A selective VEGF receptor pill, first approved in China, repeated its effect in a global trial of 691 heavily treated patients: 7.4 against 4.8 months.
Dasari, Lonardi, Garcia-Carbonero and colleagues conducted an international randomised double-blind placebo-controlled phase 3 study at 124 hospitals and cancer centres across 14 countries in patients aged 18 or older with metastatic colorectal adenocarcinoma who had received all current standard cytotoxic and targeted therapies and had progressed on or been intolerant to trifluridine-tipiracil or regorafenib, or both. Patients were randomised 2:1 to fruquintinib 5 mg or matched placebo orally once daily on days 1 to 21 of 28-day cycles plus best supportive care, stratified by previous trifluridine-tipiracil or regorafenib, RAS status and duration of metastatic disease. The primary endpoint was overall survival.
Between August 2020 and December 2021, 691 patients were randomised; they had received a median of four previous lines and 502 (73 percent) had received more than three.
A third refractory-line option, and the clearest example in colorectal cancer of a drug developed and approved in China going on to a global registration trial.
Trifluridine-tipiracil with bevacizumab is the refractory-line standard, and a reminder that combining two drugs already on the shelf can beat anything new in the same line.
The start of the refractory-line era in colorectal cancer: a survival benefit measured in weeks, with real toxicity, which is why dose-escalation strategies and patient selection have occupied the field since.
Shares Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT), Trifluridine-tipiracil and bevacizumab in refractory metastatic colorectal cancer (SUNLIGHT), Eric Van Cutsem, Colorectal cancer roadmap: from the adenoma-carcinoma sequence and the first screening trials to total mesorectal excision, oxaliplatin, RAS testing, immunotherapy for mismatch repair-deficient disease, ctDNA-guided treatment and organ preservation and the tag colorectal-evidence.
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Shares The Lancet, Colorectal cancer roadmap: from the adenoma-carcinoma sequence and the first screening trials to total mesorectal excision, oxaliplatin, RAS testing, immunotherapy for mismatch repair-deficient disease, ctDNA-guided treatment and organ preservation, Colorectal cancer and the tag colorectal-evidence.
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Shares Eric Van Cutsem, Colorectal cancer roadmap: from the adenoma-carcinoma sequence and the first screening trials to total mesorectal excision, oxaliplatin, RAS testing, immunotherapy for mismatch repair-deficient disease, ctDNA-guided treatment and organ preservation, Small-molecule kinase inhibitors, Colorectal cancer and the tag colorectal-evidence.