Safety Profile of T-DM1 for Metastatic Breast Cancer

The antibody–drug conjugate trastuzumab emtansine (T-DM1) was recently approved by the FDA for patients with HER2-positive metastatic breast cancer previously treated with trastuzumab and taxane. Within treatment pathways, T-DM1 has been positioned as second-line therapy following disease progression on trastuzumab-based therapy. The efficacy results of T-DM1 were impressive, and the adverse effects in individual trials were manageable.

To further define the safety profile of this new agent, investigators conducted an integrated analysis of toxicity data from six industry-supported, randomized, phase II and III trials involving 884 patients with HER2-positive metastatic disease who received T-DM1.

The most common all-grade, adverse events wer…