Pyo Jeung Hui, Lee Hyuk, Min Byung-Hoon, Lee Jun Haeng, Choi Min Gew, Lee Jun Ho, Sohn Tae Sung, Bae Jae Moon, Kim Kyung-Mee, Ahn Joong Hyun, Carriere Keumhee C, Kim Jae J, Kim Sung
Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Am J Gastroenterol. 2016 Feb;111(2):240-9. doi: 10.1038/ajg.2015.427. Epub 2016 Jan 19.
Few studies have compared the long-term outcomes of endoscopic resection and surgery. The aim of this study was to compare the long-term outcomes of endoscopic resection with those of surgery for early gastric cancer (EGC).
We reviewed prospectively collected data of patients who had undergone endoscopic resection (1,290 patients) or surgery (1,273 patients) for EGC. To reduce the effect of selection bias, we performed a propensity score-matching analysis between the two groups. The primary outcome was overall survival (OS). The secondary outcomes were disease-specific survival, disease-free survival (DFS), recurrence-free survival (RFS), occurrence of metachronous gastric cancer, treatment-related complications, length of hospital stay, and 30-day outcomes. The study was designed as a non-inferiority study and tested in an intention-to-treat analysis.
In a propensity-matched analysis of 611 pairs, the 10-year OS proportion was 96.7% in the endoscopic resection group and 94.9% in the surgery group (P=0.120) (risk difference -1.8%, 95% confidence interval (CI) -4.04-0.44, Pnon-inferiority=0.014), which met the non-inferiority criterion. In contrast, the 10-year RFS proportion was 93.5% in the endoscopic resection group and 98.2% in the surgery group (P<0.001) (risk difference 4.7%, 95% CI 2.50-6.97, Pnon-inferiority=0.820), which did not meet the non-inferiority criterion, mainly because of metachronous recurrence in the endoscopic resection group. The rate of early complications was higher in the endoscopic resection group than in the surgery group (9.0 vs. 6.6%, P=0.024), whereas the rate of late complications was higher in the surgery group than in the endoscopic resection group (0.5 vs. 2.9%, P<0.001). In the multiple Cox regression analysis, patient's age, the comorbidity index, the performance index, sex, tumor morphology, and depth of invasion were predictors of OS in patients with EGC.
Endoscopic resection might not be inferior to surgery with respect to OS in patients with EGC lesions that meet the absolute or expanded criteria. However, DFS, RFS, and metachronous RFS might be lower after endoscopic resection than after surgery.
很少有研究比较内镜切除术和手术的长期疗效。本研究旨在比较早期胃癌(EGC)内镜切除术与手术的长期疗效。
我们回顾了前瞻性收集的接受EGC内镜切除术(1290例患者)或手术(1273例患者)的患者数据。为减少选择偏倚的影响,我们对两组进行了倾向评分匹配分析。主要结局是总生存期(OS)。次要结局包括疾病特异性生存期、无病生存期(DFS)、无复发生存期(RFS)、异时性胃癌的发生、治疗相关并发症、住院时间和30天结局。本研究设计为非劣效性研究,并在意向性分析中进行检验。
在611对倾向评分匹配分析中,内镜切除组10年OS比例为96.7%,手术组为94.9%(P=0.120)(风险差异-1.8%,95%置信区间(CI)-4.04-0.44,非劣效性P=0.014),符合非劣效性标准。相比之下,内镜切除组10年RFS比例为93.5%,手术组为98.2%(P<0.001)(风险差异4.7%,95%CI 2.50-6.97,非劣效性P=0.820),未达到非劣效性标准,主要原因是内镜切除组出现异时性复发。内镜切除组早期并发症发生率高于手术组(9.0%对6.6%,P=0.024),而手术组晚期并发症发生率高于内镜切除组(0.5%对2.9%,P<0.001)。在多因素Cox回归分析中,患者年龄、合并症指数、体能指数、性别、肿瘤形态和浸润深度是EGC患者OS的预测因素。
对于符合绝对或扩展标准的EGC病变患者而言,内镜切除术在OS方面可能不劣于手术。然而,内镜切除术后的DFS、RFS和异时性RFS可能低于手术。