贝伐单抗联合FOLFIRI方案一线治疗转移性结直肠癌的临床评价

Evaluation of Bevadzumab Combined with FOLFIRI as First-line Treatment for Patients with Metastatic Colorectal Cancer

目的评价贝伐单抗联合FOLFIRI方案一线治疗转移性结直肠癌的疗效和安全性。方法将40例转移性结直肠癌患者随机分为FOLFIRI组和FOLFIRI+贝伐单抗组。FOLFIRI组采用CPT-11(180 mg/m2)+甲酰四氢叶酸(200 mg/m2)+5-Fu(1 000 mg/m2)。FOLFIRI+贝伐单抗组采用贝伐单抗(每2周5 mg/kg)+FOLFIRI方案;两组患者均持续治疗至病情进展或毒性不能耐受。结果 40例患者均可评价疗效和不良反应。FOLFIRI组和FOLFIRI+贝伐单抗组的治疗有效率分别为25%(5/20)和60%(12/20)(χ2=5.013,P=0.025),中位无疾病进展时间(DFS)分别为5.1和10.1月(χ2=9.703,P=0.002)。两组患者的1年生存率分别为48%和70%,中位生存时间(OS)分别为11.0月和18.0月,总生存期在两组间差异有统计学意义(χ2=5.852,P=0.016)。两组的主要不良反应为迟发性腹泻和中性粒细胞减少,FOLFIRI+贝伐单抗组增加的不良反应主要有高血压、出血、蛋白尿和心脏毒性,但患者可以耐受。结论 FOLFIRI方案化疗联用贝伐单抗提高了晚期结直肠癌患者治疗的有效率,并延长了DFS及OS,不良反应患者可以耐受。

Objective To assess the efficacy and safety of bevacizumab plus FOLFIRI for the first line treatment in metastatic colorectal cancer（mCRC） patients.Methods From May 2008 to July 2009,40 previously untreated mCRC patients received treatment of FOLFIRI（n=20） or FOLFIRI plus Bevacizumab（n=20）.The treatment continued until disease progression or unacceptable toxicity.The data were retrospectively analyzed.Results All patients were evaluable for response,survival and toxicity analysis.The objective response rate of FOLFIRI and FOLFIRI plus Bevacizumab regimen groups was 25%（5/20） and 60%（12/20）,respectively（χ2=5.013,P=0.025）.The median disease-free survival（DFS） of FOLFIRI and FOLFIRI plus bevacizumab group was 5.1 and 10.1 months,respectively（χ2=9.703,P=0.002）.The one-year survival rate was 48% and 70%,and the median overall survival（OS） was 11.0 and 18.0 months,respectively,with significant difference among the two treatment groups（χ2=5.852,P=0.016）.The common toxicity profiles of FOLFIRI and FOLFIRI plus bevacizumab regimens were diarrhea and neutropenia,while the toxicity related to bevacizumab was consistent with that documented in previous literature such as hypertension,hemorrhage,cardiac,and proteinuria toxicity.Conclusion The addition of bevacizumab to FOLFIRI regimen significantly improves the response rate.DFS and OS in first-line treatment for patients with mCRC and its toxicity is well tolerated.