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Abstract：
UNASSIGNED: This study aims to analyze how changes in pathological diagnosis practice and molecular detection technology have affected clinical outcomes for colorectal cancer (CRC) patients in Fudan University Shanghai Cancer Center (FUSCC).
UNASSIGNED: This retrospective cohort study analyzed 21,141 pathologically confirmed CRC cases diagnosed at FUSCC from 2008 to 2020. Patients were divided into five groups for different analytical purposes: (1) the before vs. since 2014 groups to analyze the influence of the changes in the classification criteria of pT3 and pT4 staging on the survival of patients; (2) the partial vs. total mesorectal excision (TME) groups to analyze whether evaluation of completeness of the mesorectum have impact on the survival of patients; (3) the tumor deposit (TD)(+)N0 vs. TD(+)N1c groups to analyze the influence of the changes in the pN staging on the survival of patients with positive TD and negative regional lymph node metastasis (LNM); (4) the before vs. since 2013 groups to analyze the influence of the changes in the testing process of deficient mismatch repair on the survival of patients; and (5) the groups with vs. without RAS/BRAF gene mutation testing to analyze the influence of these testing on the survival of patients. Patients\' clinicopathological parameters, including age at diagnosis, sex, tumor size, location, differentiation, mucinous subtype, TD, lymphovascular invasion, perineural invasion, tumor depth, LNM and distant metastasis, and tumor-node-metastasis (TNM) stage, were compared between groups. Kaplan-Meier analysis with log rank method was performed for patients\' overall survival (OS) and disease-free survival (DFS) analyses.
UNASSIGNED: In pathological reports, there were three parameter changes that impacted patient outcomes. Firstly, changes in the pT staging criteria led to a shift of the ratio of patients with stage pT3 to stage pT4 from 1: 110.9 to 1: 0.26. In comparison to patients admitted before 2014 (n = 4,754), a significant difference in prognosis between pT3 and pT4 stages was observed since 2014 (n = 9,965). Secondly, we began to evaluate the completeness of the mesorectum since 2016. As a result, 91.0% of patients with low rectal cancer underwent TME (n = 4,111) surgery, and patients with TME had significantly better OS compared with partial mesorectal excision (PME, n = 409). Thirdly, we began to stage TD (+) LNM (-) as N1c since 2017. The results showed that N1c (n = 127) but not N0 (n = 39) can improve the prognosis of patients without LNM and distal metastasis. In molecular testing, there have been three and five iterations of updates regarding mismatch repair (MMR)/microsatellite instability (MSI) status and RAS/BRAF gene mutation detection, respectively. The standardization of MMR status testing has sharply decreased the proportion of deficient MMR (dMMR) patients (from 32.5% to 7.4%) since 2013. The prognosis of patients underwent MMR status testing since 2013 (n = 867) were significantly better than patients before 2013 (n = 1,313). In addition, detection of RAS/BRAF gene mutation status (n = 5,041) resulted in better DFS but not OS, for patients with stage I-III disease (n = 16,557).
UNASSIGNED: Over the past few decades, updates in elements in pathological reports, as well as the development of standardized tests for MMR/MSI status and RAS/BRAF gene mutations have significantly improved patient outcomes.
UNASSIGNED: This retrospective cohort study analyzed 21,141 pathologically confirmed CRC cases diagnosed at FUSCC from 2008 to 2020. Patients were divided into five groups for different analytical purposes: (1) the before vs. since 2014 groups to analyze the influence of the changes in the classification criteria of pT3 and pT4 staging on the survival of patients; (2) the partial vs. total mesorectal excision (TME) groups to analyze whether evaluation of completeness of the mesorectum have impact on the survival of patients; (3) the tumor deposit (TD)(+)N0 vs. TD(+)N1c groups to analyze the influence of the changes in the pN staging on the survival of patients with positive TD and negative regional lymph node metastasis (LNM); (4) the before vs. since 2013 groups to analyze the influence of the changes in the testing process of deficient mismatch repair on the survival of patients; and (5) the groups with vs. without RAS/BRAF gene mutation testing to analyze the influence of these testing on the survival of patients. Patients\' clinicopathological parameters, including age at diagnosis, sex, tumor size, location, differentiation, mucinous subtype, TD, lymphovascular invasion, perineural invasion, tumor depth, LNM and distant metastasis, and tumor-node-metastasis (TNM) stage, were compared between groups. Kaplan-Meier analysis with log rank method was performed for patients\' overall survival (OS) and disease-free survival (DFS) analyses.
UNASSIGNED: In pathological reports, there were three parameter changes that impacted patient outcomes. Firstly, changes in the pT staging criteria led to a shift of the ratio of patients with stage pT3 to stage pT4 from 1: 110.9 to 1: 0.26. In comparison to patients admitted before 2014 (n = 4,754), a significant difference in prognosis between pT3 and pT4 stages was observed since 2014 (n = 9,965). Secondly, we began to evaluate the completeness of the mesorectum since 2016. As a result, 91.0% of patients with low rectal cancer underwent TME (n = 4,111) surgery, and patients with TME had significantly better OS compared with partial mesorectal excision (PME, n = 409). Thirdly, we began to stage TD (+) LNM (-) as N1c since 2017. The results showed that N1c (n = 127) but not N0 (n = 39) can improve the prognosis of patients without LNM and distal metastasis. In molecular testing, there have been three and five iterations of updates regarding mismatch repair (MMR)/microsatellite instability (MSI) status and RAS/BRAF gene mutation detection, respectively. The standardization of MMR status testing has sharply decreased the proportion of deficient MMR (dMMR) patients (from 32.5% to 7.4%) since 2013. The prognosis of patients underwent MMR status testing since 2013 (n = 867) were significantly better than patients before 2013 (n = 1,313). In addition, detection of RAS/BRAF gene mutation status (n = 5,041) resulted in better DFS but not OS, for patients with stage I-III disease (n = 16,557).
UNASSIGNED: Over the past few decades, updates in elements in pathological reports, as well as the development of standardized tests for MMR/MSI status and RAS/BRAF gene mutations have significantly improved patient outcomes.
摘要：
■本研究旨在分析复旦大学上海癌症中心（FUSCC）的结直肠癌（CRC）患者的病理诊断实践和分子检测技术的变化如何影响临床结局。
■这项回顾性队列研究分析了2008年至2020年在FUSCC诊断的21,141例经病理证实的CRC病例。出于不同的分析目的，将患者分为五组：(1)2014年以来分组分析pT3和pT4分期分级标准的改变对患者生存的影响;(2)全直肠系膜切除术（TME）组，分析直肠系膜完整性评估是否对患者生存有影响；（3）肿瘤沉积（TD）（+）N0vs.TD(+)N1c组分析pN分期变化对TD阳性和区域淋巴结转移(LNM)阴性患者生存率的影响;(4)前2013年以来分组分析缺失错配修复检测过程中的变化对患者生存的影响;(5)未进行RAS/BRAF基因突变检测，分析这些检测对患者生存的影响。患者临床病理参数，包括诊断时的年龄，性别,肿瘤大小,location,分化,粘液亚型，TD,淋巴管浸润,神经周浸润,肿瘤深度,LNM和远处转移，和肿瘤淋巴结转移（TNM）分期，进行组间比较。采用对数秩（logrank）方法进行Kaplan-Meier分析，用于患者总生存期（OS）和无病生存期（DFS）分析。
■在病理报告中，有3个参数变化影响患者结局.首先,pT分期标准的改变导致pT3期与pT4期患者的比例从1:110.9变为1:0.26.与2014年之前收治的患者相比（n=4,754），自2014年以来,观察到pT3和pT4分期之间的预后存在显著差异(n=9,965).其次,自2016年以来,我们开始评估直肠系膜的完整性.因此,91.0%的低位直肠癌患者接受了TME(n=4,111)手术,与部分直肠系膜切除术相比，TME患者的OS明显更好（PME，n=409)。第三，自2017年以来，我们开始将TD（+）LNM（-）作为N1c。结果表明，N1c（n=127）而非N0（n=39）可以改善无LNM和远端转移的患者的预后。在分子测试中，关于错配修复（MMR）/微卫星不稳定性（MSI）状态和RAS/BRAF基因突变检测，分别。自2013年以来，MMR状态测试的标准化大大降低了MMR（dMMR）缺陷患者的比例（从32.5％降至7.4％）。自2013年以来接受MMR状态检测的患者（n=867）的预后明显优于2013年之前的患者（n=1,313）。此外,检测RAS/BRAF基因突变状态（n=5,041）导致更好的DFS而不是OS，I-III期患者（n=16,557）。
■在过去的几十年里，病理报告中元素的更新，以及针对MMR/MSI状态和RAS/BRAF基因突变的标准化测试的开发，显着改善了患者的预后。
■这项回顾性队列研究分析了2008年至2020年在FUSCC诊断的21,141例经病理证实的CRC病例。出于不同的分析目的，将患者分为五组：(1)2014年以来分组分析pT3和pT4分期分级标准的改变对患者生存的影响;(2)全直肠系膜切除术（TME）组，分析直肠系膜完整性评估是否对患者生存有影响；（3）肿瘤沉积（TD）（+）N0vs.TD(+)N1c组分析pN分期变化对TD阳性和区域淋巴结转移(LNM)阴性患者生存率的影响;(4)前2013年以来分组分析缺失错配修复检测过程中的变化对患者生存的影响;(5)未进行RAS/BRAF基因突变检测，分析这些检测对患者生存的影响。患者临床病理参数，包括诊断时的年龄，性别,肿瘤大小,location,分化,粘液亚型，TD,淋巴管浸润,神经周浸润,肿瘤深度,LNM和远处转移，和肿瘤淋巴结转移（TNM）分期，进行组间比较。采用对数秩（logrank）方法进行Kaplan-Meier分析，用于患者总生存期（OS）和无病生存期（DFS）分析。
■在病理报告中，有3个参数变化影响患者结局.首先,pT分期标准的改变导致pT3期与pT4期患者的比例从1:110.9变为1:0.26.与2014年之前收治的患者相比（n=4,754），自2014年以来,观察到pT3和pT4分期之间的预后存在显著差异(n=9,965).其次,自2016年以来,我们开始评估直肠系膜的完整性.因此,91.0%的低位直肠癌患者接受了TME(n=4,111)手术,与部分直肠系膜切除术相比，TME患者的OS明显更好（PME，n=409)。第三，自2017年以来，我们开始将TD（+）LNM（-）作为N1c。结果表明，N1c（n=127）而非N0（n=39）可以改善无LNM和远端转移的患者的预后。在分子测试中，关于错配修复（MMR）/微卫星不稳定性（MSI）状态和RAS/BRAF基因突变检测，分别。自2013年以来，MMR状态测试的标准化大大降低了MMR（dMMR）缺陷患者的比例（从32.5％降至7.4％）。自2013年以来接受MMR状态检测的患者（n=867）的预后明显优于2013年之前的患者（n=1,313）。此外,检测RAS/BRAF基因突变状态（n=5,041）导致更好的DFS而不是OS，I-III期患者（n=16,557）。
■在过去的几十年里，病理报告中元素的更新，以及针对MMR/MSI状态和RAS/BRAF基因突变的标准化测试的开发，显着改善了患者的预后。
