贝伐珠单抗联合FOLFOX4化疗方案治疗晚期转移性结直肠癌的临床研究

Clinical study of avastin combined with FOLFOX4 in the treatment of advanced metastatic colorectal cancer

目的探讨贝伐珠单抗（Avastin）联合奥沙利铂（L-OHP）＋5-氟尿嘧啶（5-FU）＋亚叶酸钙（LV）（FOLFOX4）治疗晚期转移性结直肠癌（MCC）的临床疗效与安全性。方法入选2011年4月至2013年12月武警浙江总队嘉兴医院收治的MCC患者84例,其中用贝伐珠单抗联合FOLFOX4方案治疗者39例,单纯用FOLFOX4方案化疗者45例。FOLFOX4化疗方案：第1天,奥沙利铂85mg·m-2静脉滴注2 h;第1,2天,亚叶酸钙200 mg·m-2静脉滴注,2 h;5-氟尿嘧啶400 mg·m-2静脉推注,第1,2天;5-氟尿嘧啶600 mg·m-2静脉滴注,第1,2天;贝伐珠单抗方案：贝伐珠单抗10 mg·kg-1＋0.9%氯化钠注射液100 m L静脉滴注1 h（第1次应用时为90 min）,每2周1次。2组患者均接受2个周期化疗后,比较近期临床疗效及其化疗相关不良反应发生率。结果贝伐珠单抗＋FOLFOX4组客观有效率和疾病控制率均显著高于FOLFOX4组,且差异有统计学意义（P〈0.05）;2组患者Ⅲ~Ⅳ级恶心呕吐、粒细胞下降及血小板下降等药品不良反应发生率比较,差异无统计学意义（P〉0.05）。结论 FOLFOX4联合贝伐珠单抗可显著提高晚期转移性结直肠癌的近期临床疗效,且不增加化疗相关不良反应。

Abstract： Objective To evaluate combined with oxaliplatin （ L - OHP） leucovorin （ LV ） （ FOLFOX4 ） on the the clinical efficacy of avastin ＋ 5- fluorouracil （5- FU） ＋ treatment of advanced metastatic colorectal cancer（MCC）. Methods Eighty four patients with MCC were recruited from April 2011 to December 2013 in our hospital. Of the included 84 cases, 39 patients received avastin plus FOLFOX4 regimen and other 45 cases received FOLFOX4 chemotherapy only. FOLFOX4 regimen： L- OHP 85 mg · m-2 by travenous drip in 2 hours on day 1 and LV 200 mg· m-2 by intravenous drip in 2 hours on day 1 and 2, 5 - FU 400 mg · m -2 by intravenous injection on day 1 and 2 and 5 - FU 600 mg · m-2 by intravenous drip on day 1 and 2. Avastin regimen： avastin 10 mg · kg-1 ＋0.9% NaC1 injection 100 mL by intravenous drip in 1 hour（90 min for the first time） , once two weeks. After two cycles treatment, the data of objective response rate （ORR） and chemotherapy related adverse reactions were compared between the two groups. Results The ORR and disease control rate （DCR） in avastin ＋ FOLFOX4group were much higher than those in FOLFOX4 group （ P 〈 0. 05 ）. But the chemotherapy related adverse reactions were not statistically different between the two groups （P 〉 0. 05 ）. Conclusion FOLFOX4 chemotherapy regimen combined with avastin can significantly increase the clinical efficacy on patients with MCC, without increasing adverse reactions.