阿帕替尼用于铂耐药复发卵巢癌二线以上化疗后维持治疗的临床观察

Clinical observation of apatinib in the maintenance treatment of platinumresistant recurrent ovarian cancer after second-line chemotherapy

摘要:

目的： 观察阿帕替尼用于铂耐药复发上皮性卵巢癌患者二线以上化疗后维持治疗的临床疗效和安全性。方法： 36例确诊为铂耐药复发上皮性卵巢癌的患者，接受非铂类二线以上药物化疗至少4疗程，并已获得临床缓解或稳定后，给予口服阿帕替尼维持治疗，初始剂量均为500 mg，qd，直至疾病进展或毒副作用不能耐受。采用实体瘤疗效评价标准（response evaluation criteria in solid tumors，RECIST）1.0版和CA125、HE4两个指标综合评价疗效，按照美国国家癌症研究院（National Cancer Institute，NCI）的常见毒性标准3.0版对药物的不良反应进行分级。结果： 36例患者客观缓解率（objective response rate，ORR）为52.2%，疾病控制率（disease control rate，DCR）为69.4%。在19例获得部分缓解的患者中，中位缓解持续时间为8.1（2.5～23.1）个月，其中12例患者（63.2%）的缓解持续时间≥6个月，6例获得疾病稳定评价的患者中，中位稳定持续时间为5.85（3.2～9.3）个月，其中3例患者（50%）的疾病稳定状态持续时间≥6个月。阿帕替尼每天250 mg剂量，患者可以很好耐受。结论： 阿帕替尼对铂耐药复发上皮性卵巢癌患者二线以上化疗后的维持治疗是安全、有效的。

Abstract:

Objective: To observe the clinical efficacy and safety of apatinib in the maintenance treatment of platinum-resistant recurrent ovarian cancer after second-line chemotherapy. Methods: This study collected 36 patients diagnosed with platinum-resistant recurrent ovarian cancer, and who had received at least 4 courses of non-platinum second-line chemotherapy and had achieved clinical remission or stabilization. Then they were given apatinib with initial dose of 500 mg every day for maintenance treatment until disease progressed or toxic side effects were intolerable. In combination with the response evaluation criteria in solid tumors (RECIST) 1.0 and CA125 and HE4 two measures as the synthesis evaluation of curative effect, according to the National Cancer Institute (NCI) of the common toxic standard version 3.0 of BEV, the paclitaxel and platinum drug adverse reaction of chemotherapy were graded. Results: The objective response rate (ORR) of 36 patients was 52.2%, and the disease control rate (DCR) was 69.4%. Among 19 patients who achieved partial remission, the median duration of remission was 8.1 months (2.5-23.1), of which 12 patients (63.2%) had a remission duration equal to or greater than 6 months. Among the 6 patients with stable disease evaluation, the median stable duration was 5.85 months, and 3 patients had stable disease duration of 6 months or longer. Patients who orally took apatinib 250 mg daily could be well tolerated. Conclusion: Apatinib in the maintenance treatment of platinum-resistant recurrent ovarian cancer after second-line chemotherapy is safe and effective.