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[摘要]
目的 比较西妥昔单抗联合FOLFOX4与贝伐单抗联合FOLFOX4两种方案治疗野生型KRAS晚期直肠癌的临床疗效及安全性。方法 选取2012年1月-2017年1月至柳州市柳江区人民医院肿瘤内科治疗的野生型KRAS晚期直肠癌患者75例,根据治疗方案的不同分为A、B、C 3组,A组23例单纯利用FOLFOX4方案治疗,B组27例采用贝伐单抗联合FOLFOX4方案,C组25例采用西妥昔单抗联合FOLFOX4方案,比较各组临床有效率,观察每组不良反应发生情况。随访后,计算各组平均无进展生存期(PFS)。结果 3组客观有效率(ORR)分别为13.04%、51.85%、60.00%,AB、AC组间比较差异均有统计学意义(P<0.01),B、C两组间差异无统计学意义。3组疾病控制率(DCR)分别为73.91%、88.89%、92.00%,各组之间两两比较差异也均无统计学意义。A、B、C 3组中位PFS分别为8.2、10.1、9.4个月,3组间中位PFS差异无统计学意义,3组患者均未出现治疗相关的死亡,主要不良反应有骨髓抑制和呕吐,另外偶发外周神经毒性、肝损伤、手足综合症等,发生率较低。B组未出现贝伐单抗相关的高血压、鼻出血、肠穿孔等不良反应,C组出现6例皮疹(24.00%)。结论 西妥昔单抗或贝伐单抗联合FOLFOX4方案均可提高野生型KRAS晚直肠癌的临床疗效,两种方案疗效相当,不良反应均较小,值得临床推广使用。
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[Abstract]
Objective To compare the clinical efficacy and safety of cetuximab plus FOLFOX4 and bevacizumab combined with FOLFOX4 in the treatment of wild-type KRAS advanced rectal cancer.Methods From January 2012 to January 2017,75 patients with wild type KRAS advanced rectal cancer treated in our department were divided into A,B and C groups according to the treatment regimen,and 23 patients in group A FOLFOX4 regimen,27 patients in group B received bevacizumab combined with FOLFOX4 regimen,25 patients in group C received cetuximab plus FOLFOX4 regimen.The clinical efficacy of each group was compared,and the incidence of adverse reactions in each group was observed.After follow-up,mean progression-free survival (PFS) was calculated for each group.Results The objective response rates (ORR) of three groups were 13.04%,51.85% and 60.00%,respectively,with significant difference between the three groups (P<0.01).The difference between A and C,B and C groups was statistically significant (P<0.01).There was no significant difference between B and C groups.The control rates (DCR) were 73.91%,88.89%,92.00% respectively.There was no significant difference among the three groups.The median PFS of group A,B and C were 8.2 months,10.1 months and 9.4 months respectively.There was no significant difference in median PFS between the three groups.Related to death,the main adverse reactions are myelosuppression and vomiting,the other occasional peripheral neurotoxicity,liver injury,hand-foot syndrome,the incidence is low.B group did not appear bevacizumab related hypertension,nosebleeds,intestinal perforation and other adverse reactions,C group appeared in 6 cases of rash (24.00%).Conclusion Both cetuximab and bevacizumab combined with FOLFOX4 can improve the clinical efficacy of wild-type KRAS late-rectal cancer.The two regimens have similar curative effect and small adverse reactions,which are worthy of clinical promotion.
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