Abstract
T-DM1 is an antibody drug conjugate that combines trastuzumab with emtansine via a stable thioether linker. In two phase III clinical trials, EMILIA and TH3RESA, T-DM1 was shown to be effective in HER2-positive metastatic breast cancer patients who had progressed to taxanes and trastuzumab. We have performed a real-world study to complement the findings of the clinical trials. From 2012 to 2016, 15 patients with HER2-positive breast cancer who had progressed to prior treatment received T-DM1 at our center. We have retrospectively analyzed outcomes in these patients and compared our findings with those of the two clinical trials. Progression-free survival (PFS) was 10 months compared with the 9.6 months of the EMILIA trial and the 6.2 months of the TH3RESA trial, overall survival was 34 months compared with the 29.9 months of the EMILIA trial and the 22.7 months of the TH3RESA trial. PFS was ≥12 months in five patients, three of whom attained a PFS of ≥23 months. Among five patients with metastases of the central nervous system, PFS was six months, OS was not reached, and the objective response rate was 80%. Our findings are in line with those of the EMILIA study and slightly superior to those of the TH3RESA study. In our series of patients, T-DM1 has demonstrated efficacy in the treatment of HER2-positive metastatic breast cancer. Our real-world data thus confirm and support the findings of the two major phase III trials and indicate the usefulness of T-DM1 in routine clinical practice.
Highlights
T-DM1 is an antibody drug conjugate that combines trastuzumab with emtansine via a stable thioether linker
Several studies have shown that the combination of trastuzumab plus emtansine (T-DM1) is active in human epidermal growth receptor 2 (HER2)-positive breast cancer patients who have progressed after prior treatment6–9
In the present retrospective real-world study, we have evaluated the efficacy of T-DM1 in a series of HER2-positive breast cancer patients treated in our center
Summary
T-DM1 is an antibody drug conjugate that combines trastuzumab with emtansine via a stable thioether linker. In two phase III clinical trials, EMILIA and TH3RESA, T-DM1 was shown to be effective in HER2positive metastatic breast cancer patients who had progressed to taxanes and trastuzumab. The combination of trastuzumab, pertuzumab, and a taxane significantly prolonged progression-free survival (PFS) in a randomized trial and is the standard first-line treatment for HER2-positive breast cancer. Several studies have shown that the combination of trastuzumab plus emtansine (T-DM1) is active in HER2-positive breast cancer patients who have progressed after prior treatment. The randomized phase III EMILIA trial included 991 HER2-positive metastatic or locally advanced breast cancer patients who had previously received trastuzumab and a taxane. Based on the results of the EMILIA trial, in February 2013, T-DM1 was approved by the US Food & Drug Administration (FDA) for the second-line treatment of HER2-positive breast cancer
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