Department of Gastrointestinal Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, Shandong, China.
Department of Gastrointestinal Surgery, Shandong Provincial Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.
JAMA Netw Open. 2022 May 2;5(5):e2210861. doi: 10.1001/jamanetworkopen.2022.10861.
Two large randomized clinical trials (RCTs) found that laparoscopic surgery failed to yield noninferior pathologic outcomes compared with open surgery for patients with rectal cancer. The results raised concerns regarding the effectiveness of the laparoscopic approach for patients with rectal cancer.
To compare the long-term oncologic outcomes of laparoscopic and open surgery for patients with rectal cancer.
PubMed, Web of Science, Embase, and Cochrane Central Register of Controlled Trials were searched from database inception to August 13, 2021. Studies published in English were retrieved.
The meta-analysis included RCTs that compared laparoscopic surgery with open surgery for patients with rectal cancer and reported the outcome of disease-free survival (DFS) or overall survival (OS). The following exclusion criteria were used: (1) non-RCTs, (2) studies without long-term survival outcomes of interest, and (3) studies that did not report Kaplan-Meier survival curves.
This meta-analysis was performed in line with the Preferred Reporting Items for Systematic Reviews and Meta-analyses reporting guideline for individual participant data development groups. Individual participant data on DFS and OS were extracted from the published Kaplan-Meier survival curves. One-stage and 2-stage meta-analyses were performed.
Meta-analyses were conducted for DFS and OS. Hazard ratios (HRs) were used as effective measures.
Of 8471 records screened, 10 articles with 12 RCTs and 3709 participants were selected. The reconstructed survival curves for the combined population showed that the 5-year estimated DFS rates were 72.2% (95% CI, 69.4%-74.8%) for the laparoscopic group and 70.1% (95% CI, 67.0%-73.0%) for the open surgery group, and the 5-year estimated OS rates were 76.2% (95% CI, 73.8%-78.5%) for the laparoscopic group and 72.7% (95% CI, 69.8%-75.3%) for open surgery group. In 1-stage meta-analyses, DFS had a nonsignificant HR of 0.92 (95% CI, 0.80-1.06; P = .26), which suggested that DFS in the laparoscopic and open surgery groups was comparable; however, OS was significantly better in the laparoscopic group (HR, 0.85; 95% CI, 0.74-0.97; P = .02). The results were confirmed by 2-stage meta-analyses and were validated by sensitivity analysis with large RCTs.
A similar DFS but significantly better OS were found for patients who have undergone laparoscopic surgery compared with open surgery for rectal cancer. These findings address concerns regarding the effectiveness of laparoscopic surgery and support the routine use of laparoscopic surgery for patients with rectal cancer.
两项大型随机临床试验（RCT）发现，与开腹手术相比，腹腔镜手术未能在直肠癌患者中获得非劣效的病理结果。这些结果引发了人们对腹腔镜方法在直肠癌患者中的有效性的担忧。
比较腹腔镜与开腹手术治疗直肠癌患者的长期肿瘤学结果。
从数据库成立到 2021 年 8 月 13 日，检索了 PubMed、Web of Science、Embase 和 Cochrane 对照试验中心注册库，检索了发表的英文研究。
荟萃分析纳入了比较腹腔镜手术与开腹手术治疗直肠癌患者的 RCT，并报告了无病生存率（DFS）或总生存率（OS）的结果。使用了以下排除标准：（1）非 RCT；（2）没有长期生存结果的研究；（3）未报告 Kaplan-Meier 生存曲线的研究。
该荟萃分析是根据个体参与者数据开发组的系统评价和荟萃分析报告指南的首选报告项目进行的。从已发表的 Kaplan-Meier 生存曲线中提取 DFS 和 OS 的个体参与者数据。进行了单阶段和两阶段荟萃分析。
对 DFS 和 OS 进行荟萃分析。风险比（HR）用作有效措施。
在筛选出的 8471 条记录中，有 10 篇文章中的 12 项 RCT 和 3709 名参与者入选。合并人群的重建生存曲线显示，腹腔镜组的 5 年估计 DFS 率为 72.2%（95%CI，69.4%-74.8%），开腹手术组为 70.1%（95%CI，67.0%-73.0%），腹腔镜组的 5 年估计 OS 率为 76.2%（95%CI，73.8%-78.5%），开腹手术组为 72.7%（95%CI，69.8%-75.3%）。在单阶段荟萃分析中，DFS 的 HR 无统计学意义为 0.92（95%CI，0.80-1.06；P=0.26），这表明腹腔镜和开腹手术组的 DFS 相当；然而，腹腔镜组的 OS 显著更好（HR，0.85；95%CI，0.74-0.97；P=0.02）。两阶段荟萃分析的结果得到了证实，并通过对大型 RCT 的敏感性分析进行了验证。
与开腹手术相比，腹腔镜手术治疗直肠癌患者的 DFS 相似，但 OS 明显更好。这些发现解决了对腹腔镜手术有效性的担忧，并支持对直肠癌患者常规使用腹腔镜手术。
