Objective: To compare the efficacy and safety of short-course radiotherapy with total neoadjuvant therapy (SCRT-TNT) and neoadjuvant chemoradiotherapy (nCRT) in patients with locally advanced middle and low rectal cancer. Methods: A retrospective cohort study was carried out. A of 126 patients with locally advanced middle and low rectal cancer who were treated in the Department of Gastrointestinal Cancer Surgery of Fujian Cancer Hospital from September 2016 to March 2020 were enrolled, including 73 males and 53 females, with a mean age of (56.5±9.8) (23-77) years. Based on neoadjuvant regimen (nCRT treatment was performed before December 2018 and SCRT-TNT treatment was carried out after January 2019), patients were divided into nCRT group (n=68) and SCRT-TNT group (n=58). There were no statistically significant differences in age, sex, distance from tumor to anal verge, Eastern Cooperative Oncology Group (ECOG) performance status and clinical TNM stage between the two groups (all P>0.05). Patients in both groups received pelvic intensity-modulated radiotherapy (IMRT). The radiotherapy dose of nCRT group was 50Gy/25 times/5 weeks. Patients in nCRT group received oral capecitabine chemotherapy during radiotherapy and underwent surgery 6-8 weeks after chemoradiation. However, patients in SCRT-TNT group received CapeOX regimen (oxaliplatin+capecitabine) for 2 cycles of induction chemotherapy, followed by short-course radiotherapy (25Gy/5 times/5 days), then underwent a radical surgery two weeks after completion of consolidation chemotherapy (4 cycles). The adverse reactions, perioperative safety and efficacy of neoadjuvant therapy were compared and analyzed between the two groups. Results: Both groups completed neoadjuvant therapy as planned. Patients in nCRT group and SCRT-TNT group had similar incidence of adverse reactions to radiotherapy and chemotherapy, however, there were no statistically significant differences in the incidence of surgical complications, operation time, intraoperative blood loss and postoperative length of hospital stay (all P>0.05). A total of 119 patients underwent total mesenterectomy (TME), including 64 patients in the nCRT group and 55 patients in the SCRT-TNT group, all with R0 resection. The pathological complete response (pCR) rate was 10.9% (7/64) in the nCRT group and 25.5% (14/55) in the SCRT-TNT group, respectively, with a statistically significant difference (P=0.038). Two years after surgery, there was no statistically significant difference in local recurrence rate and overall survival rate between the two groups (both P>0.05). However, the clinical metastasis rate of SCRT-TNT group was significantly lower than that of nCRT group (20.3% vs 9.1%), with a statistically significant difference (P<0. 05). Conclusion: SCRT-TNT do not increase the adverse reactions of radio chemotherapy and perioperative risks in the treatment of locally advanced middle and low rectal cancer, and the tumor regression effect is good, which is worthy of clinical promotion.
目的： 比较中低位局部进展期直肠癌术前采用短程放疗联合化疗的全程新辅助治疗（SCRT-TNT）和新辅助放化疗（nCRT）两种模式的安全性与有效性。 方法： 采用回顾性队列研究方法。分析2016年9月至2020年3月在福建省肿瘤医院胃肠肿瘤外科就诊的126例中低位局部进展期直肠癌患者。其中男73例，女53例，年龄23~77（56.5±9.8）岁。根据患者接受的新辅助治疗方案（2018年12月前为nCRT治疗，2019年1月后为接受SCRT-TNT治疗），将患者分为nCRT组（68例）和SCRT-TNT组（58例）。2组患者年龄、性别、肿瘤距肛缘距离、美国东部肿瘤协作组（ECOG）体力状态评分、肿瘤TNM分期等基线资料的比较，差异均无统计学意义（均P>0.05）。2组均采用三维适形调强放疗（IMRT），nCRT组放疗剂量为5周（50Gy/25次），放疗期间口服卡培他滨化疗，放疗结束休息6~8周后行直肠癌全直肠系膜切除术（TME）；SCRT-TNT组给予奥沙利铂+卡培他滨（CapeOX）方案诱导化疗2周期后开始予短程放疗5 d（25 Gy/5次），巩固化疗（4周期）治疗结束后2周行手术治疗。比较分析两组放化疗不良反应、围手术期安全性以及新辅助治疗疗效。 结果： 两组患者均按计划完成新辅助治疗。nCRT组和SCRT-TNT组患者放化疗不良反应发生率相当，手术并发症发生率、手术时间、术中出血量、术后住院时间方面的差异均无统计学意义（均P>0.05）。共119例患者完成TME，nCRT组64例，SCRT-TNT组55例，均为R0切除。nCRT组完全缓解率（pCR）为10.9%（7/64），SCRT-TNT组pCR为25.5%（14/55），差异有统计学意义（P=0.038）。术后2年，2组患者的局部复发率与总生存率比较，差异无统计学意义（P>0.05）；但SCRT-TNT组的临床转移率明显低于nCRT 组（20.3%比9.1%），差异有统计学意义（χ2=4.267，P=0.039）。 结论： 在中低位局部进展期直肠癌的治疗中，SCRT-TNT不增加放化疗不良反应及围手术期风险，肿瘤退缩效果良好，有临床推广应用价值。.