Context
Trastuzumab emtansine (T-DM1), the first antibody-drug conjugate targeting human epidermal growth factor receptor 2 (HER2), offers new alternatives for the treatment of metastatic breast cancer (mBC) and for the treatment of breast cancer. early stage breast (esBC) since 2020. We characterized T-DM1 users and assessed the risk of hospitalization for certain adverse events.
Material and methods
Using data from the National Health Data System (SNDS), we identified patients receiving T-DM1 from 2014 to 2022. Sociodemographic data, medical history and overall survival were described by indication. The risk of hospitalization linked to an adverse event was quantified.
Results
We included in the study 12,822 patients starting treatment with T-DM1: 9,232 (72%) with mBC (median age: 59 years, 54.6% with at least one comorbidity) and 3,590 (28% ) with ESBC (median age: 54 years, 33.9% with at least one comorbidity). In the case of mBC, the median overall survival was 32.6 months, showing progressive improvement over the years. At one year, 75.8% of patients had stopped treatment and 22.0% had died. Study patients faced higher risks of hospitalization than patients with incident breast cancer, with increases of 5.7- and 10.5-fold for thrombocytopenia, 3.0- and 4-fold .5 times for interstitial lung disease, 3.3 and 5.9 times for acute liver injury, and 2.3 and 7.3 times for sepsis, for esBC and mBC, respectively.
Conclusion
Real-world T-DM1 users often have comorbidities and prior treatment, with a higher risk of hospitalization for serious toxic events than the incident breast cancer population. This study highlights the importance of monitoring treated patients to manage the risk of toxicity and prevent treatment discontinuation.
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