A multicenter phase II trial of mFOLFOX6 plus bevacizumab as treatment for liver-only metastases from colorectal cancer unsuitable for upfront resection (TRICC 0808).

Authors

null

Hiroyuki Uetake

Department of Translational Oncology, Tokyo Medica

Hiroyuki Uetake , Masamichi Yasuno , Megumi Ishiguro , Shingo Kameoka , Yasuhiro Shimada , Keiichi Takahashi , Toshiaki Watanabe , Kei Muro , Hideo Baba , Junji Yamamoto , Nobuyuki Mizunuma , Hiroshi Tamagawa , Izumi Mochizuki , Yusuke Kinugasa , Yoshihiro Matsubara , Kenichi Sugihara

Organizations

Department of Translational Oncology, Tokyo Medica, Department of Surgery,Tokyo Metropolitan Hiroo Hos, Department of Surgery II, Tokyo Women's Medical Un, Gastrointestinal Medical Oncology Division, Nation, Department of Surgery, Tokyo Metropolitan Cancer a, Department of Surgical Oncology, Graduate School o, Department of Clinical Oncology, Aichi Cancer Cent, Department of Gastroenterological Surgery, Graduat, Department of Surgery National Defense Medical Col, Department of Medical Oncology, Cancer Institute H, Department of Surgery, Osaka General Medical Cente, Department of Surgery, Iwate Prefectural Central H, Colon and Rectal Surgery, Shizuoka Cancer Center, Statstical Analysis Group, Department of Clinical , Department of Surgical Oncology, Tokyo Medical and

Research Funding

Other Foundation

Background: Liver resection is a standard treatment for resectable liver metastases (mets) from colorectal cancer. In patients (pts) with multiple or large liver mets, liver tumors may not be resected completely or recurrence after complete resection are frequently observed. Methods: This prospective single arm phase II trial assessed R0 liver resection rate after mFOLFOX6 + bevacizumab (BV) in pts with liver mets considered unsuitable for upfront resection. Pts with liver-only mets, those were larger than 5cm in diameter or more than 4 in number, were treated with 6 cycles of mFOLFOX6 + BV (without BV in the 6th cycle). After chemotherapy, resectability of liver mets was assessed by CT or MRI. Secondary endpoints included liver resection rate, conversion rate from unresectable to resectable, safety of liver resection, recurrence rate, and survival. Results: Between May 2009 to October 2011, 46 pts were registered (one was excluded after registration due to ineligibility). Among the 19 pts with resectable mets at entry, 18, except one who refused the continuation of chemotherapy after the first cycle, underwent liver resection after 6 cycles of chemotherapy. In 16 of the 18 pts, R0 resection was performed. Among the 26 pts with unresectable mets at entry, 6 underwent liver resection and 4 had R0 resection. Overall R0 resection rate, liver resection rate and conversion rate were 44.4% (20/45), 53.3% (24/45) and 23.1% (6/26), respectively. The grade 3/4 adverse effects (AEs) by mFOLFOX6 + BV included fatigue (6.5%), stomatitis and nausea (2.2%), neutropenia (16.3%) and increase of serum total bilirubin (2.2%). As to BV related grade 3/4 AEs, hypertension (6.5%) and thromboembolism (2.2%) were observed. After liver resection, grade 3 wound infection, intra-abdominal abscess and delayed wound healing were complicated in two, in one and in one, respectively. Conclusions: In pts considered unsuitable for upfront resection of liver-only mets, mFOLFOX6 + BV was associated with high R0 resection rate, liver resection rate and conversion rate without severe toxicities and surgical complications. Updated results including survival will be presented. Clinical trial information: UMIN000002101.

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Abstract Details

Meeting

2013 Gastrointestinal Cancers Symposium

Session Type

Poster Session

Session Title

General Poster Session C: Cancers of the Colon and Rectum

Track

Cancers of the Colon, Rectum, and Anus

Sub Track

Multidisciplinary Treatment

Clinical Trial Registration Number

UMIN000002101

Citation

J Clin Oncol 31, 2013 (suppl 4; abstr543)

DOI

10.1200/jco.2013.31.4_suppl.543

Abstract #

543

Poster Bd #

D43

Abstract Disclosures