基于临床及MR影像特征评估直肠癌新辅助放化疗疗效的临床研究
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1.南京医科大学第一附属医院放射科,南京医科大学附属逸夫医院放射科;2.南京医科大学第一附属医院放射科

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江苏省科教能力提升工程(JSDW202243)


Evaluate the efficacy of neoadjuvant chemoradiotherapy for locally advanced rectal cancer based on clinical and MR image data
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    目的:基于临床及磁共振成像影像特征,探讨评估局部进展期直肠癌新辅助放化疗后病理完全缓解的危险因素。方法:回顾性分析2014年12月至2022年11月经活检及临床诊断为局部进展期直肠癌且经过新辅助放化疗后行全直肠系膜切除术的175例患者,男117例,女58例,年龄22-82岁,平均(56.93±11.886)岁。训练组122例,其中病理完全缓解(pathological complete response,pCR)组n=30,非病理完全缓解(non-pathological complete response,non-pCR)组n=92;验证组53例(pCR组n=10,non-pCR组n=43)。收集治疗前后患者的临床资料、影像检查及病理学数据。组间差异比较采用独立样本t检验或Kruskal Wallis秩和检验;计数资料组间比较采用χ2检验或Fisher精确检验。对于所有统计分析结果,P<0.05被视为差异具有统计学意义。采用单因素、多因素逻辑回归分析局部进展期直肠癌新辅助治疗疗效。采用受试者工作特征(receiver operating characteristic,ROC)曲线评估预测因素的诊断效能。将患者按7:3比例随机分为训练组、验证组,对模型进行验证,计算曲线下面积(area under curve,AUC)、截断值、敏感度、特异度,并采用DeLong检验比较AUC值的差异。结果:治疗前后肿块长径、治疗前后壁外深度、治疗后癌胚抗原值、治疗后肿块周围淋巴结数、治疗前后壁外血管侵犯、治疗后的影像T分期及N分期、直肠系膜筋膜在pCR组和non-pCR组间有显著差异,经单因素及多因素逻辑回归分析发现:治疗后壁外深度为评估新辅助放化疗疗效的独立危险因素。治疗后壁外深度在训练组和验证组中对预测新辅助放化疗疗效有较好的诊断效能。训练组和验证组的AUC值分别为0.783和0.765,截断值分别为0.555和0.627,灵敏度分别为0.870和0.852以及特异度分别为0.733和0.773。经Hosmer-Lemeshow拟合优度检验后无统计学差异。结论: 评估肿瘤侵犯壁外深度有助于评估局部进展期直肠癌新辅助放化疗后pCR率,为临床提供了方便无创的诊断手段,指导临床个体化治疗。

    Abstract:

    Objective:Based on clinical and magnetic resonance imaging data,to explore the risk factors of pathological complete remission after neoadjuvant chemoradiotherapy for locally advanced rectal cancer.Methods:From December 2014 to November 2022,175 patients with locally advanced rectal cancer diagnosed by biopsy and clinical diagnosis who underwent TME after neoadjuvant chemoradiotherapy were retrospectively analyzed,including 117 males and 58 females,aged from 22 to 82 years,with an average of (56.93±11.886) years.There were 122 cases in the training group (pathological complete response group n=30,non-pathological complete response group n=92) and 53 cases in the verification group (pCR group n=10,non-pCR group n=43).Clinical data,imaging examination and pathological data of patients before and after treatment were collected.The differences between groups were compared by independent sample T test or Kruskal Wallis rank sum test .χ2 test or Fisher exact test were used to compare the counting data sets.For all statistical analysis results,P<0.05 is considered as a statistical difference.We use the univariate and multivariate Logistic regression to analyze the efficacy of LARC neoadjuvant chemoradiotherapy.The diagnostic efficacy of predictive factors was evaluated by receiver's operating characteristic (ROC) curve.Patients were randomly divided into testing set and validation set according to the ratio of 7:3.The model was validated,and the area under the curve (AUC),cutoff value,sensitivity and specificity were calculated,and the differences of AUC values were compared by DeLong test.Results: There were significant differences in some clinical features between the training set and the validation set between the pCR group and the non-pCR group (the length and diameter of the tumor before and after treatment,the depth of tumor infiltration,the CEA value after treatment,the number of lymph nodes around the tumor after treatment,extramural vascular invasion before and after treatment,the mrT stage after treatment,mesorectal fascia and mrN).After univariate and multivariate logistic regression analysis,The extramural depth after treatment was an independent risk factor for evaluating the efficacy of neoadjuvant chemoradiotherapy.The extramural depth has a good diagnostic efficiency in predicting the curative effect of nCRT in testing set and verification set.The AUC values of the testing set and the validation set were 0.783 and 0.765,the cutoff values were 0.555 and 0.627,the sensitivity was 0.870 and 0.852,and the specificity was 0.733 and 0.773 respectively.There was no statistical difference after Hosmer-Lemeshow goodness of fit test.Conclusion: Evaluating the extramural depth is helpful to evaluate the pCR rate of locally advanced rectal cancer after nCRT,which provides a convenient and noninvasive diagnostic method for clinic and guides clinical individualized treatment.

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  • 收稿日期:2024-10-02
  • 最后修改日期:2024-12-23
  • 录用日期:2025-03-26
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