241例局部晚期中低位直肠癌术前同步放化疗联合TME根治术长期疗效分析

Long-term efficacy of preoperative chemoradiotherapy combined with total mesorectal excision for locally advanced rectal cancer： an analysis of 241 patients

目的 回顾性分析 241例局部晚期中低位直肠癌行术前同步放化疗联合TME根治性手术的长期疗效以及影响预后因素。方法 2006—2014年中国医学科学院北京协和医学院肿瘤国家癌症中心连续收治经盆腔MRI或腹盆CT确诊的局部晚期中低位直肠腺癌患者 241例进行分析,该组患者术前盆腔放疗剂量 42.0-50.4 Gy （中位数50 Gy）,同步化疗采用卡培他滨 ±奥沙利铂,于同步放化疗后 4-15周（中位数7周）接受TME原则的根治性手术（R0切除）,术后均建议行辅助化疗,但需考虑患者恢复情况及意愿。Kaplan-Meier法计算DFS、LRR、DM及OS并Logrank法检验,Cox模型多因素分析。结果 全组患者中位随访42个月,3年LRR、DFS、OS和DM分别为3.8%、76.2%、85.9%和20.6%。亚组分析发现ypT0-2、ypN阴性、pCR、TRG4级患者可以获得更高的DFS （ypT0-2∶ypT3-4：86.0%∶69.3%,P=0.002;ypN阴性∶ypN阳性：88.1%∶56.9%,P=0.000;pCR∶非pCR：100%∶72.4%,P=0.001;TRG4级∶TRG2-3级∶TGR0-1级：94.9%∶73.6%∶66.3%,P=0.011）,多因素分析结果显示术后ypN状态是影响DFS的因素（P=0.000）。结论 局部晚期中低位直肠癌行术前同步放化疗联合根治性手术局部区域控制较理想,远处转移是治疗失败的主要原因,放化疗后ypN状态是影响DFS的独立预后因素。

Objective To retrospectively analyze the long-term efficacy of and prognostic factors after preoperative chemoradiotherapy combined with total mesorectal excision （TME） in the treatment of 241 patients with locally advanced rectal cancer. Methods A total of 241 patients who were consecutively admitted to our hospital and diagnosed with locally advanced mid-low rectal adenocarcinoma by pelvic magnetic resonance imaging or computed tomography from January 2006 to November 2014 were enrolled as subjects. All patients received preoperative radiotherapy with doses ranging between 42.0 and 50.4 Gy （median dose=50 Gy） and concurrent chemotherapy with capecitabine±oxaliplatin. Patients received TME （R0 excision） at 4-15 weeks （median time=7 weeks） after chemoradiotherapy. Adjuvant postoperative chemotherapy was given depending on the recovery and preference of each patient. Disease-free survival （DFS）, locoregional recurrence （LRR）, overall survival （OS）, and distant metastasis （DM） rates were calculated by the Kaplan-Meier method and analyzed by the log-rank test. The Cox model was used for multivariate analysis. Results In all the patients, the median follow-up time was 42 months;the 3-year LRR, DFS, OS, and DM rates were 3.8%, 76.2%, 85.9%, and 20.6%, respectively. The subgroup analysis showed that ypT0-2, ypN-, pCR, and TRG4 were associated with improved DFS （ypT0-2 vs. ypT3-4：86.0% vs. 69.3%, P=0.002;ypN-vs ypN＋：88.1% vs. 56.9%, P=0.000;pCR vs. non-pCR：100% vs. 72.4%, P=0.001;TRG4 vs. TRG2-3 vs. TRG0-1：94.9% vs. 73.6% vs. 66.3%, P=0.011）. The multivariate analysis revealed that the postoperative ypN status was an independent prognostic factor for DFS （P=0.000）. Conclusions For patients with locally advanced mid-low rectal adenocarcinoma, preoperative chemoradiotherapy combined with radical surgery achieves satisfactory outcomes in local control. The major reason for treatment failure lies in distant metastasis. The ypN status after chemoradiotherapy is an independent prognostic factor for DFS.