Johns Hopkins University, The Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland.
Dana-Farber Cancer Institute, Boston, Massachusetts.
Clin Cancer Res. 2021 Oct 15;27(20):5688-5696. doi: 10.1158/1078-0432.CCR-21-0733. Epub 2021 Aug 10.
The prognostic utility of Breast Cancer Index (BCI) for risk assessment of overall (0-10 years), early (0-5 years), and late (5-10 years) distant recurrence (DR) in hormone receptor-positive (HR+) invasive lobular carcinoma (ILC) was evaluated.
BCI gene expression analysis was performed blinded to clinical outcome utilizing tumor specimens from patients with HR+ ILC from a multi-institutional cohort. The primary endpoint was time to DR. Kaplan-Meier analyses of overall, early, and late DR risk were performed, and statistical significance was evaluated by log-rank test and Cox proportional hazards regression. The prognostic contribution of BCI in addition to clinicopathologic factors was evaluated by likelihood ratio analysis.
Analysis of 307 patients (99% ER+, 53% T1, 42% N+, 70% grade II) showed significant differences in DR over 10 years based on BCI risk categories. BCI low- and intermediate-risk patients demonstrated similar DR rates of 7.6% and 8.0%, respectively, compared with 27.0% for BCI high-risk patients. BCI was a significant independent prognostic factor for overall 10-year DR [HR = 4.09; 95% confidence interval (CI), 2.00-8.34; = 0.0001] as well as for both early (HR = 8.19; 95% CI, 1.85-36.30; = 0.0042) and late (HR = 3.04; 95% CI, 1.32-7.00; = 0.0224) DR. In multivariate analysis, BCI remained the only statistically significant prognostic factor for DR (HR = 3.49; 95% CI, 1.28-9.54; = 0.0150).
BCI is an independent prognostic factor for ILC and significantly stratified patients for cumulative risk of 10-year, early, and late DR. BCI added prognostic value beyond clinicopathologic characteristics in this distinct subtype of breast cancer.
评估乳腺癌指数（BCI）在预测激素受体阳性（HR+）浸润性小叶癌（ILC）患者总体（0-10 年）、早期（0-5 年）和晚期（5-10 年）远处复发（DR）风险方面的预后价值。
利用多机构队列中 HR+ILC 患者的肿瘤标本，对 BCI 基因表达进行盲法分析。主要终点为 DR 时间。通过 Kaplan-Meier 分析进行总体、早期和晚期 DR 风险分析，并通过对数秩检验和 Cox 比例风险回归评估统计学意义。通过似然比分析评估 BCI 在临床病理因素之外的预后贡献。
对 307 例患者（99%ER+，53%T1，42%N+，70%分级 II）进行分析，结果显示根据 BCI 风险类别，10 年内 DR 存在显著差异。BCI 低危和中危患者的 DR 率分别为 7.6%和 8.0%，而 BCI 高危患者的 DR 率为 27.0%。BCI 是总体 10 年 DR 的显著独立预后因素[HR=4.09；95%置信区间（CI），2.00-8.34；P=0.0001]，也是早期（HR=8.19；95%CI，1.85-36.30；P=0.0042）和晚期（HR=3.04；95%CI，1.32-7.00；P=0.0224）DR 的独立预后因素。在多变量分析中，BCI 仍然是 DR 的唯一统计学显著预后因素（HR=3.49；95%CI，1.28-9.54；P=0.0150）。
BCI 是 ILC 的独立预后因素，可显著分层患者 10 年、早期和晚期 DR 的累积风险。BCI 在这种独特的乳腺癌亚型中，除了临床病理特征外，还具有预后价值。
