DYNAMIC
Circulating Tumor DNA Analysis Guiding Adjuvant Therapy in Stage II Colon Cancer
N = 455
- Population
- Patients with stage II colon cancer; 455 randomised, 302 to ctDNA-guided management and 153 to standard management.
- Design
- Patients with stage II colon cancer were randomly assigned 2:1 to treatment decisions guided by ctDNA results or by standard clinicopathological features. In the ctDNA-guided group a positive result at 4 or 7 weeks after surgery prompted oxaliplatin-based or fluoropyrimidine chemotherapy, and ctDNA-negative patients were not treated. Primary efficacy endpoint recurrence-free survival at 2 years, tested for noninferiority (margin -8.5 percentage points); key secondary endpoint adjuvant chemotherapy use. Registered as ACTRN12615000381583 (Australian New Zealand Clinical Trials Registry).
- Primary endpoint
- RFS
- Arms
- ctDNA-guided management (experimental, n = 302): Postoperative ctDNA testing; ctDNA-positive patients received oxaliplatin-based or fluoropyrimidine chemotherapy, ctDNA-negative patients were not treated
- Standard management (control, n = 153): Treatment decisions based on clinicopathological features
- People
- Tie J, DYNAMIC Investigators
Δ 24-month RFS+1.1 pointsΔ Adjuvant chemotherapy use−13 pointsΔ 60-month RFS+1 pointsOSHR 1.05Δ 60-month OS+0.5 points
Show the numbers
| Endpoint | Analysis | ctDNA-guided management | Standard management | Effect |
|---|---|---|---|---|
| RFSRandomised patients with stage II colon cancer (455); analysis population not labelled in the abstract | primarymedian follow-up 37 monthsTie 2022 | 93.5% at 2 y | 92.4% at 2 y | ctDNA-guided management was noninferior: absolute difference 1.1 percentage points (95% CI -4.1 to 6.2) against a noninferiority margin of -8.5 percentage points. Three-year RFS was 86.4 percent among ctDNA-positive patients who received adjuvant chemotherapy and 92.5 percent among ctDNA-negative patients who did not; these two groups are not a randomised comparison. |
| Adjuvant chemotherapy useRandomised patients with stage II colon cancer (455); analysis population not labelled in the abstract | primaryTie 2022 | 15% | 28% | Key secondary endpoint. Relative risk 1.82 (95% CI 1.25 to 2.65) as published, the abstract does not state which direction it is expressed in. |
| RFSRandomised patients with stage II colon cancer; analysis population not labelled in the abstract | long term-updatemedian follow-up 59.7 monthsTie 2025 | 88% at 5 y | 87% at 5 y | Difference 1.1 percentage points (95% CI -5.8 to 8.0) as published. |
| OSRandomised patients with stage II colon cancer; analysis population not labelled in the abstract | long term-updatemedian follow-up 59.7 monthsTie 2025 | 93.8% at 5 y | 93.3% at 5 y | HR 1.05P=0.887Prespecified analysis; the abstract gives no confidence interval for the hazard ratio. |
| Endpoint | Analysis | ctDNA-guided management | Standard management | Effect |
|---|---|---|---|---|
| RFSRandomised patients with stage II colon cancer (455); analysis population not labelled in the abstract | primarymedian follow-up 37 monthsTie 2022 | 93.5% at 2 y | 92.4% at 2 y | ctDNA-guided management was noninferior: absolute difference 1.1 percentage points (95% CI -4.1 to 6.2) against a noninferiority margin of -8.5 percentage points. Three-year RFS was 86.4 percent among ctDNA-positive patients who received adjuvant chemotherapy and 92.5 percent among ctDNA-negative patients who did not; these two groups are not a randomised comparison. |
| Adjuvant chemotherapy useRandomised patients with stage II colon cancer (455); analysis population not labelled in the abstract | primaryTie 2022 | 15% | 28% | Key secondary endpoint. Relative risk 1.82 (95% CI 1.25 to 2.65) as published, the abstract does not state which direction it is expressed in. |
| RFSRandomised patients with stage II colon cancer; analysis population not labelled in the abstract | long term-updatemedian follow-up 59.7 monthsTie 2025 | 88% at 5 y | 87% at 5 y | Difference 1.1 percentage points (95% CI -5.8 to 8.0) as published. |
| OSRandomised patients with stage II colon cancer; analysis population not labelled in the abstract | long term-updatemedian follow-up 59.7 monthsTie 2025 | 93.8% at 5 y | 93.3% at 5 y | HR 1.05P=0.887Prespecified analysis; the abstract gives no confidence interval for the hazard ratio. |
Appears in
Sources
Tie J, Cohen JD, Lahouel K, Lo SN, Wang Y, Kosmider S, et al. Circulating Tumor DNA Analysis Guiding Adjuvant Therapy in Stage II Colon Cancer. N Engl J Med. 2022;386(24):2261-2272.
Tie J, Wang Y, Lo SN, Lahouel K, Cohen JD, Wong R, et al. Circulating tumor DNA analysis guiding adjuvant therapy in stage II colon cancer: 5-year outcomes of the randomized DYNAMIC trial. Nat Med. 2025;31(5):1509-1518.