贝伐珠单抗联合FOLFOX或FOLFIRI方案治疗转移性结直肠癌的临床研究

目的 观察贝伐珠单抗联合FOLFOX或FOLFIRI方案用于转移性结直肠癌一线及二线治疗的临床疗效和毒副反应。方法 回顾性分析2005年11月至2012年8月接受贝伐珠单抗联合FOLFOX或FOLFIRI方案作为一线及二线治疗的57例转移性结直肠癌患者的临床资料。采用RECIST 1.1版评价疗效，用NCI-CTC 3.0版评价不良反应，用Kaplan-Meier法进行生存分析。结果 57例结直肠癌患者中，19例（33.3％）获PR，28例（49.2％）获SD，有效率（RR）为33.3％，疾病控制率（DCR）为82.5％。贝伐珠单抗联合化疗用于一线与二线治疗患者的RR或DCR差异均无统计学意义（P＞0.05）；贝伐珠单抗联合FOLFOX方案与FOLFIRI方案的RR或DCR差异均无统计学意义（P＞0.05）。57例患者的无进展生存期（PFS）及总生存期（OS）分别为8.83个月及14.80个月。一线与二线治疗及贝伐珠单抗联合FOLFOX方案与FOLFIRI方案的中位PFS或OS差异均无统计学意义（P＞0.05）。主要不良反应包括白细胞减少、血小板减少及恶心呕吐。贝伐珠单抗相关的不良反应主要包括高血压3例，蛋白尿1例，鼻衄2例，均为1～2级，药物可以控制。结论 贝伐珠单抗联合化疗治疗转移性结直肠癌能够提高治疗疗效，不良反应可以耐受。

Clinical study of bevacizumab combined with FOLFOX regimen or FOLFIRI regimen for patients with metastatic colorectal cancer

Objective To investigate the efficacy and toxicity of bevacizumab combined with FOLFOX regimen or FOLFIRI regimen for patients with metastatic eolorectal cancer（mCRC） as first- or second-line treatment. Methods Fifty-seven patients with mCRC treated by bevacizumab combined with FOLFOX or FOLFIRI in the PLA General Hospital from December 2005 to August 2012 were analyzed retrospectively with their overall response rate（RR） , disease control rate（DCR） , progression-free survival（PFS） , and overall survival（OS）. The tumor responses were assessed by response evaluation criteria in solid tumors guidelines（RECIST） version 1.1. The adverse reation was evaluated by common terminology criteria for adverse events version 3.0. The survival analysis was used by Kaplan-Meier method. Results Of 57 patients with mCRC, 19（33.3% ） patients achieved partial response（PR） and 28 patients （49. 2% ） had stable disease（ SD）, exhibited an RR of 33.3% , and a DCR of 82. 5%. Stratification analysis by first- and second-line treatment or different chemotherapy of bevacizumab combined FOLFOX regimen or FOLFIRI regimen, there were no statistical signifi- cance in RR and DCR（P 〉0.05）. The median PFS and OS of 57 patients were 8.83 months and 14. 80 months, respectively. Stratifi- cation analysis by first- and second-line treatment or different chemotherapy of bevacizumab combined FOLFOX regimen or FOLFIRI regimen, there were no statistical significance in median PFS and OS （ P 〉 0.05 ）. The main side effects were leukocytopenia, leukocyto- penia and nausea and vomiting. The adverse events related to bevacizumab included hypertension, proteinuria and epistaxis,which were mostly in gradel-2 and alleviated by drug treatment. Conclusion Bevacizumab combined with FOLFOX regimen or FOLFIRI regimen is effective and well tolerated in patients with metastatic colorectal cancer.