卡瑞利珠单抗联合甲磺酸阿帕替尼治疗PD-L1阳性和/或dMMR的复发或持续性病变的子宫或卵巢恶性肿瘤的疗效和安全性研究  

The efficacy and safety of camrelizumab combined with apatinib recurrent/persistent uterine or ovarian carcinoma with PD-L1 positive and/or dMMR

作　　者：李菁[1] 王群[2] 沈立翡[2] 沈育红[2] 刘华[2] 奚文崎[3] 冯炜炜 Li Jing;Wang Qun;Shen Lifei;Shen Yuhong;Liu Hua;Xi Wenqi;Feng Weiwei(Department of Obstetrics and Gynecology,Ruijin Hainan Hospital,Shanghai Jiao Tong University School of Medicine(Boao Research Hospital),Qionghai 571434,China;Department of Obstetrics and Gynecology,Ruijin Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai 200025,China;Department of Oncology,Ruijin Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai 200025,China)

机构地区：[1]上海交通大学医学院附属瑞金医院海南医院(博鳌研究型医院)妇产科,琼海571434 [2]上海交通大学医学院附属瑞金医院妇产科,上海200025 [3]上海交通大学医学院附属瑞金医院肿瘤科,上海200025

出　　处：《中华转移性肿瘤杂志》2024年第3期213-219,共7页Chinese Journal of Metastatic Cancer

摘　　要：目的研究评价了卡瑞利珠单抗联合甲磺酸阿帕替尼,用于PD-L1阳性和/或dMMR的复发/持续性子宫或卵巢恶性肿瘤的疗效和安全性。方法本研究为前瞻性、单臂、单中心的Ⅱ期临床研究,纳入了复发/持续性子宫或卵巢恶性肿瘤,接受卡瑞利珠单抗联合阿帕替尼的方案。主要研究终点为客观缓解率(ORR),次要研究终点包括疾病控制率(DCR)、疾病控制持续时间(DC)、无进展生存(PFS)、总生存(OS)及安全性。结果入组20例患者,中位年龄54岁(32~68岁)。15例进行了至少1次的疗效评估,中位随访时间为34个月(14~43个月),8周的ORR为33.3%,3例完全缓解。16周的DCR为73.3%;中位DC为9个月(0~36个月),中位PFS期为12个月,中位OS期为31个月,1年OS率为66.7%。最常见的不良事件为高血压(35%)、乏力(35%)、蛋白尿(30%),3~4级不良反应发生率为30%(6/20)。结论甲磺酸阿帕替尼联合卡瑞利珠单抗可能提高PD-L1阳性和/或dMMR子宫或卵巢恶性肿瘤的客观肿瘤应答、延长PFS和OS。不良事件可耐受。Objective The purpose of this study was to evaluate the efficacy and safety of combination therapy with camrelizumab and apatinib for recurrent/persistent uterine or ovarian malignancies with PD-L1 positive and/or dMMR.Methods This study was a prospective,single arm,single center phaseⅡstudy,which included recurrent/persistent uterine or ovarian malignancies.Patients were received a combination regimen of camrelizumab and apatinib.The main endpoint of the study was the objective response rate(ORR).Secondary study endpoints were disease control rate(DCR),duration of disease control(DC),progression free survival(PFS),overall survival(OS),and safety.Results Twenty patients were enrolled,with a median age of 54 years(32-68 years).15 patients underwent at least one efficacy evaluation,with a median follow-up time of 34 months(14-43 months).ORR(8th week)was 33.3%,with 3 complete responses.DCR(16th week)was 73.3%and median DC was 9 months(range,0-36 months).Median PFS was 12 months,median OS was 31 months,and the 12-month OS rate was 66.7%.The most common adverse events(AEs)were hypertension(35%),fatigue(35%),and proteinuria(30%),and grade 3 or 4 AEs occurred in 30%(6/20)of patients.Conclusions Camrelizumab plus apatinib can improve the ORR,prolonged PFS and OS of uterine or ovarian malignancies with PD-L1 positive and/or dMMR.The adverse events were tolerable.

关 键 词：卡瑞利珠单抗 甲磺酸阿帕替尼 治疗结果 不良事件 宫颈癌 宫体恶性肿瘤 卵巢恶性肿瘤 

分 类 号：R737.3[医药卫生—肿瘤]