托泊替康单药及与奥沙利铂联用治疗铂耐药性卵巢癌的临床研究

Clinical study on the efficacy of topotecan monotherapy and oxaliplatin plus topotecan in the treatment of patients with platinum-resistant ovarian cancer

目的回顾性分析奥沙利铂联合托泊替康与托泊替康单药在铂耐药性卵巢癌治疗中的疗效及安全性。方法纳入铂耐药性卵巢癌患者41例,使用奥沙利铂联合托泊替康方案患者21例,托泊替康单药方案患者20例。奥沙利铂联合托泊替康组给药方案:奥沙利铂130 mg/m^2d1,托泊替康1.75~2 mg/m^2d1、d8、d15,每3周重复1次;托泊替康组给药方案:托泊替康1.75~2 mg/m^2d1、d8、d15,每3周重复1次。每组的主要研究终点为疾病总缓解率[完全缓解率(CR)+部分缓解率(PR)]、疾病控制率[CR+PR+疾病稳定(SD)]和无进展生存期(PFS);次要研究终点为化疗副反应事件,包括:血液学毒性、胃肠道毒性及肝肾功损伤。每2~3个化疗周期后,采用实体瘤疗效评价标准1.1版评价临床缓解率;化疗副反应事件采用常见不良反应事件评价标准4.0版评价。结果奥沙利铂联合托泊替康组、托泊替康组的总缓解率分别为33.3%、15.0%(P=0.172),疾病控制率分别为66.7%、35.0%(P<0.05),平均无进展生存期分别为5.1、2.3个月(P<0.05)。两组的主要不良反应均为血液学毒性、胃肠道毒性及肝功能损伤,两组比较差异无统计学意义(P>0.05)。结论奥沙利铂联合托泊替康方案为铂耐药性卵巢癌患者提供了更加有效的辅助化疗方案,且毒副作用可耐受。

Objective To retrospectively compare the efficacy and safety of oxaliplatin plus topotecan and single use of topotecan on patients with platinum-resistant ovarian cancer.Methods Forty one patients with platinum-resistant ovarian cancer were enrolled and divided into two groups.Patients in combination group,（n =21） received oxaliplatin plus topotecan polichemotherapy（oxaliplatin 130 mg/m2 dl,topotecan 1.75~2 mg/m^2 at d1,d8 and d15 every 3 weeks）,patients in topotecan group（n =20） received topotecan monochemotherapy（topotecan 1.75~2 mg/m2 at d1,d8 and d15 every 3 weeks）.The primary end points study included overall response rate which contained complete response（CR） ＋partial response（PR）,disease control rate which contained CR ＋ PR ＋ stable disease（SD） and progression-free survival（PFS）;the secondary study end point included adverse effects of chemotherapy,such as hematological toxicity gastrointestinal toxicity hepatic and renal dysfunction.Clinical response was evaluated every 2 or 3cycles using the Response Evaluation Criteria in Solid Tumors criteria v.1.1.Adverse effects of chemotherapy were evaluated using Common Terminology Criteria for Adverse Events（CTCAE） v.4.0.Results The total remission rate,disease control rate and PFS in combination group and topotecan group were 33.3%and 15.0%,66.7%and 35.0%,5.1 and 2.3 months respectively,there were significant differences in disease control rate and PFS between the two groups（P 〈 0.05）.The main adverse reactions in both groups included hematological toxicity,gastrointestinal toxicity and liver toxicity.No significant difference was found in adverse reactions between the two groups（P 〉 0.05）.Conclusion Oxaliplatin plus topotecan polichemotherapy provides more efficient adjuvant chemotherapy for patients with platinum-resistant ovarian cancer than topotecan monochemotherapy,and the toxic side effects are tolerable.