The main result of the NHS-Galleri trial: among 142,250 people in England, three yearly rounds of the Galleri blood test added to usual care did not reduce the number of cancers found at stage III or IV.
Sasieni and colleagues report the primary endpoint of NHS-Galleri, the randomised controlled trial in England in which people aged 50 to 77 gave blood at up to three annual visits and were randomised 1:1 to have it tested with GRAIL's methylation-based multi-cancer early detection test (intervention) or stored (control). The primary endpoint was stage III or IV cancer among 12 prespecified cancer types; a key secondary endpoint was stage IV cancer among the same 12.
71,122 participants were randomised to the intervention group and 71,128 to control. The incidence rate of stage III or IV cancer did not differ significantly (incidence rate ratio 1.03; 95% CI 0.92 to 1.14; P = 0.63). The incidence rate ratio for stage IV cancer after three rounds was 0.86 (95% CI 0.74 to 1.00). Fewer than 1% of participants had trial-related adverse events and none were serious. The authors conclude that further follow-up is warranted to see how the stage III or IV and stage IV differences evolve.
This is the first randomised answer to whether a multi-cancer blood test changes outcomes, and for its main question the answer was no: adding the test to NHS care for three years did not lower the number of cancers diagnosed at stage III or IV. The stage IV result is a secondary finding with a confidence interval that touches no effect, and deaths have not yet been reported, so the trial continues to follow participants.
Shares NHS-Galleri: design of the largest randomised trial of a multi-cancer blood test, NHS-Galleri, Stage shift, Galleri.
Shares Cell-free DNA methylation tests, GRAIL, Galleri, Screening.
Shares NHS-Galleri, Stage shift, Galleri, Overdiagnosis and false alarms.
Shares Charles Swanton, Cell-free DNA methylation tests, GRAIL, Galleri.
Shares GRAIL, Galleri, Multi-cancer early detection (MCED), Liquid biopsy (ctDNA).
Shares GRAIL, Galleri, Multi-cancer early detection (MCED), Liquid biopsy (ctDNA).
Shares GRAIL, Galleri, Multi-cancer early detection (MCED), Liquid biopsy (ctDNA).
Shares GRAIL, Galleri, Multi-cancer early detection (MCED), Liquid biopsy (ctDNA).
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