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The first pill to extend life after every standard treatment had failed, by 1.4 months, at the price of hand-foot skin reaction in one patient in six.
Grothey, Van Cutsem, Sobrero and colleagues ran CORRECT at 114 centres in 16 countries in patients with metastatic colorectal cancer progressing during or within three months after the last standard therapy, randomising them 2:1 to best supportive care plus oral regorafenib 160 mg or placebo once daily for the first three weeks of each four-week cycle. The primary endpoint was overall survival, and efficacy analyses were by intention to treat.
Between April 2010 and March 2011, 760 patients were randomised (505 regorafenib, 255 placebo) and 753 started treatment. The primary endpoint was met at a preplanned interim analysis.
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.
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 became the other refractory-line standard alongside regorafenib, and the backbone that SUNLIGHT later improved on by adding bevacizumab.
Shares Fruquintinib versus placebo in patients with refractory metastatic colorectal cancer (FRESCO-2), Randomized trial of TAS-102 for refractory metastatic colorectal cancer (RECOURSE), Eric Van Cutsem, VEGF / VEGFR and the tag colorectal-evidence.
Shares Heinz-Josef Lenz, Takayuki Yoshino, 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.
Shares Takayuki Yoshino, Eric Van Cutsem, Acquired resistance to every therapy, 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.
Shares Heinz-Josef Lenz, VEGF / VEGFR, 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, Anti-angiogenic therapy and the tag colorectal-evidence.
Shares Takayuki Yoshino, 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, Colorectal cancer and the tag colorectal-evidence.
Shares Takayuki Yoshino, 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, Toxicity and quality of life are undervalued, Colorectal cancer and the tag colorectal-evidence.
Shares Takayuki Yoshino, 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, Toxicity and quality of life are undervalued, Colorectal cancer and the tag colorectal-evidence.
Shares Heinz-Josef Lenz, Eric Van Cutsem, VEGF / VEGFR, 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.