Efficacy and safety of trastuzumab emtansine (T-DM1) in the treatment of HER2-positive metastatic breast cancer (MBC): a meta-analysis of randomized controlled trial

Hongjing Yan, Kewei Yu, Kaile Zhang, Linxia Liu and Yue Li _

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Oncotarget. 2017; 8:102458-102467. https://doi.org/10.18632/oncotarget.22270

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Hongjing Yan1, Kewei Yu2, Kaile Zhang3, Linxia Liu4 and Yue Li5

1Department of Microbial Testing, Minhang District Centers for Disease Control and Prevention, Shanghai 201101, China

2Department of Rehabilitation Medicine, Huashan Hospital, Fudan University, Shanghai 200040, China

3Department of Urology, Shanghai Sixth People’s Hospital, Shanghai 200233, China

4Shanghai University of Medicine and Health Sciences, Shanghai 201318, China

5Department of Immunization Program, Hongkou District Centers for Disease Control and Prevention, Shanghai 200082, China

Correspondence to:

Yue Li, email: [email protected]

Keywords: trastuzumab emtansine, HER2-positive, breast cancer, meta-analysis

Received: June 28, 2017     Accepted: September 29, 2017     Published: November 01, 2017


Aims: Trastuzumab emtansine (T-DM1), an antibody-drug conjugate against human epidermal growth factor receptor 2 (HER2), has been used in the treatment of patients with HER2-positive metastatic breast cancer (MBC). We conducted a meta-analysis to evaluate the efficacy and toxicity of T-DM1 for the treatment of patients with HER2-positive MBC.

Materials and Methods: Randomized controlled trials (RCTs), published in Pubmed, Embase, and Web of Science were systematically reviewed to assess the survival benefits and toxicity profile of HER2-positive patients with MBC who were treated with T-DM1. Outcomes included progression-free survival (PFS), overall survival (OS), overall response rate (ORR), and toxicities. Results were expressed as the hazard ratio (HR) with 95% confidence intervals (CIs).

Results: A total of 5 RCTs involving 3,720 patients met the inclusion criteria and were included in this meta-analysis. T-DM1 significantly prolonged PFS (HR = 0.73, 95% CI: 0.61, 0.86; P < 0.05), OS (HR = 0.68, 95% CI: 0.62, 0.74; P < 0.05), but it did not increase ORR (RR = 1.25, 95% CI: 0.94, 1.66; P = 0.148). Subgroup analysis indicated that T-DM1 significantly improved PFS when it was used as first-line (HR = 0.86, 95% CI: 0.74, 1.00; P < 0.05) or non-first-line treatment (HR = 0.65, 95% CI: 0.53, 0.81; P < 0.05). T-DM1 was associated with more frequent adverse events, including fatigue, elevated ALT, elevated AST, and thrombocytopenia, than other anti-HER2 therapies.

Conclusions: Based on the current evidence, T-DM1 significantly prolonged PFS and OS with a tolerated toxicity than other anti-HER2 therapies in patients with HER2-positive MBC. These findings confirm the use of T-DM1 for the treatment of patients with HER2-positive MBC. Further well-designed, multi-center RCTs needed to identify these findings.

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