腹腔镜与开放手术治疗临床 II/III 期胃癌的长期疗效：日本多中心队列研究（LOC-A 研究）。
Long-term Outcomes of Laparoscopic Versus Open Surgery for Clinical Stage II/III Gastric Cancer: A Multicenter Cohort Study in Japan (LOC-A Study).
机构信息
Gastric Surgery Division, National Cancer Center Hospital East, Kashiwa, Japan.
Department of Surgery, Fujita Health University, Toyoake, Japan.
出版信息
Ann Surg. 2019 May;269(5):887-894. doi: 10.1097/SLA.0000000000002768.
OBJECTIVE
A large-scale multicenter historical cohort study was conducted to investigate the efficacy of laparoscopic gastrectomy (LG) in comparison to open gastrectomy (OG) for locally advanced gastric cancer.
BACKGROUND
LG is now practiced widely, but its applicability for advanced gastric cancer is still controversial. As oncologic outcomes of randomized trials are still pending, there is an urgent need for information that would be relevant to current practice.
METHODS
Through a consensus meeting involving surgeons and biostatisticians, 30 preoperative variables possibly influencing the choice of surgical approach and associated with outcome were identified to enable rigorous estimation of propensity scores. A total of 1948 consecutive patients who underwent gastrectomy for clinical stage II/III gastric adenocarcinoma between 2008 and 2014 were identified, and their clinical data were collected from 8 participating hospitals. After propensity score matching, 610 cases (OG = 305, LG = 305) were finally selected for comparison of long-term outcomes.
RESULTS
In the propensity-matched OG and LG populations, the mean observation period was 3.5 and 3.4 years, and the 5-year overall survival was 53.0% and 54.2%, respectively. The hazard ratio (LG/OG) for overall survival was 1.01 (95% confidence interval, 0.80-1.29), and noninferiority of LG was demonstrated statistically as the upper 95% confidence limit was less than the prespecified margin (1.33). The recurrence rate was 30.8% and 29.8% for OG and LG, respectively, and the hazard ratio for recurrence was 0.98 (95% confidence interval, 0.74-1.31). The patterns of recurrence in the 2 groups were similar.
CONCLUSIONS
This observational study strictly adjusted for confounding factors has provided evidence to suggest that LG is oncologically comparable to OG for locally advanced gastric cancer. The validity of this result will be examined in ongoing randomized trials.
目的
本大规模多中心历史队列研究旨在探讨腹腔镜胃切除术（LG）与开腹胃切除术（OG）治疗局部进展期胃癌的疗效。
背景
LG 目前已广泛应用，但对于进展期胃癌的适用性仍存在争议。由于随机试验的肿瘤学结果仍有待确定，因此迫切需要提供与当前实践相关的信息。
方法
通过涉及外科医生和生物统计学家的共识会议，确定了 30 个术前变量，这些变量可能影响手术方式的选择，并与结果相关，以实现倾向评分的严格估计。共纳入 2008 年至 2014 年间接受临床 II/III 期胃腺癌胃切除术的 1948 例连续患者，并从 8 家参与医院收集其临床数据。经过倾向评分匹配后，最终选择 610 例（OG=305，LG=305）进行长期结果比较。
结果
在匹配的 OG 和 LG 人群中，平均观察期分别为 3.5 年和 3.4 年，5 年总生存率分别为 53.0%和 54.2%。总生存的风险比（LG/OG）为 1.01（95%置信区间，0.80-1.29），LG 具有非劣效性，因为上限 95%置信区间小于预设的边界（1.33）。OG 和 LG 的复发率分别为 30.8%和 29.8%，复发的风险比为 0.98（95%置信区间，0.74-1.31）。两组的复发模式相似。
结论
这项严格调整混杂因素的观察性研究提供了证据，表明 LG 在肿瘤学上与 OG 治疗局部进展期胃癌相当。正在进行的随机试验将检验这一结果的有效性。
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