部分铂敏感复发卵巢癌患者两种铂类治疗方案的疗效及安全性研究  

Evaluation of the Efficiency and Safety of Different Chemotherapy Regimens for Platinum-Partial Sensitive Relapsed Ovarian Cancer

作　　者：王瑛[1] 苏婧 李宁[2] 马雨[3] 王海霞 祝英杰[5] 李利[6] 于明新[7] 蔡红兵[8] 王鹤[9] 黄奕[10] 王巍 段微[12] 吴令英[2] 王静[1] WANG Ying;SU Jing;LI Ning;MA Yu;WANG Haixia;ZHU Yingjie;LI Li;YU Mingxin;CAI Hongbing;WANG He;HUANG Yi;WANG Wei;DUAN Wei;WU Lingying;WANG Jing(Hunan Cancer Hospital,Changsha,Hunan,410013,China;Cancer Hospital Chinese Academy of Medical Sciences,Beijing,100021,China;West China Second University Hospital,Sichuan University,Chengdu,Sichuan,610044,China;Chongqing University Cancer Hospital,Chongqing,400030,China;Yunnan Cancer Hospital,Kunming,Yunnan,650118,China;The Fourth Hospital of Hebei Medical University,Shijiazhuang,Hebei,050010,China;Liaoning Cancer Hospital,Shenyang,Liaoning,110042,China;Zhongnan Hospital of Wuhan University,Wuhan,Hubei,430071,China;Guangxi Medical Univer-sity Affiliated Tumor Hospital,Nanning,Guangxi,530012,China;Hubei Cancer Hospital,Wuhan,Hubei,430079,China;Peking Union Medical College Hospital,Beijing,100000,China;Beijing Obstetrics and Gynecology Hospital,Capital Medical University,Beijing,100006,China)

机构地区：[1]湖南省肿瘤医院,湖南长沙410013 [2]中国医学科学院肿瘤医院,北京100021 [3]四川大学华西第二医院,四川成都610044 [4]重庆大学附属肿瘤医院,重庆400030 [5]云南省肿瘤医院,云南昆明650118 [6]河北医科大学第四医院,河北石家庄050010 [7]辽宁省肿瘤医院,辽宁沈阳110042 [8]武汉大学中南医院,湖北武汉430071 [9]广西医科大学附属肿瘤医院,广西南宁530012 [10]湖北省肿瘤医院,湖北武汉430079 [11]中国医学科学院附属北京协和医院,北京100032 [12]首都医科大学附属北京妇产医院,北京100006

出　　处：《肿瘤药学》2021年第3期257-262,共6页Anti-Tumor Pharmacy

基　　金：国家重点研发计划重大慢性非传染性疾病防控研究重点专项(2016YFC1303703)。

摘　　要：目的比较紫杉醇和多柔比星脂质体联合铂类化疗在部分铂敏感复发卵巢癌患者中的疗效及安全性。方法本试验为前瞻性、全国多中心、随机分组研究,选取末次化疗后6~12个月内复发的卵巢癌患者,随机分为紫杉醇联合铂类治疗组和多柔比星脂质体联合铂类治疗组,主要研究终点是无进展生存期(PFS),次要研究终点为药物安全性及总生存期。本研究通过了各研究中心伦理委员会批准,所有患者均签署了知情同意书。结果共216例患者入组,其中106例接受紫杉醇联合铂类方案治疗,110例接受多柔比星脂质体联合铂类方案治疗。紫杉醇组与多柔比星组相比有更长的PFS(18.0个月vs.14.0个月,HR=0.71,95%CI:0.44~1.45),但差异无统计学意义(P>0.05)。紫杉醇组疾病控制率为87.7%,多柔比星组为86.4%,差异无统计学意义(P>0.05)。对PFS>7个月的患者进行亚组分析发现,紫杉醇组较多柔比星组有更长的PFS(21.0个月vs.16.0个月,HR=1.31,95%CI:0.72~2.41),差异有统计学意义(P<0.05)。紫杉醇组和多柔比星组发生率最高的Ⅲ-Ⅳ级不良反应均为白细胞减少(6.4%vs.8.5%)和血小板减少(10.9%vs.3.8%)。消化道反应中,紫杉醇组与多柔比星组的呕吐发生率分别为3.5%和2.7%,铂类过敏发生率分别为38.5%和0.9%。结论在部分铂敏感复发卵巢癌患者的治疗中,紫杉醇联合铂类和多柔比星脂质体联合铂类的疗效相似,但多柔比星脂质体联合铂类治疗的消化道反应和过敏反应发生率更低,两种方案均可作为治疗选择。Objective To compare the efficacy and safety of doxorubicin liposomes or paclitaxel combined with platinum chemotherapy in the treatment of platinum-partial sensitive relapsed ovarian cancer patients.Methods This study is a prospective,multicenter,randomized trial.Ovarian cancer patients who got recurrence within 6~12 months from the last chemotherapy were selected and randomly assigned into two groups:the paclitaxel combined with platinum group(TP group)and the doxorubicin liposome combined with platinum group(PP group).The primary endpoint is progression-free survival(PFS),and the secondary endpoint is drug safety and overall survival of patients.All patients signed an informed consent form.The study was approved by the Ethics Committee of Hunan Cancer Hospital.Results A total of 216 ovarian cancer patients were enrolled.Of them,106 received TP therapy and 110 received PP therapy.Patients in the TP group had a little longer PFS(18.0 months vs.14.0 months,HR=0.71,95%CI:0.44~1.45,P>0.05)than those in the PP group.The disease control rate was 87.7%in the TP group and 86.4%in the PP group(P>0.05).Subgroup analysis found that patients with PFS>7 months in TP group had a longer PFS than those in PP group(21.0 months vs.16.0 months,HR=1.31,95%CI:0.72~2.41),and the difference was statistically significant(P<0.05).In the study,the highest incidence of gradeⅢ-Ⅳadverse reactions were leukopenia(6.4%vs.8.5%)and thrombocytopenia(10.9%vs.3.8%)in both TP and PP groups.As for digestive tract reactions,the incidence of vomiting was 3.5%in TP group and 2.7%in PP group,while the incidence of platinum allergy was 38.5%in TP group,but was 0.9%in PP group.Conclusion In the treatment of platinum-partial sensitive recurrent ovarian cancer patients,paclitaxel-platinum therapy and doxorubicin-platinum therapy have no significant difference in efficacy,but doxorubicin-platinum therapy had less digestive tract adverse reactions.Both regimens are good options in the treatment of platinum-partial sensitive recurrent ovarian cancer patie

关 键 词：卵巢癌 部分铂敏感 复发 紫杉醇 多柔比星脂质体 

分 类 号：R737.31[医药卫生—肿瘤]