Department of Medicine, Institut Gustave Roussy, Villejuif, Université Paris-Sud, Le Kremlin Bicêtre, France.
Eur J Cancer. 2013 Apr;49(6):1236-45. doi: 10.1016/j.ejca.2012.12.011. Epub 2013 Jan 24.
The combination of bevacizumab and bolus 5-fluorouracil, leucovorin and irinotecan is highly effective in patients with metastatic colorectal cancer (mCRC). This randomised, multicenter, non-comparative phase II trial assessed the efficacy and safety of bevacizumab plus oral capecitabine plus irinotecan (XELIRI) or infusional 5-fluorouracil, leucovorin plus irinotecan (FOLFIRI) as first-line therapy for patients with mCRC.
Patients received bevacizumab 7.5mg/kg on day 1 plus XELIRI (irinotecan 200mg/m(2) on day 1 and oral capecitabine 1,000 mg/m(2) bid on days 1-14) every 3 weeks or bevacizumab 5mg/kg on day 1 plus FOLFIRI (5-fluorouracil 400mg/m(2) on day 1 plus 2,400 mg/m(2) as a 46-h infusion, leucovorin 400mg/m(2) on day 1, and irinotecan 180 mg/m(2) on day 1) every 2 weeks. Patients aged ≥ 65 years received a lower dose of capecitabine (800 mg/m(2) twice daily). The primary endpoint was 6-month progression-free survival (PFS) rate.
A total of 145 patients were enrolled (bevacizumab-XELIRI, n=72; bevacizumab-FOLFIRI, n=73). The 6-month PFS rate was 82% (95% confidence intervals (CI) 71-90%) in the bevacizumab-XELIRI arm and 85% (95% CI 75-92%) in the bevacizumab-FOLFIRI arm. In both the bevacizumab-XELIRI and bevacizumab-FOLFIRI arms, median PFS and overall survival (OS) were 9 and 23 months, respectively. The most frequent toxicities were grade 3/4 neutropenia (bevacizumab-XELIRI 18%; bevacizumab-FOLFIRI 26%) and grade 3 diarrhoea (12% and 5%, respectively).
This randomised non-comparative study demonstrates that bevacizumab-XELIRI and bevacizumab-FOLFIRI are effective regimens for the first-line treatment of patients with mCRC with manageable toxicity profiles.
贝伐珠单抗联合氟尿嘧啶、亚叶酸钙和伊立替康推注治疗转移性结直肠癌（mCRC）患者具有显著疗效。本随机、多中心、非对照Ⅱ期临床试验评估了贝伐珠单抗联合卡培他滨和伊立替康（XELIRI）或氟尿嘧啶、亚叶酸钙和伊立替康持续输注（FOLFIRI）作为 mCRC 患者一线治疗的疗效和安全性。
患者接受贝伐珠单抗 7.5mg/kg，第 1 天，联合 XELIRI（伊立替康 200mg/m²，第 1 天，卡培他滨 1000mg/m²，bid，第 1-14 天），每 3 周 1 次，或贝伐珠单抗 5mg/kg，第 1 天，联合 FOLFIRI（氟尿嘧啶 400mg/m²，第 1 天，2400mg/m² 持续输注 46 小时，亚叶酸钙 400mg/m²，第 1 天，伊立替康 180mg/m²，第 1 天），每 2 周 1 次。年龄≥65 岁的患者接受卡培他滨（800mg/m²，bid）低剂量治疗。主要终点为 6 个月无进展生存（PFS）率。
共纳入 145 例患者（贝伐珠单抗-XELIRI 组 72 例，贝伐珠单抗-FOLFIRI 组 73 例）。贝伐珠单抗-XELIRI 组和贝伐珠单抗-FOLFIRI 组的 6 个月 PFS 率分别为 82%（95%CI，71-90%）和 85%（95%CI，75-92%）。贝伐珠单抗-XELIRI 组和贝伐珠单抗-FOLFIRI 组的中位 PFS 和总生存（OS）分别为 9 个月和 23 个月。最常见的毒性反应为 3/4 级中性粒细胞减少（贝伐珠单抗-XELIRI 组 18%；贝伐珠单抗-FOLFIRI 组 26%）和 3 级腹泻（贝伐珠单抗-XELIRI 组 12%；贝伐珠单抗-FOLFIRI 组 5%）。
本随机非对照研究表明，贝伐珠单抗联合 XELIRI 和贝伐珠单抗联合 FOLFIRI 是 mCRC 患者一线治疗的有效方案，具有可管理的毒性特征。
