You Kai-yun, Peng Hai-hua, Gao Yuan-hong, Chen Li, Zhou Guan-qun, Chang Hui, Du Xiao-jing, Xiao Lin, Zeng Zhi-fan, Wen Bi-xiu, Liu Meng-zhong
State Key Laboratory of Oncology in South China; Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou 510060, China.
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Zhonghua Zhong Liu Za Zhi. 2013 Sep;35(9):708-13.
The purpose of this study was to investigate the value of postoperative chemotherapy for locally advanced rectal cancer patients who reached pathological ypT1-4N0 after neo-adjuvant chemoradiotherapy.
We performed a retrospective study of 104 patients treated with preoperative chemoradiotherapy followed by radical resection, who achieved pathological ypT1-4N0, between Mar 2003 and Dec 2010. There were 73 patients who received postoperative adjuvant chemotherapy, and the other 31 patients did not. The distribution of final pathologic stages for these patients was ypT1-2N0 in 39 cases and ypT3-4N0 in 65 cases.
The median follow-up was 41 months. The 3-year overall survival rate (OS) and recurrence-free survival rate (RFS) for the whole group (ypT1-4N0) were 93.4% and 85.3%, respectively. The 3-year OS and RFS in the adjuvant chemotherapy group and non-adjuvant chemotherapy group were 95.5%, 88.6% and 88.6%, 77.2%, respectively. There were no significant differences in 3-year RFS (P = 0.108) and OS (P = 0.106) between the two groups. The 3-year local recurrence and distant metastasis rates in the adjuvant chemotherapy group were 4.1% (3/73) and 5.5% (4/73), while for the non-adjuvant chemotherapy group, the 3-year local recurrence rate and distant metastasis rate were 3.2% (1/31) and 16.1% (5/31), respectively. Significant difference was found in distant metastasis rates (P = 0.030) between the two groups, but not in local recurrence rates (P = 0.676).Further subgroup analysis indicated that for the ypT1-2N0 patients, there were no significant differences in 3-year OS (P = 0.296) and RFS (P = 0.939) between the adjuvant and non-adjuvant chemotherapy groups, while negative results displayed in 3-year local recurrence rates (P = 0.676) and distant metastasis rates (P = 0.414). However, for patients with ypT3-4N0, significant differences were showed in both the 3-year OS (P = 0.034) and RFS (P = 0.025), and further analysis revealed that the 3-year distant metastasis rate was significantly higher in the non-adjuvant chemotherapy group than in the adjuvant chemotherapy group (P = 0.010) , but with non-significant difference in the 3-year local recurrence (P = 0.548).
Adjuvant chemotherapy may not improve survival for ypT1-2N0 patients. However, it may be clinically meaningful for ypT3-4N0 patients by decreasing distant metastasis rate. Further randomized controlled clinical trials are needed to confirm our results.
本研究旨在探讨新辅助放化疗后达到病理ypT1-4N0的局部晚期直肠癌患者术后化疗的价值。
我们对2003年3月至2010年12月期间104例行术前放化疗后行根治性切除术且病理结果为ypT1-4N0的患者进行了回顾性研究。其中73例患者接受了术后辅助化疗,另外31例患者未接受。这些患者最终病理分期为ypT1-2N0的有39例,ypT3-4N0的有65例。
中位随访时间为41个月。整个组(ypT1-4N0)的3年总生存率(OS)和无复发生存率(RFS)分别为93.4%和85.3%。辅助化疗组和非辅助化疗组的3年OS和RFS分别为95.5%、88.6%和88.6%、77.2%。两组间3年RFS(P = 0.108)和OS(P = 0.106)无显著差异。辅助化疗组的3年局部复发率和远处转移率分别为4.1%(3/73)和5.5%(4/73),而非辅助化疗组的3年局部复发率和远处转移率分别为3.2%(1/31)和16.1%(5/31)。两组间远处转移率有显著差异(P = 0.030),但局部复发率无显著差异(P = 0.676)。进一步亚组分析表明,对于ypT1-2N患者,辅助化疗组和非辅助化疗组的3年OS(P = 0.296)和RFS(P = 0.939)无显著差异,3年局部复发率(P = 0.676)和远处转移率(P = 0.414)也无差异。然而,对于ypT3-4N0患者,3年OS(P = 0.034)和RFS(P = 0.025)均有显著差异,进一步分析显示非辅助化疗组的3年远处转移率显著高于辅助化疗组(P =s0.010),但3年局部复发率无显著差异(P = 0.548)。
辅助化疗可能无法提高ypT1-2N0患者的生存率。然而,对于ypT3-4N0患者,通过降低远处转移率可能具有临床意义。需要进一步的随机对照临床试验来证实我们的结果。