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术前 C 反应蛋白-白蛋白比值对根治性胃切除术后胃癌患者早期复发和化疗获益的预测价值:使用随机 III 期试验数据。

The predictive value of the preoperative C-reactive protein-albumin ratio for early recurrence and chemotherapy benefit in patients with gastric cancer after radical gastrectomy: using randomized phase III trial data.

机构信息

Department of Gastric Surgery, Fujian Medical University Union Hospital, No. 29 Xinquan Road, Fuzhou, 350001, Fujian, China.

Department of General Surgery, Fujian Medical University Union Hospital, Fuzhou, China.

出版信息

Gastric Cancer. 2019 Sep;22(5):1016-1028. doi: 10.1007/s10120-019-00936-w. Epub 2019 Feb 9.

DOI:10.1007/s10120-019-00936-w
PMID:30739259
Abstract

BACKGROUND

The definition and predictors of early recurrence (ER) for gastric cancer (GC) patients after radical gastrectomy are unclear.

METHODS

A minimum-p value approach was used to evaluate the optimal cutoff value of recurrence-free survival to determine ER and late recurrence (LR). Receiver operating characteristic curves were generated for inflammatory indices. Potential risk factors for ER were assessed with a Cox regression model. A decision curve analysis was performed to evaluate the clinical utility.

RESULTS

A total of 401 patients recruited in a clinical trial (NCT02327481) from January 2015 to April 2016 were included in this study. The optimal length of recurrence-free survival to distinguish between ER (n = 44) and LR (n = 52) was 12 months. Factors associated with ER included a preoperative C-reactive protein-albumin ratio (CAR) ≥ 0.131, stage III and postoperative adjuvant chemotherapy (PAC) > 3 cycles. The risk model consisting of both the CAR and TNM stage had a higher predictive ability and better clinical utility than TNM stage alone. Further stratification analysis of the stage III patients found that for the patients with a CAR < 0.131, both PAC with 1-3 cycles (p = 0.029) and > 3 cycles (p < 0.001) could reduce the risk of ER. However, for patients with a CAR ≥ 0.131, a benefit was observed only if they received PAC > 3 cycles (54.2% vs 16.0%, p = 0.004), rather than 1-3 cycles (58.3% vs 54.2%, p = 0.824).

CONCLUSIONS

A recurrence-free interval of 12 months was found to be the optimal threshold for differentiating between ER and LR. Preoperative CAR was a promising predictor of ER and PAC response. PAC with 1-3 cycles may not exert a protective effect against ER for stage III GC patients with CAR ≥ 0.131.

摘要

背景

根治性胃切除术后胃癌(GC)患者早期复发(ER)的定义和预测因素尚不清楚。

方法

采用最小 p 值法评估无复发生存的最佳截断值,以确定 ER 和晚期复发(LR)。为炎症指标生成了受试者工作特征曲线。采用 Cox 回归模型评估 ER 的潜在危险因素。进行决策曲线分析以评估临床实用性。

结果

本研究共纳入了 2015 年 1 月至 2016 年 4 月参加临床试验(NCT02327481)的 401 名患者。区分 ER(n=44)和 LR(n=52)的最佳无复发生存期长度为 12 个月。与 ER 相关的因素包括术前 C 反应蛋白-白蛋白比值(CAR)≥0.131、III 期和术后辅助化疗(PAC)>3 个周期。由 CAR 和 TNM 分期组成的风险模型比 TNM 分期单独具有更高的预测能力和更好的临床实用性。对 III 期患者的进一步分层分析发现,对于 CAR<0.131 的患者,1-3 个周期(p=0.029)和>3 个周期(p<0.001)的 PAC 均可降低 ER 风险。然而,对于 CAR≥0.131 的患者,仅在接受 PAC>3 个周期时观察到获益(54.2%比 16.0%,p=0.004),而接受 1-3 个周期时则无获益(58.3%比 54.2%,p=0.824)。

结论

发现无复发生存期 12 个月是区分 ER 和 LR 的最佳阈值。术前 CAR 是 ER 的有前途的预测指标,也是 PAC 反应的预测指标。对于 CAR≥0.131 的 III 期 GC 患者,PAC 1-3 个周期可能对 ER 没有保护作用。