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Efficacy and safety of paclitaxel liposome versus paclitaxel in combination with carboplatin in the first-line chemotherapy for ovarian cancer: a multicenter, open-label, non-inferiority, randomized controlled trial

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机构: [1]The Gynecologic Oncology Center, Chongqing University Cancer Hospital, Chongqing, China. [2]Department of Gynecologic, Yunnan Cancer Hospital, Kunming, China. [3]Department of Gynecologic Oncology, Shandong Cancer Hospital, Jinan, China. [4]Department of Gynecologic Oncology, Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China. [5]Department of Gynecologic Oncology, Hunan Cancer Hospital, Changsha, China. [6]Department of Tumor Radiotherapy and Chemotherapy, West China Second University Hospital of Sichuan University, Chengdu, China. [7]Department of Gynecologic, Guangxi Cancer Institute, Nanning, China. [8]Department of Gynecologic Oncology, Liaoning Cancer Hospital, Shenyang, China. [9]Department of Gynecologic Oncology, Hubei Cancer Hospital, Wuhan, China. [10]The Gynecologic Oncology Center, Peking Union Medical College Hospital, Beijing, China. [11]Department of Gynecologic, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.
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关键词: Ovarian cancer Paclitaxel liposome First-line chemotherapy Efficacy Safety

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The paclitaxel liposome formulation, encapsulating paclitaxel within a phospholipid bilayer, addresses the insolubility of traditional paclitaxel formulations, thereby reducing toxicity without compromising its antitumor efficacy.This multicenter, open-label, non-inferiority randomized controlled trial (ChiCTR2000038555) evaluates the efficacy and safety of paclitaxel liposome in comparison to the standard regimen of paclitaxel combined with carboplatin (PLC vs. PC) as first-line therapy in patients with epithelial ovarian cancer.An analysis of median progression-free survival (PFS) revealed non-inferior outcomes between 263 patients in the PLC group and 260 patients in the PC group (32.3 vs. 29.9 months, hazard ratio [HR], 0.89 [95% CI, 0.64-1.25]), using a non-inferior margin of 1.3. Although the overall incidence of treatment-related adverse events was comparable between groups, the PLC group experienced significantly fewer non-hematologic toxicities than those treated with the PC regimen.The findings affirm the non-inferiority of paclitaxel liposome compared to the combination of paclitaxel and carboplatin regarding therapeutic efficacy, with an enhanced safety profile marked by reduced non-hematologic toxicities.© 2024 Chinese National Cancer Center. Published by Elsevier B.V.

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第一作者机构: [1]The Gynecologic Oncology Center, Chongqing University Cancer Hospital, Chongqing, China.
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