Adding Fruquintinib to Paclitaxel Improves PFS in Gastric, GEJ Cancer

Fruquintinib plus paclitaxel could be a second-line treatment option for patients with gastric or gastroesophageal junction (GEJ) cancer, according to researchers.

The combination improved responses and progression-free survival (PFS) when compared to paclitaxel alone in the phase 3 FRUTIGA trial. There was a trend toward improved overall survival (OS) with fruquintinib, but there was no significant difference in OS between the treatment arms.

These results were presented in an ASCO Plenary Series presentation by Rui-Hua Xu, MD, PhD, of Sun Yat-sen University Cancer Center in Guangzhou, China.

The FRUTIGA trial (ClinicalTrials.gov identifier: NCT03223376) included 703 patients with advanced gastric or GEJ adenocarcinoma who had disease progression on fluoropyrimidine- or platinum-containing chemotherapy.

The patients were randomly assigned to receive fruquintinib and paclitaxel (n=351) or placebo and paclitaxel (n=352). Baseline characteristics were similar between the treatment arms. The median age was 57 years in the fruquintinib arm and 59 years in the placebo arm. Roughly 70% of patients in each arm were men, around 83% had gastric cancer, and approximately 58% had stage IV disease.

Fruquintinib was given at 4 mg daily, 3 weeks on and 1 week off. In both arms, paclitaxel was given at 80 mg/m² on days 1, 8, and 15 of each cycle. Patients continued on treatment until disease progression or intolerable toxicity.

The median PFS was 5.6 months with fruquintinib-paclitaxel and 2.7 months with placebo-paclitaxel, which was a significant difference (hazard ratio [HR], 0.57; 95% CI, 0.48-0.68; P <.0001).

There was a trend toward improved OS with fruquintinib. The median OS was 9.6 months in the fruquintinib arm and 8.4 months in the placebo arm (HR, 0.96; 95% CI, 0.81-1.13; P =.6064).

The researchers also evaluated OS in patients who received subsequent therapy and those who did not. Patients in the placebo-paclitaxel arm were more likely to receive subsequent therapy than patients in the fruquintinib-paclitaxel arm — 72.2% and 52.7%, respectively.

Among patients who did not receive subsequent therapy, the median OS was 6.9 months in the fruquintinib arm and 4.8 months in the placebo arm (HR, 0.72; 95% CI, 0.53-0.99; P =.0422). Among patients who received subsequent therapy, the median OS was 12.2 months and 10.0 months, respectively (HR, 0.90; 95% CI, 0.73-1.11; P =.3262).

The objective response rate was higher with fruquintinib-paclitaxel than with placebo-paclitaxel — 42.5% and 22.4%, respectively (P <.0001). The complete response rate was 1.4% in both arms. The median duration of response was 5.5 months in the fruquintinib arm and 3.7 months in the placebo arm.

Treatment-emergent adverse events (AEs) occurred in 99.4% of patients in both arms. Grade 3 or higher treatment-emergent AEs were observed in 86.9% of patients in the fruquintinib arm and 63.3% of patients in the placebo arm. Fatal treatment-related AEs were seen in 5.1% and 1.7%, respectively.

The most common grade 3 or higher treatment-emergent AEs (in the fruquintinib and placebo arms, respectively) were neutropenia (60.0% vs 36.4%), leukopenia (42.9% vs 23.5%), anemia (11.7% vs 10.6%), and palmar-plantar erythrodysesthesia syndrome (8.9% vs 0%).

Based on these results, Dr Xu concluded that “fruquintinib plus paclitaxel could be a promising second-line treatment option for patients with advanced gastric or GEJ adenocarcinoma who have failed fluoropyrimidine- or platinum-containing chemotherapy.”

Disclosures: This study was supported by HUTCHMED Limited. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

This article originally appeared on Cancer Therapy Advisor