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TOPLINE:

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.

METHODOLOGY:

• 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.

TAKEAWAY:

• 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%).

IN PRACTICE:

"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.

SOURCE:

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.

LIMITATIONS:

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.

DISCLOSURES:

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