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The first randomised trial to let a blood test decide who gets chemotherapy. It halved chemotherapy use in stage II colon cancer with no loss of recurrence-free survival.
Tie, Cohen, Lahouel and colleagues randomly assigned patients with stage II colon cancer 2:1 to have treatment decisions guided by circulating tumour DNA results or by standard clinicopathological features. Under circulating tumour DNA-guided management, a positive result at four or seven weeks after surgery prompted oxaliplatin-based or fluoropyrimidine chemotherapy and negative patients were not treated. The primary efficacy end point was recurrence-free survival at two years, with adjuvant chemotherapy use as a key secondary end point.
Of 455 patients randomised, 302 were assigned to circulating tumour DNA-guided management and 153 to standard management, with a median follow-up of 37 months.
De-escalation guided by a blood test is now proven in stage II colon cancer, and is the template for the stage III and rectal trials that follow; the unsolved half is what to do for the positives, whose recurrence-free survival remains the worst in the trial even after chemotherapy.
The predictive half of the ctDNA case: chemotherapy after surgery helps the patients whose blood test is positive and appears to do little for those whose test is negative, which is the rationale for the randomised CIRCULATE trials now running in Japan, the United States and Europe.
Minimal residual disease became measurable in solid tumours, and the DYNAMIC and CIRCULATE trials that followed turned the measurement into a treatment decision.
The number every stage II conversation still uses. It is also the baseline against which ctDNA-guided de-escalation is judged: DYNAMIC halved chemotherapy use in exactly this group without losing recurrence-free survival.
Shares Adjuvant chemotherapy versus observation in patients with colorectal cancer: a randomised study (QUASAR), Neoadjuvant / adjuvant / perioperative, 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 Take ctDNA-guided de-escalation beyond stage II, and stop escalating on a positive result until a trial says it helps, Neoadjuvant / adjuvant / perioperative, 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 and the tag colorectal-evidence.
Shares Adjuvant chemotherapy versus observation in patients with colorectal cancer: a randomised study (QUASAR), Neoadjuvant / adjuvant / perioperative, 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 and the tag colorectal-evidence.
Shares Kenneth W. Kinzler, Bert Vogelstein, 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 Minimal / molecular residual disease (MRD), Circulating tumour DNA (ctDNA), 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, MRD / molecular residual disease testing and the tag colorectal-evidence.
Shares Neoadjuvant / adjuvant / perioperative, 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 Kenneth W. Kinzler, Bert Vogelstein, 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 Neoadjuvant / adjuvant / perioperative, 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.