The most frequently occurring all-grade AEs in the T-DM1 arm included fatigue (30.8%) thrombocytopenia (20.6%), asthenia (19.1%), diarrhea (12.7%), and increased AST (12.4%). In the physician’s choice arm, the most common all-grade AEs included fatigue (26.1%), diarrhea (22.3%), neutropenia (21.7%), asthenia (17.9%), and dyspnea (13.0%).
Grade ≥3 AEs occurring at the highest rates in the T-DM1 arm included thrombocytopenia (6.0%) and anemia (3.5%), and neutropenia, increased AST, and dyspnea (each at 2.5%). The most frequently occurring grade ≥3 AEs in the physician’s choice arm were neutropenia (15.8%), diarrhea (4.3%), febrile neutropenia (3.8%), dyspnea (3.8%), and anemia (3.3%).
T-DM1 is currently approved by the FDA for the treatment of patients with HER2-positive, metastatic breast cancer previously treated with a taxane and trastuzumab. The approval was based on the phase III EMILIA trial, in which T-DM1 significantly improved survival versus lapatinib/capecitabine, with a median OS of 30.9 months versus 25.1 months, respectively (HR, 0.68; P
“The TH3RESA results, together with the EMILIA overall survival benefit, solidify the role of T-DM1 in the treatment of patients with previously treated HER2-positive advanced breast cancer,” said Wildiers.
Wildiers H, Kim S-B, Gonzalez-Martin A, et al. Trastuzumab emtansine improves overall survival versus treatment of physician's choice in patients with previously treated HER2-positive metastatic breast cancer: Final overall survival results from the phase 3 TH3RESA study. Presented at: 2015 San Antonio Breast Cancer Symposium; December 8-12, 2015; San Antonio, TX. Abstract S5-05.
Krop IE, Kim SB, González-Martín A, et al. Trastuzumab emtansine versus treatment of physician's choice for pretreated HER2-positive advanced breast cancer (TH3RESA): a randomised, open-label, phase 3 trial. Lancet Oncol. 2014;15(7):689-699.
Verma S, Miles D, Gianni L, et al. Trastuzumab emtansine for HER2-positive advanced breast cancer. N Engl J Med. 2012;367(19):1783-1791.
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