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ESMO GI 2025 | Efficacy and safety of fruquintinib vs placebo by metastatic site in metastatic colorectal cancer
Rocio Garcia-Carbonero, MD, PhD, University Hospital 12 de Octubre, Madrid, Spain, presents subgroup analysis from the FRESCO-2 trial (NCT04322539), which studied fruquintinib versus placebo in metastatic colorectal cancer (mCRC) patients who progressed through standard therapies including oxaliplatin, fluoropyrimidines, irinotecan, anti-VEGF, anti-EGFR, and at least one of TAS-102 or regorafenib. The analysis examined outcomes by metastatic site: liver-only (5%), lung-only (4-5%), peritoneal (15%), and bone (10%) metastases. Results showed different overall survival outcomes across sites, with lung metastases having the most favorable prognosis and peritoneal disease the worst. However, fruquintinib demonstrated consistent progression-free survival and overall survival benefits across all subgroups versus placebo, suggesting metastatic sites are prognostic rather than predictive factors. This interview took place at the European Society for Medical Oncology (ESMO) Gastrointestinal Cancer 2025 Congress in Barcelona, Spain.
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Transcript
So the FRESCO-2 trial was a global randomized placebo-controlled trial in patients with metastatic colorectal cancer that have progressed to standard of care options including oxaliplatin, in fluoropyrimidines, irinotecan, anti-VEGF, anti-EGFR if appropriate. And also it was required to have progressed to TAS-102 and/or regorafenib. So at least one of the two was mandatory. So this included over almost 700 patients worldwide...
So the FRESCO-2 trial was a global randomized placebo-controlled trial in patients with metastatic colorectal cancer that have progressed to standard of care options including oxaliplatin, in fluoropyrimidines, irinotecan, anti-VEGF, anti-EGFR if appropriate. And also it was required to have progressed to TAS-102 and/or regorafenib. So at least one of the two was mandatory. So this included over almost 700 patients worldwide. And the trial, I mean, the patients were allocated to receive fruquintinib or placebo and this trial was positive. They significantly improved progression-free survival and overall survival of these patients and led to the indication of fruquintinib in this setting. And so what we present here at ESMO GI 2025 is a subgroup analysis of this trial based on the size of metastasis. With the subgroup analysis in patients with liver only disease, with lung only, and in patients with peritoneal metastasis with or without other sites, and in patients with bone metastasis with or without other sites. So we had already presented before ESMO the subgroup analysis of with or without liver mets but not in liver only so liver only it’s only about 4% of patients lung only is about 4/5% of patients bone metastasis is about 10% and peritoneal metastasis is about 15% so the subgroups are small but what we see is that basically the outcomes in terms of overall survival in all these subgroups is different. So it’s more favorable for lung mets than for liver mets and the worst is for peritoneal only disease. But the magnitude of the benefit that they obtain versus placebo with fruquintinib is observed across all subgroups in terms of PFS and also in terms of overall survival. The only exception is the lung subgroup because they have such a good prognosis that the data in that subgroup is a bit immature because there’s a lot of censored data. But median PFS with fruquintinib was around 14 months. So these metastatic sites of disease are more prognostic factors than predictive factors of fruquintinib benefits. So basically, fruquintinib is benefiting all groups.
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