甲磺酸阿帕替尼联合SOX方案二线治疗晚期胃癌的近期疗效及安全性

Efficacy and safety of apatinib mesylate combined oxaliplatin and S-1 for treatment of advanced gastric cancer

[目的]探讨甲磺酸阿帕替尼联合SOX方案(奥沙利铂+替吉奥)对一线化疗失败后晚期胃癌患者的近期疗效、预后及安全性。[方法]选取青海地区肿瘤相关医院2014年3月~2016年5月就诊且无法行手术切除的Ⅳ期胃癌患者92例,按随机数字表法随机分为联合组(甲磺酸阿帕替尼+奥沙利铂+替吉奥)与对照组(奥沙利铂+替吉奥),每组各46例。比较2组患者的近期疗效、预后及不良反应发生情况。预期随访24个月以上,应用Kaplan-Meier生存分析法评估2组预后。[结果]联合组患者的近期临床总有效率显著高于对照组(47.83%26.09%,P<0.05)。2组患者在消化道反应、骨髓抑制以及肝功能异常、蛋白尿和乏力的发生率及程度方面比较,差异均无统计学意义(P>0.05),但联合组发生手足综合征和高血压的发生概率较对照组明显增加(P<0.05),不过绝大多数属于1-2级,经过对症治疗均已好转。联合组中位生存期为14.4个月,对照组中位生存期为10.5个月,差异有统计学意义(P<0.05);联合组中位PFS亦显著长于对照组(7.2个月4.4个月,P<0.05);联合组患者1年生存率为56.52%,显著高于对照组的30.4%(P<0.05)。[结论]甲磺酸阿帕替尼联合SOX的治疗方案二线治疗晚期胃癌患者近期疗效显著,预后良好,且不良反应轻微,值得临床推广。

[Objective]To investigate the short-term efficacy,prognosis and safety of apatinib mesylate combined with SOX regimen（oxaliplatin＋S-1）in patients with advanced gastric cancer after failure of firstline chemotherapy.[Methods]A total of 92 patients with stage IV gastric cancer who were unable to undergo surgical resection from March 2014 to May 2016 in these hospitals were randomized into a combined group according to a random number table method（apatinib mesylate＋oxaliplatin＋ S-1）and control group（Oxaliplatin＋S-1）,46 cases in each group.The short-term efficacy,prognosis and incidence of adverse reactions were compared between the two groups of patients.It was expected to be followed up for more than24 months and Kaplan-Meier survival analysis was used to evaluate the prognosis of the two groups.[Results]The total clinical effective rate of patients in the combined group was significantly higher than that of the control group（47.83% vs.26.09%,P〈0.05）.There was no significant difference in the incidence and degree of gastrointestinal reaction,myelosuppression,abnormal liver function,proteinuria,and fatigue be-tween the two groups（P〈0.05）,but hand-foot syndrome and hypertension occurred in the combined group.Occurrence rate was significantly higher than that in the control group（P〈0.05）,but the vast majority belonged to 1-2 grades and all of them had improved after symptomatic treatment.The median OS of the combined group was 14.4 months,and the median OS of the control group was 10.5 months.The difference was statistically significant（meaning P〈0.05）.The median FPS of the combined group was also significantly longer than that of the control group（7.2 months vs.4.4 months,P〈0.05）.The one-year survival rate in the combined group was 56.52%,which was significantly higher than that in the control group（30.4%）（P〈0.05）.[Conclusion]Apatinib mesylate combined with SOX,is therapeutically effective in the treatment of patients with advanced gastric cancer,the prognosis is good,and the adverse reaction is mild,and it is worthy of clinical promotion.