Adjuvant HAIP Falls Short of Prespecified Disease-Free Survival Target

This multicenter, single-arm phase II trial at three centers in the Netherlands enrolled 45 patients with resectable, liver-confined recurrence of colorectal liver metastases after prior local treatment. Patients with prior or current extrahepatic disease were excluded. Following repeat local treatment, all patients began adjuvant HAIP floxuridine, planned for up to six cycles; the primary endpoint was hepatic disease-free survival (hDFS), with a prespecified efficacy boundary of 36 months.

After a median follow-up of 38.7 months, median hDFS was 16.5 months (95% CI, 9.1–25.8). Median progression-free survival was 14.0 months (95% CI, 7.7–23.0), and 3-year overall survival was 71% (95% CI, 58%–87%). The liver was involved in the initial recurrence in 23 patients (51%).

Grade 3 or higher HAIP implantation complications occurred in 4 patients (9%), and grade 3 or higher chemotherapy-related complications in 6 (13%). Biliary sclerosis occurred in four patients; three required stenting. HAIP without systemic therapy did not meet the hypothesized hDFS target. The single-arm design and selected liver-only population limit comparisons with other strategies; these results do not establish comparative benefit or support replacing systemic therapy.