新辅助放化疗后超声内镜下径向肿瘤厚度预测局部晚期食管癌患者的反应和生存：瑞士临床癌症研究组（SAKK 75/02）的一项前瞻性多中心 II 期研究。

Endosonographic radial tumor thickness after neoadjuvant chemoradiation therapy to predict response and survival in patients with locally advanced esophageal cancer: a prospective multicenter phase ll study by the Swiss Group for Clinical Cancer Research (SAKK 75/02).

机构信息

Department of Gastroenterology, Kantonsspital St. Gallen, St. Gallen, Switzerland.

出版信息

Gastrointest Endosc. 2010 Jun;71(7):1114-21. doi: 10.1016/j.gie.2009.12.015. Epub 2010 Mar 20.

DOI:10.1016/j.gie.2009.12.015

PMID:20304399

Abstract

BACKGROUND

EUS response assessment in patients with locally advanced esophageal cancer undergoing neoadjuvant chemoradiation therapy (CRT) is limited by disintegration of the involved anatomic structures.

OBJECTIVE

Predictive and prognostic values of a prospectively defined maximum tumor thickness (MTT).

DESIGN

Prospective open-label phase ll study (SAKK 75/02).

SETTING

Multicenter, nationwide.

PATIENTS

Of 66 patients with primary CRT, 56 underwent en bloc esophagectomy.

INTERVENTIONS

EUS-measured MTT before and 2-5 weeks after CRT (yMTT).

MAIN OUTCOME MEASUREMENTS

Cutoffs: (1) absolute thickness (yMTT) after CRT < or = 6 mm; (2) relative reduction compared with baseline (ratio yMTT/MTT) < or = 50%. Correlation between EUS measurements and histopathologic tumor regression grade (TRG) and overall survival (OS).

RESULTS

Sixteen of 56 patients were not included for EUS evaluation (10 severe stenosis, 5 MTT not measured, 1 intolerance to second EUS). Characteristics (n = 40) were as follow: median age, 60 years; squamous cell carcinoma, 42%; and adenocarcinoma (AC), 58%. Initial stage was: 10 T2N1, 3 T3N0, 26 T3N1, 1 T3Nx; 14 of 23 AC Siewert type 1. Wilcoxon rank sum test showed significant correlation of TRG1 with yMTT < or = 6 mm (P = .008) and yMTT/MTT < or = 50% (P = .003). The effect of yMTT on TRG1 was significant (P = .0193; odds ratio, 0.687 [95% CI, 0.502-0.941]). The predefined cutoff of < or = 6 mm for yMTT was predictive for TRG1 (P = .0037; Fisher exact test). After a median follow-up of 28.6 months, there was a clear trend for benefit in OS with yMTT < or = 6 mm and yMTT/MTT < or = 50%.

LIMITATIONS

Small sample size.

CONCLUSION

In a multicenter setting, MTT measured by EUS after CRT was highly predictive for response and showed a clear trend for predicting survival.

摘要

背景

在接受新辅助放化疗（CRT）的局部晚期食管癌患者中，EUS 反应评估受到受累解剖结构崩解的限制。

目的

预测和预后价值的前瞻性定义的最大肿瘤厚度（MTT）。

设计

前瞻性开放标签 II 期研究（SAKK 75/02）。

设置

多中心，全国性的。

患者

66 例原发性 CRT 患者中，56 例行整块食管切除术。

干预

EUS 测量 CRT 前后的最大肿瘤厚度（yMTT）。

主要观察指标

截止值：（1）CRT 后绝对厚度（yMTT）≤6mm；（2）与基线相比的相对减少（比值 yMTT/MTT）≤50%。EUS 测量值与组织病理学肿瘤消退分级（TRG）和总生存期（OS）的相关性。

结果

16 例患者未纳入 EUS 评估（10 例严重狭窄，5 例 MTT 未测量，1 例不能耐受第二次 EUS）。特征（n=40）如下：中位年龄 60 岁；鳞状细胞癌 42%；腺癌（AC）58%。初始分期为：10 例 T2N1，3 例 T3N0，26 例 T3N1，1 例 T3Nx；23 例 AC 中 14 例为 Siewert 1 型。Wilcoxon 秩和检验显示，TRG1 与 yMTT≤6mm（P=0.008）和 yMTT/MTT≤50%（P=0.003）显著相关。yMTT 对 TRG1 的影响具有统计学意义（P=0.0193；优势比，0.687[95%CI，0.502-0.941]）。yMTT≤6mm 的预设截止值对 TRG1 具有预测价值（P=0.0037；Fisher 确切检验）。中位随访 28.6 个月后，yMTT≤6mm 和 yMTT/MTT≤50%的患者 OS 明显获益。