by Elana Gotkine

For patients with refractory metastatic colorectal cancer, fruquintinib treatment yields a significant and clinically meaningful benefit in terms of overall survival, according to a study published in the July 1 issue of The Lancet.

Arvind Dasari, M.D., from the University of Texas MD Anderson Cancer Center in Houston, and colleagues conducted an international, randomized, double-blind phase 3 study at 124 hospitals and cancer centers across 14 countries. Patients aged 18 years or older with histologically or cytologically documented metastatic colorectal adenocarcinoma who had received all current standard approved cytotoxic and targeted therapies and progressed on or were intolerant to trifluridine-tipiracil or regorafenib, or both, were included. A total of 691 patients were randomly assigned (2:1) to receive fruquintinib (5 mg capsule) or matched placebo orally once daily on days 1 to 21 followed by an off-week in 28-day cycles, plus best supportive care (461 and 230 patients, respectively).

The researchers found that median overall survival was 7.4 and 4.8 months in the fruquintinib and placebo groups, respectively (hazard ratio, 0.66). Grade 3 or worse adverse events occurred in 63 and 50 percent of patients receiving fruquintinib and placebo, respectively; the most common grade 3 or worse adverse events included hypertension, asthenia, and hand-foot syndrome in the fruquintinib group (14, 8, and 6 percent, respectively).

"The significant and clinically meaningful benefit with fruquintinib, the true extent of which will be more clear following analyses of the quality of life assessments, was coupled with a favorable safety profile," the authors write.

More information: Erika Martinelli et al, Angiogenesis inhibition in metastatic colorectal cancer continuum of care, The Lancet (2023). DOI: 10.1016/S0140-6736(23)00867-X Arvind

Dasari et al, Fruquintinib versus placebo in patients with refractory metastatic colorectal cancer (FRESCO-2): an international, multicentre, randomised, double-blind, phase 3 study, The Lancet (2023). DOI: 10.1016/S0140-6736(23)00772-9

Journal information: The Lancet 

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