阿帕替尼治疗二线化疗失败的晚期卵巢癌的疗效和安全性评价

目的:评价甲磺酸阿帕替尼片治疗二线化疗失败的晚期上皮性卵巢癌患者的有效性与安全性。方法:研究共纳入20例患者，最终分析17例。入组患者口服阿帕替尼片，500 mg或250 mg 每日1次，连用28天为一个观察周期，治疗三个周期后行疗效评价。结果:治疗3个月后，PR占35.3%（6/17），SD占11.8%（2/17），ORR为35.3%，DCR为47.1%。起始剂量为500 mg组（ORR，30%；DCR，30%）及250 mg组（ORR，42.9%；DCR，71.4%）患者治疗效果比较无明显统计学差异。患者的中位PFS为2.2个月，中位OS为6.3个月。患者出现的最主要不良反应为高血压（70.6%）、手足综合征（52.9%）、口腔黏膜损伤（35.3%）。结论:针对二线以上化疗失败的晚期卵巢癌患者，阿帕替尼口服治疗具有一定的疗效，且安全性好，无严重不良反应。

Efficacy and safety of apatinib treatment for advanced ovarian cancer after second-line chemotherapy failure

Objective:To evaluate the efficacy and safety of apatinib mesylate as treatment after failure of second-line chemotherapy in patients with advanced epithelial ovarian cancer.Methods:This study is a prospective，open label，single-arm clinical trial which enrolled 20 patients，and 17 were evaluated.Patients received an oral dosage of apatinib (500 mg or 250 mg) once daily for 28 days as an observation cycle.The efficacy of the treatment was evaluated after three treatment cycles.Results:After 3 cycles of treatment，6 (35.3%) and 2 (11.8%) patients achieved partial response (PR) and stable disease (SD)，respectively.The ORR and DCR were 35.3% and 47.1%，respectively.The efficacy of apatinib was not significantly different between patients with initial dosages of 500 mg (ORR，30%；DCR，30%) and 250 mg (ORR，42.9%；DCR，71.4%).The median PFS was 2.2 months and the median OS was 6.3 months.The most common AEs were hypertension (70.6%)，hand-foot syndrome (52.9%)，and oral mucosa damage (35.3%).Conclusion:Oral apatinib treatment was efficacious，safe，and had no serious adverse effects in patients with advanced EOC who failed second-line chemotherapy.