Oncology Unit, ASST Papa Giovanni XXIII, 24127 Bergamo, Italy.
Epidemiology & Clinical Trials Office, General Hospital, 30035 Mirano VE, Italy.
J Comp Eff Res. 2020 Apr;9(6):423-430. doi: 10.2217/cer-2019-0168. Epub 2020 Feb 14.
Adding pertuzumab to standard trastuzumab-based adjuvant therapy significantly improved invasive disease-free survival (IDFS) in the APHINITY trial. However, the magnitude of benefit was marginal in the overall population. We used GRADE (Grading of Recommendations Assessment, Development and Evaluation) analysis on data from APHINITY to build summary-of-findings tables to evaluate the efficacy, safety and quality of evidence of predefined clinical outcomes for the addition of pertuzumab to trastuzumab-based adjuvant therapy in patients with high-risk HER2-positive early breast cancer. Pertuzumab significantly improved 3-year, event-free, absolute benefit in disease-free survival, IDFS and distant relapse-free interval (DFRI) in patients with node-positive or hormone receptor-negative disease. The analysis provides strength of evidence supporting the addition of pertuzumab in this patient population.
APHINITY 试验表明，在标准曲妥珠单抗辅助治疗的基础上添加帕妥珠单抗可显著改善浸润性无病生存期（IDFS）。然而，在总体人群中，获益的幅度是微小的。我们使用 GRADE（推荐评估、制定与评价）分析方法对 APHINITY 试验的数据进行分析，以构建总结发现表，评估在高风险 HER2 阳性早期乳腺癌患者中添加帕妥珠单抗至曲妥珠单抗辅助治疗的特定临床结局的疗效、安全性和证据质量。帕妥珠单抗可显著提高 3 年无事件、绝对获益、无病生存率、IDFS 和远处无复发生存率（DFRI），在淋巴结阳性或激素受体阴性疾病患者中获益更为明显。该分析提供了支持在该患者人群中添加帕妥珠单抗的证据强度。
