| Background:Endometrial cancer is a common gynecological malignancy.Lymph node information is important for evaluating prognosis and choosing adjuvant therapy for patients with endometrial cancer.At present,the most prevalent method is to divide endometrial cancer patients into lowrisk and high-risk according to the "Mayo Criteria".High-risk patients undergo systemic lymphadenectomy(LAD),but systemic LAD brings unneglected intraoperative and postoperative complications.Moreover,80% of high-risk patients who have not metastasized will suffer unnecessary dissection.Sentinel lymph node(SLN)refers to the first node influenced when primary malignant tumor undergoes lymphatic metastasis through the regional lymphatic drainage pathway.It can reflect the involvement of lymph nodes in the entire drainage region.Current prospective and retrospective clinical studies have shown that the application of sentinel lymph node mapping(SLNM)combined with pathologic ultra-staging in patients with early-stage low-risk endometrial cancer has satisfactory SLN detection rate,sensitivity,and negative predictive value(NPV)without affecting progression-free survival(PFS)and overall survival(OS).However,the feasibility of SLNM in early-stage high-risk endometrial cancer patients is still under hot debate and undergoing further research.Recent studies have found that the application of SLNM in high-risk patients may also have similar feasibility and safety.Objective:The meta-analysis,evidence-based medicine,was used to explore the feasibility and safety of SLNM in early-stage high-risk endometrial cancer,which is to evaluate the diagnostic value,analyze its impact on treatment and prognosis,and further evaluate whether SLNM can replace LAD to provide further clinical evidence for the selection of lymph node assessment strategies for endometrial cancer.Methods:The PubMed database,the Embase database,the Cochrane Library,the Web of Science,and the Scopus database were retrieved by two individuals.Chinese databases including China National Knowledge Infrastructure(CNKI),Weipu Science and Technology Database(VIP),Wanfang Database,Superstar Journal,and China Biomedical Literature Database(CBM)were systematically searched.The references and included studies of previous systematic review and meta-analysis were also searched.Professional journals of obstetrics and gynecology were manually searched.Languages are limited to Chinese and English.The search deadline is November 1,2019.Inclusion criteria were set as follows,more than 10 patients,only high-risk endometrial cancer patients were studied,the diagnostic values such as detection rate,sensitivity and therapeutic values like PFS,OS,recurrence rate and adjuvant therapy rate were reported.The included studies were assessed for the study quality and undergone data extraction.Use Stata 12.0 to perform the meta-analysis.For all included studies,SLN detection rates were summarized analyzed.For included diagnostic studies,the total sensitivity and impacted factors were analyzed.For included therapeutic researches,the positive lymph node rate,in other words,lymph node metastasis rate,as well as adjuvant treatment rate,recurrence rate,PFS,OS,and other prognostic indicators were analyzed.Results:A total of 17 articles met the inclusion criteria,of which 12 were diagnostic studies,7 were therapeutic studies,and 2 were included in both diagnostic and therapeutic studies(Buda,A 2018 and Baiocchi,G 2017),with a total of 2572 patients.The Quality Assessment of Diagnostic Accuracy Studies-2(QUADAS-2)scale was used to evaluate the quality of diagnostic studies,and the Newcastle-Ottawa Scale(NOS)scale was used to evaluate the quality of therapeutic studies.All the included studies met the standards.The results are shown below.The various detection rates of all the included studies are summarized as follows: 1.The total SLN detection rate is 85%(95% CI: 0.81,0.90).Cervical injection and Indocyanine Green(ICG)can improve the detection rate of SLN;2.The bilateral detection rate of SLN is 62.5%(95% CI: 0.52,0.73).Cervical injection and ICG utilization result in a higher bilateral SLN detection rate;3.The detection rate of para-aortic SLN is 11.1%(95% CI: 0.052,0.169).Corpus uterus injection has a higher para-aortic SLN detection rate;4.The detection rate of isolated para-aortic SLN detection rate is 0.3%(95% CI:-0.005,0.011).The summary results of the included diagnostic studies are as follows: the sensitivity is 91%(95% CI: 0.86,0.94),and the meta-regression showed that the tracer type,injection site,the number of patients,and the type of study are not related to the sensitivity.The subgroup analysis showed that ICG has a higher sensitivity.The summary results of the therapeutic studies are shown as follows: 1.The detection rate of positive lymph nodes in the SLNM group is slightly higher than that in the LAD group(OR: 1.263;95% CI: 0.956,1.668;p = 0.100),and the difference has no statistical significance;2.The incidence of positive pelvic lymph nodes is slightly higher in the SLNM group than that in the LAD group(OR: 1.285;95% CI: 0.923,1.788;p = 0.138),the difference has no statistical significance;3.The detection rate of micrometastases(MM)in positive lymph nodes is 33.2%(95% CI: 0.072,0.591).The detection rate of isolated tumor cells(ITCs)is 20.0%(95% CI: 0.120,0.281).4.Compared with the LAD group,the SLNM group has a higher detection rate of positive paraaortic lymph nodes(OR: 1.347;95% CI: 0.422,4.232;p = 0.610),but the difference has no statistical significance.5.The detection rate of positive isolated para-aortic lymph nodes is1.9%(1/52)in the SLNM group,whereas 3.5%(5/142)in the LAD group;6.The adjuvant therapy rate is lower in the SLNM group than that in the LAD group(OR: 0.872;95% CI: 0.442,1.724;p = 0.694).There is no statistical difference;7.The rate of adjuvant chemotherapy(chemotherapy only and concurrent chemoradiotherapy)is higher in the SLNM group than that in the LAD group(OR: 1.102;95% CI: 0.580,2.093;p = 0.768),and the difference has no statistical significance;8.The chemotherapy alone rate of the SLNM group is lower than that in the LAD group(OR: 0.786;95% CI: 0.394,1.565;p = 0.493),and the difference has no statistical significance;9.The rate of radiotherapy alone in the SLNM group is lower than that in the LAD group(OR: 0.575;95% CI: 0.341,0.970;p = 0.038),and the difference has statistical significance;10.The concurrent chemoradiotherapy rate in the SLNM group is higher than that in the LAD group(OR: 1.075;95% CI: 0.343,3.363;p = 0.902),and the difference has no statistical significance;11.The SLNM group has a lower recurrence rate than that in the LAD group(OR: 0.504;95% CI: 0.344,0.738;p = 0.0001),the difference is statistically significant;12.The SLNM group reduces the risk of lymph node-related recurrence(OR: 0.754;95% CI: 0.422,1.350;p = 0.342),the difference has no statistical significance;13,SLNM group has better PFS compared to LAD group(HR: 0.843;95% CI: 0.657,1.081;p = 0.177),the difference has no statistical significance;14.SLNM group reduces the risk of death compared to LAD group,36-month OS is better(HR = 0.30;95% CI: 0.12,0.80;p = 0.02),the difference has statistical significance.Conclusion:1.The application of SLNM in early-stage high-risk EC patients is feasible and shows good SLN detection rate and sensitivity.Cervical injection,ICG can improve its detection rate.2.Compared with traditional LAD,SLNM has a similar positive lymph node detection rate and adjuvant therapy rate.It does not damage the survival outcome of patients with early-stage high-risk endometrial cancer,including PFS and OS.It may even reduce the risk of recurrence by identifying the lymph nodes which are most relevant to metastasis.3.SLNM may become an alternative to LAD in patients with early-stage high-risk endometrial cancer as part of surgical staging.However,its application requires further randomized controlled clinical studies and long-term follow-up research evidence. |
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