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Welcome to Audio Abstracts on ReachMD. Today, we’ll be reviewing a poster, titled Efficacy and safety of fruquintinib plus mFOLFOX6/FOLFIRI as first-line therapy in advanced metastatic colorectal cancer, which was presented at the 2023 American Society of Clinical Oncology Annual Meeting.

Fruquintinib is a highly selective and potent oral inhibitor of VEGF receptors one, two, and three. In China, this treatment has been recommended as a third-line treatment because of its low toxicity, good objective response rate, and survival benefit. In the US, the first-line treatment for metastatic colorectal cancer, or mCRC for short, is chemotherapy with FOLFOX/FOLFIRI.

As for the design of this study, this was a prospective, open-label, multi-center, single-arm phase 2 study that included patients who were diagnosed with unresectable mCRC without prior systemic treatment. Patients received three milligrams of fruquintinib by mouth once a day for four weeks in combination with mFOLFOX6/FOLFIRI that was administered once every two weeks up to eight cycles. And patients who had achieved at least stable disease then continued on to maintenance therapy until disease progression or intolerable toxicity. This consisted of a single dose of three milligrams of fruquintinib every four weeks plus twice-daily capecitabine every other week.

Now looking at the results, 13 of the 19 patients who were enrolled in the study had efficacy data. The median age was 60, 62% of participants were male, and 54% had RAS mutations. The median follow-up was about 6 months, and all patients remain on treatment. The objective response rate was 77% and stable disease is 23%, with a disease control rate of 100%. Most reported adverse events were grade 1/ 2. The most common grade three treatment-related adverse events were a decrease in neutrophil count in 23% and an increase in GGT reported in 15% of study participants. No patients reported any serious adverse events.

Given these findings, researchers concluded that combination treatment with fruquintinib plus mFOLFOX6/FOLFIRI as a first-line therapy, followed by fruquintinib plus capecitabine maintenance, shows promise in its safety and efficacy for patients with advanced mCRC.

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