Key result
Trastuzumab emtansine (T-DM1) increased the risk of severe thrombocytopenia (RR 10.66; 95% CI 3.23-35.18; P<0.001), anemia, elevated liver enzymes, and neuropathy in breast cancer patients.
Why the study?
The study was conducted to quantify the overall incidence and risk of severe adverse events associated with T-DM1 in patients with breast cancer.
Does trastuzumab emtansine (T-DM1) increase the risk of severe adverse events in patients with breast cancer?
Meta-Analysis (n=5,045)
Does trastuzumab emtansine (T-DM1) increase the risk of severe adverse events in patients with breast cancer?
Relative Risk: 10.66 (95% CI 3.23–35.18)
p-value: p=< 0.001
Treatment with T-DM1 in breast cancer patients increases the risk of severe hematologic, hepatic, hypertensive, and neuropathic toxicities, although the overall incidence of these adverse events is low.
T-DM1 increases severe hematologic, hepatic, hypertensive, and neuropathic AE risks; confirms RCT safety profile and supports targeted monitoring.
OBJECTIVES: We performed an up-to-date meta-analysis to quantify the overall incidence and risk of severe adverse events (AEs) associated with T-DM1 in patients with breast cancer. METHODS: Pubmed, Embase, and oncology conference proceedings were searched for relevant studies. Data were extracted to calculate the summary incidence rate and relative risk (RR) of grade ≥3 AEs. RESULTS: A total of 5,045 patients from 7 RCTs were included in the meta-analysis. The use of T-DM1 was associated with an increased risk of severe thrombocytopenia (RR 10.66, 95% CI 3.23-35.18, P < 0.001), anemia (RR 1.68, 95% CI 1.15-2.44, P = 0.007), elevated ALT (RR 2.67, 95% CI 1.60-4.47, P < 0.001), and AST (RR 3.76, 95% CI 1.45-9.78, P = 0.007). In addition, the use of T-DM1 can increase the risk of severe hypertension (RR 1.59, 95% CI 1.03-2.45, P = 0.037) and peripheral sensory neuropathy (RR 8.13, 95% CI 1.89-35.03, P = 0.005). CONCLUSIONS: Treatment with T-DM1 increases the risk of severe hematologic toxicities, hepatotoxicity, hypertension, and peripheral sensory neuropathy in patients with breast cancer, while the overall incidence of these AEs is low.
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Liu et al. (2022) conducted a meta-analysis in breast cancer (n=5,045). trastuzumab emtansine (T-DM1) was evaluated on severe thrombocytopenia (grade ≥3) (RR 10.66, 95% CI 3.23-35.18, p=< 0.001). Trastuzumab emtansine (T-DM1) increased the risk of severe thrombocytopenia (RR 10.66; 95% CI 3.23-35.18; P<0.001), anemia, elevated liver enzymes, and neuropathy in breast cancer patients.
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