Evaluation of fruquintinib's efficacy and safety in refractory metastatic colorectal cancer: a systematic review and meta-analysis of phase II and III randomized controlled trials.
Eric Ricardo Yonatan, Rivaldi Ruby, Alver Prasetya, Erlangga Saputra Arifin
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引用次数: 0
Abstract
Background: Metastatic colorectal cancer (mCRC) remains a significant cause of mortality despite advancements in treatments. Fruquintinib, a potent VEGFR inhibitor, has shown promise as an advanced therapy for mCRC. This review evaluates the efficacy and safety of fruquintinib compared to placebo in patients with refractory mCRC, focusing on Phase II and III trials.
Method: This study was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. A literature search was performed using PubMed, EBSCOHost, ProQuest, and Google Scholar. The analysis of overall survival (OS), progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and safety was pooled using hazard ratios (HR) and risk ratios (RR) in RevMan 5.4 software.
Results: Three RCTs comprising 1,178 patients were included. Fruquintinib significantly improved OS (HR: 0.66; 95% CI 0.57-0.76) and PFS (HR: 0.30; 95% CI 0.26-0.35) compared to placebo. ORR (RR: 5.91; 95% CI 1.09-32.16) and DCR (RR: 3.83; 95% CI 3.00-4.90) were also higher with fruquintinib. Grade 3 or higher adverse events were more frequent with fruquintinib (RR: 1.31; 95% CI 1.02-1.70). No significant difference was observed in serious adverse events or treatment-related deaths.
Conclusion: Fruquintinib significantly improves survival and tumor response in patients with refractory mCRC. While associated with an increased risk of high-grade adverse events, fruquintinib remains a viable and relatively safe treatment option for mCRC patients. Further studies are needed to confirm its efficacy and safety across diverse populations.
背景：尽管治疗取得了进展，但转移性结直肠癌（mCRC）仍然是导致死亡的重要原因。fruquininib是一种有效的VEGFR抑制剂，有望成为mCRC的高级治疗方法。本综述评估了fruquininib与安慰剂在难治性mCRC患者中的疗效和安全性，重点是II期和III期试验。方法：本研究采用系统评价和荟萃分析首选报告项目（PRISMA）指南进行。使用PubMed、EBSCOHost、ProQuest和谷歌Scholar进行文献检索。采用RevMan 5.4软件进行总生存期（OS）、无进展生存期（PFS）、客观缓解率（ORR）、疾病控制率（DCR）和安全性的汇总分析，采用风险比（HR）和风险比（RR）。结果：纳入3项随机对照试验，共1178例患者。fruquininib显著改善OS (HR: 0.66；95% CI 0.57-0.76)和PFS (HR: 0.30；95% CI 0.26-0.35)。ORR (rr: 5.91；95% CI 1.09-32.16)和DCR (RR: 3.83；95% CI 3.00-4.90)， fruquininib组也更高。氟喹替尼组3级及以上不良事件发生率更高(RR: 1.31；95% ci 1.02-1.70)。在严重不良事件或治疗相关死亡方面没有观察到显著差异。结论：fruquininib可显著改善难治性mCRC患者的生存和肿瘤反应。虽然与高级别不良事件的风险增加相关，但fruquininib仍然是mCRC患者可行且相对安全的治疗选择。需要进一步的研究来证实其在不同人群中的有效性和安全性。
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The journal publishes Case Reports and Clinical Reviews on all aspects of the digestive tract, liver, biliary tract, and pancreas. Critical Case Reports that show originality or have educational implications for diagnosis and treatment are especially encouraged for submission. Personal reviews of clinical gastroenterology are also welcomed. The journal aims for quick publication of such critical Case Reports and Clinical Reviews.
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