蒽环类药物序贯紫杉类新辅助化疗的相对剂量强度对人表皮生长因子受体 2 阴性乳腺癌患者生存的影响：JONIE1 研究。
Impact of the Relative Dose Intensity of Neoadjuvant Chemotherapy With Anthracycline Followed by Taxane on the Survival of Patients With Human Epidermal Growth Factor Receptor 2-negative Breast Cancer: The JONIE1 Study.
机构信息
Department of Gastroenterological Surgery, Yokohama City University Graduate School of Medicine, Yokohama, Japan.
Department of Medical Informatics, Niigata University Medical and Dental Hospital, Niigata, Japan.
出版信息
Anticancer Res. 2021 Feb;41(2):1063-1068. doi: 10.21873/anticanres.14863.
BACKGROUND/AIM: We evaluated the impact of the relative dose intensity (RDI) of neoadjuvant chemotherapy (NAC) on the survival of patients with breast cancer (BC).
PATIENTS AND METHODS
This randomized phase II trial included 188 patients with human epidermal growth factor receptor 2 (HER2)-negative BC treated with anthracycline followed by paclitaxel as NAC. We grouped patients using a relative dose intensity (RDI) threshold of 85% and evaluated clinicopathological features and clinical outcomes.
RESULTS
The 5-year overall survival rate was 91.2% and 76.3%, when RDI ≥85% and <85%, respectively (p=0.015). Age, tumor, and node status, and the RDI were significantly different on univariate analysis, but not on multivariate analysis. An exploratory subgroup analysis revealed that a low RDI was associated with low overall survival of patients with obesity, T1/2 disease, and lymph node metastases.
CONCLUSION
Maintaining the RDI of NAC is crucial for achieving the survival benefit in selected patients with HER2-negative BC.
背景/目的：我们评估了新辅助化疗（NAC）的相对剂量强度（RDI）对乳腺癌（BC）患者生存的影响。
患者和方法
本随机 II 期试验纳入了 188 例人表皮生长因子受体 2（HER2）阴性 BC 患者，她们接受蒽环类药物序贯紫杉醇的 NAC 治疗。我们使用 85%的相对剂量强度（RDI）阈值对患者进行分组，并评估了临床病理特征和临床结局。
结果
当 RDI≥85%和<R85%时，5 年总生存率分别为 91.2%和 76.3%（p=0.015）。单因素分析显示，年龄、肿瘤和淋巴结状态以及 RDI 存在显著差异，但多因素分析无此结果。探索性亚组分析显示，在肥胖、T1/2 疾病和淋巴结转移的患者中，低 RDI 与总体生存率降低相关。
结论
对于特定的 HER2 阴性 BC 患者，维持 NAC 的 RDI 对于获得生存获益至关重要。
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