Add-On Fruquintinib Delays Progression in Gastric Cancer


In patients with gastric or gastroesophageal cancer who have progressed on frontline chemotherapy, adding fruquintinib to paclitaxel significantly delays progression but fails to improve overall survival, new phase 3 data showed.


  • Second-line treatment options for patients with gastric or gastroesophageal cancer are limited to chemotherapy with or without ramucirumab, leaving an urgent need for alternative treatment options.
  • The phase 3 double-blind, placebo-controlled FRUTIGA trial enrolled 703 patients with gastric or gastroesophageal cancer who had progressed on fluoropyrimidine- or platinum-containing chemotherapy.
  • Patients were randomly assigned 1:1 to receive fruquintinib with paclitaxel or placebo with paclitaxel until disease progression. Almost all patients were Asian.
  • Primary endpoints were progression-free survival (PFS) and overall survival; secondary endpoints were overall response rate, disease control rate, duration of response, safety, and quality of life.


  • Patients in the fruquintinib group had significantly better PFS than those in the placebo group (5.6 months vs 2.7 months; hazard ratio [HR], 0.57). Almost two times as many patients receiving fruquintinib had an overall response rate (42.5% vs 22.4%).
  • However, patients receiving fruquintinib did not exhibit a significant overall survival benefit over the median study follow-up of 31.7 months. Median overall survival was 1.2 months longer in the fruquintinib group (9.6 months vs 8.4 months; HR, 0.96; P = .6064).
  • When looking at a subgroup of patients with lymph node metastases and non-diffuse histology, those receiving fruquintinib did show a nominal but significant overall survival benefit with a median overall survival difference of 1.7 months (9.6 vs 7.9 months; HR, 0.77; P = .0233). The researchers also noted a nominal but significant overall survival benefit in the fruquintinib group after adjusting for subsequent anticancer treatment and baseline characteristics (HR range, 0.79-0.83; P range = .0105-.0350).
  • Treatment-emergent grade 3 or higher adverse event rates were 86.9% in the fruquintinib arm vs 63.3 % in the placebo group. The most common grade 3 plus adverse events were neutropenia (60.0% vs 36.4%), leukopenia (42.9% vs 23.5%), and anemia (11.7% vs 10.6%).


“Fruquintinib plus paclitaxel could be a promising second-line treatment option for patients with advanced gastric/gastroesophageal adenocarcinoma who have failed fluoropyrimidine or platinum chemotherapy,” lead study author Rui-hua Xu, MD, PhD, from Sun Yat-sen University Cancer Center in Guangzhou, China, said in a press release.


This study, led by Rui-Hua Xu, MD, PhD, Sun Yat-sen University Cancer Center, was presented at the ASCO Plenary Series on February 6, 2024, and simultaneously published in the Journal of Clinical Oncology.


Almost all patients enrolled were Asians, limiting generalizability. An active comparator was not used. Information on subsequent therapies, tumor biology, and biomarkers was not available.


This study was sponsored by Hutchison Medipharma Limited. Xu declared receiving consulting/advisory fees outside of this work.

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Publish date : 2024-02-12 11:12:18

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