Effect of Apatinib Plus Pegylated Liposomal Doxorubicin vs Pegylated Liposomal Doxorubicin Alone on Platinum-Resistant Recurrent Ovarian Cancer: The APPROVE Randomized Clinical Trial
机构：[1]Department of Gynecologic Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.[2]Department of Gynecologic Oncology, Hunan Cancer Hospital, Central South University, Changsha, China.[3]Department of Gynecology, The Third Affiliated Hospital of Kunming Medical University, Yunnan Provincial Cancer Center, Kunming, China.[4]Department of Obstetrics and Gynecology, West China Second University Hospital, Sichuan University, Chengdu, China.[5]Department of Gynecology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, Shenyang, China.[6]Department of Gynecologic Oncology, Chongqing University Cancer Hospital, Chongqing, China.[7]Department of Oncology Center, The First Hospital of Jilin University, Changchun, China.[8]Department of Gynecology, Xiangya Hospital, Central South University, Changsha, China.[9]Department of Gynecologic Oncology, Guangxi Medical University Affiliated Tumor Hospital, Nanning, China.[10]Department of Gynecologic Oncology, Hubei Cancer Hospital, Wuhan, China.[11]Department of Oncology, The Second Affiliated Hospital of Dalian Medical University, Dalian, China.[12]Department of Gynecology, Peking Union Medical College Hospital, Beijing, China.[13]Jiangsu Hengrui Pharmaceuticals Co Ltd, Shanghai, China.
There are substantial unmet therapeutic needs in patients with platinum-resistant recurrent ovarian cancer (PROC), and novel therapeutic strategies should be explored.To evaluate the efficacy and safety of treatment with apatinib (a vascular endothelial growth factor receptor 2 tyrosine kinase inhibitor) plus pegylated liposomal doxorubicin (PLD) for PROC.The APPROVE trial was performed as an open-label, randomized clinical trial at 11 hospitals in China between March 22, 2018, and November 16, 2020. Patients with histologically confirmed ovarian cancer who had experienced disease progression during or within 6 months of discontinuing any prior line of treatment with platinum-based chemotherapy were eligible. This primary analysis was based on data that were current as of January 28, 2021.Patients received PLD alone (40 mg/m2, intravenously, every 4 weeks, for up to 6 cycles) or PLD plus apatinib (250 mg, orally, daily).The primary end point was progression-free survival (PFS) by Response Evaluation Criteria in Solid Tumours (RECIST), version 1.1, in the intent-to-treat population.In total, 152 female patients were randomized, with 78 (51.3%) in the apatinib plus PLD group (median age, 54 years; range, 22-76 years) and 74 (48.7%) in the PLD group (median age, 56 years; range, 33-72 years). The median follow-up duration was 8.7 months (IQR, 4.7-14.1 months). The median PFS was 5.8 months (95% CI, 3.8-8.8) for treatment with apatinib plus PLD vs 3.3 months (95% CI, 2.1-3.8) for PLD (hazard ratio, 0.44; 95% CI, 0.28-0.71; P < .001). The median overall survival was 23.0 months (95% CI, 18.9 to not reached) with treatment with apatinib plus PLD vs 14.4 months (95% CI, 12.1-23.4) with PLD (hazard ratio, 0.66; 95% CI, 0.40-1.09). The most frequent grade 3 or higher treatment-emergent adverse events were decreased neutrophil counts (11 [14.9%] in the apatinib plus PLD group vs 6 [8.3%] in the PLD group), hypertension (6 [8.1%] vs none), and decreased white blood cell count (5 [6.8%] vs 3 [4.2%]). Two patients receiving treatment with apatinib plus PLD experienced grade 2 fistulas.This randomized clinical trial found that treatment with apatinib plus PLD showed promising efficacy and manageable toxic effects in patients with PROC and may be a new alternative treatment option in this setting.Clinicaltrials.gov Identifier: NCT04348032.
基金：
National Key R&D Program of China
(No. 2016YFC1303700).
语种：
外文
PubmedID：
中科院(CAS)分区：
出版当年[2022]版：
大类|1 区医学
小类|1 区肿瘤学
最新[2023]版：
大类|1 区医学
小类|1 区肿瘤学
第一作者：
第一作者机构：[1]Department of Gynecologic Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
通讯作者：
推荐引用方式(GB/T 7714)：
Wang Tiantian,Tang Jie,Yang Hongying,et al.Effect of Apatinib Plus Pegylated Liposomal Doxorubicin vs Pegylated Liposomal Doxorubicin Alone on Platinum-Resistant Recurrent Ovarian Cancer: The APPROVE Randomized Clinical Trial[J].JAMA oncology.2022,doi:10.1001/jamaoncol.2022.2253.
APA：
Wang Tiantian,Tang Jie,Yang Hongying,Yin Rutie,Zhang Jingru...&Wu Lingying.(2022).Effect of Apatinib Plus Pegylated Liposomal Doxorubicin vs Pegylated Liposomal Doxorubicin Alone on Platinum-Resistant Recurrent Ovarian Cancer: The APPROVE Randomized Clinical Trial.JAMA oncology,,
MLA：
Wang Tiantian,et al."Effect of Apatinib Plus Pegylated Liposomal Doxorubicin vs Pegylated Liposomal Doxorubicin Alone on Platinum-Resistant Recurrent Ovarian Cancer: The APPROVE Randomized Clinical Trial".JAMA oncology .(2022)
医学