![]() That 3-year progression free survival difference of 11% is really statistically significant, as well as clinically significant, and this has changed the way we treat our patients. Meisel: KATHERINE was a fascinating study because it not only allowed us to take a very high-risk group and randomize them to a potential intervention, but it also showed that they really did much better when, instead of being given just 1 year of trastuzumab after not achieving a pathologic complete response, they were switched over to adjuvant T-DM1. OncLive®: What were the implications of the phase 3 KATHERINE and FeDeriCa trials (NCT03493854) now that more mature data have read out? In an interview with OncLive® during an Institutional Perspectives in Cancer webinar on breast cancer, Meisel, an associate professor for the Departments of Hematology and Medical Oncology, and Gynecology & Obstetrics at Winship Cancer Institute, Emory University School of Medicine, discussed the use adjuvant T-DM1 and the management of associated toxicities and the benefit of the combination pertuzumab (Perjeta)/trastuzumab in HER2-positive breast cancer. We try to do all we can to support patients through that.” It’s not the easiest thing, but for many patients, particularly those with high-risk disease, it really does make a difference. “It's a diagnosis of breast cancer, first of all, and it is a relatively toxic, intense, up-front therapy. “It's tricky because these patients have been through a lot,” Meisel said. Additionally, 18% of patients in the T-DM1 arm experienced AEs that lead to discontinuation of treatment.1 Notably, 25.7% of the patients in the T-DM1 arm experienced a grade 3 or higher adverse effect (AE) vs 15.4% in the trastuzumab arm. These data led to the May 2019 FDA approval of T-DM1 for use as an adjuvant treatment in select patients with HER2-positive early breast cancer. ![]() The phase 3 KATHERINE trial examined ado-trastuzumab emtansine (T-DM1 Kadcyla) vs trastuzumab (Herceptin) and showed that the former resulted in a 50% reduction in the risk of invasive disease recurrence or death (HR, 0.50 95% CI, 0.39-0.64 P <.0001). Data from the pivotal phase 3 KATHERINE (NCT01772472) has led to the addition of ado-trastuzumab emtansine (T-DM1 Kadcyla) to the HER2-positive breast cancer treatment arsenal, but the toxicities associated with the approach must be appropriately managed so that patients can continue to receive it, according to Jane L. ![]()
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