KEY TAKEAWAYS
- ATEMPT Phase 2 clinical trial (NCT0185374) assessed adjuvant T-DM1 for stage I HER2-positive breast cancer.
- The study evaluated the cardiac safety of adjuvant T-DM1 administered for HER2+ stage I breast cancer
- This is a sub-analysis of ATEMPT study to tackle a serious side effect of neoadjuvant TD-M1, cardiotoxicity.
- The results showed an improvement in cardiac symptoms, and normalization of LVEF was also observed in individuals who were followed up subsequently.
Adjuvant trastuzumab emtansine (T-DM1) is a promising therapeutic option for some patients with stage I HER2-positive breast cancer, as demonstrated by the outstanding outcomes in the age following trastuzumab emtansine or paclitaxel/trastuzumab (ATEMPT) trial. T-DM1 is a well-recognized adjuvant therapy for patients with HER2-positive breast cancer who still have invasive disease following neoadjuvant treatment. Researchers performed a sub-analysis of the ATEMPT study to assess the cardiac safety of adjuvant T-DM1 because cardiotoxicity is the most serious side effect of trastuzumab, a primary molecular component of T-DM1. In this study, the incidence of left ventricular systolic dysfunction (LVSD) was 0.8% in the T-DM1 arm and 1.8% in the trastuzumab plus paclitaxel arm. Also, 3 (0.8% of the T-DM1 group) and 6 (5.9% of the TH group) patients showed a significant asymptomatic reduction in left ventricular ejection fraction (LVEF) that per-protocol required holding T-DM1 or trastuzumab.
Full improvement in cardiac symptoms and normalization of LVEF was observed in all individuals for whom there was sufficient data from subsequent follow-ups. Researchers also explored the association between age, LVEF at baseline, BMI, and cardiac outcomes. No correlation was found between these preexisting conditions and the development of either symptomatic LVSD or a significant drop in asymptomatic LVEF. Studies on the cost-effectiveness of cardiac surveillance during adjuvant therapy utilizing anthracycline-free regimens are warranted in light of the low occurrence of major cardiac adverse events in this cohort following therapy with adjuvant T-DM1.
Source: https://pubmed.ncbi.nlm.nih.gov/35173164/
Clinical Trial: https://clinicaltrials.gov/ct2/show/NCT01853748
Barroso-Sousa, R., Tarantino, P., Tayob, N., Dang, C., Yardley, D. A., Isakoff, S. J., Valero, V., Faggen, M., Mulvey, T., Bose, R., Hu, J., Weckstein, D., Wolff, A. C., Reeder-Hayes, K., Rugo, H. S., Ramaswamy, B., Zuckerman, D., Hart, L., Gadi, V. K., Constantine, M., … Tolaney, S. M. (2022). Cardiac outcomes of subjects on adjuvant trastuzumab emtansine vs paclitaxel in combination with trastuzumab for stage I HER2-positive breast cancer (ATEMPT) study (TBCRC033): a randomized controlled trial. NPJ breast cancer, 8(1), 18. https://doi.org/10.1038/s41523-022-00385-2
