Department of Medical Oncology, The Sixth Affiliated Hospital of Sun Yat-Sen University, Yuancunheng 2nd Road, Guangzhou, 510655, People's Republic of China.
Department of Oncology, Xiangya Hospital of Central South University, Changsha, China.
BMC Cancer. 2018 Nov 20;18(1):1145. doi: 10.1186/s12885-018-4997-y.
The clinical factors that accurately predict the response to preoperative treatment in rectal cancer were yet unknown. The carcinoembryonic antigen (CEA) clearance pattern during neoadjuvant treatment has been developed and the predictive value explored in rectal cancer patients with elevated CEA levels (> 5 ng/mL).
The training cohort was derived from the FOWARC prospective phase III trial, and 71/483 eligible patients were included. The validation cohort consisted of 75/587 consecutive rectal cancer patients from Xiangya Hospital between 2014 and 2015. The kinetic changes in serum CEA were measured at different time points during the neoadjuvant treatment. An exponential trend line was drawn using the CEA values. The patients were categorized into two groups based on the R value of the trend line, which indicates the correlation coefficient between the exponential graph and measured CEA values: exponential decrease group (0.9 < R ≤ 1.0) and non-exponential decrease group (R ≤ 0.9).
In multivariate analysis, the patients in the CEA exponential decrease group had significantly high adequate rate of downstaging (ypT0-2N0M0), and pathologic complete response (pCR) rates after neoadjuvant treatment in the training cohort. The predictive values of the CEA clearance pattern for tumor downstaging and pCR were further confirmed in an independent validation cohort.
The CEA clearance pattern was an independent predictor of tumor response to neoadjuvant treatment in patients with rectal cancer. It might serve as an adjunct in the assessment of complete clinical response and guide individualized treatment strategies.
NCT01211210.
目前仍不清楚哪些临床因素能够准确预测直肠癌术前治疗的反应。在癌胚抗原（CEA）水平升高（>5ng/ml）的直肠癌患者中，已经开发出并探讨了新辅助治疗期间 CEA 清除模式的预测价值。
训练队列来自 FOWARC 前瞻性 III 期试验，纳入 483 例合格患者中的 71 例。验证队列由 2014 年至 2015 年来自湘雅医院的 587 例连续直肠癌患者组成。在新辅助治疗的不同时间点测量血清 CEA 的动力学变化。使用 CEA 值绘制指数趋势线。根据趋势线的 R 值将患者分为两组，R 值表示指数图与测量的 CEA 值之间的相关系数：指数下降组（0.9<R≤1.0）和非指数下降组（R≤0.9）。
多变量分析显示，CEA 指数下降组患者在训练队列中具有更高的降期（ypT0-2N0M0）和新辅助治疗后病理完全缓解（pCR）率。CEA 清除模式对肿瘤降期和 pCR 的预测价值在独立验证队列中进一步得到证实。
CEA 清除模式是直肠癌患者对新辅助治疗反应的独立预测因子。它可能作为完全临床反应评估的辅助手段，并指导个体化治疗策略。
NCT01211210。
