mFOLFOX6 plus bevacizumab to treat liver-only metastases of colorectal cancer that are unsuitable for upfront resection (TRICC0808): a multicenter phase II trial comprising the final analysis for survival.

BACKGROUND: The TRICC0808 trial is a phase II multi-institutional trial that investigated the efficacy of preoperative mFOLFOX6 + bevacizumab (BV) therapy for liver-only metastasis that is unsuitable for upfront resection. The R0 resection rate in the efficacy analysis has been reported to be 44.4%, and the final analysis for survival was conducted (data fixation on February 16, 2015).

METHODS: Six cycles of mFOLFOX6 + BV therapy were applied to patients with liver-only metastases, which were > 5 cm in diameter or more than four tumors (H2 and H3), and hepatectomy was performed if possible. Primary and secondary endpoints were the R0 hepatectomy rate and overall survival (OS), respectively.

RESULTS: Of 46 patients registered, OS was analyzed for 45 patients in whom the 3-year OS rate from the starting date of chemotherapy was 44.0% with a 33.6-month median survival time (MST). The 3-year OS rate of 31 patients with hepatectomy, including resection after an additional chemotherapy, was 61.3% with a 43.1-month MST, which was significantly better than 0% of the 3-year OS rate with a 21.0-month MST of 14 patients without hepatectomy (p value < 0.0001). In 24 patients who underwent hepatectomy after six cycles of protocol chemotherapy, the 3-year relapse-free survival rate was 8.3%, with a 36.8-month MST.

CONCLUSIONS: This final analysis of the TRICC0808 trial revealed a better long-term survival in patients with hepatectomy after mFOLFOX6 + BV therapy, although most examined patients eventually developed recurrence. Thus, hepatectomy after chemotherapy might improve the survival in patients with advanced liver metastases, although cure remains difficult.