DataSheet_1_Operative and Oncological Outcomes Comparing Sentinel Node Mapping and Systematic Lymphadenectomy in Endometrial Cancer Staging: Meta-Analysis With Trial Sequential Analysis.docx

ObjectiveTo evaluate the utility of sentinel lymph node mapping (SLN) in endometrial cancer (EC) patients in comparison with lymphadenectomy (LND).
MethodsComprehensive search was performed in MEDLINE, EMBASE, CENTRAL, OVID, Web of science databases, and three clinical trials registration websites, from the database inception to September 2020. The primary outcomes covered operative outcomes, nodal assessment, and oncological outcomes. Software Revman 5.3 was used. Trial sequential analysis (TSA) and Grading of Recommendations Assessment, Development, and Evaluation (GRADE) were performed.
ResultsOverall, 5,820 EC patients from 15 studies were pooled in the meta-analysis: SLN group (N = 2,152, 37.0%), LND group (N = 3,668, 63.0%). In meta-analysis of blood loss, SLN offered advantage over LND in reducing operation bleeding (I2 = 74%, P<0.01). Z-curve of blood loss crossed trial sequential monitoring boundaries though did not reach TSA sample size. There was no difference between SLN and LND in intra-operative complications (I2 = 7%, P = 0.12). SLN was superior to LND in detecting positive pelvic nodes (P-LN) (I2 = 36%, P<0.001), even in high risk patients (I2 = 36%, P = 0.001). While no difference was observed in detection of positive para-aortic nodes (PA-LN) (I2 = 47%, P = 0.76), even in high risk patients (I2 = 62%, P = 0.34). Analysis showed no difference between two groups in the number of resected pelvic nodes (I2 = 99%, P = 0.26). SLN was not associated with a statistically significant overall survival (I2 = 79%, P = 0.94). There was no difference in progression-free survival between SLN and LND (I2 = 52%, P = 0.31). No difference was observed in recurrence. Based on the GRADE assessment, we considered the quality of current evidence to be moderate for P-LN biopsy, low for items like blood loss, PA-LN positive.
ConclusionThe present meta-analysis underlines that SLN is capable of reducing blood loss during operation in regardless of surgical approach with firm evidence from TSA. SLN mapping is more targeted for less node dissection and more detection of positive lymph nodes even in high risk patients with conclusive evidence from TSA. Utility of SLN yields no survival detriment in EC patients.

目的：对比前哨淋巴结绘图（Sentinel Lymph Node Mapping, SLN）与淋巴结清扫术（Lymphadenectomy, LND）在子宫内膜癌（Endometrial Cancer, EC）患者中的应用价值。
方法：本研究从各数据库建库时至2020年9月，对MEDLINE、EMBASE、CENTRAL、OVID、Web of Science数据库及3个临床试验注册网站开展全面检索。主要结局指标涵盖手术相关结局、淋巴结评估结果及肿瘤学结局。采用Revman 5.3软件进行数据分析，并实施了试验序贯分析（Trial Sequential Analysis, TSA）与推荐分级的评估、制定与评价（Grading of Recommendations Assessment, Development and Evaluation, GRADE）。
结果：本荟萃分析共纳入15项研究的5820例子宫内膜癌患者，其中前哨淋巴结绘图组2152例（占比37.0%），淋巴结清扫术组3668例（占比63.0%）。在术中失血量的荟萃分析中，前哨淋巴结绘图组较淋巴结清扫术组可显著减少术中失血（I²=74%，P<0.01）。术中失血量的Z曲线跨越了试验序贯监测界值，但未达到试验序贯分析所需的样本量。两组患者术中并发症发生率无显著差异（I²=7%，P=0.12）。前哨淋巴结绘图组在检测盆腔阳性淋巴结（Pelvic Positive Lymph Nodes, P-LN）方面优于淋巴结清扫术组（I²=36%，P<0.001），即使在高危患者中亦是如此（I²=36%，P=0.001）。但两组在检测腹主动脉旁阳性淋巴结（Para-aortic Positive Lymph Nodes, PA-LN）方面无显著差异（I²=47%，P=0.76），即使在高危患者中亦无差异（I²=62%，P=0.34）。分析显示，两组切除的盆腔淋巴结数目无显著差异（I²=99%，P=0.26）。两组患者总生存率无统计学显著差异（I²=79%，P=0.94）。两组无进展生存率亦无显著差异（I²=52%，P=0.31）。两组复发率无显著差异。基于GRADE分级评估，本研究认为盆腔阳性淋巴结活检相关证据质量为中等，术中失血量、腹主动脉旁阳性淋巴结检测等相关证据质量为低等。
结论：本荟萃分析证实，无论采用何种手术入路，前哨淋巴结绘图均可减少术中失血量，试验序贯分析为该结论提供了坚实的证据支持。前哨淋巴结绘图具有更强的淋巴结清扫靶向性，可在减少淋巴结切除范围的同时更高效地检出阳性淋巴结，即使在高危患者中亦是如此，且该结论得到了试验序贯分析的确证证据。将前哨淋巴结绘图应用于子宫内膜癌患者，不会对患者的生存结局产生不利影响。