Zhou Wenjie, Wang Xueting, Dan Jie, Zhu Minjie, Liao Qian, Liu Ke, Li Jiangpeng, Jiang Xianhong, Wang Yonghong
Department of Gastrointestinal Surgery, The People's Hospital of Leshan, Leshan, China.
Department of Scientific Research and Teaching, The People's Hospital of Leshan, Leshan, China.
Front Oncol. 2025 Jun 26;15:1542885. doi: 10.3389/fonc.2025.1542885. eCollection 2025.
Long-course neoadjuvant chemoradiotherapy (Lc-NCRT) is the conventional treatment for locally advanced rectal cancer (LARC). It improves R0 resection rate and reduces local recurrence rate, but it cannot improve long-term oncological outcomes. It also causes several radiotherapy-related side effects. In recent years, some studies have shown that neoadjuvant chemotherapy (NCT) may be noninferior to Lc-NCRT. Therefore, we systematically evaluated the efficacy and safety of NCT and Lc-NCRT for LARC.
Cochrane Library, Embase, PubMed, WanFang Data, and CNKI were systematically searched as the relevant literature. The literature was screened independently by two groups, and data were extracted and evaluated for bias. A meta-analysis was performed using Revman5.4 software. The primary outcomes were tumor response to neoadjuvant therapy and long-term oncological outcomes.
A total of 17 studies with 5,168 cases (1,957 cases in NCT and 3,211 cases in Lc-NCRT) were included in our meta-analysis. Compared with the Lc-NCRT group, although the NCT group had a lower pCR rate [RR = 0.65, 95% CI (0.56-0.75), < 0.0001], less downstaging [RR = 1.11, 95%CI(1.03-1.19), = 0.06] and more adverse events of neoadjuvant therapy [RR = 1.11, 95% CI (1.03-1.19); = 0.06], it had no difference in long-term survival outcome [3-year overall survival: HR = 1.13, 95% CI (0.70-1.83), = 0.62; 3-year disease-free survival: HR = 1.16, 95% CI (0.96-1.39), = 0.12; 3-year local recurrence-free survival: HR = 1.36, 95% CI (0.9-2.08), = 0.15] and serious adverse events [RR = 0.84, 95% CI (0.45-1.57), = 0.58] from the Lc-NCRT group. Moreover, the incidence of anastomotic leakage [RR = 0.48, 95% CI (0.34-0.45)] and permanent stoma rate [RR = 0.7, 95% CI (0.58-0.84), < 0.0001] after operation was lower in the NCT group.
NCT is a potential option for the treatment of LARC as it is beneficial for improving the sphincter preservation rate and reducing anastomotic leakage, the long-term oncological outcome is considerable, and the safety is controllable. Larger randomized controlled trials (RCT) with longer follow-up data are needed to clarify the specific regimens of NCT and the risk stratification of rectal cancer.
https://www.crd.york.ac.uk/PROSPERO/home identifier, CRD42024579586.
长疗程新辅助放化疗（Lc-NCRT）是局部晚期直肠癌（LARC）的传统治疗方法。它提高了R0切除率，降低了局部复发率，但不能改善长期肿瘤学结局。它还会引起一些放疗相关的副作用。近年来，一些研究表明新辅助化疗（NCT）可能不劣于Lc-NCRT。因此，我们系统评价了NCT和Lc-NCRT治疗LARC的疗效和安全性。
系统检索Cochrane图书馆、Embase、PubMed、万方数据和中国知网作为相关文献。由两组独立筛选文献，提取数据并评估偏倚。使用Revman5.4软件进行荟萃分析。主要结局是肿瘤对新辅助治疗的反应和长期肿瘤学结局。
我们的荟萃分析共纳入17项研究，5168例患者（NCT组1957例，Lc-NCRT组3211例）。与Lc-NCRT组相比，NCT组虽然pCR率较低[RR = 0.65，95%CI（0.56-0.75），<0.0001]，降期较少[RR = 1.11，95%CI（1.03-1.19），= 0.06]，新辅助治疗的不良事件较多[RR = 1.11，95%CI（1.03-1.19）；= 0.06]，但在长期生存结局[3年总生存率：HR = 1.13，95%CI（0.70-1.83），= 0.62；3年无病生存率：HR = 1.16，95%CI（0.96-1.39），= 0.12；3年局部无复发生存率：HR = 1.36，95%CI（0.9-2.08），= 0.15]和严重不良事件[RR = 0.84，95%CI（0.45-1.57），= 0.58]方面与Lc-NCRT组无差异。此外，NCT组术后吻合口漏发生率[RR = 0.48，95%CI（0.34-0.45）]和永久性造口率[RR = 0.7，95%CI（0.58-0.84），<0.0001]较低。
NCT是治疗LARC的一种潜在选择，因为它有利于提高保肛率和降低吻合口漏，长期肿瘤学结局可观，安全性可控。需要更大规模的随机对照试验（RCT）和更长的随访数据来明确NCT的具体方案和直肠癌的风险分层。
