Medicinal Products for Human Use. Guideline on the Choice of the Non-Inferiority Margin (EMA, 2005).

  • Tannock, I. F. et al. The tyranny of non-inferiority trials. Lancet Oncol. 25, e520–e525 (2024).

  • Committee for Medicinal Products for Human Use. Concept Paper for the Development of a Guideline on Non-Inferiority and Equivalence Comparisons in Clinical Trials (EMA, 2024).

  • André, F. et al. Alpelisib plus fulvestrant for PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor-2-negative advanced breast cancer: final overall survival results from SOLAR-1. Ann. Oncol. 32, 208–217 (2021).

    Article 
    PubMed 

    Google Scholar
     

  • Robson, M. E. et al. OlympiAD final overall survival and tolerability results: Olaparib versus chemotherapy treatment of physician’s choice in patients with a germline BRCA mutation and HER2-negative metastatic breast cancer. Ann. Oncol. 30, 558–566 (2019).

    Article 
    CAS 
    PubMed 
    PubMed Central 

    Google Scholar
     

  • Casparie, M. et al. Pathology databanking and biobanking in The Netherlands, a central role for PALGA, the nationwide histopathology and cytopathology data network and archive. Cell Oncol. 29, 19–24 (2007).

    CAS 
    PubMed 
    PubMed Central 

    Google Scholar
     

  • Eisenhauer, E. A. et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur. J. Cancer 45, 228–247 (2009).

    Article 
    CAS 
    PubMed 

    Google Scholar
     

  • Cancer Therapy Evaluation Program. Common Terminology Criteria for Adverse Events (CTCAE) v.4.0 (National Cancer Institute, 2010).

  • Brady, M. J. et al. Reliability and validity of the functional assessment of cancer therapy-breast quality-of-life instrument. J. Clin. Oncol. 15, 974–986 (1997).

    Article 
    CAS 
    PubMed 

    Google Scholar
     

  • Eton, D. T. et al. A combination of distribution- and anchor-based approaches determined minimally important differences (MIDs) for four endpoints in a breast cancer scale. J. Clin. Epidemiol. 57, 898–910 (2004).

    Article 
    PubMed 

    Google Scholar
     

  • RELATED ARTICLES

    Most Popular

    Recent Comments