直肠癌患者的短期与长期新辅助放化疗:一项随机对照试验的长期结果。

IF 2.3 3区 医学 Q2 GASTROENTEROLOGY & HEPATOLOGY
Mahdi Aghili, Mohammad-Mahdi Aghaei, Romina Abyaneh, Mohammad Babaei, Farshid Farhan, Marzieh Lashkari, Borna Farazmand, Kasra Kolahdouzan, Guglielmo Niccolò Piozzi, Felipe Counago, Reza Ghalehtaki
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引用次数: 0

摘要

背景与目的:短期放疗(SCRT)和长期放疗(LCRT)是局部晚期直肠癌新辅助放疗的主要方案。最近的研究对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,通过比较这两种策略的长期结果,延长了随访时间,以评估5年的结果。材料和方法:本随机对照试验比较了SCRT和LCRT治疗局部晚期中、重度直肠腺癌的疗效。SCRT组在1周内给予25 Gy/5分数加CAPOX,而LCRT组在5-5.5周内给予50-50.4 Gy/25-28分数加卡培他滨。所有患者均接受巩固化疗,放疗后8周及以上延迟手术。这项最新分析的终点包括总生存期(OS)、无病生存期(DFS)、局部复发(LR)和远处转移(DM)。结果:99例(45例LCRT, 54例SCRT)随访中位数为4.7年。LCRT组5年OS率为77.3%,SCRT组为65.6% (P = 0.4)。LCRT组5年DFS为69.6%,SCRT组为54.9% (P = 0.07)。Cox回归显示两组在OS、LR或DM方面无显著差异。亚组分析显示,LCRT在男性患者([HR] = 2.48, 95%CI: 1.04-5.93, P = 0.03)、60岁以下患者(HR = 3.19, 95%CI: 1.03-9.92, P = 0.04)和cT4患者(HR未计算:LCRT组无事件,P = 0.004)中的DFS明显优于SCRT。结论:DFS有偏向LCRT组的趋势,LCRT组在男性、60岁以下、cT4期患者中明显优于LCRT组。尽管得到了强化,但SCRT未能达到与LCRT相当的长期结果。需要进一步的研究来比较这两种方法在完全新辅助治疗的背景下。试验注册数据:IRCT2017110424266N3(注册日期:2017-11-12)。https://irct.behdasht.gov.ir/trial/20526。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Short-course versus long-course neoadjuvant chemoradiotherapy in patients with rectal cancer: long-term results of a randomized controlled trial.

Short-course versus long-course neoadjuvant chemoradiotherapy in patients with rectal cancer: long-term results of a randomized controlled trial.

Short-course versus long-course neoadjuvant chemoradiotherapy in patients with rectal cancer: long-term results of a randomized controlled trial.

Short-course versus long-course neoadjuvant chemoradiotherapy in patients with rectal cancer: long-term results of a randomized controlled trial.

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 .

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来源期刊
CiteScore
4.90
自引率
3.60%
发文量
206
审稿时长
3-8 weeks
期刊介绍: The International Journal of Colorectal Disease, Clinical and Molecular Gastroenterology and Surgery aims to publish novel and state-of-the-art papers which deal with the physiology and pathophysiology of diseases involving the entire gastrointestinal tract. In addition to original research articles, the following categories will be included: reviews (usually commissioned but may also be submitted), case reports, letters to the editor, and protocols on clinical studies. The journal offers its readers an interdisciplinary forum for clinical science and molecular research related to gastrointestinal disease.
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