Mitch Dowsett and Andrew Dodson, Royal Marsden Hospital; Mitch Dowsett, Institute of Cancer Research; Ivana Sestak and Jack Cuzick, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, United Kingdom; Meredith M. Regan, Dana Farber Cancer Institute and Harvard Medical School, Boston, MA; Giuseppe Viale, University of Milan; Guiseppe Viale and Marco Colleoni, European Institute of Oncology, Milan, Italy; Beat Thürlimann, Kantonsspital St Gallen, St Gallen, and International Breast Cancer Study Group and Swiss Group for Clinical Cancer Research, Berne, Switzerland.
J Clin Oncol. 2018 Jul 1;36(19):1941-1948. doi: 10.1200/JCO.2017.76.4258. Epub 2018 Apr 20.
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.
对于接受 5 年内分泌治疗且无复发的激素受体阳性乳腺癌患者，评估远处无病生存期（DR）的延迟复发风险是管理的重要目标。我们开发并验证了一种简单的临床病理工具（5 年后临床治疗评分，CTS5），以估计内分泌治疗 5 年后 DR 的残留风险。
使用 ATAC（阿那曲唑、他莫昔芬、单独或联合）数据集（N=4735）创建用于预测 5 年后 DR 风险的预后评分。在 BIG 1-98 数据集（N=6711）中验证了 CTS5（ATAC）的有效性。主要终点为结束计划内分泌治疗后 5 年的晚期 DR 时间。Cox 回归模型估计了 CTS5（ATAC）的预后性能。
CTS5（ATAC）在 ATAC 队列中对晚期 DR 具有显著的预后意义（风险比，2.47；95%CI，2.24 至 2.73；P<0.001）和 BIG 1-98 验证队列（风险比，2.07；95%CI，1.88 至 2.28；P<0.001）。在训练队列中，将 CTS5（ATAC）风险分层定义为低（<5%DR 风险，第 5 年至第 10 年）、中（5%至 10%）或高（>10%），43%的验证队列被确定为低风险，在第 5 年至第 10 年期间观察到的 DR 率为 3.6%（95%CI，2.7%至 4.9%）。从第 5 年到第 10 年，63%的淋巴结阴性患者为低风险，DR 率为 3.9%（95%CI，2.9%至 5.3%），有 1 至 3 个阳性淋巴结的患者中有 24%为低风险，DR 率为 1.5%（95%CI，0.5%至 3.8%）。最终的 CTS5 是从 ATAC 和 BIG 1-98 的汇总数据中推导出来的。
CTS5 是一种基于所有临床医生都能轻易获得的信息的简单工具。在独立的 BIG 1-98 研究中，CTS5 被验证对晚期 DR 具有高度的预后意义。最终的 CTS5 算法确定了 42%的 DR 年风险<1%的女性，她们可以被建议延长内分泌治疗的潜在价值有限。
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