Zeng De-Xin, Liu Ruo-Nan, Ren Xian-Kun, Zhang Peng, Tang Ling-Han, Tan Ling, Ur Rehman Zia, Zhao Mao-Ru, Guo Peng, Zhang Pan, Du Jun, Qin Xian, Wan Shi-Yan, Deng Lu-Qian, Luo Ya-Jun, Liu Zi-Lin, Xiao Jiang-Wei
Department of Gastrointestinal Surgery, Clinical Medical College and The First Affiliated Hospital of Chengdu Medical College, Chengdu, Sichuan Province, China.
Department of Gastrointestinal Surgery, Medical Center Hospital of Qionglai City, Qionglai, China.
Int J Surg. 2025 Mar 1;111(3):2686-2696. doi: 10.1097/JS9.0000000000002262.
Preoperative neoadjuvant chemoradiotherapy (nCRT) is considered to be the standard treatment strategy for locally advanced rectal cancer (LARC); however, the risk of adverse events and postoperative recurrence remains significant. This study aimed to evaluate the non-inferiority of neoadjuvant chemotherapy (nCT) compared with nCRT in patients with LARC and to assess the possibility of eliminating radiotherapy on the basis of guaranteed efficacy.
We searched the PubMed, Embase, and Cochrane Library databases to identify randomized controlled trials (RCTs) comparing the efficacy of nCRT and nCT for LARC. The study protocol was registered with the Prospective Register of Systematic Reviews (PROSPERO).
A total of 2706 patients from seven studies were included in the meta-analysis. There was no significant difference in overall survival (OS) or disease-free survival (DFS) between the nCT and nCRT groups. This study demonstrated a lower rate of infection (OR = 0.53, 95% CI = 0.34-0.82; P = 0.005), anastomotic leak (OR = 0.55, 95% CI = 0.34-0.87; P = 0.01), tumor regression grade (TRG) 0-1 (OR = 0.50, 95% CI = 0.36-0.69; P < 0.0001), preventive diverting ileostomy (OR = 0.41, 95% CI = 0.17-1.02; P = 0.05), and leukopenia (OR = 0.50, 95% CI = 0.25-1.01; P = 0.05) in the nCT group. However, there was no significant difference in the other toxic events, such as intestinal obstruction, urinary complications, diarrhea, and surgical or pathological outcomes, such as clinical fistula, sphincter preservation, postoperative mortality (≤ 60 d), R0 resection, ypStage 0-I, positive circumferential resection margin (CRM+), or pathological complete response (pCR) between the two groups.
This study indicated that OS and DFS were not lower in the nCT group than in the nCRT group. In addition, the nCT group had fewer complications. Preoperative nCT is expected to become a standard treatment option for most patients with stage II-III LARC. It is worth noting that radiotherapy cannot be ignored for some patients who need to ensure the conversion effect of neoadjuvant therapy and strongly request to preserve organ function.
术前新辅助放化疗(nCRT)被认为是局部晚期直肠癌(LARC)的标准治疗策略;然而,不良事件风险和术后复发风险仍然很高。本研究旨在评估新辅助化疗(nCT)与nCRT相比在LARC患者中的非劣效性,并在保证疗效的基础上评估消除放疗的可能性。
我们检索了PubMed、Embase和Cochrane图书馆数据库,以确定比较nCRT和nCT对LARC疗效的随机对照试验(RCT)。研究方案已在系统评价前瞻性注册库(PROSPERO)注册。
荟萃分析共纳入了来自7项研究的2706例患者。nCT组和nCRT组在总生存期(OS)或无病生存期(DFS)方面无显著差异。本研究表明,nCT组的感染率(比值比[OR]=0.53,95%置信区间[CI]=0.34-0.82;P=0.005)、吻合口漏(OR=0.55,95%CI=0.34-0.87;P=0.01)、肿瘤退缩分级(TRG)0-1(OR=0.50,95%CI=0.36-0.69;P<0.0001)、预防性回肠造口术(OR=0.41,95%CI=0.17-1.02;P=0.05)和白细胞减少症(OR=0.50,95%CI=0.25-1.01;P=0.05)较低。然而,两组在其他毒性事件(如肠梗阻、泌尿系统并发症、腹泻)以及手术或病理结果(如临床瘘、括约肌保留、术后死亡率(≤60天)、R0切除、yp分期0-I、环周切缘阳性(CRM+)或病理完全缓解(pCR))方面无显著差异。
本研究表明,nCT组的OS和DFS不低于nCRT组。此外,nCT组的并发症较少。术前nCT有望成为大多数II-III期LARC患者的标准治疗选择。值得注意的是,对于一些需要确保新辅助治疗的转化效果并强烈要求保留器官功能的患者,放疗不能被忽视。