The FRUTIGA trial, a phase 3 double-blind, placebo-controlled study, evaluated the efficacy of adding fruquintinib to paclitaxel in patients with advanced gastric or gastroesophageal cancer who had progressed on frontline chemotherapy. The study enrolled 703 patients, predominantly Asian, and assessed progression-free survival (PFS) and overall survival as primary endpoints. The results showed that patients receiving fruquintinib with paclitaxel had significantly better PFS (5.6 months vs. 2.7 months) compared to those receiving placebo with paclitaxel. However, there was no significant improvement in overall survival, with a median survival of 9.6 months in the fruquintinib group versus 8.4 months in the placebo group. Notably, a subgroup of patients with lymph node metastases and non-diffuse histology showed a nominal but significant overall survival benefit with fruquintinib. The treatment was associated with higher rates of treatment-emergent grade 3 or higher adverse events.
Key Insights
- Potential Second-Line Treatment Option: Fruquintinib plus paclitaxel could be a promising option for patients with advanced gastric/gastroesophageal adenocarcinoma who have not responded to fluoropyrimidine or platinum chemotherapy.
- Improved Progression-Free Survival: The significant improvement in PFS indicates that fruquintinib can delay disease progression in this patient population.
- Considerations for Overall Survival Benefit: While the overall survival benefit was not significant in the general study population, certain subgroups did show a nominal benefit, suggesting the need for further research to identify patients who might benefit the most from this treatment.
- Safety Profile and Adverse Events: The higher incidence of grade 3 or higher adverse events in the fruquintinib group highlights the importance of careful patient monitoring and management of side effects in clinical practice.
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