Table_1_Validation of the Clinical Treatment Score Post–Five Years in Breast Cancer Patients for Predicting Late Distant Recurrence: A Single-Center Investigation in Korea.docx

BackgroundEndocrine therapy is administered to hormone-positive breast cancer patients to prevent distant metastasis. It is important to evaluate the risk of recurrence and to determine which patients are viable candidates for such treatment because hormone therapy has side effects that can include postmenopausal symptoms. The Clinical Treatment Score post–five years (CTS5), a simple tool for identifying candidates for endocrine therapy, was recently introduced; however, CTS5 only has been applied in validation studies with postmenopausal women. We aimed to validate CTS5 among premenopausal breast cancer patients.
MethodsWe identified patients treated between 1994 and 2014 at Samsung Medical Center in Seoul, Korea, and followed their treatment outcomes for more than 60 months after surgery using clinicopathologic parameters. According to menopausal status, we divided the study population into two groups: pre- and postmenopausal women. After calculating CTS5 values based on some parameters, we stratified the rate of late distant recurrence (DR) and analyzed the correlation between CTS5 value and late DR by risk.
ResultsAmong 16,904 patients treated surgically for breast cancer, 2,605 with hormone receptor–positive breast cancer who received endocrine therapy were included. Of these, 1,749 (67.14%) patients were premenopausal women, and the median age was 44.00 years. When categorizing study participants according to CTS5-related risk for late DR, 86.79% were categorized as low risk, 5.95% were categorized as intermediate risk, and 7.26% were categorized as high risk. The annual rate of DR was 1.41% for those in the present study and was similar between pre- and postmenopausal participants (1.40 vs. 1.42). Distant metastasis-free survival was not different between the two groups (hazard ratio: 0.817, 95% confidence interval [CI]: 0.547–1.221). The area under the receiver operating characteristic curve at 10 years for premenopausal and postmenopausal patients was 61.75 (95% CI: 52.97–70.53) and 72.71 (95% CIs: 63.30–82.12), respectively.
ConclusionsAlthough CTS5 was able to predict late DR, it should be applied with caution in premenopausal women. A CTS5 calculator for premenopausal women might be needed to not underestimate the risk of recurrence in Korea.

【研究背景】内分泌治疗（Endocrine Therapy）被应用于激素受体阳性乳腺癌患者，以预防其发生远处转移。由于内分泌治疗存在包括绝经相关症状在内的不良反应，因此评估复发风险、筛选适宜接受该治疗的患者至关重要。术后五年临床治疗评分（Clinical Treatment Score post–five years, CTS5）是一款用于筛选内分泌治疗适宜人群的简易工具，近年已被推出；但目前CTS5仅在绝经后女性患者的验证研究中得到应用。本研究旨在针对绝经前乳腺癌患者群体开展CTS5的验证工作。
【研究方法】本研究纳入了1994年至2014年间在韩国首尔三星医疗中心接受治疗的乳腺癌患者，并通过临床病理参数追踪术后60个月以上的治疗结局。按照绝经状态，将研究人群划分为绝经前与绝经后女性两组。基于相关参数计算CTS5值后，我们对晚期远处复发（Distant Recurrence, DR）率进行分层，并按风险分层分析CTS5值与晚期远处复发的相关性。
【研究结果】在16904例接受乳腺癌手术治疗的患者中，共纳入2605例激素受体阳性且接受内分泌治疗的患者。其中1749例（67.14%）为绝经前女性，中位年龄为44.00岁。依据CTS5相关晚期远处复发风险对研究对象进行分组后，86.79%被归类为低风险组，5.95%为中风险组，7.26%为高风险组。本研究整体的年远处复发率为1.41%，绝经前与绝经后患者的年复发率相近（1.40% vs 1.42%）。两组患者的无远处转移生存期无显著差异（风险比：0.817，95%置信区间[CI]：0.547–1.221）。绝经前与绝经后患者10年受试者工作特征曲线下面积（Area Under the Receiver Operating Characteristic Curve, AUC）分别为61.75（95% CI：52.97–70.53）与72.71（95% CI：63.30–82.12）。
【研究结论】尽管CTS5能够预测晚期远处复发，但在绝经前女性患者中应用时需保持谨慎。在韩国人群中，或许需要开发针对绝经前女性的CTS5计算器，以避免低估其复发风险。