贝伐单抗在中低位直肠癌新辅助治疗中的有效性及安全性观察

Efficacy and Safety of Bevacizumab in Neoadjuvant Chemradiotherapy for Middle and Low Rectal Cancer

目的探讨贝伐单抗在中低位局部进展期直肠癌新辅助放化疗治疗中的有效性及安全性。方法贝伐单抗联合FOLFOX方案的新辅助放化疗患者为观察组(n=25),FOLFOX方案新辅助放化疗患者为对照组(n=31)。观察两组的病理完全缓解率、肿瘤降期率、低位直肠癌的保肛率、常见放化疗不良反应及围手术期的主要并发症。结果两组的病理完全缓解率、总降期率及低位直肠癌保肛率无统计学意义(P>0.05)。观察组的高血压发生率高于对照组(P=0.03),差异有统计学意义,其他常见放化疗不良反应及围手术期的主要并发症差异无统计学意义(P>0.05)。结论贝伐单抗在中低位直肠癌的新辅助放化疗中有较高的安全性,没有明显增加新辅助放化疗的不良反应,没有明显增加围手术期的严重并发症。但未能提高直肠癌的病理完全缓解率、病理降期率及低位直肠癌的保肛率。

Objective To explore the efficacy and safety of bevacizumab combination in neoadjuvant therapy in the middle and low locally advanced rectal cancer.Methods Middle and low locally advanced rectal cancer patients who were treated by bevacizumab and FOLFOX with the combination of neoadjuvant radiotherapy were regarded as the observation group,and the patients treated by FOLFOX with the combination of neoadjuvant radiotherapy were regarded as the control group.The pathological complete response rate,tumor downstaging rate,anal sphincter preservation rate,the incidence of adverse events and perioperation complications were compared between the two groups.Results There was no significant difference in the pathological complete response rate,tumor downstaging rate and anal sphincter preservation rate between the two groups（P〉 0.05）.The incidence of hypertension in the observation group was higher than that in the control group（P = 0.03）,with statistical significance.There were no significant differences in other adverse reactions of radiotherapy and chemotherapy and perioperative complications（P 〉0.05）.Conclusion Bevacizumab combined with neoadjuvant therapy is well tolerated in the treatment of middle and low locally advanced rectal cancer,it does not obviously increase the adverse events of neoadjuvant therapy and perioperation complications.However,the p CR rate,tumor down staging rate and sphincter preservation rate is not improved in the comparison with the other trials that used FOLFOX in preoperative radiochemotherapy.