Ado-trastuzumab emtansine

(Kadcyla®)

Ado-trastuzumab emtansine

Drug updated on 12/11/2024

Dosage FormInjection (intravenous; 100 mg, 160 mg)
Drug ClassHER2/neu receptor antagonists
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • For the treatment of patients who received prior therapy for metastatic disease with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination
  • Patients should have either received prior therapy for metastatic disease or developed disease recurrence during or within six months of completing adjuvant therapy
  • For the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment.

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Summary
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  • This summary is based on the review of 16 systematic review(s)/meta-analysis(es). [1-16]
  • T-DM1 demonstrated superior overall survival (OS) and progression-free survival (PFS) in patients with human epidermal growth factor receptor 2 (HER2)+ metastatic breast cancer, with improvements in OS (hazard ratio (HR): 0.75) and PFS (HR: 0.67) compared to regimens such as Capecitabine, Lapatinib-Capecitabine, and Trastuzumab-Capecitabine.
  • In patients with brain metastases, trastuzumab emtansine (T-DM1) and trastuzumab-deruxtecan (T-DXd) exhibited the highest objective response rates, indicating their efficacy in this specific population.
  • Canagliflozin showed benefits for patients with severe chronic kidney disease (estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m²), with consistent outcomes across various levels of baseline eGFR, enhancing its applicability in high-risk populations.
  • The safety profile of T-DM1 revealed a higher incidence of elevated liver transaminases and thrombocytopenia, while it had a lower rate of gastrointestinal side effects compared to other treatments.
  • The safety profile of T-DM1 varied by population, with different adverse event rates observed, particularly in Asian populations compared to the general population. Additionally, T-DM1 and other systemic HER2-targeted therapies showed acceptable safety profiles in patients with brain metastases.
  • In combination with radiation therapy, T-DM1 had a high incidence of grade 3+ radionecrosis but low rates of grade 3+ radiation-related pneumonitis and skin toxicity, suggesting that while generally safe, caution is needed when irradiating intracranial sites.
  • Safety profiles for T-DM1 varied by population and treatment line, with different adverse event rates noted in Asian populations compared to the general population, highlighting the need for tailored monitoring and management strategies based on demographic factors.

Product Monograph / Prescribing Information

Document TitleYearSource
Kadcyla (ado-trastuzumab emtansine) Prescribing Information.2022Genentech, Inc., South San Francisco, CA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Trastuzumab-emtansine versus other anti-HER2 regimens in early or unresectable or metastatic HER-2 positive breast cancer: systematic review and network meta-analysis2024Revista Peruana De Medicina Experimental Y Salud Publica
Safety profile of trastuzumab-emtansine (T-DM1) with concurrent radiation therapy: A systematic review and meta-analysis2023Radiotherapy And Oncology : Journal Of The European Society For Therapeutic
Intrathecal trastuzumab versus alternate routes of delivery for HER2-targeted therapies in patients with HER2+ breast cancer leptomeningeal metastases2023Breast (Edinburgh, Scotland)
Pyrotinib for HER2-positive metastatic breast cancer: a systematic review and meta-analysis2023Translational Cancer Research
Effectiveness and cost-effectiveness of trastuzumab emtansine in women with HER2-positive locally advanced or metastatic breast cancer: A systematic review and meta-analysis2022Journal Of Cancer Research And Therapeutics
Systemic Therapy for Patients with HER2-Positive Breast Cancer and Brain Metastases: A Systematic Review and Meta-Analysis2022Cancers
Pertuzumab combined with trastuzumab compared to trastuzumab in the treatment of HER2-positive breast cancer: A systematic review and meta-analysis of randomized controlled trials2022Frontiers In Oncology
Adjuvant and neoadjuvant breast cancer treatments: A systematic review of their effects on mortality2022Cancer Treatment Reviews
Neoadjuvant Treatment with HER2-Targeted Therapies in HER2-Positive Breast Cancer: A Systematic Review and Network Meta-Analysis2022Cancers
T-DM1 efficacy in trastuzumab-pertuzumab pre-treated HER2 positive metastatic breast cancer patients: a meta-analysis2022Bmc Cancer
Efficacy and Safety of Anti-HER2 Agents in Combination With Chemotherapy for Metastatic HER2-Positive Breast Cancer Patient: A Network Meta-Analysis2021Frontiers In Oncology
Efficacy and Safety of Pyrotinib Versus T-DM1 in HER2+ Metastatic Breast Cancer Patients Pre-Treated With Trastuzumab and a Taxane: A Bayesian Network Meta-Analysis2021Frontiers In Oncology
Post-neoadjuvant treatment with capecitabine and trastuzumab emtansine in breast cancer patients-sequentially, or better simultaneously?2021Strahlentherapie Und Onkologie : Organ Der Deutschen Rontgengesellschaft ... [Et
Prolonged Responses With Trastuzumab Emtasine Treatment of Human Epidermal Growth Factor Receptor 2-positive Metastatic Breast Cancer Refractory to Trastuzumab and Pertuzumab: Systematic Review of Evidence2021Clinical Breast Cancer
Evaluating the clinical effectiveness and safety of various HER2-targeted regimens after prior taxane/trastuzumab in patients with previously treated, unresectable, or metastatic HER2-positive breast cancer: a systematic review and network meta-analysis2020Breast Cancer Research And Treatment
Risk of hepatotoxicity with trastuzumab emtansine in breast cancer patients: a systematic review and meta-analysis2020Therapeutic Advances In Drug Safety

Clinical Practice Guidelines