1. Overall survival was significantly greater in the fruquintinib group versus placebo.
2. The majority of adverse events were mild-to-moderate and were slightly more common among patients receiving fruquintinib.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Colorectal cancer is the third-most prevalent cancer in the world and the second leading cause of death worldwide. Patients with advanced, chemotherapy-refractory colorectal cancer generally do not respond to systemic therapy and so, an alternate form of treatment is needed. This randomized controlled trial aimed to evaluate the safety and efficacy of fruquintinib, a potent vascular endothelial growth factor (VEGF) inhibitor, in patients with chemotherapy-refractory metastatic colorectal cancer. The primary outcome was overall survival, while the key secondary outcome included the recurrence of grade 3 or worse adverse events. According to study results, fruquintinib resulted in a significant and clinically meaningful improvement in overall survival. However, the study was limited by the absence of ongoing recruitment and the need for further analysis of quality-of-life data.
Click to read the study in The Lancet
Relevant Reading: Effect of Colonoscopy Screening on Risks of Colorectal Cancer and Related Death
In-depth [randomized-controlled trial]: Between Aug 12, 2020, and Dec 2, 2021, 934 patients were screened for eligibility across 124 hospitals in 14 countries. Included were patients ≥ 18 years old with histologically confirmed metastatic colorectal cancer. Altogether, 691 patients (461 in fruquintinib and 230 in placebo) were included in the final analysis. The primary outcome of overall survival was significantly greater in the fruquintinib group (7.4 months, 95% confidence interval [CI] 6.7-8.2) versus the placebo group (4.8 months, 95% CI 4.0-5.8, hazard ratio [HR] 0.66, 95% CI 0.55-0.80, p<0.0001). However, the occurrence of grade 3 or worse adverse events was more common in the fruquintinib group (63% in fruquintinib vs. 50% in placebo), with the most common being hypertension (14% vs. 1%), asthenia (8% vs. 4%), and hand-foot syndrome (6% vs. 0%). Overall, findings from this study suggest that fruquintinib significantly improved overall survival in patients with refractory metastatic colorectal cancer, supporting its potential as a global treatment option for this patient population.
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