Department of Clinical Oncology, Aichi Cancer Center Hospital, Chikusa-ku, Nagoya, 464-8681, Aichi, Japan.
Invest New Drugs. 2011 Aug;29(4):688-93. doi: 10.1007/s10637-009-9382-x. Epub 2010 Jan 14.
The aim of this study was to prospectively evaluate the efficacy of combination irinotecan and cetuximab chemotherapy in patients with pretreated metastatic colorectal cancer harboring wild-type KRAS. Patients with metastatic colorectal cancer that had progressed after chemotherapy with irinotecan, oxaliplatin, and fluoropyrimidine were included. KRAS status was evaluated using the Cycleave PCR method; only patients without KRAS mutations were included. Cetuximab was administered initially at 400 mg/m² followed by weekly 250 mg/m² infusions. Irinotecan was administered biweekly. From October 2008 to April 2009, a total of 30 patients were enrolled. The objective response rate was 30.0% (95% confidence interval [CI], 14.7-49.4%) and the disease control rate (complete response, partial response, or stable disease) was 80.0% (95% CI, 61.4-92.3%). Among the 15 patients with stable disease, 11 patients experienced >10% tumor shrinkage. Median progression-free survival was 5.8 months (95% CI, 4.1-7.6). Median overall survival was not reached at a median follow-up of 10.1 months. Grade 2 skin toxicity was observed in 23 patients, while no grade 3 skin toxicity was observed. Combined irinotecan and cetuximab is effective for pretreated metastatic wild-type KRAS colorectal cancer.
本研究旨在前瞻性评估伊立替康联合西妥昔单抗化疗对野生型 KRAS 预处理转移性结直肠癌患者的疗效。纳入转移性结直肠癌患者，这些患者在接受伊立替康、奥沙利铂和氟嘧啶化疗后进展。采用 Cycleave PCR 法评估 KRAS 状态；仅纳入无 KRAS 突变的患者。西妥昔单抗初始剂量为 400mg/m²，随后每周输注 250mg/m²。伊立替康每两周给药一次。2008 年 10 月至 2009 年 4 月，共纳入 30 例患者。客观缓解率为 30.0%（95%置信区间[CI]，14.7-49.4%），疾病控制率（完全缓解、部分缓解或稳定疾病）为 80.0%（95%CI，61.4-92.3%）。在 15 例稳定疾病的患者中，有 11 例患者的肿瘤缩小超过 10%。中位无进展生存期为 5.8 个月（95%CI，4.1-7.6）。中位随访 10.1 个月时，中位总生存期尚未达到。23 例患者出现 2 级皮肤毒性，无 3 级皮肤毒性。伊立替康联合西妥昔单抗对预处理野生型 KRAS 转移性结直肠癌有效。
