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Abstract：
BACKGROUND: HER2-low has emerged as a new predictive biomarker in metastatic breast cancer. However, its prognostic value in early-stage carcinomas needs to be revisited. We aimed to evaluate the association of HER2-low carcinomas with PAM50 risk groups combined with clinicopathological variables in early breast cancer.
METHODS: We conducted a retrospective analysis of 332 patients with early-stage breast cancer that underwent PAM50 signature analysis between 2015 and 2021at Hospital Universitario 12 de Octubre (Madrid, Spain). Clinical and pathological variables were collected from medical records. After adjusting for potential confounders, we estimated Odds Ratio (OR) and 95% confidence interval for high-risk PAM50 subgroup, comparing HER2-low versus HER2-zero carcinomas by multivariable logistic regression. P values below 0.05 were deemed statistically significant.
RESULTS: 192 (57%) patients were classified as HER2-low carcinomas. Median follow-up was 34 months. Adjusted OR for high-risk PAM50 when comparing HER2-low versus HER2-zero carcinomas was 1.31 (95% CI: 0.75-2.30, p = 0.33). The multivariable model detected significant associations for Ki-67% (≥20% vs. <20%: OR = 4.03, 95% CI: 2.15-7.56, p < 0.001), T staging category (T2/T3 vs. T1: OR = 3.44, 95% CI: 1.96-6.04, p < 0.001), progesterone receptor (PR ≥ 20% vs. <20%: OR = 0.44, 95% CI: 0.23-0.83, p = 0.01), nodal staging category (N+ vs. N0: OR = 3.8, 95% CI: 1.89-7.62, p < 0.001) and histological grade (grade 2 vs. 1: OR = 2.41, 95% CI: 1.01-5.73, p = 0.04; grade 3 vs 1: OR = 5.40, 95%CI: 1.98-14.60, p = 0.001).
CONCLUSIONS: In this early-stage breast cancer cohort, HER2-low was not associated with a high-risk PAM50 compared to HER2-zero carcinomas. Ki-67 ≥ 20%, T2/T3, histological grade 2/3, N+ and PR<20% were significantly associated to a high-risk PAM50.
METHODS: We conducted a retrospective analysis of 332 patients with early-stage breast cancer that underwent PAM50 signature analysis between 2015 and 2021at Hospital Universitario 12 de Octubre (Madrid, Spain). Clinical and pathological variables were collected from medical records. After adjusting for potential confounders, we estimated Odds Ratio (OR) and 95% confidence interval for high-risk PAM50 subgroup, comparing HER2-low versus HER2-zero carcinomas by multivariable logistic regression. P values below 0.05 were deemed statistically significant.
RESULTS: 192 (57%) patients were classified as HER2-low carcinomas. Median follow-up was 34 months. Adjusted OR for high-risk PAM50 when comparing HER2-low versus HER2-zero carcinomas was 1.31 (95% CI: 0.75-2.30, p = 0.33). The multivariable model detected significant associations for Ki-67% (≥20% vs. <20%: OR = 4.03, 95% CI: 2.15-7.56, p < 0.001), T staging category (T2/T3 vs. T1: OR = 3.44, 95% CI: 1.96-6.04, p < 0.001), progesterone receptor (PR ≥ 20% vs. <20%: OR = 0.44, 95% CI: 0.23-0.83, p = 0.01), nodal staging category (N+ vs. N0: OR = 3.8, 95% CI: 1.89-7.62, p < 0.001) and histological grade (grade 2 vs. 1: OR = 2.41, 95% CI: 1.01-5.73, p = 0.04; grade 3 vs 1: OR = 5.40, 95%CI: 1.98-14.60, p = 0.001).
CONCLUSIONS: In this early-stage breast cancer cohort, HER2-low was not associated with a high-risk PAM50 compared to HER2-zero carcinomas. Ki-67 ≥ 20%, T2/T3, histological grade 2/3, N+ and PR<20% were significantly associated to a high-risk PAM50.
摘要：
背景：低HER2已成为转移性乳腺癌新的预测生物标志物。然而,其在早期癌的预后价值需要重新审视.我们旨在评估低HER2癌与PAM50风险组的相关性，并结合早期乳腺癌的临床病理变量。
方法：我们对2015年至2021年在Octubre大学12号医院接受PAM50签名分析的332例早期乳腺癌患者进行了回顾性分析（马德里，西班牙)。从医疗记录中收集临床和病理变量。在调整了潜在的混杂因素后，我们估计高风险PAM50亚组的赔率比(OR)和95%置信区间，通过多变量逻辑回归比较低HER2与零HER2癌。低于0.05的P值被认为是统计学上显著的。
结果：192例（57%）患者被归类为低HER2癌。中位随访时间为34个月。当比较低HER2与零HER2癌时，高风险PAM50的校正OR为1.31（95％CI：0.75-2.30，p=0.33）。多变量模型检测到Ki-67%(≥20%与<20%：OR=4.03，95%CI：2.15-7.56，p<0.001），T分期类别(T2/T3vs.T1：OR=3.44，95%CI：1.96-6.04，p<0.001），孕激素受体（PR≥20%vs.<20%：OR=0.44，95%CI：0.23-0.83，p=0.01），节点分期类别(N+与N0：OR=3.8，95％CI：1.89-7.62，p<0.001）和组织学分级（2级与1：OR=2.41，95％CI：1.01-5.73，p=0.04；3级vs1：OR=5.40，95CI：1.98-14.60，p=0.001）。
结论：在这个早期乳腺癌队列中，与HER2零癌相比，低HER2与高风险PAM50无关。Ki-67≥20%,T2/T3、组织学分级2/3、N+和PR<20%与高风险PAM50显著相关。
方法：我们对2015年至2021年在Octubre大学12号医院接受PAM50签名分析的332例早期乳腺癌患者进行了回顾性分析（马德里，西班牙)。从医疗记录中收集临床和病理变量。在调整了潜在的混杂因素后，我们估计高风险PAM50亚组的赔率比(OR)和95%置信区间，通过多变量逻辑回归比较低HER2与零HER2癌。低于0.05的P值被认为是统计学上显著的。
结果：192例（57%）患者被归类为低HER2癌。中位随访时间为34个月。当比较低HER2与零HER2癌时，高风险PAM50的校正OR为1.31（95％CI：0.75-2.30，p=0.33）。多变量模型检测到Ki-67%(≥20%与<20%：OR=4.03，95%CI：2.15-7.56，p<0.001），T分期类别(T2/T3vs.T1：OR=3.44，95%CI：1.96-6.04，p<0.001），孕激素受体（PR≥20%vs.<20%：OR=0.44，95%CI：0.23-0.83，p=0.01），节点分期类别(N+与N0：OR=3.8，95％CI：1.89-7.62，p<0.001）和组织学分级（2级与1：OR=2.41，95％CI：1.01-5.73，p=0.04；3级vs1：OR=5.40，95CI：1.98-14.60，p=0.001）。
结论：在这个早期乳腺癌队列中，与HER2零癌相比，低HER2与高风险PAM50无关。Ki-67≥20%,T2/T3、组织学分级2/3、N+和PR<20%与高风险PAM50显著相关。
