S-1、奥沙利铂联合西妥昔单抗治疗初治不可切除或非最佳可切除肝转移结直肠癌患者的II期试验（KSCC1002）
Phase II Trial of S-1 and Oxaliplatin Plus Cetuximab for Colorectal Cancer Patients with Initially Unresectable or Not Optimally Resectable Liver Metastases (KSCC1002).
作者信息
Oki Eiji, Emi Yasunori, Miyamoto Yuji, Kabashima Akira, Higashi Hidefumi, Ogata Yutaka, Ikebe Masahiko, Saeki Hiroshi, Tokunaga Shoji, Shirabe Ken, Beppu Toru, Uchida Shinji, Takatsuki Mitsuhisa, Sakoda Masahiko, Eguchi Susumu, Akagi Yoshito, Kakeji Yoshihiro, Baba Hideo, Natsugoe Shoji, Maehara Yoshihiko
机构信息
Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Fukuoka, Japan.
Department of Surgery, Saiseikai Fukuoka General Hospital, Fukuoka, Japan.
出版信息
Ann Surg Oncol. 2015 Dec;22 Suppl 3:S1067-74. doi: 10.1245/s10434-015-4771-1. Epub 2015 Sep 3.
BACKGROUND
The Kyushu Study Group of Clinical Cancer (KSCC) conducted phase II trials of KSCC1002 (UMIN000001308) concerning liver resectability after first-line treatment of initially unresectable or not optimally resectable colorectal liver metastases in a prospective, multicenter study.
METHODS
Patients with wild-type KRAS received 4-6 cycles of S-1 and oxaliplatin (SOX) plus cetuximab. Liver resectability was evaluated subsequently with the liver resection rate as the primary endpoint.
RESULTS
Of the 33 patients enrolled between March 2010 and July 2013, the median number of administration cycles was 4 (range 0-10). The overall response rate was 63.6 % (95 % confidence interval [CI] 45.1-79.6 %). Liver resection was possible in 16 of 33 (48.5 %) patients, and there were 13 R0 cases (39.4 %). We conducted a central review of liver resectability evaluated by five liver surgeons, and the resectability increased from 18.2 to 66.7 % after chemotherapy, based on imaging. The median overall survival for all 33 cases was 31.6 months (95 % CI 14.8-not reached). The median progression-free survival was 9.7 months (95 % CI 6.2-11.8).
CONCLUSIONS
SOX plus cetuximab is safe and effective for advanced colorectal cancer with limited liver metastasis, and may lead to high liver resectability.
背景
九州临床癌症研究小组（KSCC）开展了KSCC1002（UMIN000001308）的II期试验，该试验是一项前瞻性多中心研究，针对初始不可切除或切除条件不佳的结直肠癌肝转移患者一线治疗后的肝脏可切除性。
方法
KRAS基因野生型患者接受4 - 6周期的S-1与奥沙利铂（SOX）联合西妥昔单抗治疗。随后以肝脏切除率作为主要终点评估肝脏可切除性。
结果
在2010年3月至2013年7月入组的33例患者中，给药周期中位数为4（范围0 - 10）。总缓解率为63.6%（95%置信区间[CI] 45.1 - 79.6%）。33例患者中有16例（48.5%）可行肝脏切除，其中13例为R0切除（39.4%）。我们由五位肝脏外科医生对肝脏可切除性进行了中心评估，基于影像学检查，化疗后可切除性从18.2%提高到了66.7%。33例患者的总生存期中位数为31.6个月（95% CI 14.8 - 未达到）。无进展生存期中位数为9.7个月（9% CI 6.2 - 11.8）。
结论
SOX联合西妥昔单抗治疗肝脏转移局限的晚期结直肠癌安全有效，且可能带来较高的肝脏可切除性。
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