贝伐单抗联合IFL方案治疗转移性结直肠癌的临床研究

Clinical research of bevacizumab in combination with irinotecan, fluorouracil and leucovorin for advanced metastatic colorectal cancer

目的评价贝伐单抗联合IFL方案（伊立替康、氟尿嘧啶、亚叶酸钙）治疗既往接受过以草酸铂为主的化疗方案的进展期转移性结直肠癌的疗效和安全性。方法回顾性总结2004年7月至2006年6月间分别予以贝伐单抗联合IFL方案（A组，30例）和单纯使用IFL方案（B组，32例）进行化疗患者的治疗后反应率、治疗中不良反应和治疗前后血清肿瘤标志物的动态变化及随访1年的生存率。结果A组和B组的有效率分别为30．0％和21．8％；疾病控制率分别为80％和50％。所有患者治疗前后肿瘤标志物的浓度均有明显变化（P〈0．05），A组与B组比较，差异有统计学意义（P〈0．05）。两组均未出现明显的Ⅲ、Ⅳ度不良反应，两组间不良反应的差异无统计学意义（P〉0．05）。A、B两组患者1年存活率分别为26．7％和18．8％，中位疾病进展时间分别为5．9个月和3．9个月，中位总生存期分别为10．9个月和8．9个月。差异均有统计学意义（P〈0．05）。结论与单纯使用IFL方案相比．贝伐单抗联合IFL方案能进一步延长既往接受过以草酸铂为主化疗方案的转移性结直肠癌患者的生存时间．治疗耐受性良好。

Objective To evaluate the efficacy of bevacizumab in combination of irinotecan, fluorouracil and leucovorin for metastatic colorectal cancer treated by failed prior oxaliplatin -based regiment. Methods Sixty-two patients were randomly divided into two groups, group A of 30 patients received bevacizumab plus irinotecan, fluorouracil and leucovorin, group B of 32 patients received irinotecan, fluorouracil and leucovorin. The response rate, change of tumor markers, one year survival rate and safety were observed. Results Tumor response rate was 30% in group A, 21.8% in group B respectively. Disease control rate （CR＋PR＋SD） was 80% in group A, 50% in group B. The obvious change of concentration of tumor markers was observed between pre-treatment and post-treatment, which was significantly different in group A（P〈0.05）. One year survival rate, median of time to progression and median duration of survival between group A and group B were 26.7% vs 18.8%, 5.9 months vs 3.9 months, 10.9 months vs 8.9 months（P〈0.05）. The adverse effect in group A was the same as group B. Bevacizumab was associated with hypertension and bradycardia. Conclusions The chemotherapy of bevacizumab combined with irinotecan, fluorouracil and leucovorin results in better efficacy in patients with progressive metastatic colorectal cancer.