Paclitaxel plus nedaplatin vs. paclitaxel plus carboplatin in women with epithelial ovarian cancer: A multi-center, randomized, open-label, phase III trial
机构：[1]Department of Gynecology, Cancer Hospital of Guangxi Medical University, Nanning, Guangxi 530021[2]Department of Gynecology, The First People's Hospital of Jining, Jining, Shandong 272000[3]Department of Gynecology, The Second Affiliated Hospital of Tsinghua University, Beijing 100049[4]Department of Gynecology, West China Second University Hospital, Sichuan University, Chengdu, Sichuan 610041[5]Department of Gynecology, Shanghai General Hospital, Shanghai 200080[6]Department of Gynecology, Peking University First Hospital, Beijing 100034[7]Department of Gynecology, Women's Hospital School of Medicine Zhejiang University, Hangzhou, Zhejiang 310006浙江大学医学院附属妇产科医院[8]Department of Gynecology, Qilu Hospital of Shandong University, Jinan, Shandong 250012[9]Department of Gynecology, Daping Hospital, Research Institute of Surgery Third Military Medical University, Chongqing 400042[10]Department of Gynecology, Jiangsu Cancer Hospital, Nanjing, Jiangsu 210009[11]Department of Gynecology, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang 150001[12]Department of Gynecology, Peking University People's Hospital, Beijing 100044[13]Department of Gynecology, Chongqing Cancer Hospital, Chongqing 400030[14]Department of Gynecology, Cancer Hospital, Chinese Academy of Medical Sciences, Beijing 100021[15]Department of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, P.R. China华中科技大学同济医学院附属同济医院
The multi-center, randomized, open-label, phase III trial discussed in the present study was performed to compare the clinical outcomes of nedaplatin (NDP) plus paclitaxel, and carboplatin (CBP) plus paclitaxel for the treatment of epithelial ovarian cancer (EOC). In the current study, 182 patients with International Federation of Gynecology and Obstetrics (FIGO) stage II-IV EOC were randomly assigned to receive NDP plus paclitaxel or CBP plus paclitaxel at 3-week intervals for a total of six courses. The primary endpoints were progression-free survival rate (PFS) and overall survival rate (OS). The secondary endpoints were toxicity profiles. The median follow-up was 44.63 months [95% confidence interval (CI) 33.67-46.47 months] for the NDP group and 47.63 months (95% CI 45.13-49.07 months) for the CBP group. Overall, there was no significant difference in PFS or OS between the two groups (P=0.09 for PFS, and P=0.65 for OS). For the patients with FIGO stage III-IV EOC, the NDP plus paclitaxel regimen significantly prolonged PFS (P=0.02) but did not result in improved OS (P=0.53) when compared with the CBP group. The patients in the NDP plus paclitaxel group also exhibited a lower incidence rate of grade 3 or 4 leucopenia (P=0.03). Other hematological and non-hematological toxicity profiles were similar between the two groups. Compared with CBP plus paclitaxel regimens, NDP plus paclitaxel regimens achieved comparable survival outcomes and similar toxicity profiles. However, patients of FIGO stage III-IV EOC may experience more clinical benefits from NDP plus paclitaxel treatment, including a prolonged PFS and a lower incidence rate of leucopenia. Therefore, an NDP-based regimen may be an alternative choice when using platinum-based agents to treat EOC.
基金：
The present study was supported by National Natural
Science Foundation of China (grant. no. 81672580).
第一作者机构：[1]Department of Gynecology, Cancer Hospital of Guangxi Medical University, Nanning, Guangxi 530021
共同第一作者：
通讯作者：
通讯机构：[5]Department of Gynecology, Shanghai General Hospital, Shanghai 200080[15]Department of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, P.R. China[*1]Department of Gynecology, Shanghai General Hospital, 100 Haining Road, Shanghai 200080, P.R. China[*2]Department of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jie Fang Avenue, Wuhan, Hubei 430030, P.R. China
推荐引用方式(GB/T 7714)：
LI LI,QINGQING ZHUANG,ZEYI CAO,et al.Paclitaxel plus nedaplatin vs. paclitaxel plus carboplatin in women with epithelial ovarian cancer: A multi-center, randomized, open-label, phase III trial[J].ONCOLOGY LETTERS.2018,15(3):3646-3652.doi:10.3892/ol.2018.7761.
APA：
LI LI,QINGQING ZHUANG,ZEYI CAO,RUTIE YIN,YAPING ZHU...&CHANGYU WANG.(2018).Paclitaxel plus nedaplatin vs. paclitaxel plus carboplatin in women with epithelial ovarian cancer: A multi-center, randomized, open-label, phase III trial.ONCOLOGY LETTERS,15,(3)
MLA：
LI LI,et al."Paclitaxel plus nedaplatin vs. paclitaxel plus carboplatin in women with epithelial ovarian cancer: A multi-center, randomized, open-label, phase III trial".ONCOLOGY LETTERS 15..3(2018):3646-3652
