Table_1_Ki67 Index Changes and Tumor-Infiltrating Lymphocyte Levels Impact the Prognosis of Triple-Negative Breast Cancer Patients With Residual Disease After Neoadjuvant Chemotherapy.docx

PurposeThe aim of this study was to assess the prognostic influence of Ki67 index changes in patients with primary triple-negative breast cancer (TNBC) treated with neoadjuvant chemotherapy (NAC), and to evaluate whether the combination of Ki67 index changes and residual disease (RD) tumor-infiltrating lymphocytes (TILs) provides additional prognostic information for this group.Materials and MethodsData from 109 patients with primary TNBC and RD after NAC were analyzed retrospectively. Ki67 changes and RD TIL levels were investigated for associations with recurrence-free survival (RFS) and overall survival (OS) using Kaplan–Meier and Cox analyses.ResultsKi67 index decreased after NAC in 53 patients (48.6%) and high RD TIL levels (≥30%) were observed in 54 patients (49.5%). In multivariate Cox analyses, no Ki67 decrease status and low RD TIL levels were significantly associated with reduced RFS (hazard ratio (HR): 2.038, 95% confidence interval (CI): 1.135–3.658, P = 0.017; HR: 2.493, 95% CI: 1.335–4.653, P = 0.004), and OS (HR: 2.187, 95% CI: 1.173–4.077, P = 0.014; HR: 2.499, 95% CI: 1.285–4.858, P = 0.007), respectively. Notably, low RD TIL levels were significantly associated with reduced RFS (HR: 3.567, 95% CI: 1.475–8.624, P = 0.005) and reduced OS (HR: 3.873, 95% CI: 1.512–9.918, P = 0.005) in only the no Ki67 decrease group. The differences in 3-year RFS and OS between patients with no Ki67 decrease and low or high RD TIL levels were 24.4% vs 79.1% (P = 0.0001) and 33.1% vs 87.5% (P = 0.0001), respectively.ConclusionKi67 index changes and RD TIL levels were associated with the prognosis of patients with primary TNBC with RD after NAC. RD TIL levels had greater prognostic significance in the no Ki67 decrease group.

本研究旨在评估Ki67指数变化对接受新辅助化疗（NAC）治疗的原发性三阴性乳腺癌（TNBC）患者预后影响，并探讨Ki67指数变化与残留疾病（RD）肿瘤浸润淋巴细胞（TILs）的结合是否为该群体提供额外的预后信息。研究方法：对109例接受NAC治疗后出现RD的原发性TNBC患者的数据进行回顾性分析。通过Kaplan-Meier和Cox分析，研究Ki67指数变化和RD TIL水平与无病生存期（RFS）和总生存期（OS）的相关性。结果：在53名患者（48.6%）中观察到NAC后Ki67指数降低，54名患者（49.5%）观察到高RD TIL水平（≥30%）。在多因素Cox分析中，无Ki67指数降低状态和低RD TIL水平与RFS（风险比（HR）：2.038，95%置信区间（CI）：1.135–3.658，P = 0.017；HR：2.493，95% CI：1.335–4.653，P = 0.004）和OS（HR：2.187，95% CI：1.173–4.077，P = 0.014；HR：2.499，95% CI：1.285–4.858，P = 0.007）的降低显著相关。值得注意的是，仅在无Ki67指数降低组中，低RD TIL水平与RFS（HR：3.567，95% CI：1.475–8.624，P = 0.005）和OS（HR：3.873，95% CI：1.512–9.918，P = 0.005）的降低显著相关。无Ki67指数降低且RD TIL水平低或高的患者在3年RFS和OS方面的差异分别为24.4% vs 79.1%（P = 0.0001）和33.1% vs 87.5%（P = 0.0001）。结论：Ki67指数变化和RD TIL水平与接受NAC治疗后出现RD的原发性TNBC患者的预后相关。在无Ki67指数降低组中，RD TIL水平具有更大的预后意义。