Background: To evaluate a strategy combining high-dose 5FU-irinotecan-leucovorin (HD-FOLFIRI) chemotherapy, radiofrequency ablation and surgery in patients with unresectable liver metastases from colorectal cancer.
Patients and methods: Patients, all presenting UDP glucuronosyl transferase-1A1 (UGT1A1) 6/6 or 6/7 genotype, received HD-FOLFIRI (with high-dose irinotecan: 260 mg/m(2)), one cycle every two weeks. The feasibility of local therapy (surgery and/or radiofrequency) was assessed every four cycles. The objective of therapy was the complete clearance rate of metastases.
Results: The trial was terminated after inclusion of 18 out of the 40 planned patients due to insufficient recruitment. The median number of metastases was seven (range=2-30). On intention-to-treat analysis, six patients (33.3%) received local treatment of metastases with complete clearance of metastases in each case. Median progression-free and overall survivals were 15.3 months and 33.7 months, respectively.
Conclusion: The assessed strategy is feasible and allows for a complete clearance of metastases in one third of patients, with prolonged survival.