Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions
Trastuzumab Emtansine vs Taxane Plus Trastuzumab
J Clin Oncol; ePub 2016 Nov 7; Perez, et al
Trastuzumab emtansine (T-DM1) worked just as well as taxane plus trastuzumab for first-line treatment in people with HER2-positive, advanced breast cancer in a phase 3 study involving nearly 1,100 individuals. Additionally, it was better tolerated.
Participants—all of whom had not been previously treated for advanced disease—were randomly assigned to receive trastuzumab plus taxane, T-DM1 plus placebo, or T-DM1 plus pertuzumab. Investigators evaluated progression-free survival. Among the results:
- Patients taking T-DM1/placebo and T-DM1/pertuzumab experienced similar progression free survival: ~14 months for both; it was similar in those taking trastuzumab/taxane: ~15 months.
- Response rate was ~68% in patients taking trastuzumab/taxane; it was ~60% with T-DM1/placebo, and ~64% with T-DM1/pertuzumab.
- Median response duration was 12.5 months for trastuzumab/taxane; it was ~21 months in the other 2 groups.
- The incidence of grade ≥3 adverse events was ~54% in the trastuzumab/taxane arm, compared with ~45% in the T-DM1/placebo group and ~46% in the T-DM1/pertuzumab contingent.
Perez E, 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. [Published online ahead of print November 7, 2016]. J Clin Oncol. doi:10.1200/JCO.2016.67.4887.
