伊立替康联合顺铂对比伊立替康单药对晚期胃癌患者二线化疗效果的回顾性研究

Clinical study of Irinotecan plus ciplatin versus irinotecan monotherapy in the treatment of advanced gastric cancer

目的:观察伊立替康联合顺铂(CPT-11+CDDP)与伊立替康(CPT-11)单药对进展期胃癌患者化疗的临床疗效。方法:回顾性分析2011年6月至2013年6月就诊于延安大学附属医院经替吉奥(S-1)单药化疗失败的进展期胃癌患者136例,将其分为CPT-11+CDDP组(70例)和CPT-11(66例),分析其近期疗效、远期疗效及不良反应发生的差异。结果:CPT-11+CDDP方案与CPT-11单药化疗方案相比,虽不能改善患者的近期疗效(P>0.05)和患者总生存期OS(χ~2=0.688,P=0.407),但能提高患者无疾病进展时间(χ~2=6.360,P=0.012)。在不良反应发生方面,CPT-11+CDDP方案较CPT-11单药化疗方案较易出现中性粒细胞减少(χ~2=2.748,P=0.006)、血小板减少(χ~2=2.269,P=0.023)、恶心(χ~2=5.457,P=0.001)、乏力(χ~2=2.134,P=0.033),但会减少腹泻的发生(χ~2=0.383,P=0.001)。结论:CPT-11+CDDP方案与CPT-11单药化疗相比,可明显提高S-1单药化疗失败的进展期胃癌患者的PFS,但不能改善该类患者的近期疗效、总生存期及不良反应的发生。

Objective：To investigatein the survival benefit of CPT-11/CDDP combination over CPT-11 monotherapy for the patients with advanced gastric cancer（AGC）.Methods：AGC patients with tumor progression after S-1 monotherapy were randomly allocated to CPT-11/CDDP group（CPT-11,60 mg·m^（-2）;CDDP,30 mg·m^（-2）,q2w） or CPT-11 group（150 mg·m^（-2）,q2w）.Aanalysis the recent curative effect,long-term effect and adverse events were retrospectively analyzed.Results：A total of 136 AGC patients were evaluated.There were no significant differences in the ORR（χ~2=0.19,P=0.663）,DCR（χ~2=0.569,P=0.451）,and OS（χ~2=0.688,P=0.407） between CPT-11/CDDP group and CPT-11 group.However,compared with CPT-11 regimen,CPT-11/CDDP regimen was more significantly effective in PFS（X^2=6.360,P=0.012）.The adverse reaction in two groups were compared.The incidence rate of in neutropenia（χ~2=2.748,P=0.006）,thrombocytopenia（χ~2=2.269,P=0.023）,nausea（χ~2=5.457,P=0.001） and fatigue（χ~2=0.383,P=0.001） were lower in CPT-11/CDDP group than in CPT-11 group.The incidence of diarrhoea（χ~2=2.134,P=0.033）were lower in CPT-11 group.Conclusion：Compared with CPT-11 regimen,CPT-11/CDDP regimen is more superior in the progression free survival for the patients with AGC.However,it can not improve the recent curative effect,OS and adverse events for these patients.