medwireNews: Phase III trial results indicate that third- or later-line treatment with fruquintinib leads to significantly improved overall survival (OS) in Chinese patients with metastatic colorectal cancer (CRC).
In the double-blind FRESCO (Fruquintinib Efficacy and Safety in 3+ Line Colorectal Cancer Patients) study of patients who had progressed after at least two lines of chemotherapy, OS was a median of 9.3 months for the 278 patients who were randomly assigned to receive the highly selective inhibitor of VEGFR-1, 2, and 3 at a dose of 5 mg/day for 21 days of each 28-day cycle.
This was significantly longer than the median time of 6.6 months for the 138 participants treated with placebo, giving a hazard ratio (HR) for death of 0.65.
Fruquintinib-treated patients also had a significantly better progression-free survival than those given placebo, with corresponding median durations of 3.7 and 1.8 months. And the objective response and disease control rates were also significantly higher in the fruquintinib than placebo group, at 4.7% versus 0.0% and 62.2% versus 12.3%, respectively.
In terms of toxicity, fruquintinib treatment was associated with a higher rate of treatment-emergent adverse events of grade 3 or 4 (61.2 vs 19.7%) – most commonly hypertension, hand–foot skin reaction, and proteinuria – and serious adverse events (15.5 vs 5.8%) than placebo.
The study authors point out, however, that “most [adverse events] occurred during the first 2 cycles of treatment and could be managed with supportive care and dose adjustment,” and that “the duration of fruquintinib treatment was twice as long as that of placebo.”
Noting that “the outcomes were evaluated in a purely Chinese population,” researcher Shukui Qin (Nanjing Chinese Medicine University–Affiliated Bayi Hospital) and team comment that “further studies will be needed to confirm fruquintinib’s efficacy and tolerability in other populations.”
Furthermore, the standard of care for metastatic CRC differs between China and Western countries, such that the VEGF inhibitors bevacizumab and aflibercept are not routinely integrated into first- or second-line therapy in China, unlike in North America and Europe, the team writes in JAMA.
“This raises the possibility that results achieved in this study with a VEGFR inhibitor might not generalize to contexts where all patients receive VEGF inhibitors early in their treatment course.”
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