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Treating the blood test result before the cancer shows up on a scan did not work. It delayed relapse by about four months and caused severe blood toxicity in three-quarters of patients.
ALTAIR was the double-blind randomised phase 3 trial embedded in the CIRCULATE-Japan platform. Patients with resected colorectal cancer who became ctDNA-positive after completing standard-of-care therapy, with no radiological evidence of disease, were randomised 1:1 to trifluridine/tipiracil or placebo for six months. Between July 2020 and June 2023, 243 patients were randomised (122 to the drug, 121 to placebo). Median disease-free survival was 9.30 against 5.55 months (hazard ratio 0.79, 95% CI 0.60 to 1.05, p=0.107) and the primary endpoint was not met. Grade 3 or higher haematological adverse events occurred in 73.0 against 3.3 percent. The conclusion is that late-line chemotherapy started at molecular recurrence does not clear minimal residual disease, and that a better drug, not earlier timing, is what ctDNA-positive patients need.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
243 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Disease-free survivalprimary | Trifluridine/tipiracil | 122 | 9.3 months | 0.79 (0.6 to 1.05) | 0.107 | link |
| Placebo | 121 | 5.55 months |
Shares CIRCULATE-Japan (GALAXY / VEGA / ALTAIR), National Cancer Center Hospital, Signatera, Minimal / molecular residual disease (MRD).
Shares DYNAMIC, Signatera, Minimal / molecular residual disease (MRD), Circulating tumour DNA (ctDNA).
Shares CIRCULATE-Japan (GALAXY / VEGA / ALTAIR), DYNAMIC, Signatera, Minimal / molecular residual disease (MRD).
Shares Signatera, Minimal / molecular residual disease (MRD), Circulating tumour DNA (ctDNA), MRD / molecular residual disease testing.
Shares DYNAMIC, Signatera, Minimal / molecular residual disease (MRD), Circulating tumour DNA (ctDNA).
Shares BESPOKE CRC, CIRCULATE-US, DYNAMIC, Signatera.
Shares CIRCULATE-US, DYNAMIC, Signatera, Minimal / molecular residual disease (MRD).
Shares CIRCULATE-Japan (GALAXY / VEGA / ALTAIR), Signatera, Minimal / molecular residual disease (MRD), Circulating tumour DNA (ctDNA).