A multicenter phase II trial of mFOLFOX6 plus bevacizumab as treatment for liver-only metastases from colorectal cancer unsuitable for upfront resection (TRICC0808): Final analysis for survival.

Authors

null

Hiroshi Tamagawa

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

Organizations

Department of Surgery, Osaka General Medical Center, Osaka, Japan, Department of Surgical Specialties, Tokyo Medical and Dental University, Tokyo, Japan, Department of Translational Oncology, Tokyo Medical and Dental University, Tokyo, Japan, Department of Medical Oncology, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan, Division of Colon and Rectal Surgery, Shizuoka Cancer Center Hospital, Shizuoka, Japan, Department of Gastroenterological Surgery, Iwate Prefectural Central Hospital, Iwate, Japan, Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Tokyo, Japan, Department of Surgery, Osaka Rosai Hospital, Osaka, Japan, Department of Gastrointestinal and Pediatric Surgery, Tokyo Medical University, Tokyo, Japan, Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, Saitama, Japan, Department of Surgery, Kurume University Medical Center, Kurume, Japan, Department of Gastroenterological Surgery, Niigata Cancer Center Hospital, Niigata, Japan, Department of Surgery, Toho University Sakura Medical Center, Chiba, Japan, Foundation for Biomedical Research and Innovation, Translational Research Informatics Center, Kobe, Japan, Tokyo Medical and Dental University, Tokyo, Japan

Research Funding

Other Foundation

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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Abstract Details

Meeting

2016 Gastrointestinal Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session C: Cancers of the Colon, Rectum, and Anus

Track

Cancers of the Colon, Rectum, and Anus

Sub Track

Multidisciplinary Treatment

Clinical Trial Registration Number

UMIN000010209

Citation

J Clin Oncol 34, 2016 (suppl 4S; abstr 704)

DOI

10.1200/jco.2016.34.4_suppl.704

Abstract #

704

Poster Bd #

L1

Abstract Disclosures

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