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日本的前瞻性的、多中心的试验中，目前还没有关于不可切除的KRAS 外显子2野生型结直肠癌局限性肝转移患者应用S-1+L-OHP (C-SOX) +西妥昔单抗一线治疗后肝转移灶的可切除性的数据。九州临床癌症研究小组  (KSCC)  在这一方面进行了一个II期试验。研究结果将在2015年ASCO GI研讨会上发布。

研究方法

入选标准包括:组织活检证实为晚期结直肠癌的不可切除的局限性肝转移，ECOG 体力状态评分0-1，一般情况良好。患者应用4-6疗程的C-SOX (第一天应用奥沙利铂130 mg/m2, 第1-14天口服 S-1 80 mg/m2 ，3周一疗程) ，同时每周持续静脉滴注西妥昔单抗，首剂400 mg/m2 ，以后每周250 mg/m2 ，随后评估肝转移灶的可切除性。

研究结果

2010年3月-2013年7月入组的33位患者中，男性20人，女性13人；年龄的中位数为64岁，范围48-83岁；ECOG 体力状态评分0分的27人，1分的6人；原发灶阴性的18人，阳性的15人；肝转移灶的数目1-4个的10人，5个以上的23人；单叶肝转移的5人，双叶肝转移的28人；同侧转移的30人，不同侧转移的3人。FAS和SAS的病例数为33。未确认CR, PR, SD, PD和NE的人数分别为1 (3.0%), 20 (60.6%), 6 (18.2%), 3 (9.1%) 和3 (9.1%)。总缓解率为63.6% (95% CI: 46.3–81.0%)。

经过所有治疗的患者的肝转移灶的可切除率为16/33 (48.5%)。R0切除的病例数为13(39.4%)。肝转移灶可切除的16位患者的无进展生存期的中位数为25.0个月(8.1-？)，肝转移灶不可切除的17位患者的无进展生存期的中位数为4.5个月(3.0-10.8)。肝切除术后未出现不良事件，不良事件包括复发、进展、继发性癌症和死亡。所有33位患者的总生存期的中位数为31.6个月(14.8-？)。肝转移灶不可切除的17位患者的总生存期的中位数为14.0个月(6.4-？)，肝转移灶可切除的16位患者的总生存期的中位数还未得出，3年生存率为51.4%。

结论

C-SOX +西妥昔单抗方案治疗不可切除的KRAS外显子2野生型结直肠癌局限性肝转移是安全有效的，并且可以提高肝转移灶的切除率。

英文摘要原文

Liver resectability following S-1+L-OHP with cetuximab as the first-line treatment of unresectable liver limited metastases from KRAS exon 2 wild-colorectal cancer in Japanese patients (KSCC 1002).（Abstract No:755） 

Background: There is no data concerning liver resectability following S-1+L-OHP (C-SOX) with cetuximab (Cmab) as the first-line treatment of unresectable liver limited metastases from KRAS exon 2 wild-colorectal cancer by prospective, multi-center study in Japan. The Kyushu Study group of Clinical Cancer (KSCC) conducted phase II trials in this setting. 

Methods: Eligibility criteria included unresectable liver limited metastases from histologically confirmed advanced colorectal cancer, ECOG PS 0-1 and adequate general condition. Patients (pts) received 4-6 cycles of C-SOX (oxaliplatin 130 mg/m2, day 1 followed by S-1 80 mg/m2 po [days 1-14] every 3 weeks) with weekly durable intravenous (DIV) Cmab administration at 400 mg/m2 (day 1) and 250 mg/m2/week (except day 1), followed by evaluating the liver resectability. 

Results: Of the 33 pts enrolled from March 2010 to July 2013; M/F, 20/13; median age, 64 years (range 48-83); ECOG PS 0/1, 27/6; primary lesion -/+, 18/15; number of liver metastasis 1-4/5 or more, 10/23; uni-/bi-lobular liver meta. 5/28; synchronous/metachronous 30/3. The number of FAS and SAS cases was 33. Response without confirmation for CR, PR, SD, PD and NE were 1 (3.0%), 20 (60.6%), 6 (18.2%), 3 (9.1%) and 3 (9.1%), respectively. An overall response rate was 63.6% (95% CI: 46.3–81.0%). 

The liver resectability for all time treatment was 16/33 (48.5%). The number of R0 cases was 13 pts (39.4%). Median progression free survival (liver resection was not censored and not event, events = relapse, progression, secondary cancer, and death) for 16 liver resection cases and 17 not-resection cases were 25.0 months (8.1-not reached), 4.5 months (3.0-10.8), respectively. Median overall survival (mOS) for all 33cases was 31.6 months (14.8, not reached). Median OS for 17 not-resection cases was 14.0 (6.4-not reached), and mOS for 16 liver resection cases was not reached and 3-year survival rate was 51.4%. 

Conclusions: C-SOX + Cmab regimen is safe and effective for unresectable liver limited metastases from KRAS exon 2 wild-colorectal cancer, and might be to lead the high liver resectability.  

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