Incidence and risk of severe adverse events associated with trastuzumab emtansine (T-DM1) in the treatment of breast cancer: an up-to-date systematic review and meta-analysis of randomized controlled clinical trials

References

• Slamon DJ, Clark GM, Wong SG, et al. Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene. Science. 1987;235(4785):177–182.
   Google Scholar
• Dawood S, Broglio K, Buzdar AU, et al. Prognosis of women with metastatic breast cancer by HER2 status and trastuzumab treatment: an institutional-based review. J Clin Oncol. 2010;28(1):92–98.
   Google Scholar
• Lewis Phillips GD, Li G, Dugger DL, et al. Targeting HER2-positive breast cancer with trastuzumab-DM1, an antibody-cytotoxic drug conjugate. Cancer Res. 2008;68(22):9280–9290.
   Google Scholar
• Verma S, Miles D, Gianni L, et al. Trastuzumab emtansine for HER2-positive advanced breast cancer [published correction appears in N Engl J Med 2013 Jun 20;368(25):2442]. N Engl J Med. 2012;367(19):1783–1791.
   Google Scholar
• Diéras V, Miles D, Verma S, et al. Trastuzumab emtansine versus capecitabine plus lapatinib in patients with previously treated HER2-positive advanced breast cancer (EMILIA): a descriptive analysis of final overall survival results from a randomised, open-label, phase 3 trial [published correction appears in Lancet Oncol. 2017 Aug;18(8):e433] [published correction appears in Lancet Oncol. 2018 Dec;19(12):e667]. Lancet Oncol. 2017;18(6):732–742.
   Google Scholar
• Food and Drug Administration (2013) Kadcyla. cited 2019 Aug 06. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125427s105lbl.pdf
   Google Scholar
• Food and Drug Administration (2019) FDA approves Ado-trastuzumab emtansine for early breast cancer. cited 2019 Jun 24. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-adotrastuzumab-emtansine-early-breast-cancer
   Google Scholar
• Diéras V, Harbeck N, Budd GT, et al., Trastuzumab emtansine in human epidermal growth factor receptor 2-positive metastatic breast cancer: an integrated safety analysis. J Clin Oncol. 2014;32(25): 2750–2757.
   Google Scholar
• Yan H, Yu K, Zhang K, et al. Efficacy and safety of trastuzumab emtansine (T-DM1) in the treatment of HER2-positive metastatic breast cancer (MBC): a meta-analysis of randomized controlled trial. Oncotarget. 2017;8(60):102458–102467.
   Google Scholar
• Choueiri TK, Schutz FA, Je Y, et al. Risk of arterial thromboembolic events with sunitinib and sorafenib: a systematic review and meta-analysis of clinical trials. J Clin Oncol. 2010;28(13):2280–2285.
   Google Scholar
• Hurvitz SA, Dirix L, Kocsis J, et al. Phase II randomized study of trastuzumab emtansine versus trastuzumab plus docetaxel in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer. J Clin Oncol. 2013 Mar 20;31(9):1157–1163.
   Google Scholar
• Perez EA, Barrios C, Eiermann W, et al. Trastuzumab emtansine with or without pertuzumab versus trastuzumab plus taxane for human epidermal growth factor receptor 2-Positive, advanced breast cancer: primary results from the phase III MARIANNE study. J Clin Oncol. 2017 Jan 10;35(2):141–148.
   Google Scholar
• Krop IE, Kim SB, Martin AG, et al. Trastuzumab emtansine versus treatment of physician’s choice in patients with previously treated HER2-positive metastatic breast cancer (TH3RESA): final overall survival results from a randomised open-label phase 3 trial. Lancet Oncol. 2017 Jun;18(6):743–754.
   Google Scholar
• von Minckwitz G, Huang CS, Mano MS, et al., Trastuzumab emtansine for residual invasive HER2-positive breast cancer. N Engl J Med. 2019;380(7): 617–628.
   Google Scholar
• Hurvitz SA, Martin M, Jung KH, et al. Neoadjuvant trastuzumab emtansine and pertuzumab in human epidermal growth factor receptor 2-positive breast cancer: three-year outcomes from the phase III KRISTINE study. J Clin Oncol. 2019;37(25):2206–2216.
   Google Scholar
• Harbeck N, Gluz O, Christgen M, et al. De-Escalation strategies in human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (BC): final analysis of the West German study group adjuvant dynamic marker-adjusted personalized therapy trial optimizing risk assessment and Therapy Response Prediction in Early BC HER2- and hormone receptor-positive phase II randomized trial-efficacy, safety, and predictive markers for 12 weeks of neoadjuvant trastuzumab emtansine with or without endocrine therapy (ET) versus trastuzumab plus ET. J Clin Oncol. 2017 Sep 10;35(26):3046–3054.
   Google Scholar
• Thon JN, Devine MT, Jurak Begonja A, et al. High-content live-cell imaging assay used to establish mechanism of trastuzumab emtansine (T-DM1)–mediated inhibition of platelet production. Blood. 2012;120(10):1975–1984.
   Google Scholar
• Uppal H, Doudement E, Mahapatra K, et al., Potential mechanisms for thrombocytopenia development with trastuzumab emtansine (T-DM1). Clin Cancer Res. 2015;21(1): 123–133.
   Google Scholar
• Krop IE, Lin NU, Blackwell K, et al. Trastuzumab emtansine (T-DM1) versus lapatinib plus capecitabine in patients with HER2-positive metastatic breast cancer and central nervous system metastases: a retrospective, exploratory analysis in EMILIA. Ann Oncol. 2015;26(1):113–119.
   Google Scholar
• Cobert AM, Helms C, Larck C, et al. Risk of hepatotoxicity with trastuzumab emtansine in breast cancer patients: a systematic review and meta-analysis. Ther Adv Drug Saf. 2020;11:2042098620915058.
   Google Scholar
• Kadcyla (ado-trastuzumab). Kadcyla (adotrastuzumab emtansine) for injection [prescribing information]. South San Francisco–CA: Genentech Inc; 2019.
   Google Scholar
• Barok M, Tanner M, Köninki K, et al. Trastuzumab-DM1 causes tumour growth inhibition by mitotic catastrophe in trastuzumab-resistant breast cancer cells in vivo. Breast Cancer Res. 2011;13(2):R46.
   Google Scholar
• Vakifahmetoglu H, Olsson M, Zhivotovsky B. Death through a tragedy: mitotic catastrophe. Cell Death Differ. 2008;15(7):1153–1162.
   Google Scholar
• Kowalczyk L, Bartsch R, Cf S, et al. Adverse events of trastuzumab emtansine (T-DM1) in the treatment of HER2-positive breast cancer patients. Breast Care (Basel). 2017;12(6):401–408.
   Google Scholar