FRUTIGA
Trial question
What is the role of fruquintinib plus paclitaxel in patients with advanced gastric or GEJ adenocarcinoma?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
30.0% female
70.0% male
N = 703
703 patients (214 female, 489 male).
Inclusion criteria: patients with advanced gastric or GEJ adenocarcinoma who progressed on fluorouracil- and platinum-containing chemotherapy.
Key exclusion criteria: SCC; any factors influencing the usage of oral administration; brain metastasis; alcohol/drug abuse; uncontrolled active infection; malignancy within prior 5 years.
Interventions
N=351 fruquintinib plus paclitaxel (fruquintinib at an oral dose of 4 mg once daily for 3 weeks followed by 1 week off plus paclitaxel IV 80 mg/m² on days 1, 8, and 15 per cycle).
N=352 placebo plus paclitaxel (matching placebo for 3 weeks plus paclitaxel IV 80 mg/m² on days 1, 8, and 15 per cycle).
Primary outcome
Median progression-free survival
5.6 months
2.7 months
5.6 months
4.2 months
2.8 months
1.4 months
0.0 months
Fruquintinib plus
paclitaxel
Placebo plus
paclitaxel
Significant
increase ▲
Significant increase in median progression-free survival (5.6 months vs. 2.7 months; HR 1.75, 95% CI 1.47 to 2.08).
Secondary outcomes
No significant difference in median overall survival (9.6 months vs. 8.4 months; HR 0.96, 96% CI 0.81 to 1.13).
Significant increase in objective response rate (42.5% vs. 22.4%; OR 2.56, 95% CI 1.85 to 3.56).
Significant increase in disease control rate (77.2% vs. 56.3%; OR 2.65, 95% CI 1.91 to 3.67).
Safety outcomes
No significant difference in treatment-emergent adverse events.
Conclusion
In patients with advanced gastric or GEJ adenocarcinoma who progressed on fluorouracil- and platinum-containing chemotherapy, fruquintinib plus paclitaxel was superior to placebo plus paclitaxel with respect to median progression-free survival.
Reference
Feng Wang, Lin Shen, Weijian Guo et al. Fruquintinib plus paclitaxel versus placebo plus paclitaxel for gastric or gastroesophageal junction adenocarcinoma: the randomized phase 3 FRUTIGA trial. Nat Med. 2024 Aug;30(8):2189-2198.
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