术后 CEA 与 II 期结肠癌患者生存和奥沙利铂获益的关系：MOSAIC 试验的事后分析。
Association of post-operative CEA with survival and oxaliplatin benefit in patients with stage II colon cancer: a post hoc analysis of the MOSAIC trial.
机构信息
Department of Hepato-Gastroenterology and Gastrointestinal Oncology, Sorbonne Paris-Cité, Paris Descartes University, Hôpital Européen Georges Pompidou, Paris, France.
Methodology and Quality of Life Unit in Oncology, University Hospital of Besançon, Besançon, France.
出版信息
Br J Cancer. 2019 Aug;121(4):312-317. doi: 10.1038/s41416-019-0521-7. Epub 2019 Jul 12.
BACKGROUND
Adjuvant treatment for stage II colon cancer (CC) can be proposed to patients with high-risk disease. Recently, 2.35 ng/mL carcinoembryonic antigen (CEA) was identified as the best cut-off value. This post hoc analysis of the MOSAIC trial assessed post-operative CEA prognostic value for survival outcomes and predictive value for the addition of oxaliplatin to adjuvant treatment.
METHODS
Prognostic and predictive values of post-operative CEA in patients with stage II CC were evaluated with Kaplan-Meier survival curves and Cox model with interaction terms. Disease-free survival (DFS) and overall survival (OS) were estimated.
RESULTS
Among 899 stage II CC patients, post-operative CEA was available in 867 (96.4%); and 434 (48.65%) had a high-risk stage II disease. The 3-year DFS rate was 88.5% and 78.7% in the ≤ 2.35 ng/mL and > 2.35 ng/mL group, respectively (P = 0.006). Use of oxaliplatin showed survival benefit only in patients with high-risk stage II CC and post-operative CEA > 2.35 ng/ml (interaction term P = 0.09 and 0.03 for DFS and OS).
CONCLUSION
CEA is a strong prognostic factor for DFS and OS in stage II CC. In the MOSAIC trial, only high-risk stage II CC patients with post-operative CEA > 2.35 ng/mL benefited from the addition of oxaliplatin to LV5FU2.
TRIAL REGISTRATION
NCT00275210 (January 11, 2006).
背景
对于 II 期结肠癌（CC）患者，可以提出辅助治疗高危疾病。最近，2.35ng/mL 癌胚抗原（CEA）被确定为最佳截断值。MOSAIC 试验的这项事后分析评估了术后 CEA 对生存结果的预后价值，以及对奥沙利铂添加到辅助治疗中的预测价值。
方法
采用 Kaplan-Meier 生存曲线和 Cox 模型及其交互项评估 II 期 CC 患者术后 CEA 的预后和预测价值。估计无病生存期（DFS）和总生存期（OS）。
结果
在 899 例 II 期 CC 患者中，867 例（96.4%）有术后 CEA 数据；434 例（48.65%）患有高危 II 期疾病。≤2.35ng/mL 和>2.35ng/mL 组的 3 年 DFS 率分别为 88.5%和 78.7%（P=0.006）。仅在高危 II 期 CC 和术后 CEA>2.35ng/ml 的患者中，奥沙利铂的使用显示出生存获益（DFS 和 OS 的交互项 P 值分别为 0.09 和 0.03）。
结论
CEA 是 II 期 CC 患者 DFS 和 OS 的强有力预后因素。在 MOSAIC 试验中，只有术后 CEA>2.35ng/ml 的高危 II 期 CC 患者从 LV5FU2 中添加奥沙利铂中获益。
试验注册
NCT00275210（2006 年 1 月 11 日）。
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