Colon cancer is one of the most frequent and in most cases it is associated with risk factors related to lifestyle, such as an inadequate diet with little fiber and vitamins and an excess of fats of animal origin and red meat. , alcohol consumption and a sedentary lifestyle, as well as suffering from inflammatory bowel diseases or having polyps that can turn malignant, hence the importance of undergoing regular check-ups from the age of 50 (occult blood in feces and colonoscopy).
Although early detection and advances in colon cancer treatment have improved survival, patients with metastatic colorectal cancer still have poor long-term survival rates. Therefore, the findings of a new study are very promising, showing that the targeted therapy fruquintinib significantly improves overall survival (OS) and progression-free survival (PFS) in patients with refractory metastatic colorectal cancer, researchers have reported. from the MD Anderson Cancer Center of the University of Texas (USA).
The results of the global FRESCO-2 trial were first presented at the 2022 European Society for Medical Oncology (ESMO) Congress and have just been published in the prestigious scientific journal The Lancet. Overall survival was 7.4 months with fruquintinib vs. 4.8 months in the placebo group, while the median PFS was 3.7 months with fruquintinib vs. 1.8 months in the placebo group. These results represent a statistically significant improvement relative to controls.
The Japanese company Takeda and the Chinese company HUTCHMED, which have developed the drug, have announced that the European Medicines Agency (EMA) has validated and accepted for regulatory review the marketing authorization application for fruquintinib for the treatment of adult patients with previously metastatic colorectal cancer. treaty. If approved, fruquintinib will be the first and only highly selective inhibitor of all three VEGF receptors approved in the EU for this type of colorectal cancer.
Fruquintinib, a new option in advanced colorectal cancer
The Phase III randomized clinical trial FRESCO-2 was conducted at 153 sites in the United States, Europe, Japan, and Australia to evaluate treatment with the novel oral therapy fruquintinib, a small-molecule receptor tyrosine kinase inhibitor. of vascular endothelial growth factor (VEGFR), plus best supportive care compared to placebo, plus best supportive care in patients with intensive prior treatment with treatment-resistant metastatic colorectal cancer.
“These results confirm that fruquintinib may be a new treatment opportunity for patients who previously had no other options”
The 691 patients included in the trial were selected for treatment because they had diagnosed metastatic colorectal cancer and had been previously treated with chemotherapy, anti-VEGF therapy, or immune checkpoint inhibitors (if their disease was mismatch repair-deficient or instability). of microsatellites). Patients had an ECOG Performance Status Scale score of 0 or 1, measurable disease, and an expected survival of 12 weeks or longer.
Participants were randomized to receive fruquintinib or placebo daily for three weeks, followed by a week off, in 28-day cycles. Subsequent anticancer therapies were administered to 29.4% of individuals in the fruquintinib group and 34.3% of those in the placebo group. The disease control rate was 55.5% with fruquintinib versus 16.1% with placebo.
Grade 3 or 4 treatment-related adverse events occurred in 62.7% of patients in the fruquintinib group and 50.4% in the placebo group. The most frequent events observed in those receiving fruquintinib were hypertension (in 13.6%), asthenia (in 7.7%) and hand-foot syndrome –redness, swelling and pain in the palms of the hands or the soles of the feet that can appear after taking certain medications– (in 6.4%).
“Patients with refractory metastatic colorectal cancer have very limited treatment options and poor outcomes,” said Arvind Dasari, MD, associate professor of Gastrointestinal Medical Oncology and principal investigator. “These results are very encouraging and confirm that fruquintinib may be a new treatment opportunity for patients who previously had no other options.” “This study supports the significant survival improvement and manageable safety profile of fruquintinib,” Dasari said. I am excited that this treatment can prolong the lives of patients with advanced colorectal cancer and preserve their quality of life.”
The next step will be to review the quality of life data of the trial participants, as they are patients with a high tumor burden who suffer from residual side effects of numerous therapies known to decrease measures of quality of life. Ongoing and future studies will investigate new treatment combinations with fruquintinib for patients with colorectal cancer.
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