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Pegylated liposomal doxorubicin in patients with epithelial ovarian cancer

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机构: [1]Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing Zip code: 100730, China. [2]Department of Gynecologic Oncology, Shandong Cancer Hospital & Institute, Shandong, China. [3]Department of Gynecologic Oncology, Sichuan Cancer Hospital & Institute, Sichuan, China. [4]Department of Gynecologic Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. [5]Department of Obstetrics and Gynecology, The Second Hospital of Jilin University, Jilin, China. [6]Department of Obstetrics and Gynecology, The First Bethune Hospital of Jilin University, Jilin, China. [7]Department of Obstetrics and Gynecology, Jiangsu Province Hospital, Jiangsu, China. [8]Department of Gynecologic Oncology, He Nan Cancer Hospital, Henan, China. [9]Department of Obstetrics and Gynecology, Tianjin Central Hospital of Gynecology Obstetrics, Tianjin, China. [10]Department of Obstetrics and Gynecology, The Second Xiangya Hospital of Central South University, Hunan, China. [11]Department of Obstetrics and Gynecology, Yantai Yuhuangding Hospital, Shandong, China. [12]Department of Gynecologic Oncology, Shanxi Cancer Hospital, Shanxi, China. [13]Department of Obstetrics and Gynecology, Chinese PLA General Hospital, Beijing, China. [14]Department of Obstetrics and Gynecology, Wuhan Union Hospital of China, Hubei, China. [15]Department of Obstetrics and Gynecology, Shandong Provincial Hospital, Shandong, China. [16]Department of Obstetrics and Gynecology, The First Affiliated Hospital of Zhengzhou University, Henan, China. [17]Department of Gynecologic Oncology, Zhejiang Cancer Hospital, Zhejiang, China.
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关键词: CA125 Pegylated liposomal doxorubicin Platinum-refractory relapse Platinum-resistant relapse Partially platinum-sensitive relapse

摘要:
Objective: To evaluate the efficacy and safety of PLD in treating of in patients who experience epithelial ovarian, fallopian tubal, and peritoneal cancer progression within 12 months after the first-line platinum-based therapy. Methods: This was an open-label, single-arm and multicenter clinical trial. The ORR was the interim primary objective, and the DCR, AEs and QOL were the secondary objectives. The impact of factors on efficacy outcomes, the change trend of CA125 and the artificial platinum-free interval were exploratory endpoints. Results: Totally, 115 patients were enrolled in this study and included in the ITT population. Moreover, 101 patients were included in the safety population. The median follow-up time was 4 months (IQR 2-6). In the ITT population, the confirmed ORR was 37.4% (95% CI, 28.4-46.4%), and the DCR was 65.2% (95% CI, 56.4-74.1%). The previous response status to platinum-based chemotherapy and baseline CA125 levels were significantly correlated with the ORR. The ORR was significantly higher in patients with a CA125 decrease after the first cycle than in the patients with a CA125 increase. The most common grade 3 or higher AE was hand-foot syndrome (3 [3.0%] of 101 patients). No statistically significant differences existed between the baseline and the postbaseline questionnaires. Conclusions: For patients who experience platinum-resistant and platinum-refractory relapse, the use of PLD may be acceptable because of the associated satisfactory efficacy, low frequency of AEs and high patient QOL. Moreover, a low CA125 level at baseline and a reduction in CA125 after the first cycle are predictive factors for satisfactory efficacy.

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出版当年[2021]版:
大类 | 2 区 医学
小类 | 2 区 生殖生物学
最新[2023]版:
大类 | 3 区 医学
小类 | 3 区 生殖生物学
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Q1 REPRODUCTIVE BIOLOGY
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Q1 REPRODUCTIVE BIOLOGY

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第一作者机构: [1]Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing Zip code: 100730, China.
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