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基于短程放疗与标准长程放化疗的局部晚期直肠癌全新辅助治疗:一项随机对照试验的系统评价和荟萃分析

Total neoadjuvant therapy based on short-course radiotherapy versus standard long-course chemoradiotherapy for locally advanced rectal cancer: a systematic review and meta-analysis of randomized controlled trials.

作者信息

Pu Wenji, Chen Wenqi, Jing Haiman, Li Jishi, Jiang Yong, Li Shasha, Wen Weijie, Xu Zhiyuan, Jin Jing

机构信息

Department of Clinical Oncology, The University of Hong Kong-Shenzhen Hospital, Shenzhen, China.

Medical Department of Shenzhen University, General Hospital of Shenzhen University, Academy of Clinical Medicine of Shenzhen University, Shenzhen, China.

出版信息

Front Oncol. 2024 Dec 24;14:1515756. doi: 10.3389/fonc.2024.1515756. eCollection 2024.

DOI:10.3389/fonc.2024.1515756
PMID:39801655
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11718365/
Abstract

BACKGROUND

We conducted the meta-analysis to compare the therapeutic effects of total neoadjuvant therapy (TNT) based on short-course radiotherapy followed by consolidation chemotherapy (SCRT/CCT) and long-course chemoradiotherapy (LCCRT) for locally advanced rectal cancer (LARC) according to certain significant randomized controlled trials (RCTs).

METHODS

The researchers retrieved several databases, including PubMed, Embase, Web of Science, and the Cochrane Library, to collect all the relevant literature published since the establishment of the databases until July 30, 2024, and then screened to determine the qualified literature and extracted the relevant information. Finally, RevMan 5.4 software was utilized to conduct the meta-analysis for determining the 95% confidence interval (CI) and pooled risk ratio (RR). There were 9 study indicators, including the pathologic complete remission (pCR) rate, tumor downstaging rate, R0 resection rate, sphincter preservation rate, disease-free survival (DFS), overall survival (OS), acute ≥3 grade toxicity rate, surgery complication rate, and distant recurrence rate. When moderate, even severe, heterogeneity was found, a random-effect model was applied; otherwise, a fixed-effect model was used for the analysis.

RESULTS

A total of 6 eligible RCTs and 2259 participants were included in this meta-analysis. Compared with the standard LCCRT, TNT treatment on the basis of SCRT/CCT increased the pCR rate significantly [RR = 1.67, 95% CI (1.36, 2.04), P < 0.00001], especially in ≥ 4 cycles of the CCT arm [RR = 1.77, 95% CI: (1.41-2.23), p < 0.00001], and led to a similar tumor downstaging rate [RR = 0.99, 95% CI (0.85, 1.15), P = 0.92]. Moreover, survival outcomes, distant recurrence rate, and surgical indicators were comparable between the two groups.

CONCLUSION

For LARC patients, the SCRT/CCT regimen not only has a higher pCR rate, equivalent OS, and comparable additional indicators versus standard LCCRT but also shortens the treatment time, costs less, and improves patients' adherence to the innovative anti-tumor therapy; hence, with the concept of acute toxicity control, it could be further widely and safely utilized, especially in resource-limited settings.

SYSTEMATIC REVIEW REGISTRATION

https://www.crd.york.ac.uk/prospero/, identifier CRD42024600180.

摘要

背景

我们进行了这项荟萃分析,以根据某些重要的随机对照试验(RCT),比较基于短程放疗后巩固化疗(SCRT/CCT)的全新辅助治疗(TNT)与长程放化疗(LCCRT)对局部晚期直肠癌(LARC)的治疗效果。

方法

研究人员检索了多个数据库,包括PubMed、Embase、Web of Science和Cochrane图书馆,以收集自数据库建立至2024年7月30日发表的所有相关文献,然后进行筛选以确定合格文献并提取相关信息。最后,使用RevMan 5.4软件进行荟萃分析,以确定95%置信区间(CI)和合并风险比(RR)。共有9个研究指标,包括病理完全缓解(pCR)率、肿瘤降期率、R0切除率、保肛率、无病生存期(DFS)、总生存期(OS)、急性≥3级毒性率、手术并发症率和远处复发率。当发现存在中度甚至重度异质性时,应用随机效应模型;否则,使用固定效应模型进行分析。

结果

本荟萃分析共纳入6项合格的RCT和2259名参与者。与标准LCCRT相比,基于SCRT/CCT的TNT治疗显著提高了pCR率[RR = 1.67,95% CI(1.36,2.04),P < 0.00001],尤其是在CCT组≥4个周期时[RR = 1.77,95% CI:(1.41 - 2.23),p < 0.00001],并且导致类似的肿瘤降期率[RR = 0.99,95% CI(0.85,1.15),P = 0.92]。此外,两组之间的生存结局、远处复发率和手术指标相当。

结论

对于LARC患者,SCRT/CCT方案不仅与标准LCCRT相比具有更高的pCR率、相当的OS和可比的其他指标,而且缩短了治疗时间,成本更低,并提高了患者对创新抗肿瘤治疗的依从性;因此,基于急性毒性控制的概念,它可以进一步广泛且安全地应用,尤其是在资源有限的环境中。

系统评价注册

https://www.crd.york.ac.uk/prospero/,标识符CRD42024600180。

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