Beppu Toru, Emi Yasunori, Tokunaga Shoji, Oki Eiji, Shirabe Ken, Ueno Shinichi, Kuramoto Masafumi, Kabashima Akira, Takahashi Ikuo, Samura Hironori, Eguchi Susumu, Akagi Yoshito, Natsugoe Shoji, Ogata Yutaka, Kakeji Yoshihiro, Baba Hideo, Maehara Yoshihiko
Department of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.
Department of Surgery, Saiseikai Fukuoka General Hospital, Fukuoka, Japan.
Anticancer Res. 2014 Nov;34(11):6655-62.
BACKGROUND/AIM: The Kyushu Study group of Clinical Cancer (KSCC) conducted phase II trials (KSCC0802-UMIN000001308) concerning liver resectability after first-line treatment of advanced liver-limited colorectal metastases (CRLM) by a prospective, multi-center study.
Patients received 6 cycles of mFOLFOX6 with bevacizumab followed by evaluating liver resectability. The primary end-point was liver resection rate.
The 40 patients enrolled from September 2008 to August 2010. The median number of administration cycles was 6 (range=1-7). The liver resectability cases were 16/40 (40.0 %) and the number of R0 cases was 10 patients (25.0%). An overall response rate was 30.0% (95% CI=15.2%-44.8%). Median progression-free and overall survival of all patients was 9.7 months and 33.0 months), respectively.
mFOLFOX6 with bevacizumab regimen is safe and effective for advanced liver-limited CRLM and might lead to high liver resectability.
背景/目的：九州临床癌症研究小组（KSCC）通过一项前瞻性多中心研究，开展了关于晚期肝脏局限性结直肠癌肝转移（CRLM）一线治疗后肝切除可能性的II期试验（KSCC0802-UMIN000001308）。
患者接受6个周期的mFOLFOX6联合贝伐单抗治疗，随后评估肝切除可能性。主要终点为肝切除率。
2008年9月至2010年8月共纳入40例患者。给药周期中位数为6（范围=1-7）。肝切除可行病例为16/40（40.0%），R0切除病例数为10例患者（25.0%）。总缓解率为30.0%（95%CI=15.2%-44.8%）。所有患者的无进展生存期和总生存期中位数分别为9.7个月和33.0个月。
mFOLFOX6联合贝伐单抗方案对晚期肝脏局限性CRLM安全有效，可能导致较高的肝切除可行性。
