Department of Surgery, Osaka General Medical Center, Osaka, Japan
Hiroshi Tamagawa , Hiroyuki Uetake , Megumi Ishiguro , Nobuyuki Mizunuma , Yusuke Kinugasa , Izumi Mochizuki , Tetsuya Hamaguchi , Junichi Hasegawa , Kenji Katsumata , Keiichiro Ishibashi , Yutaka Ogata , Yasumasa Takii , Mitsuru Ooshiro , Tatsuo Kagimura , Kenichi Sugihara
Background: TRICC0808 trial is a phase II trial to evaluate the liver resection rate and safety after mFOLFOX6 + bevacizumab therapy for liver-only metastasis that is unsuitable for upfront resection (H2 and H3) from colorectal cancer. Primary endpoint was the R0 resection rate, which was reported to be 44.4% (Ann Surg Oncol 22: 908-915, 2015). Final analysis of TRICC0808 was performed (February 16, 2015 data fixation). Methods: Forty six patients were registered and OS was analyzed for 45 patients (FAS). In 24 cases with liver resection after protocol chemotherapy, RFS, recurrence rate and recurrence patterns were analyzed. Results: The1, 2 and 3 year OS rate in FAS from the starting date of the chemotherapy was 91.1%, 68.9%, 44.0%, respectively, with 2.80 years of MST. The 3 year OS rate in 31 patients with liver resection including resection after additional chemotherapy was 61.3% with 3.59 years of MST, which was better than 0% of the 3 year OS rate with 1.75 years of MST in patients without liver resection. In 24 who underwent liver resection after 6 cycles of protocol chemotherapy, the 1, 2 and 3 year RFS rate was 29.2%, 12.5%, 8.3%, respectively, with 3.07 years of MST. The recurrence rate for 20 patients with R0 liver resection was 80%, and 100% in those with R1 and R2 liver resection. In the 20 patients with R0 liver resection, the 3 year OS rate of 16 patients with technically resectable liver metastasis at registration and 4 with technically unresectable tumors was 53.6% and 50.0%, respectively. Conclusions: The present final analysis of TRICC0808 trial disclosed good OS in the patients with liver resection, though the large population of the patients recurred afterward. The results were concordant with those of other reported trials for liver metastasis which is unsuitable for upfront resection. Liver resection was thought to be effective for liver metastasis which converted from unresectable to resectable after chemotherapy. Clinical trial information: UMIN000010209.
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