Results from the phase III EMILIA trial presented at the ASCO plenary session could mean a new treatment option for women with HER2-positive tumours that might avoid the usual adverse effects of chemotherapy. Trastuzumab emtansine (T-DM1), an antibody–drug conjugate of trastuzumab and DM1, provides both antitumour activity and targeted delivery. Patients with progressive disease or metastasis who had previously been treated with a taxane and trastuzumab were randomly assigned to T-DM1 or capecitabine plus lapatinib—the only approved therapy for patients with trastuzumab-refractory breast cancer.
T-DM1 was associated with a significant improvement in progression-free survival (9.6 versus 6.4 months). Overall survival was not reached in the T-DM1 arm and was 23.3 months in the capecitabine plus lapatinib arm. Subgroup analyses showed that T-DM1 was better for all groups except those aged 65 or older. Importantly, the safety of T-DM1 was considerably superior to capecitabine and lapatinib. Dose reduction was required in only 16.3% of patients receiving T-DM1, whereas the capecitabine and lapatinib doses were reduced for 53.4% and 27.3% of patients, respectively.
The time to symptom progression was also much longer for T-DM1 compared with capecitabine and lapatinib. Notably, the incidence of adverse events was lower for patients treated with T-DM1, and cardiac toxicity was not increased with this agent. T-DM1 is an active, well tolerated novel therapy with a clinically meaningful improvement in outcome.
ORIGINAL RESEARCH PAPER
Blackwell, K. L. et al. Primary results from EMILIA, a phase III study of trastuzumab emtansine (T-DM1) versus capecitabine (X) and lapatinib (L) in HER2-positive locally advanced or metastatic breast cancer (MBC) previously treated with trastuzumab (T) and a taxane [abstract]. J. Clin. Oncol. 30 (Suppl.) LBA1 (2012)
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Hutchinson, L. EMILIA trial offers hope. Nat Rev Clin Oncol 9, 430 (2012). https://doi.org/10.1038/nrclinonc.2012.105
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DOI: https://doi.org/10.1038/nrclinonc.2012.105