编者按：对于已经完成5年内分泌治疗的激素受体阳性乳腺癌女性，预测远期远处复发风险，是决定有无必要延长内分泌治疗的重要步骤。不过，现有预测工具过于复杂，而且太贵，例如多基因检测，临床难以推广。
2018年4月20日，美国临床肿瘤学会《临床肿瘤学杂志》在线发表英国伦敦大学癌症研究院、皇家马斯登医院、伦敦玛丽王后大学、美国哈佛大学医学院、达纳法伯癌症研究所、意大利米兰大学、欧洲肿瘤研究所、瑞士临床癌症研究协作组、圣加仑州立医院、国际乳腺癌研究协作组（IBCSG）的研究报告，开发并验证了一种简单整合病理学变量的5年临床治疗评分工具（CTS5），对雌激素受体阳性乳腺癌患者5年内分泌治疗后残癌远期远处复发风险进行了预测。
该研究利用阿那曲唑、他莫昔芬单药或联合研究（ATAC）4735例患者数据集创建了5年后远处复发风险的预后评分（CTS5），随后利用BIG 1-98研究6711例患者数据集检验了CTS5（ATAC）的有效性。主要终点为完成5年内分泌治疗后至远期远处复发的时间。通过多变量比例回归模型对CTS5（ATAC）的预后效果进行估算。
CTS5（ATAC）＝0.471×阳性淋巴结数＋0.980×（0.164×肿瘤大小－0.003×肿瘤大小平方＋0.312×肿瘤分级＋0.03×年龄）
结果发现，CTS5（ATAC）能够较好预测远期远处复发风险：
ATAC风险比：2.47（95%置信区间：2.24～2.73，P<0.001）
BIG 1-98风险比：2.07（95%置信区间：1.88～2.28，P<0.001）
根据训练队列（演算组）CTS5（ATAC）风险分层定义（5～10年远处复发风险<5%为低，5%～10%为中，>10%为高）确认验证队列（验算组）低风险占43%，其5～10年所见远处复发率为3.6%（95%置信区间：2.7%～4.9%）。
淋巴结阴性患者低风险占63%，5～10年远处复发率为3.9%（95%置信区间：2.9%～5.3%）；淋巴结阳性1～3个低风险占24%，5～10年远处复发率为1.5%（95%置信区间：0.5%～3.8%）。
最终的CTS5根据ATAC和BIG 1-98研究汇总数据进行了调整。
最终的CTS5＝0.438×阳性淋巴结数＋0.988×（0.093×肿瘤大小－0.001×肿瘤大小平方＋0.375×肿瘤分级＋0.017×年龄）
因此，CTS5是一种简单的工具，数据来自所有临床医生随时可以获取的信息，已被BIG 1-98独立研究证实对于远期远处复发的预后准确率较高。最终的CTS5算法确定42%的女性每年远处复发风险低于1%，可以告之没有必要延长内分泌治疗。
J Clin Oncol. 2018 Apr 20. [Epub ahead of print]
Integration of Clinical Variables for the Prediction of Late Distant Recurrence in Patients With Estrogen Receptor-Positive Breast Cancer Treated With 5 Years of Endocrine Therapy: CTS5.
Dowsett M, Sestak I, Regan MM, Dodson A, Viale G, Thürlimann B, Colleoni M, Cuzick J.
Royal Marsden Hospital; Institute of Cancer Research; Queen Mary University of London, London, United Kingdom; Dana Farber Cancer Institute and Harvard Medical School, Boston, MA; University of Milan; European Institute of Oncology, Milan, Italy; Kantonsspital St Gallen, St Gallen; International Breast Cancer Study Group; Swiss Group for Clinical Cancer Research, Berne, Switzerland.
PURPOSE: Estimating risk of late distant recurrence (DR) is an important goal for managing women with hormone receptor-positive breast cancer after 5 years of endocrine treatment without recurrence. We developed and validated a simple clinicopathologic tool (Clinical Treatment Score post-5 years [CTS5]) to estimate residual risk of DR after 5 years of endocrine treatment.
PATIENTS AND METHODS: The ATAC (Arimidex, Tamoxifen, Alone or in Combination) data set (N = 4,735) was used to create a prognostic score for post-5-year risk of DR. Validity of CTS5 (ATAC) was tested in the BIG 1-98 data set (N = 6,711). Time to late DR, 5 years after finishing scheduled endocrine therapy, was the primary end point. Cox regression models estimated the prognostic performance of CTS5 (ATAC).
RESULTS: CTS5 (ATAC) was significantly prognostic for late DR in the ATAC cohort (hazard ratio, 2.47; 95% CI, 2.24 to 2.73; P < .001) and BIG 1-98 validation cohort (hazard ratio, 2.07; 95% CI, 1.88 to 2.28; P < .001). CTS5 (ATAC) risk stratification defined in the training cohort as low (< 5% DR risk, years 5 to 10), intermediate (5% to 10%), or high (> 10%) identified 43% of the validation cohort as low risk, with an observed DR rate of 3.6% (95% CI, 2.7% to 4.9%) during years 5 to 10. From years 5 to 10, 63% of node-negative patients were low risk, with a DR rate of 3.9% (95% CI, 2.9% to 5.3%), and 24% with one to three positive nodes were low risk, with a DR rate of 1.5% (95% CI, 0.5% to 3.8%). A final CTS5 for future use was derived from pooled data from ATAC and BIG 1-98.
CONCLUSION: CTS5 is a simple tool based on information that is readily available to all clinicians. CTS5 was validated as highly prognostic for late DR in the independent BIG 1-98 study. The final CTS5 algorithm identified 42% of women with < 1% per-year risk of DR who could be advised of the limited potential value of extended endocrine therapy.
PMID: 29676944
DOI: 10.1200/JCO.2017.76.4258
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