Применение комбинации FOLFOXiRi у больных раком толстой кишки с изолированным нерезектабельным метастатическим поражением печени: проспективное нерандомизированное одноцентровое исследование ii фазы

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.