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不同淋巴结转移分期标准预测进展期胆囊癌预后的应用价值

Application value of the different lymph node staging system predicting prognosis of advanced gallbladder carcinoma

摘要:

目的 探讨美国癌症联合会(AJCC)第7版肿瘤TNM分期系统N分期、阳性淋巴结数目(NMLN)、阳性淋巴结率(LNR)、阳性淋巴结对数发生比(LODDS)4种不同淋巴结转移分期标准预测进展期胆囊癌患者预后的应用价值.方法 采用回顾性横断面研究方法.收集2008年1月至2014年12月西安交通大学第一附属医院收治的176例行根治术的进展期胆囊癌患者的临床病理资料.根据术前评估、术中探查和快速冷冻切片病理学检查分期确定手术方式.观察指标和评价标准:(1)手术和术后情况.(2)随访和生存情况.(3)依据AJCC第7版肿瘤TNM分期系统N分期淋巴结相关指标情况.LNR=NMLN/淋巴结清扫总数.LODDS=Log(NMLN+0.5)/(淋巴结清扫总数-NMLN+0.5).(4)依据NMLN、LNR、LODDS进行淋巴结转移分期情况.LODDS<-1.0为LODDS 1期,-1.0≤LODDS<0为LODDS 2期,LODDS≥0为LODDS 3期.(5)不同淋巴结转移分期患者预后比较.(6)4种淋巴结转移分期标准预测患者预后的准确性.采用门诊和电话方式进行随访,了解患者术后生存情况.随访时间截至2017年12月31日.正态分布的计量资料以x±s表示.偏态分布的计量资料以M(范围)表示,其比较采用非参数检验.采用Kaplan-Meier法计算生存率,生存情况比较采用Log-rank检验.相关性分析采用Spearman相关性分析,r≥0.800为高度相关,0.500≤r<0.800为中度相关,0.300≤r<0.500为低度相关.受试者工作特征(ROC)曲线的绘制和ROC曲线下面积(AUC)计算分别基于4种二元逻辑回归模型,赤池信息量准则(AIC)、Harrell一致性指数(Harrell c-index)的计算分别基于4种COX风险比例回归模型.AUC值、Harrellc-index值越大,AIC值越小,则该淋巴结转移分期标准预测患者预后准确性越高.Harrell c-index<0.50为该模型无预测能力,0.50≤Harrell c-index≤1.00为该模型有预测作用.结果 (1)手术和术后情况:176例患者均顺利完成胆囊癌根治术,其中R0切除161例,R1切除15例;D1淋巴结清扫术99例,D2淋巴结清扫术77例.176例患者中,9例发生术后并发症,包括6例胆汁漏、2例肝功能不全、1例腹腔出血,均经对症处理后好转.术后病理学检查结果:淋巴结清扫总数为(6.7±4.4)枚,NMLN为0(0~12.0枚),LNR为0(0~1.00);肿瘤高分化16例,中分化81例,低分化79例;T3期162例,TT4期14例;60例患者合并肿瘤肝脏浸润.(2)随访和生存情况:176例患者均获得术后随访,随访时间为1~ 118个月,中位随访时间为33个月.176例患者术后1、3、5年总体生存率分别为63.1%、42.0%、32.0%.(3)依据AJCC第7版肿瘤TNM分期系统N分期淋巴结相关指标情况:N0、N1、N2期患者分别为95、45、36例.N1期患者NMLN、LNR、LODDS分别为2.0枚(1.0~7.0枚)、0.40(0.08 ~1.00)、-0.15(-0.99~ 1.04),N2期患者上述指标分别为4.0枚(1.0~12.0枚)、0.57(0.13~1.00)、0.11(-0.70~1.04),两者上述指标比较,NMLN差异有统计学意义(Z=-3.888,P<0.05);而LNR、LODDS差异均无统计学意义(Z=-1.492,-1.689,P>0.05).(4)依据NMLN、LNR、LODDS进行淋巴结转移分期情况:依据NMLN、LNR进行淋巴结转移分期截点分别为4.0枚、0.70,则NMLN=0为NMLN 1期(95例),1.0枚≤NMLN≤4.0枚为NMLN 2期(61例),NMLN>4.0枚为NMLN 3期(20例);LNR=0为LNR 1期(95例),0<LNR≤0.70为LNR 2期(58例),LNR>0.70为LNR 3期(23例).LODDS 1、2、3期患者分别为61、70、45例.依据NMLN、LNR进行淋巴结转移分期与依据AJCC第7版肿瘤TNM分期系统N分期均为高度相关,差异均有统计学意义(r=0.949,0.922,P<0.05);依据LODDS进行淋巴结转移分期与依据AJCC第7版肿瘤TNM分期系统N分期中度相关,差异有统计学意义(r=0.758,P<0.05).(5)不同淋巴结转移分期患者预后比较:N0期患者术后1、3、5年总体生存率分别为86.3%、65.3%、52.2%,N1期患者分别为44.4%、22.2%、13.3%,N2期患者分别为25.0%、5.6%、2.8%,3者生存情况比较,差异有统计学意义(x2=88.895,P<0.05).NMLN 1期患者术后1、3、5年总体生存率分别为86.3%、65.3%、52.2%,NMLN 2期患者分别为47.5%、19.7%、11.1%,NMLN 3期患者均为0,3者生存情况比较,差异有统计学意义(x2=121.086,P<0.05).LNR 1期患者术后1、3、5年总体生存率分别为86.3%、65.3%、52.2%,LNR 2期患者分别为41.4%、17.2%、11.8%,LNR 3期患者分别为17.4%、8.7%、0,3者生存情况比较,差异有统计学意义(x2=86.503,P<0.05).LODDS 1期患者术后1、3、5年总体生存率分别为85.2%、65.5%、51.8%,LODDS 2期患者分别为65.7%、40.0%、31.3%,LODDS 3期患者分别为28.9%、13.3%、5.9%,3者生存情况比较,差异有统计学意义(x2=59.195,P<0.05).(6)4种淋巴结转移分期标准预测患者预后的准确性:依据AJCC第7版肿瘤TNM分期系统N分期、NMLN、LNR、LODDS进行淋巴结转移分期的AUC分别为0.878、0.881、0.870、0.864,AIC分别为1 047.5、1 026.4、1 044.2、1 063.6,Harrell c-index分别为0.77、0.78、0.77、0.76.依据NMLN进行淋巴结转移分期的AUC值、Harrell c-index值最大,AIC值越小,预测患者预后准确性最高.结论 在AJCC第7版肿瘤TNM分期系统N分期、NMLN、LNR、LODDS 4种淋巴结转移分期标准中,NMLN对预测行根治术的进展期胆囊癌患者预后更精准.

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abstracts:

Objective To investigate the application value of the anatomical location of positive nodes (N staging) from TNM staging systems published by American Joint Committee on Cancer (AJCC) (7th edition),number of metastatic lymph nodes (NMLN),lymph node ratio (LNR) and log odds of metastatic lymph nodes (LODDS) as prognostic predictors in advanced gallbladder carcinoma(GBC).Methods The retrospective crosssectional study was conducted.The clinicopathological data of 176 patients who underwent radical resection of advanced GBC in the First Affiliated Hospital of Xi'an Jiaotong University between January 2008 and December 2014 were collected.According to preoperative assessment,intraoperative exploration and frozen section biopsy,staging and surgical procedure were confirmed.Observation indicators and evaluation criteria:(1) surgical and postoperative situations;(2) follow-up and survival situations;(3) N staging related indicators based on TNM staging systems of AJCC (7th edition):LNR =NMLN / total number of lymph node dissection,LODDS =Log (NMLN+0.5) / (total number of lymph node dissection-NMLN+0.5);(4) lymph node staging based on NMLN,LNR and LODDS:LODDS <-1.0 as LODDS 1 staging,-1.0 ≤ LODDS < 0 as LODDS 2 staging,LODDS ≥0 as LODDS 3 staging;(5) prognostic comparisons of patients with different lymph node staging;(6) accuracy of 4 different types of lymph node staging predicting the prognosis of patients.Follow-up using outpatient examination and telephone interview was performed to detect postoperative survival up to December 31,2017.Measurement data with normal distribution were represented as x-±s.Measurement data with skewed distribution were described as M (range),and comparisons were done using the nonparametric test.The survival rate was calculated by the Kaplan-Meier method,and the Log-rank test was used for survival comparison.Correlation analysis was done using the Spearman correlation analysis,r ≥ 0.800 as a high correlation,0.500 ≤ r < 0.800 as a moderate correlation and 0.300 ≤ r < 0.500 as a low correlation.The receiver operating characteristic (ROC) curve and area under the curve (AUC) were respectively drawn and calculated based on 4 kinds of binary logistic regression model.Akaike information criterion (AIC) and Harrell concordance index (Harrell c-index) were respectively calculated based on 4 kinds of COX proportional hazard regression model.The larger values of AUC and Harrell c-index caused a smaller value of AIC,but a lymph node staging standard correlated with greater prognostic accuracy.Harrell c-index < 0.50 was no prediction,and 0.50 ≤ Harrell c-index ≤ 1.00 was an obvious prediction.Results (1) Surgical and postoperative situations:176 patients underwent successful radical resection of GBC,including 161 in R0 resection and 15 in R1 resection,99 with D1 lymph node dissection and 77 with D2 lymph node dissection.Of 176 patients,9 with postoperative complications were improved by symptomatic treatment,including 6 with bile leakage,2 with hepatic dysfunction and 1 with intra-abdominal hemorrhage.Results of postoperative pathological examination:total number of lymph node dissection,NMLN and LNR were respectively 6.7±4.4,0 (range,0-12.0) and 0 (range,0-1.00);high-differentiated,moderate-differentiated and low-differentiated tumors were respectively detected in 16,81 and 79 patients;162 and 14 patients were in T3 and T4 stages;60 patients were combined with infiltration of the liver.(2) Follow-up and survival situations:176 patients were followed up for l-118 months,with a median time of 33 months.The 1-,3-and 5-year overall survival rates were respectively 63.1%,42.0% and 32.0%.(3) N staging related indicators based on TNM staging systems ofAJCC (7th edition):95,45 and 36 patients were respectively detected in staging N0,N1 and N2.NMLN,LNR and LODDS were respectively 2.0 (range,1.0-7.0),0.40 (range,0.08-1.00),-0.15 (range,-0.99-1.04) in staging N1 and 4.0 (range,1.0-12.0),0.57 (range,0.13-1.00),0.11 (range,-0.70-1.04) in staging N2,with a statistically significant difference in NMLN (Z=-3.888,P<0.05) and with no statistically significant difference in LNR and LODDS (Z=-1.492,-1.689,P>0.05).(4) Lymph node staging based on NMLN,LNR and LODDS:NMLN and LNR as a cut-off point were respectively 4.0 and 0.70,NMLN 1 staging (NMLN=0) was detected in 95 patients,NMLN 2 staging (1.0 ≤ NMLN ≤ 4.0) in 61 patients and NMLN 3 staging (NMLN>4.0) in 20 patients;LNR 1 staging (LNR=0) was detected in 95 patients,LNR 2 staging (0 < LNR ≤ 0.70) in 58 patients and LNR 3 staging (LNR>0.70) in 23 patients.LODDS 1,2 and 3 stagings was detected in 61,70 and 45 patients,respectively.The lymph node staging based on NMLN and LNR was significantly correlated with based on N staging of TNM staging systems of AJCC (7th edition) (r =0.949,0.922,P<0.05);the lymph node staging based on LODDS was moderately correlated with based on N staging of TNM staging systems of AJCC (7th edition) (r =0.758,P< 0.05).(5) Prognostic comparisons of patients with different lymph node staging:1-,3-and 5-year overall survival rates were respectively 86.3%,65.3%,52.2% in N0 staging patients and 44.4%,22.2%,13.3% in N1 staging patients and 25.0%,5.6%,2.8% in N2 staging patients,with a statistically significant difference (x2=88.895,P<0.05).The 1-,3-and 5-year overall survival rates were respectively 86.3%,65.3%,52.2% in NMLN 1 staging patients and 47.5%,19.7%,11.1% in NMLN 2 staging patients and 0,0,0 in NMLN 3 staging patients,with a statistically significant difference (x2=121.086,P<0.05).The 1-,3-and 5-year overall survival rates were respectively 86.3%,65.3%,52.2% in LNR 1 staging patients and 41.4%,17.2%,11.8% in LNR 2 staging patients and 17.4%,8.7%,0 in LNR 3 staging patients,with a statistically significant difference (x2 =86.503,P< 0.05).The 1-,3-and 5-year overall survival rates were respectively 85.2%,65.5%,51.8% in LODDS 1 staging patients and 65.7%,40.0%,31.3% in LODDS 2 staging patients and 28.9%,13.3%,5.9% in LODDS 3 staging patients,with a statistically significant difference (x2=59.195,P<0.05).(6) Accuracy of 4 different types of lymph node staging predicting the prognosis of patients:according to N staging of TNM staging systems of AJCC (7th edition),NMLN,LNR and LODDS,AUC,AIC and Harrell c-index of lymph node staging were respectively 0.878,0.881,0.870,0.864 and 1 047.5,1 026.4,1 044.2,1 063.6 and 0.77,0.78,0.77,0.76.AIC value was smaller with increased values of AUC and Harrell c-index based on NMLN,showing a greatest accuracy predicting the prognosis of patients.Conclusion Among N staging of TNM staging system of AJCC (7 edition),NMLN,LNR and LODDS as prognostic predictors,NMLN can more precisely predict radical resection of advanced GBC.

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作者: 陈晨 [1] 刘德春 [1] 张震 [2] 孟强劳 [1] 蔡慧强 [1] 张瑞 [1] 张东 [1] 王林 [1] 耿智敏 [1]
期刊: 《中华消化外科杂志》2018年17卷3期 244-251页 ISTICPKUCSCD
栏目名称: 论著
DOI: 10.3760/cma.j.issn.1673-9752.2018.03.007
发布时间: 2018-05-07
基金项目:
国家自然科学基金 陕西省重点研发计划(2017ZDXM-SF-055)National Natural Science Foundation of China Key Research and Development Program of Shaanxi Province
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