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Phase III trial finds trastuzumab emtansine improves long-term survival in HER2 breast cancer

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In patients with high-risk HER2-positive breast cancer, adjuvant treatment with trastuzumab emtansine (T-DM1) has been shown to significantly improve long-term outcomes. The Phase III KATHERINE clinical trial, led by researchers from the University of Pittsburgh and UPMC Hillman Cancer Center, demonstrated that T-DM1 reduced the risk of death or invasive disease by 46% compared to trastuzumab alone. Published in the New England Journal of Medicine, these findings confirm the efficacy of T-DM1 as an adjuvant therapy for this patient population.

T-DM1 is an antibody-drug conjugate that combines trastuzumab with the chemotherapy agent emtansine. This design allows for targeted delivery of the cytotoxic drug to HER2-positive cancer cells, enhancing treatment effectiveness while minimizing systemic exposure. The KATHERINE trial involved 1,486 patients with HER2-positive early breast cancer who had residual invasive disease after neoadjuvant therapy and surgery. At a seven-year follow-up, invasive disease-free survival was 80.8% in the T-DM1 group, compared to 67.1% in the trastuzumab group. Overall survival rates were also higher in the T-DM1 group (89.1% vs. 84.4%). While adverse events were more frequent with T-DM1, the safety profile was deemed acceptable. These results support the integration of T-DM1 into standard care protocols for patients with residual invasive HER2-positive breast cancer following surgery. Click for More Details

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