Incidence and risk of severe adverse events associated with trastuzumab emtansine (T-DM1) in the treatment of breast cancer: an up-to-date systematic review and meta-analysis of randomized controlled clinical trials. Issue 11 (2nd November 2022)

• Record Type: Journal Article
• Authors: Liu, Kuan; Li, Yan-Hong; Zhang, Xi; Su, Lei; Li, Jing-Hua; Shi, Hong-Yun; Zhang, Jun-Hua
• Is Part Of: Expert review of clinical pharmacology. Volume 15:Issue 11(2022)
• Page Start: 1343
• Page End: 1350
• Publication Date: 2022-11-02
• Subjects: T-DM1 -- breast cancer -- safety -- adverse event -- high grade; Clinical pharmacology -- Periodicals; 615.105
• DOI: 10.1080/17512433.2022.2121704
• Languages: English
• ISSNs: 1751-2433

Abstract

ABSTRACT: 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.