阿帕替尼用于铂类耐药复发性卵巢癌的疗效与安全性

Efficacy and safety of apatinib in platinum-resistant recurrent ovarian cancer

目的探讨阿帕替尼用于铂类耐药复发性卵巢癌的疗效与安全性。方法选取宁波大学附属鄞州医院2017年1月~2018年1月间诊断及治疗的铂类耐药复发性卵巢癌患者72例,采用随机数表法分为阿帕替尼组(36例)及吉西他滨组(36例),阿帕替尼组采用口服阿帕替尼方案,0.25 g,bid;吉西他滨组采用静滴吉西他滨方案,每日剂量1000 mg/m^2,比较两组患者的疗效、总生存、无进展生存以及不良反应。结果阿帕替尼组ORR显著高于吉西他滨组(47.22%vs 22.22%;χ2=4.963,P=0.025);阿帕替尼组中位无进展生存时间为8.0(5.0~10.5)个月,吉西他滨组中位PFS为5.0(3.0~8.8)个月,阿帕替尼组疾病进展风险显著低于吉西他滨组[HR=0.631,95%CI(0.382,1.043),P=0.046];阿帕替尼组未达到中位生存时间,吉西他滨组中位生存时间为6.0(3.8~12.0)个月,阿帕替尼组死亡风险显著低于吉西他滨组[HR=0.556,95%CI(0.300,1.030),P=0.049];阿帕替尼组3级及以上不良反应发生率显著低于吉西他滨组(30.56%vs 47.22%;χ2=6.769,P=0.009)。结论阿帕替尼具有较好的治疗铂类耐药复发性卵巢癌的疗效与安全性。

Objective To investigate the efficacy and safety of apatinib in platinum-resistant recurrent ovarian cancer.Methods 72 patients with platinum-resistant recurrent ovarian cancer who were diagnosed and treated from January2017 to January 2018 in Affiliated Yinzhou Hospital of Ningbo University were selected. The random number table method was used to divide the patients into apatinib group(36 cases) and gemcitabine group(36 cases). The apatinib group was orally given apatinib, 0.25 g, bid;the gemcitabine group was given intravenous infusion of gemcitabine at a daily dose of 1000 mg/m^2. The efficacy, overall survival, progression-free survival, and adverse reactions were compared between the two groups. Results The ORR in the apatinib group was significantly higher than that in the gemcitabine group(47.22% vs 22.22%;χ2=4.963, P=0.025);the median progression-free survival time in the apatinib group was 8.0(5.0-10.5) months. The median PFS in the gemcitabine group was 5.0(3.0-8.8) months. The risk of disease progression was significantly lower in the apatinib group than in the gemcitabine group[HR=0.631, 95%CI(0.382, 1.043), P=0.046)];the apatinib group did not reach the median survival time. The median survival time in the gemcitabine group was 6.0(3.8-12.0) months. The risk of death was significantly lower in the apatinib group than in the gemcitabine group [HR=0.556, 95%CI(0.300, 1.030), P=0.049];the incidence rate of adverse reactions of grade 3 and above in the apatinib group was significantly lower than that in the gemcitabine group(30.56% vs 47.22%;χ2=6.769, P=0.009). Conclusion Apatinib has a good efficacy and safety in the treatment of platinum-resistant recurrent ovarian cancer.