Phase II Randomized Study of Trastuzumab Emtansine Versus Trastuzumab Plus Docetaxel in Patients With Human Epidermal Growth Factor Receptor 2–Positive Metastatic Breast Cancer

医学 曲妥珠单抗 曲妥珠单抗 转移性乳腺癌 内科学 肿瘤科 多西紫杉醇 危险系数 乳腺癌 不利影响 癌症 胃肠病学 置信区间
作者
Sara A. Hurvitz,Luc Dirix,Judit Kocsis,Giulia Bianchi,Janice Lu,J. Vinholes,Ellie Guardino,Chunyan Song,Barbara Tong,Vivian Ng,Yu-Waye Chu,Edith A. Perez
出处
期刊:Journal of Clinical Oncology [American Society of Clinical Oncology]
卷期号:31 (9): 1157-1163 被引量:370
标识
DOI:10.1200/jco.2012.44.9694
摘要

Purpose Trastuzumab emtansine (T-DM1), an antibody-drug conjugate composed of the cytotoxic agent DM1 conjugated to trastuzumab via a stable thioether linker, has shown clinical activity in single-arm studies enrolling patients with human epidermal growth factor receptor 2 (HER2) –positive metastatic breast cancer (MBC) whose disease had progressed on HER2-targeted therapy in the metastatic setting. Patients and Methods Patients (N = 137) with HER2-positive MBC or recurrent locally advanced breast cancer were randomly assigned to trastuzumab plus docetaxel (HT; n = 70) or T-DM1 (n = 67) as first-line treatment until disease progression or unacceptable toxicity. Primary end points were investigator-assessed progression-free survival (PFS) and safety. Key secondary end points included overall survival (OS), objective response rate (ORR), duration of objective response, clinical benefit rate, and quality of life. Results Median PFS was 9.2 months with HT and 14.2 months with T-DM1 (hazard ratio, 0.59; 95% CI, 0.36 to 0.97); median follow-up was approximately 14 months in both arms. ORR was 58.0% (95% CI, 45.5% to 69.2%) with HT and 64.2% (95% CI, 51.8% to 74.8%) with T-DM1. T-DM1 had a favorable safety profile versus HT, with fewer grade ≥ 3 adverse events (AEs; 46.4% v 90.9%), AEs leading to treatment discontinuations (7.2% v 40.9%), and serious AEs (20.3% v 25.8%). Preliminary OS results were similar between treatment arms; median follow-up was approximately 23 months in both arms. Conclusion In this randomized phase II study, first-line treatment with T-DM1 for patients with HER2-positive MBC provided a significant improvement in PFS, with a favorable safety profile, versus HT.
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