Korean Journal of Clinical Pharmacy (한국임상약학회지)

Korean College Of Clinical Pharmacy (한국임상약학회)
권호 표지
DOI QR코드

DOI QR Code

A Comparative Study on the Clinical Efficacy and Safety between Combination Therapy with CDK 4/6 Inhibitor and AI Versus AI Monotherapy in HR+/HER type2- Advanced Breast Cancer: Updated Meta-analysis

메타분석을 이용한 호르몬 수용체 양성/인체 상피세포 성장 인자 수용체 음성 진행성 유방암에서 사이클린 의존성 인산화효소 4/6 억제제와 방향화효소 억제제 병용요법과 방향화효소 억제제 단독요법의 임상적 유효성 및 안전성 비교 연구

  • 김민지 (경성대학교 약학대학) ;
  • 김경 (경성대학교 약학대학) ;
  • 조문경 (경성대학교 약학대학) ;
  • 손기호 (경성대학교 약학대학) ;
  • 백인환 (경성대학교 약학대학)
  • 투고 : 2019.10.22
  • 심사 : 2020.02.17
  • 발행 : 2020.03.31
Download PDF
⟨ Previous Next ⟩

초록

Objective: The aim of the study was to perform a meta-analysis of randomized clinical trials to compare the clinical efficacy and safety between combination of cyclin-dependent kinase (CDK) 4/6 inhibitors with aromatase inhibitors (AIs) and AIs alone in patients with hormone receptor+/human epidermal growth factor receptor type2-(HR+/HER2-) advanced breast cancer. Methods: Published clinical studies were identified through electronic database searches until February 2019. Literature qualities were assessed by the Scottish Intercollegiate Guidelines Network Checklist. Key endpoints of efficacy were progression-free survival (PFS), objective response rate (ORR), and clinical benefit (CB). Endpoints of safety were adverse events (AEs) (neutropenia, leukopenia, any grade 3/4 AEs, and serious AEs) and on-treatment death. Meta-analysis was performed using the RevMan 5.3 software. Results: The selected five studies were evaluated as "good" in quality assessment. Compared to AIs alone, the combination therapy significantly improved PFS (pooled hazard ratio=0.55; 95% confidence interval (CI) 0.49-0.62), ORR (odds ratio=1.78; 95% CI=1.49-2.13), and CB (odds ratio=1.86; 95% CI=1.51-2.28). The prevalence of AEs was significantly higher in the combination group than in the AIs alone group. On-treatment death was greater in the combination group than in the AIs alone group, although insignificant. Conclusion: The combination therapy of CDK4/6 inhibitors with AIs was more effective for the treatment of HR+/HER2- advanced breast cancer, but less safe than AIs alone. The combination therapy should be effectively managed through patient monitoring, and further studies are needed to reduce AEs in the combination therapy of CDK4/6 inhibitors with AIs.

키워드

참고문헌

  1. Ferlay J, Soerjomataram I, Dikshit R, et al. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer 2015;136(5):E359-86. https://doi.org/10.1002/ijc.29210
  2. National Cancer Institute. SEER Cancer Stat Facts :Female Breast Cancer. Available from https://seer.cancer.gov/statfacts/html/breast.html. Accessed May 2, 2019.
  3. Korea Central Cancer Registry, National Cancer Center. Annual report of cancer statistics in Korea in 2015, Ministry of Health and Welfare, 2017. Available from http://ncc.re.kr/cancerStatsList.ncc?searchKey=total&searchValue=&pageNum=1. Accessed May 2, 2019.
  4. Migliaccio I, Malorni L, Hart CD, Guarducci C, Di Leo A. Endocrine therapy considerations in postmenopausal patients with hormone receptor positive, human epidermal growth factor receptor type 2 negative advanced breast cancers. BMC Med 2015;13:46. https://doi.org/10.1186/s12916-015-0280-0
  5. Reinbolt RE, Mangini N, Hill JL, et al. Endocrine therapy in breast cancer: the neoadjuvant, adjuvant, and metastatic approach. Semin Oncol Nurs 2015;31(2):146-55. https://doi.org/10.1016/j.soncn.2015.02.002
  6. Smith IE, Dowsett M. Aromatase inhibitors in breast cancer. N Engl J Med 2003;348(24):2431-42. https://doi.org/10.1056/NEJMra023246
  7. Ramos-Esquivel A, Hernandez-Steller H, Savard MF, Landaverde DU. Cyclin-dependent kinase 4/6 inhibitors as first-line treatment for post-menopausal metastatic hormone receptor-positive breast cancer patients: a systematic review and meta-analysis of phase III randomized clinical trials. Breast Cancer 2018;25(4):479-88. https://doi.org/10.1007/s12282-018-0848-6
  8. Hadji P, Ziller M, Albert US, Kalder M. Assessment of fracture risk in women with breast cancer using current vs emerging guidelines. Br J Cancer 2010;102(4):645-50. https://doi.org/10.1038/sj.bjc.6605548
  9. O'Sullivan CC. Overcoming endocrine resistance in hormonereceptor positive advanced breast cancer-the emerging role of CDK4/6 inhibitors. Int J Cancer Clin Res 2015;2(4):029. https://doi.org/10.23937/2378-3419/2/4/1029
  10. Boyle F, Beith J, Burslem K, et al. Hormone receptor positive, HER2 negative metastatic breast cancer: Impact of CDK4/6 inhibitors on the current treatment paradigm. Asia Pac J Clin Oncol 2018;14(Suppl 4):3.
  11. National Comprehensive Cancer Network. NCCN Clinical practice guidelines in oncology: Breast cancer Version3.2015. Available from http://www.consensocancermamario.com/guias/NCCN_2015.pdf. Accessed July 29, 2019.
  12. National Comprehensive Cancer Network. NCCN Clinical practice guidelines in oncology: Breast Cancer Version3.2019. Available from https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Accessed December 2, 2019.
  13. Finn RS, Crown JP, Ettl J, et al. Efficacy and safety of palbociclib in combination with letrozole as first-line treatment of ER-positive, HER2-negative, advanced breast cancer: expanded analyses of subgroups from the randomized pivotal trial PALOMA-1/TRIO-18. Breast Cancer Res 2016;18(1):67. https://doi.org/10.1186/s13058-016-0721-5
  14. Scottish Intercolle giate Guidelines Network (SIGN). Critical appraisal notes and checklists Methodology checklist2: randomised controlled trial. Available from https://www.sign.ac.uk/checklistsand-notes.html. Accessed August 15, 2018.
  15. Choi YY, Sohn HS, Shin HT. Clinical benefits of self-monitoring of blood glucose in non-insulin treated patients with type 2 diabetes: a systematic review and meta-analysis. Korean J of Clin Pharm 2010;20(3):183-92.
  16. Ministry of Food and Drug Safety. Easy-to-understand cancer glossary. Available from http://www.nifds.go.kr/brd/m_90/view.do?seq=23801&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1. Accessed July 29, 2019.
  17. Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 2009;45(2):228-47. https://doi.org/10.1016/j.ejca.2008.10.026
  18. National Cancer Institute Cancer Therapy Evaluation Program. Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Available from http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm. Accessed August 15, 2018.
  19. Thill M, Schmidt M. Management of adverse events during cyclindependent kinase 4/6 (CDK4/6) inhibitor-based treatment in breast cancer. Ther Adv Med Oncol 2018;10:1-10.
  20. Wallace BC, Schmid CH, Lau J, Trikalinos TA. Meta-Analyst: software for meta-analysis of binary, continuous and diagnostic data. BMC Med Res Methodol 2009;9:80. https://doi.org/10.1186/1471-2288-9-80
  21. 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):1541-7. https://doi.org/10.1093/annonc/mdy155
  22. Tripathy D, Im SA, Colleoni M, 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 2018;19(7):904-15. https://doi.org/10.1016/S1470-2045(18)30292-4
  23. Johnston S, Martin M, Di Leo A, et al. MONARCH 3 final PFS: a randomized study of abemaciclib as initial therapy for advanced breast cancer. NPJ Breast Cancer 2019;5:5. https://doi.org/10.1038/s41523-018-0097-z
  24. Finn RS, Martin M, Rugo HS, et al. Palbociclib and letrozole in advanced breast cancer. N Engl J Med 2016;375(20):1925-36. https://doi.org/10.1056/NEJMoa1607303
  25. Baselga J, Segalla JG, Roche H, et al. Sorafenib in combination with capecitabine: an oral regimen for patients with HER2-negative locally advanced or metastatic breast cancer. J Clin Oncol 2012; 30(13):1484-91. https://doi.org/10.1200/JCO.2011.36.7771
  26. Keller AM, Mennel RG, Georgoulias VA, et al. Randomized phase III trial of pegylated liposomal doxorubicin versus vinorelbine or mitomycin C plus vinblastine in women with taxane-refractory advanced breast cancer. J Clin Oncol 2004;22(19):3893-901. https://doi.org/10.1200/JCO.2004.08.157
  27. Yardley DA, Hart L, Favret A, et al. Efficacy and safety of ribociclib with letrozole in US patients enrolled in the MONALEESA-2 study. Clin Breast Cancer 2019;19(4):268-77. https://doi.org/10.1016/j.clbc.2019.02.007
  28. Mukai H, Shimizu C, Masuda N, et al. Palbociclib in combination with letrozole in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: PALOMA-2 subgroup analysis of Japanese patients. Int J Clin Oncol 2019;24(3):274-87. https://doi.org/10.1007/s10147-018-1353-9
  29. Masuda N, Nishimura R, Takahashi M, et al. Palbociclib in combination with letrozole as first-line treatment for advanced breast cancer: A Japanese phase II study. Cancer Sci 2018; 109(3):803-13. https://doi.org/10.1111/cas.13507