贝伐珠单抗联合方案治疗既往未治疗的转移性结直肠癌患者的疗效和安全性：贝伐珠单抗联合 5-氟尿嘧啶、亚叶酸钙加伊立替康与贝伐珠单抗联合卡培他滨加伊立替康随机 II 期研究的最终结果（FNCLCC ACCORD 13/0503 研究）。
Efficacy and safety of bevacizumab-based combination regimens in patients with previously untreated metastatic colorectal cancer: final results from a randomised phase II study of bevacizumab plus 5-fluorouracil, leucovorin plus irinotecan versus bevacizumab plus capecitabine plus irinotecan (FNCLCC ACCORD 13/0503 study).
机构信息
Department of Medicine, Institut Gustave Roussy, Villejuif, Université Paris-Sud, Le Kremlin Bicêtre, France.
出版信息
Eur J Cancer. 2013 Apr;49(6):1236-45. doi: 10.1016/j.ejca.2012.12.011. Epub 2013 Jan 24.
BACKGROUND
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 AND METHODS
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.
RESULTS
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).
CONCLUSIONS
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.
背景
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。
患者和方法
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。
结果
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%）。
结论
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。
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