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TDM-1 for HER2-Positive Advanced Breast Cancer – Clinical Practice Experience at University Hospital for Tumors

Trastuzumab emtansine (TDM-1) in monotherapy is standardised second line treatment option for HER2-positive advanced breast cancer patients, who had previously been treated with trastuzumab and a taxane. The EMILIA study assessed the efficacy and safety of T-DM1, as compared to lapatinib plus capecitabine, and has shown significantly improved progression-free and overall survival with median duration of response 12, 6 months in comparison to 6, 5 months with lapatinib plus capecitabine. In this trial, more patients had luminal breast cancer (282), whereas 202 patients had non- luminal breast cancer. Also, there were 334 patients included with visceral disease involvement compared to 161 patients with non- visceral site of disease. Everyday clinical practice results often differ from study results. We wanted to share TDM-1 treat- ment results from our clinic, from March 2017 through March 2020, with 36 patients included, who received at least 4 cycles of TDM-1. From 36 enrolled patients, there were 26 patients with hormone dependent breast cancer, related to 10 patients with non-luminal disease. Overall 19 patients had visceral disease only, 17 patients had vis- ceral and bone disease involvement, and there was no patient with solitary bone disease involvement. After initial four cycles of treatment with TDM-1, control diagnostic evaluation was performed. Anal- ysis has shown that 26 patients had positive response to treatment, which was assessed by either stable disease or improving disease burden (evaluated by RECIST criteria), with clear clinical benefit. Unfortu- nately, disease progression with clinical deterioration has been registered in 10 patients. In the group of patients who had positive response to treatment, there were 19 patients with hor- mone- dependent disease and seven with non-luminal type of breast cancer. There was no significant dif- ference in subgroups according to sites of disease involvement. In the group of patients who had disease progression, there were seven patients with luminal breast cancer and three patients with non- luminal breast cancer. The above group was dominated by patients with exclusively visceral disease, seven of them, while three patients had both bone and visceral disease involvement. In our clinical practice experience study, median duration of treatment was 7, 5 months. Our data evaluation, as reflected in referent study, did not show significant differences in the median duration of treatment, within subgroups of patients based on tumor characteristics such as site of disease and hormone receptor status. Although, in reference to EMILIA trial results, our analysis indicates shorter duration of treatment in real-life conditions, a fact that is often shown in everyday clinical practice. For further analysis and clarifi- cation of the observed pattern causes, longer patient follow- up should be performed, however, this pilot project and preliminary findings clearly show a tendency which should be worked on for improvement.

Breast cancer, TDM-1

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