Yonatan Eric Ricardo, Ruby Rivaldi, Prasetya Alver, Arifin Erlangga Saputra
Faculty of Medicine and Health Sciences, Atma Jaya Catholic University of Indonesia, Special Capital Region of Jakarta, Pluit Raya Street No. 2, North Jakarta, 14440, Indonesia.
Clin J Gastroenterol. 2025 Feb;18(1):11-22. doi: 10.1007/s12328-024-02087-7. Epub 2024 Dec 20.
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.
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.
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.
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.
尽管治疗方法有所进步，但转移性结直肠癌（mCRC）仍是导致死亡的重要原因。呋喹替尼是一种强效的血管内皮生长因子受体（VEGFR）抑制剂，已显示出作为mCRC晚期治疗药物的潜力。本综述评估了呋喹替尼与安慰剂相比，在难治性mCRC患者中的疗效和安全性，重点关注II期和III期试验。
本研究采用系统评价和Meta分析的首选报告项目（PRISMA）指南进行。使用PubMed、EBSCOHost、ProQuest和谷歌学术进行文献检索。在RevMan 5.4软件中，采用风险比（HR）和风险率（RR）对总生存期（OS）、无进展生存期（PFS）、客观缓解率（ORR）、疾病控制率（DCR）和安全性进行汇总分析。
纳入了三项随机对照试验（RCT），共1178例患者。与安慰剂相比，呋喹替尼显著改善了OS（HR：0.66；95%置信区间[CI] 0.57 - 0.76）和PFS（HR：0.30；95% CI 0.26 - 0.35）。呋喹替尼的ORR（RR：5.91；95% CI 1.09 - 32.16）和DCR（RR：3.83；95% CI 3.00 - 4.90）也更高。3级或更高等级的不良事件在呋喹替尼组中更常见（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未观察到显著差异。
呋喹替尼显著改善了难治性mCRC患者的生存期和肿瘤反应。虽然与高级别不良事件风险增加相关，但呋喹替尼仍然是mCRC患者可行且相对安全的治疗选择。需要进一步研究以确认其在不同人群中的疗效和安全性。
