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An oral chemotherapy that works where fluorouracil no longer does, adding 1.8 months after everything else has failed, and delaying the slide in performance status by nearly two months.
Mayer, Van Cutsem, Falcone and colleagues randomly assigned 800 patients with refractory colorectal cancer 2:1 to TAS-102, an oral agent combining trifluridine and tipiracil hydrochloride, or placebo in a double-blind trial, with overall survival as the primary end point. Early trials conducted primarily in Japan had suggested activity in this setting.
One death related to TAS-102 was reported. The time to worsening of ECOG performance status from 0 or 1 to 2 or more was a pre-specified secondary endpoint and favoured treatment.
Trifluridine-tipiracil became the other refractory-line standard alongside regorafenib, and the backbone that SUNLIGHT later improved on by adding bevacizumab.
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.
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 Josep Tabernero, 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, 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, New England Journal of Medicine 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, New England Journal of Medicine and the tag colorectal-evidence.
Shares Josep Tabernero, 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, New England Journal of Medicine 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, Josep Tabernero, 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.