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Paclitaxel plus nedaplatin vs. paclitaxel plus carboplatin in women with epithelial ovarian cancer: A multi-center, randomized, open-label, phase III trial

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单位: [1]Guangxi Med Univ, Canc Hosp, Dept Gynecol, Nanning 530021, Guangxi, Peoples R China [2]First Peoples Hosp Jining, Dept Gynecol, Jining 272000, Shandong, Peoples R China [3]Tsinghua Univ, Affiliated Hosp 2, Dept Gynecol, Beijing 100049, Peoples R China [4]Sichuan Univ, West China Univ Hosp 2, Dept Gynecol, Chengdu 610041, Sichuan, Peoples R China [5]Shanghai Gen Hosp, Dept Gynecol, 100 Haining Rd, Shanghai 200080, Peoples R China [6]Peking Univ, Hosp 1, Dept Gynecol, Beijing 100034, Peoples R China [7]Zhejiang Univ, Womens Hosp, Sch Med, Dept Gynecol, Hangzhou 310006, Zhejiang, Peoples R China [8]Shandong Univ, Qilu Hosp, Dept Gynecol, Jinan 250012, Shandong, Peoples R China [9]Third Mil Med Univ, Daping Hosp, Res Inst Surg, Dept Gynecol, Chongqing 400042, Peoples R China [10]Jiangsu Canc Hosp, Dept Gynecol, Nanjing 210009, Jiangsu, Peoples R China [11]Harbin Med Univ, Affiliated Hosp 1, Dept Gynecol, Harbin 150001, Heilongjiang, Peoples R China [12]Peking Univ Peoples Hosp, Dept Gynecol, Beijing 100044, Peoples R China [13]Chongqing Canc Hosp, Dept Gynecol, Chongqing 400030, Peoples R China [14]Chinese Acad Med Sci, Canc Hosp, Dept Gynecol, Beijing 100021, Peoples R China [15]Huazhong Univ Sci & Technol, Tongji Hosp, Tongji Med Coll, Dept Obstet & Gynecol, 1095 Jie Fang Ave, Wuhan 430030, Hubei, Peoples R China
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关键词: epithelial ovarian cancer nedaplatin carboplatin paclitaxel chemotherapy

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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.

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出版当年[2017]版:
大类 | 4 区 医学
小类 | 4 区 肿瘤学
最新[2025]版:
大类 | 4 区 医学
小类 | 4 区 肿瘤学
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出版当年[2016]版:
Q4 ONCOLOGY
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Q3 ONCOLOGY

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第一作者单位: [1]Guangxi Med Univ, Canc Hosp, Dept Gynecol, Nanning 530021, Guangxi, Peoples R China [9]Third Mil Med Univ, Daping Hosp, Res Inst Surg, Dept Gynecol, Chongqing 400042, Peoples R China
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