直肠癌患者短疗程与长疗程新辅助放化疗：一项随机对照试验的长期结果
Short-course versus long-course neoadjuvant chemoradiotherapy in patients with rectal cancer: long-term results of a randomized controlled trial.
作者信息
Aghili Mahdi, Aghaei Mohammad-Mahdi, Abyaneh Romina, Babaei Mohammad, Farhan Farshid, Lashkari Marzieh, Farazmand Borna, Kolahdouzan Kasra, Piozzi Guglielmo Niccolò, Counago Felipe, Ghalehtaki Reza
机构信息
Radiation Oncology Research Center, Cancer Research Institute, IKHC, Tehran University of Medical Sciences, Tehran, Iran.
Department of Radiation Oncology, Cancer Institute, IKHC, Tehran University of Medical Sciences, Tehran, Iran.
出版信息
Int J Colorectal Dis. 2025 May 14;40(1):118. doi: 10.1007/s00384-025-04901-1.
BACKGROUND AND PURPOSE
Short-course radiotherapy (SCRT) and long-course radiotherapy (LCRT) are the primary neoadjuvant radiotherapy schedules for locally advanced rectal cancer. Recent research has questioned the efficacy of SCRT. This study presents an updated analysis of our previous research, extending the follow-up to evaluate 5-year outcomes by comparing the long-term results of these two strategies.
MATERIALS AND METHODS
This randomized controlled trial compared SCRT and LCRT in locally advanced middle or high rectal adenocarcinoma. The SCRT group received 25 Gy/5 fractions over 1 week plus CAPOX, while the LCRT group received 50-50.4 Gy/25-28 fractions over 5-5.5 weeks plus capecitabine. All patients received consolidation chemotherapy and then underwent delayed surgery after 8 weeks or more post-radiotherapy. The endpoints of this updated analysis include overall survival (OS),disease-free survival (DFS), locoregional recurrence (LR) and distant metastasis (DM).
RESULTS
Ninety-nine cases (45 LCRT, 54 SCRT) were followed for a median of 4.7 years. Five-year OS rates were 77.3% for LCRT vs. 65.6% for SCRT group (P = 0.4). The 5-year DFS rates were 69.6% for LCRT vs. 54.9% for SCRT (P = 0.07). Cox regression indicated no prominent difference between the two groups regarding OS, LR, or DM. Subgroup analysis demonstrated a significantly better DFS with LCRT compared to SCRT in male patients ([HR] = 2.48, 95%CI: 1.04-5.93, P = 0.03), patients under the age of 60 (HR = 3.19, 95%CI: 1.03-9.92, P = 0.04), and cT4 patients (HR not calculated: no events in LCRT group, P = 0.004).
CONCLUSION
DFS showed a trend in favor of the LCRT group, with LCRT being significantly superior among men, patients under 60, and cT4 stage. Despite being intensified, SCRT failed to achieve long-term outcomes comparable to LCRT. Further research is needed to compare these two approaches in the context of total neoadjuvant treatment.
TRIAL REGISTRATION DATA
IRCT2017110424266N3 (Registration date: 2017-11-12). https://irct.behdasht.gov.ir/trial/20526 .
背景与目的
短程放疗（SCRT）和长程放疗（LCRT）是局部晚期直肠癌的主要新辅助放疗方案。近期研究对SCRT的疗效提出了质疑。本研究对我们之前的研究进行了更新分析，延长随访时间以比较这两种策略的长期结果，评估5年结局。
材料与方法
本随机对照试验比较了SCRT和LCRT在局部晚期中高位直肠腺癌中的应用。SCRT组在1周内接受25 Gy/5次分割，联合CAPOX方案，而LCRT组在5 - 5.5周内接受50 - 50.4 Gy/25 - 28次分割，联合卡培他滨。所有患者均接受巩固化疗，然后在放疗后8周或更长时间接受延迟手术。本次更新分析的终点包括总生存期（OS）、无病生存期（DFS）、局部区域复发（LR）和远处转移（DM）。
结果
99例患者（45例LCRT，54例SCRT）中位随访4.7年。LCRT组5年总生存率为77.3%，SCRT组为65.6%（P = 0.4）。LCRT组5年无病生存率为69.6%，SCRT组为54.9%（P = 0.07）。Cox回归分析表明两组在总生存期、局部区域复发或远处转移方面无显著差异。亚组分析显示，在男性患者（[风险比] = 2.48，95%置信区间：1.04 - 5.93，P = 0.03）、60岁以下患者（风险比 = 3.19，95%置信区间：1.03 - 9.92，P = 0.04）和cT4患者（风险比未计算：LCRT组无事件发生，P = 0.004）中，LCRT组的无病生存期明显优于SCRT组。
结论
无病生存期显示出有利于LCRT组的趋势，在男性、60岁以下患者和cT4期患者中，LCRT明显更优。尽管SCRT有所强化，但仍未能实现与LCRT相当的长期结局。需要进一步研究在全新辅助治疗背景下比较这两种方法。
试验注册数据
IRCT2017110424266N3（注册日期：2017 - 11 - 12）。https://irct.behdasht.gov.ir/trial/20526 。
Zotero 插件