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Pegylated liposomal doxorubicin in partially platinum-sensitive, platinum-resistant, or platinum-refractory ovarian cancer: a prospective study

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机构: [1]Peking Union Med Coll Hosp, Dept Obstet & Gynecol, 1 Shuaifuyuan, Beijing 100730, Peoples R China [2]Sichuan Canc Hosp, Dept Gynaecol Oncol, Chengdu, Peoples R China [3]Shandong First Med Univ, Dept Gynecol, Canc Hosp, Jinan, Peoples R China [4]Second Hosp Jilin Univ, Dept Gynecol, Changchun, Peoples R China [5]Jiangsu Prov Hosp, Dept Gynecol, Nanjing, Peoples R China [6]Chinese Peoples Liberat Army Gen Hosp, Dept Obstet & Gynecol, Beijing, Peoples R China [7]Fudan Univ, Shanghai Canc Ctr, Dept Gynaecol Oncol, Shanghai, Peoples R China [8]First Hosp Jilin Univ, Dept Gynaecol Oncol, Changchun, Peoples R China [9]Henan Canc Hosp, Dept Gynecol, Zhengzhou, Peoples R China [10]Yantai Yuhuangding Hosp, Dept Gynecol, Yantai, Peoples R China [11]Shandong Prov Hosp, Dept Gynecol, Jinan, Peoples R China [12]Tianjin Canc Hosp Gynecol Obstet, Dept Gynaecol Oncol, Tianjin, Peoples R China [13]Shanxi Canc Hosp, Dept Gynecol 2, Taiyuan, Peoples R China [14]Cent South Univ, Xiangya Hosp 2, Dept Gynecol, Changsha, Peoples R China [15]Huazhong Univ Sci & Technol, Union Hosp, Tongji Med Coll, Dept Gynaecol Oncol, Shanghai, Peoples R China [16]Univ Chinese Acad Sci, Canc Hosp, Dept Gynecol Surg, Hangzhou, Peoples R China [17]Zhengzhou Univ, Dept Gynecol, Affiliated Hosp 1, Zhengzhou, Peoples R China
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关键词: ovarian cancer pegylated liposomal doxorubicin platinum-refractory platinum-resistant partially platinum-sensitive

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Background: This study aimed to evaluate the efficacy and safety of pegylated liposomal doxorubicin (PLD) for patients with partially platinum-sensitive, platinum-resistant, or platinum-refractory ovarian cancer. Methods: Patients with partially platinum-sensitive, platinum-resistant, or platinum-refractory ovarian cancer were recruited in this prospective, open-label, single-arm, multicenter study. Eligible patients were given 4-6 cycles of PLD (40 mg/m(2) on day 1, every 4 weeks). The primary endpoint was progression-free survival (PFS). Secondary endpoints were overall survival (OS), objective response rate (ORR), disease control rate (DCR), quality of life, and safety. Exploratory endpoints included the change trend of CA125 and platinum-free interval. Results: Between June 2017 and November 2020, 167 eligible patients were included in the full analysis set. The median PFS and OS were 6.8 months (95% CI, 4.4-9.3 months) and 19.1 months (95% CI, 15.0-23.3 months), respectively. The ORR and DCR were 32.3% and 60.5%, respectively. The ORR (62.3 vs 22.5%) and DCR (84.9 vs 60.7%) of patients with a CA125 decrease after the first cycle were significantly higher than those without a CA125 decrease (all P < .05). Grade >= 3 and serious adverse events were reported in 9.9% and 3.9% of patients, respectively. No treatment-related death was observed. Conclusion: PLD showed promising efficacy and manageable tolerability in patients with partially platinum-sensitive, platinum-resistant, or platinum-refractory ovarian cancer. ClinicalTrials.gov Identifier: Chinese Clinical Trial Registry, ChiCTR1900022962.

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大类 | 2 区 医学
小类 | 2 区 肿瘤学
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Q1 ONCOLOGY

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第一作者机构: [1]Peking Union Med Coll Hosp, Dept Obstet & Gynecol, 1 Shuaifuyuan, Beijing 100730, Peoples R China
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