General Surgery Dept. 1, Zhongshan People's Hospital, Zhongshan Hospital of Sun Yat-Sen University, Zhongshan, China.
School of Public Health and Preventive Medicine, Monash University, Clayton, Australia.
Hepatol Int. 2021 Oct;15(5):1215-1235. doi: 10.1007/s12072-021-10219-1. Epub 2021 Jul 13.
BACKGROUND/PURPOSE OF THE STUDY: Laparoscopic hepatectomy (LH) has been widely used in the treatment of hepatocellular carcinoma (HCC). It is generally believed that the long-term outcomes of LH are not inferior to open hepatectomy (OH). However, the quality of evidence is low. The purpose of this study was to reconstruct time-to-event data for meta-analysis based on Kaplan-Meier curves from propensity-score matched studies and compare survival rates following LH and OH for hepatocellular carcinoma.
All published propensity-score matched studies reported in English that compared LH and OH for hepatocellular carcinoma with Kaplan-Meier curves were screened. Patients' survival information was reconstructed with the aid of a computer vision program. Different models (fixed-effects model for two-stage survival analysis and Cox regression for one-stage survival analysis) were performed for sensitivity analysis. In addition to the primary meta-analysis, two specific subgroup analyses were performed on patients by types of resection, cirrhosis status.
Time-to-event data were extracted from 45 propensity-score matched studies (N = 8905). According to the time-to-event data and the reconstructed Kaplan-Meier curves, the cumulative overall survival rate was 49.0% and 50.9% in the LH and OH cohorts, respectively, a log-rank test did not demonstrate statistical significance (p > 0.05). The cumulative recurrence-free survival (RFS) probability was both close to 0.0%. The median RFS time was 49.1 (95% CI 46.1 ~ 51.7) and 44.3 (95% CI 41 ~ 46.1) months. The difference in disease status was statistically significant by the Log-rank test (p < 0.05). Using the random-effects model of two-stage analysis, the minor hepatectomy subgroup (HR = 1.32, 95% CI [1.09, 1.55], I = 6.2%, p = 0.383) and the shared fragile model of one-stage analysis (HR = 1.44 95% CI [1.23, 1.69], p < 0.001) suggested that LH could significantly prolong RFS of patients compared with OH. This result was consistent with sensitivity analysis using different models.
This study was the first reconstructed time-to-event data based on a high-quality propensity-score matching study to compare the survival outcomes of LH and OH in the treatment of HCC. Results suggested that LH can improve RFS in patients with HCC undergoing minor hepatectomy and may also benefit long-term RFS in overall patients.
背景/研究目的:腹腔镜肝切除术(LH)已广泛应用于肝细胞癌(HCC)的治疗。一般认为,LH 的长期疗效并不逊于开腹肝切除术(OH)。然而,证据质量较低。本研究的目的是基于倾向评分匹配研究的 Kaplan-Meier 曲线,为荟萃分析重建时间事件数据,并比较 LH 和 OH 治疗肝细胞癌的生存率。
筛选了所有以英语发表的、比较 LH 和 OH 治疗 HCC 并报告 Kaplan-Meier 曲线的已发表倾向评分匹配研究。借助计算机视觉程序重建患者的生存信息。采用不同的模型(两阶段生存分析的固定效应模型和单阶段生存分析的 Cox 回归模型)进行敏感性分析。除了主要的荟萃分析外,还根据切除类型和肝硬化状态对两组患者进行了两次特定的亚组分析。
从 45 项倾向评分匹配研究中提取时间事件数据(N=8905)。根据时间事件数据和重建的 Kaplan-Meier 曲线,LH 组和 OH 组的累积总生存率分别为 49.0%和 50.9%,对数秩检验无统计学意义(p>0.05)。累积无复发生存(RFS)概率均接近 0.0%。中位 RFS 时间为 49.1(95%CI 46.151.7)和 44.3(95%CI 4146.1)个月。Log-rank 检验显示疾病状态差异有统计学意义(p<0.05)。采用两阶段分析的随机效应模型,亚肝切除术亚组(HR=1.32,95%CI[1.09,1.55],I=6.2%,p=0.383)和单阶段分析的共享脆弱模型(HR=1.44,95%CI[1.23,1.69],p<0.001)提示 LH 可显著延长 OH 患者的 RFS。该结果与不同模型的敏感性分析结果一致。
这是第一项基于高质量倾向评分匹配研究,重建时间事件数据,比较 LH 和 OH 治疗 HCC 患者生存结局的研究。结果表明,LH 可改善行亚肝切除术 HCC 患者的 RFS,可能对整体患者的长期 RFS也有益。