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中华结直肠疾病电子杂志

中华结直肠疾病电子杂志 ›› 2023, Vol. 12 ›› Issue (01) : 50 -55. doi: 10.3877/cma.j.issn.2095-3224.2023.01.007

论著

直肠癌新辅助治疗后病理完全缓解情况及预测因素分析
白中元1, 张伟2, 王雅婧3, 冯永亮4, 白文启5, 李灵敏3,†()   
  1. 1. 030000 太原，山西医科大学第一临床医学院
    2. 030000　太原，山西医科大学第一临床医学院
    3. 030000 太原，山西医科大学基础医学院
    4. 030000 太原，山西医科大学公共卫生学院
    5. 030000 太原，山西省肿瘤医院结直肠外科
  • 收稿日期:2022-01-26 出版日期:2023-02-25
  • 通信作者: 李灵敏
  • 基金资助:
    国家自然科学基金资助项目(82172659); 山西省重点研发计划(201603D321049); 山西省高等学校大学生创新创业训练项目(202010114008)

Pathological complete response and predictive factors analysis of rectal cancer after neoadjuvant therapy

Zhongyuan Bai1, Wei Zhang2, Yongliang Feng4, Wenqi Bai5, Lingmin Li3,†()   

  1. 1. First Clinical Medical School, Shanxi Medical University, Taiyuan 030000, China
    3. Basic Medical School, Shanxi Medical University, Taiyuan 030000, China
    4. Public Health School, Shanxi Medical University, Taiyuan 030000, China
    5. Department of Colorectal Surgery, Shanxi Cancer Hospital, Taiyuan 030000, China
  • Received:2022-01-26 Published:2023-02-25
  • Corresponding author: Lingmin Li
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白中元, 张伟, 王雅婧, 冯永亮, 白文启, 李灵敏. 直肠癌新辅助治疗后病理完全缓解情况及预测因素分析[J]. 中华结直肠疾病电子杂志, 2023, 12(01): 50-55.

Zhongyuan Bai, Wei Zhang, Yongliang Feng, Wenqi Bai, Lingmin Li. Pathological complete response and predictive factors analysis of rectal cancer after neoadjuvant therapy[J]. Chinese Journal of Colorectal Diseases(Electronic Edition), 2023, 12(01): 50-55.

目的

探讨进展期直肠癌患者新辅助治疗（NAT）疗效，寻找可以有效预测NAT后病理完全缓解的临床和病理因素。

方法

回顾性分析2018年6月~2020年12月期间在山西省肿瘤医院行NAT并行全直肠系膜切除术的进展期直肠癌患者129例，根据其NAT后的反应（术后病理结果），分为病理完全缓解（pCR）和非病理完全缓解（non-pCR）两组，对性别、年龄、肿瘤距肛缘距离、术前T分期、N分期、治疗前CEA水平、肿瘤最大直径、微卫星状态、术前联合放疗等几项指标进行统计学分析。

结果

共纳入129例患者，其中NAT后pCR患者15例（11.6%）。单因素分析显示，术前CEA水平低的患者NAT后pCR的比例（21.3%）明显高于CEA水平高者（2.9%），术前联合放化疗的患者pCR比例（23.1%）明显高于术前单纯化疗的患者（6.7%）（χ2=5.623，P＜0.05）；微卫星状态稳定的患者pCR比例（12.3%）在数值上高于微卫星状态不稳定的患者（6.7%），差异无统计学意义（P＞0.05）。Logistic回归分析显示，治疗前CEA水平高（OR=12.570，95%CI：2.515~62.830）和术前联合放化疗（OR=6.319，95%CI：1.850~21.580），是NAT后达到pCR的独立因素。通过ROC曲线发现Logistic回归模型预测pCR率最佳截断值为0.87，灵敏度为0.82，特异度为0.87，AUC值为0.885。术前CEA＜2.315 μg/L是预测NAT达到pCR的有效指标。

结论

治疗前CEA水平和术前联合放化疗可以作为临床评估NAT疗效的参考指标。

关键词: 直肠肿瘤, 新辅助治疗, 病理完全缓解
Objective

To explore the efficacy of neoadjuvant therapy in patients with advanced rectal cancer, and to find pathological and clinical factors that can predict pathological complete response of neoadjuvant therapy.

Methods

A retrospective analysis was conducted in 129 patients with rectal cancer who underwent neoadjuvant therapy and total mesorectal resection at Shanxi Cancer Hospital from June 2018 to December 2020. According to their response to neoadjuvant therapy (postoperative pathological results), they were divided into two groups of pathological complete response (pCR) and non- pathological complete response(non-pCR). Statistical analysis was performed on several indicators of gender, age, distance from the tumor to the anal verge, preoperative T stage, N stage, CEA level before treatment, maximum tumor diameter, microsatellite status, and preoperative combined radiotherapy.

Results

A total of 129 patients were included, including 15 patients (11.6%) with pCR after neoadjuvant therapy. Univariate analysis showed that the proportion of patients with low preoperative CEA level in pCR after neoadjuvant therapy (21.3%) was significantly higher than that in patients with high CEA level (2.9%), and the proportion of patients with preoperative combined chemoradiotherapy (23.1%) was significantly higher in pCR than that in patients with preoperative chemotherapy alone (6.7%) (χ2=5.623, P＜0.05); the proportion of pCR in patients with microsatellite stability (12.3%) was numerically higher than that in patients with microsatellite instability (6.7%) (P＞0.05). Logistic regression analysis showed that high CEA level before treatment (OR=12.570, 95%CI: 2.515~62.830) and preoperative combined chemoradiotherapy (OR=6.319, 95%CI: 1.850~21.580) were associated with pCR after neoadjuvant therapy independent factor. The ROC curve, it was found that the best cut-off value of the logistic regression model to predict the pCR rate was 0.87, the sensitivity was 0.82, the specificity was 0.87, and the AUC value was 0.885. Preoperative CEA <2.315 μg/L was an effective indicator to predict pCR with neoadjuvant therapy.

Conclusion

CEA level before treatment and preoperative combined chemoradiotherapy can be used as reference indicators for clinical evaluation of the efficacy of neoadjuvant therapy. Microsatellite status was not found to be an independent prognostic factor for pCR after neoadjuvant therapy for rectal cancer.

Key words: Rectal neoplasms, Neoadjuvant therapy, Pathological complete response
表1 直肠癌NAT后病理完全缓解情况［例（%）］
临床特征 例数 pCR（n=15） non-pCR（n=114） χ2值 P值
性别 0.130 0.718
男 87 9（10.4） 78（89.6）
女 42 6（14.3） 36（85.7）
年龄（岁） 0.343 0.558
＜60 77 10（13.0） 67（87.0）
≥60 52 5（9.6） 47（90.4）
肿瘤距肛缘距离（cm） 0.057 0.812
＜5 48 6（12.5） 42（87.5）
≥5 81 9（11.1） 72（88.9）
术前T分期 0.008 0.928
T3 53 6（11.3） 47（88.7）
T4 76 9（11.8） 67（88.2）
术前N分期 0.531*
N（-） 6 1（16.7） 5（83.3）
N（+） 123 14（11.4） 109（88.6）
治疗前CEA水平（µg/L） 0.001*
CEA＜5 61 13（21.3） 48（79.7）
CEA≥5 68 2（2.9） 66（97.1）
肿瘤最大直径（cm） 0.006 0.939
＜5 59 7（11.8） 52（88.2）
≥5 70 8（11.4） 62（88.6）
微卫星状态 0.834*
不稳定 15 1（6.7） 14（93.3）
稳定 114 14（12.3） 100（87.7）
术前联合放疗 5.623 0.018
单独化疗 90 6（6.7） 84（93.3）
联合放疗 39 9（23.1） 30（76.9）
表2 直肠癌NAT后病理完全缓解影响因素的Logistic回归分析
临床特征 OR（95%CI） aOR（95%CI）*

治疗前CEA

（＜5/≥5 ng/mL）

 17.961（2.626~122.843） 12.570（2.515~62.830）

是否联合放化疗

（联合放疗/单纯化疗）

 14.158（2.772~72.316） 6.319（1.850~21.580）
图1 Logistic回归模型与术前CEA水平对NAT后pCR的预测能力
表3 术前CEA水平与NAT后pCR的相关性［例（%）］
治疗前CEA水平（µg/L） 例数 pCR non-pCR χ2值 P值
CEA＜2.31 30 12（40.0） 18（60.0） - 0.0001*
CEA≥2.31 99 3（3.0） 96（97.0）
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