Formally qualify tumour-DNA blood tests as a surrogate endpoint for adjuvant trials
If a blood test reliably shows whether cancer will come back after surgery, trials could use it instead of waiting years for relapse. Regulators have a process to bless such a test; oncology should use it.
FDA's Biomarker Qualification Program creates a drug-independent, context-of-use qualification for biomarkers. ctDNA clearance after adjuvant therapy correlates strongly with recurrence in colorectal, bladder and lung cancer, and trial-level meta-analysis is becoming possible as ctDNA-guided trials report. A consortium submission to qualify ctDNA clearance as a reasonably likely surrogate for disease-free survival in defined settings would let adjuvant trials read out in one to two years rather than five.
- Biomarkers are not validated or standardised · Tests that decide who gets a drug are often not validated prospectively and are measured differently in every lab.
- Dormant cells and minimal residual disease · After a 'successful' treatment, cells can sleep for years then relapse. We can barely detect them and cannot target them.
Pages like this
not linked directly; found by shared links- Key paperDYNAMIC: a blood test safely halved chemotherapy use after surgery for stage II colon cancer
Shares ctDNA-guided adjuvant therapy as the default in stage II-III colon cancer, ctDNA MRD → adjuvant therapy decision, GALAXY: tumour DNA in blood four weeks after bowel cancer surgery predicts relapse tenfold, DYNAMIC.
- IdeaA national residual-disease weather service: serial blood tests for every curatively treated patient, pooled
Shares DYNAMIC, IMvigor011, Signatera, Circulating tumour DNA (ctDNA).
- Key paperIMvigor011: using a blood test for leftover cancer to decide who gets immunotherapy after bladder surgery
Shares ctDNA MRD → adjuvant therapy decision, IMvigor011, Signatera, Circulating tumour DNA (ctDNA).
- IdeaA national platform trial that every ctDNA-positive patient can join
Shares DYNAMIC, IMvigor011, CIRCULATE-Japan (GALAXY / VEGA / ALTAIR), Dormant cells and minimal residual disease.
- IdeaTake the blood test, and give the drug, at the right time of day
Shares Circulating tumour DNA (ctDNA), Dormant cells and minimal residual disease, Minimal / molecular residual disease (MRD), Biomarkers are not validated or standardised.
- IdeactDNA-triggered escalation in early TNBC
Shares ctDNA MRD → adjuvant therapy decision, IMvigor011, Signatera, Dormant cells and minimal residual disease.
- IdeaUse tumour DNA in blood to decide when to pause treatment in metastatic cancer
Shares DYNAMIC, IMvigor011, Circulating tumour DNA (ctDNA), MRD / molecular residual disease testing.
- IdeaStrip the platelet coat off travelling tumour cells in ctDNA-positive patients
Shares DYNAMIC, CIRCULATE-Japan (GALAXY / VEGA / ALTAIR), Dormant cells and minimal residual disease, MRD / molecular residual disease testing.