Department of Hematology-Oncology, National University Hospital, 119074 Singapore, Singapore.
World J Gastroenterol. 2011 Apr 14;17(14):1879-88. doi: 10.3748/wjg.v17.i14.1879.
To evaluate the efficacy and safety of cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer (mCRC) patients from South-East Asia and Australia.
In this open-label, phase II study, the main eligibility criteria were epidermal growth factor receptor-positive mCRC with progressive disease within 3 mo of an irinotecan-based regimen as the most recent chemotherapy. Patients received cetuximab 400 mg/m2 initially, then 250 mg/m2 every week, with the same regimen of irinotecan on which the patients had progressed (4 pre-defined regimens allowed). The primary objective was evaluation of progression-free survival (PFS) at 12 wk. Secondary objectives included a further investigation of PFS, and an assessment of the overall response rate (ORR), duration of response, time to treatment failure (TTF), overall survival and the safety profile.
One hundred and twenty nine patients were enrolled from 25 centers in the Asia-Pacific region and of these 123 received cetuximab plus irinotecan. The most common recent irinotecan regimen used was 180 mg/m2 every 2 wk which had been used in 93 patients (75.6%). The PFS rate at 12 wk was 50% (95% confidence interval (CI, 41-59) and median PFS time was 12.1 wk (95% CI: 9.7-17.7). The ORR was 13.8% (95% CI: 8.3-21.2) and disease control rate was 49.6% (95% CI: 40.5-58.8). Median duration of response was 31.1 wk (95% CI: 18.0-42.6) and median overall survival was 9.5 mo (95% CI, 7.5-11.7). The median TTF was 11.7 wk (95% CI: 9.1-17.4). Treatment was generally well tolerated. The most common grade 3/4 adverse events were diarrhea (13.8%), neutropenia (8.9%), rash (5.7%) and vomiting (5.7%).
In patients from Asia and Australia, this study confirms the activity and safety of cetuximab plus irinotecan observed in previous studies in Europe and South America.
评估西妥昔单抗联合伊立替康在对伊立替康耐药的转移性结直肠癌（mCRC）患者中的疗效和安全性，这些患者来自东南亚和澳大利亚。
在这项开放标签、Ⅱ期研究中，主要入选标准为表皮生长因子受体阳性的 mCRC 患者，在最近的基于伊立替康的方案治疗后 3 个月内疾病进展，最近的化疗方案为伊立替康。患者先接受西妥昔单抗 400 mg/m2，然后每周 250 mg/m2，方案与患者疾病进展时使用的方案相同（允许使用 4 种预先确定的方案）。主要终点是 12 周时无进展生存期（PFS）的评估。次要终点包括进一步调查 PFS，以及评估总缓解率（ORR）、缓解持续时间、治疗失败时间（TTF）、总生存期和安全性。
从亚太地区的 25 个中心共纳入 129 例患者，其中 123 例患者接受了西妥昔单抗联合伊立替康治疗。最近使用最常见的伊立替康方案为 180 mg/m2，每 2 周使用 1 次，有 93 例患者（75.6%）接受了该方案。12 周时的 PFS 率为 50%（95%CI，41-59），中位 PFS 时间为 12.1 周（95%CI：9.7-17.7）。ORR 为 13.8%（95%CI：8.3-21.2），疾病控制率为 49.6%（95%CI：40.5-58.8）。中位缓解持续时间为 31.1 周（95%CI：18.0-42.6），中位总生存期为 9.5 个月（95%CI，7.5-11.7）。中位 TTF 为 11.7 周（95%CI：9.1-17.4）。治疗总体耐受性良好。最常见的 3/4 级不良事件为腹泻（13.8%）、中性粒细胞减少（8.9%）、皮疹（5.7%）和呕吐（5.7%）。
在来自亚洲和澳大利亚的患者中，这项研究证实了西妥昔单抗联合伊立替康在欧洲和南美洲先前研究中观察到的疗效和安全性。
