FOLFOXIRI in patients with colon cancer and isolated non-resectable liver metastases: phase II prospective non-randomized single-center study

Abstract

Objective: to assess the frequency of liver resections in patients with metastatic colon cancer and isolated non-resectable liver metastases receiving FOLFOXIRI. Materials and methods. In this single-center non-randomized prospective study, we assessed the frequency of liver resections. According to the statistical hypothesis, the frequency of R0-resections in patients with metastatic colon cancer receiving FOLFOXIRI is between 11 % and 33 % (mean 20 %); to increase it up to 50 % in patients with isolated metastatic lesions in the liver, we had to recruit 20 patients (with β = 0.9 and a = 0.05). We enrolled 20 patients with potentially resectable metastases and 22 patients with non-resectable metastases. The primary endpoint was the frequency of R0 liver resections; secondary endpoints included objective response rate, progression-free survival, overall survival, and tolerability of therapy. Patients receiving targeted therapy (according to the tumor mutation status) were also included in the study.Results. Objective response was observed in 32 out of 42 patients (76 %) (in 17 out of 20 participants (85 %) with potentially resectable metastases), whereas progressive disease was registered in 2 patients (5 %). Radical resection of organs affected by metastasis was performed in 19 out of 42 patients (45 %): 15 out of 20 (75 %) in the group with potentially resectable metastases and 4 out of 22 (18 %) in the group with non-resectable metastasis (р <0.01). At a median follow-up of 11 months (range: 1–32 months), median progression-free survival was 10 months (95 % confidence interval (CI) 8.9–11.1), while median length of life was 34 months (95 % CI 21.3–46.7). Median overall survival was 34 months in patients that had undergone metastasectomy vs 19 months in patients that had no metastasectomy (hazard ratio 0.7; 95 % CI 0.01–0.70; p = 0.02).Conclusions. FOLFOXIRI increased the frequency of metastasectomy in patients with potentially resectable liver metastases from colon cancer, which was associated with a pronounced increase in the length of life.