What is the role of ado-trastuzumab emtansine (Kadcyla) in the adjuvant therapy for breast cancer?

Updated: May 21, 2019
  • Author: Erin V Newton, MD; Chief Editor: Neetu Radhakrishnan, MD  more...
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Ado-trastuzumab emtansine (Kadcyla) undergoes receptor-mediated internalization and subsequent lysosomal degradation, resulting in intracellular release of DM1-containing cytotoxic catabolites. Binding of DM1 to tubulin disrupts microtubule networks in the cell, which results in cell cycle arrest and apoptotic cell death. [34]

In May 2019, the FDA approved ado-trastuzumab emtansine for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane- and trastuzumab-based treatment.

Approval was based on KATHERINE, a randomized, multicenter, open-label clinical trial in which ado-trastuzumab emtansine reduced the risk of an invasive recurrence or death by 50% compared with trastuzumab, in 1486 patients with HER2-positive early-stage breast cancer with residual invasive disease after receiving neoadjuvant chemotherapy and trastuzumab. At the interim analysis, invasive disease or death had occurred in 12.2% of patients in the ado-trastuzumab emtansine arm, versus 22.2% in the trastuzumab arm. Secondary efficacy endpoints of disease-free survival and distant recurrence–free survival interval also showed clinically meaningful improvements with ado-trastuzumab emtansine relative to trastuzumab. [35]

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