According to results from the phase 3 ALTAIR study, trifluridine plus tipiracil provided a promising disease-free survival (DFS) benefit for patients with resected oligometastatic colorectal cancer. 

These results were presented by Hideaki Bando, MD, PhD, National Cancer Center Hospital East, Kashiwa, Japan, at the 2025 ASCO Gastrointestinal Cancers Symposium in San Francisco, California.

In this double-blind study, 243 patients with stage IV (n = 66) or non-stage IV (n = 177) ctDNA-positive oligometastatic colorectal cancer who underwent curative resection of the primary and or metastatic sites and standard-of-care adjuvant therapy with no radiological recurrence were randomized to receive either trifluridine plus tipiracil (n = 122) or placebo (n = 121) for 6 months. Radiological and ctDNA analyses were conducted every 2 months for the first year, every 3 months for the second year, and every 6 months for the third year. The primary end point was DFS. Key secondary end points included ctDNA clearance and safety. 

At analysis, median DFS was 9.30 months in the trifluridine plus tipiracil arm and 5.55 months in the placebo arm (hazard ratio [HR], 0.79; 95% confidence interval [CI], 0.60 to 1.05; P = .107) in the intention-to-treat population, which did not reach the threshold for statistical significance. The median DFS for patients with stage IV disease was 9.76 months in the trifluridine plus tipiracil arm and 3.96 months in the placebo arm (HR, 0.53; P = .012). The median DFS for patients with non-stage IV disease was 9.26 months and 6.05 months (HR, 0.86; P = .378), respectively. Baseline MTM/ml levels were 0.40 in the intention-to-treat population, 0.68 for patients with stage IV disease, and 0.32 for patients with non-stage IV disease (P = .024). 

Grade ≥3 adverse events occurred in 73.0% of patients in the trifluridine plus tipiracil arm and 3.3% of patients in the placebo arm. No new safety signals were identified. 

“Although statistical significance was not reached in the primary population, [trifluridine plus tipiracil] showed clinically meaningful DFS benefit in pts with resected oligometastatic disease and a trend towards increasing DFS benefits with increasing MTM/mL values,” concluded Dr Bando et al. 

Source: 

Bando H, Watanabe J, Kotaka M, et al. A randomized, double-blind, phase III study comparing trifluridine/tipiracil (FTD/TPI) versus placebo in patients with molecular residual disease following curative resection of colorectal cancer (CRC): The ALTAIR study. Presented at The 2025 ASCO Gastrointestinal Cancers Symposium. January 23-25, 2025. Abstract LBA22