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Abstract：
UNASSIGNED: It has been reported that breast cancer (BC) with low expression of human epidermal growth factor receptor 2 (HER2) might be a distinct subtype of BC. However, the prognostic effect of low HER2 expression on BC patients remains controversial. We aim to conduct this single-institution retrospective analysis to assess HER2-low-positive BC outcomes in Chinese women and the prognostic role of TILs in HER2-low-positive early-stage BC.
UNASSIGNED: We retrospectively enrolled 1,763 BC patients treated in a single institution from 2017 to 2018. TILs are regarded as continuous variables and are divided into low TILs (≤10%) and high TILs (>10%) for statistical analysis. Univariate and multivariable Cox proportional hazards regression models were used to test the associations between TILs and disease-free survival (DFS) with adjustment for clinicopathologic characteristics.
UNASSIGNED: High TIL levels (>10%) were associated with tumor size (>2 cm, p = 0.042), age at diagnosis (p = 0.005), Ki-67 index (>25%; p <0.001), HR (hormone receptor) status (positive, p <0.001), advanced pathological stage (p = 0.043), subtype (p <0.001), and HER2 status (p <0.001). The Kaplan-Meier analysis indicated that no significant difference in DFS (p = 0.83) could be found between HER2-positive, HER2-low-positive, and HER2-0 BC. The DFS of HER2-low-positive BC and HER2-nonamplified BC with high levels of TILs was statistically better than that of patients with low levels of TILs (p = 0.015; p = 0.047). In HER2-low-positive BC patients with high TIL levels (>10%), DFS was significantly improved in both the univariate (HR = 0.44, 95% CI 0.22-0.87, P = 0.018) and multivariate (HR = 0.47, 95% CI 0.23-0.95, P = 0.035) Cox models. For further subgroup analysis, HR (+)/HER2-low-positive BC with high TIL (>10%) levels was associated with improved DFS in both the univariate (HR = 0.41, 95% CI 0.19-0.90, P = 0.025) and multivariate (HR = 0.42, 95% CI 0.19-0.93, P = 0.032) Cox models. The HR (-)/HER2-0 BC with high TIL (>10%) level was not statistically significant in the univariate Cox model, but it was statistically significant in the multivariate (HR = 0.16, 95% CI 0.28-0.96, P = 0.045) Cox model.
UNASSIGNED: Among early-stage BC, no significant survival difference could be found between the HER2-positive, HER2-low-positive, and HER2-0 cohorts. High levels of TILs were significantly associated with improved DFS in HER2-low-positive patients, especially in the HR (+)/HER2-low-positive subtype.
UNASSIGNED: We retrospectively enrolled 1,763 BC patients treated in a single institution from 2017 to 2018. TILs are regarded as continuous variables and are divided into low TILs (≤10%) and high TILs (>10%) for statistical analysis. Univariate and multivariable Cox proportional hazards regression models were used to test the associations between TILs and disease-free survival (DFS) with adjustment for clinicopathologic characteristics.
UNASSIGNED: High TIL levels (>10%) were associated with tumor size (>2 cm, p = 0.042), age at diagnosis (p = 0.005), Ki-67 index (>25%; p <0.001), HR (hormone receptor) status (positive, p <0.001), advanced pathological stage (p = 0.043), subtype (p <0.001), and HER2 status (p <0.001). The Kaplan-Meier analysis indicated that no significant difference in DFS (p = 0.83) could be found between HER2-positive, HER2-low-positive, and HER2-0 BC. The DFS of HER2-low-positive BC and HER2-nonamplified BC with high levels of TILs was statistically better than that of patients with low levels of TILs (p = 0.015; p = 0.047). In HER2-low-positive BC patients with high TIL levels (>10%), DFS was significantly improved in both the univariate (HR = 0.44, 95% CI 0.22-0.87, P = 0.018) and multivariate (HR = 0.47, 95% CI 0.23-0.95, P = 0.035) Cox models. For further subgroup analysis, HR (+)/HER2-low-positive BC with high TIL (>10%) levels was associated with improved DFS in both the univariate (HR = 0.41, 95% CI 0.19-0.90, P = 0.025) and multivariate (HR = 0.42, 95% CI 0.19-0.93, P = 0.032) Cox models. The HR (-)/HER2-0 BC with high TIL (>10%) level was not statistically significant in the univariate Cox model, but it was statistically significant in the multivariate (HR = 0.16, 95% CI 0.28-0.96, P = 0.045) Cox model.
UNASSIGNED: Among early-stage BC, no significant survival difference could be found between the HER2-positive, HER2-low-positive, and HER2-0 cohorts. High levels of TILs were significantly associated with improved DFS in HER2-low-positive patients, especially in the HR (+)/HER2-low-positive subtype.
摘要：
■据报道，人表皮生长因子受体2（HER2）低表达的乳腺癌（BC）可能是BC的独特亚型。然而,低HER2表达对BC患者的预后影响仍存在争议.我们的目标是进行这项单机构回顾性分析，以评估中国女性HER2低阳性BC结局以及TILs在HER2低阳性早期BC中的预后作用。
■我们回顾性地纳入了2017年至2018年在单一机构接受治疗的1,763例BC患者。TIL被视为连续变量，分为低TIL（≤10％）和高TIL（>10％）进行统计分析。使用单变量和多变量Cox比例风险回归模型来测试TILs与无病生存期（DFS）之间的关联，并调整临床病理特征。
■高TIL水平（>10％）与肿瘤大小（>2厘米，p=0.042),诊断年龄（p=0.005），Ki-67指数（>25%；p<0.001），HR（激素受体）状态（阳性，p<0.001)，晚期病理阶段（p=0.043），亚型（p<0.001），和HER2状态（p<0.001）。Kaplan-Meier分析表明，在HER2阳性之间没有发现DFS的显着差异（p=0.83）。HER2-低阳性，和HER2-0BC。具有高水平TIL的HER2低阳性BC和HER2非扩增BC的DFS在统计学上优于具有低水平TIL的患者(p=0.015;p=0.047)。在具有高TIL水平（>10％）的HER2低阳性BC患者中，单变量（HR=0.44，95％CI0.22-0.87，P=0.018）和多变量（HR=0.47，95％CI0.23-0.95，P=0.035）Cox模型的DFS均显着改善。对于进一步的亚组分析，在单变量（HR=0.41，95％CI0.19-0.90，P=0.025）和多变量（HR=0.42，95％CI0.19-0.93，P=0.032）Cox模型中，高TIL（>10％）水平的HR（）/HER2低阳性BC与DFS改善相关。高TIL(>10%)水平的HR(-)/HER2-0BC在单变量Cox模型中没有统计学意义,但在多变量(HR=0.16,95%CI0.28-0.96,P=0.045)Cox模型中有统计学意义.
■在早期BC中，在HER2阳性患者之间没有发现显著的生存差异，HER2-低阳性，和HER2-0队列。高水平的TIL与HER2低阳性患者的DFS改善显著相关，特别是在HR（+）/HER2低阳性亚型中。
■我们回顾性地纳入了2017年至2018年在单一机构接受治疗的1,763例BC患者。TIL被视为连续变量，分为低TIL（≤10％）和高TIL（>10％）进行统计分析。使用单变量和多变量Cox比例风险回归模型来测试TILs与无病生存期（DFS）之间的关联，并调整临床病理特征。
■高TIL水平（>10％）与肿瘤大小（>2厘米，p=0.042),诊断年龄（p=0.005），Ki-67指数（>25%；p<0.001），HR（激素受体）状态（阳性，p<0.001)，晚期病理阶段（p=0.043），亚型（p<0.001），和HER2状态（p<0.001）。Kaplan-Meier分析表明，在HER2阳性之间没有发现DFS的显着差异（p=0.83）。HER2-低阳性，和HER2-0BC。具有高水平TIL的HER2低阳性BC和HER2非扩增BC的DFS在统计学上优于具有低水平TIL的患者(p=0.015;p=0.047)。在具有高TIL水平（>10％）的HER2低阳性BC患者中，单变量（HR=0.44，95％CI0.22-0.87，P=0.018）和多变量（HR=0.47，95％CI0.23-0.95，P=0.035）Cox模型的DFS均显着改善。对于进一步的亚组分析，在单变量（HR=0.41，95％CI0.19-0.90，P=0.025）和多变量（HR=0.42，95％CI0.19-0.93，P=0.032）Cox模型中，高TIL（>10％）水平的HR（）/HER2低阳性BC与DFS改善相关。高TIL(>10%)水平的HR(-)/HER2-0BC在单变量Cox模型中没有统计学意义,但在多变量(HR=0.16,95%CI0.28-0.96,P=0.045)Cox模型中有统计学意义.
■在早期BC中，在HER2阳性患者之间没有发现显著的生存差异，HER2-低阳性，和HER2-0队列。高水平的TIL与HER2低阳性患者的DFS改善显著相关，特别是在HR（+）/HER2低阳性亚型中。
