Pegylated liposomal doxorubicin plus carboplatin versus paclitaxel plus carboplatin as first-line therapy for epithelial ovarian cancer (CGCS-04): a multicenter, randomized clinical trial
Year: 2026
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: Background: The current standard-of-care chemotherapy for treatment-naïve epithelial ovarian cancer is paclitaxel plus carboplatin. Objectives: To compare the efficacy and safety of pegylated liposomal doxorubicin (PLD) plus carboplatin versus paclitaxel plus carboplatin as first-line treatment in patients with epithelial ovarian cancer. Design: This was an investigator-initiated, multicenter, open-label, randomized, noninferiority trial. Methods: This trial with a prespecified noninferiority margin (HR 0 ) of 1.2, was conducted in 20 clinic centers in China. Eligible patients were randomly assigned in a 1:1 ratio to receive either PLD (30 mg/m 2 on day 1) plus carboplatin (area under the curve (AUC) 5 on day 1; experimental group) or paclitaxel (175 mg/m 2 on day 1) plus carboplatin (AUC 5 on day 1; control group) for up to six cycles. The primary endpoint was progression-free survival (PFS). The key secondary endpoints included overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety. Results: Between March 21, 2019, and December 8, 2021, 395 eligible patients were enrolled, of whom 195 were randomly assigned to receive PLD-carboplatin and 196 received paclitaxel-carboplatin. Median PFS was 35.3 months (95% confidence interval (CI), 23.7–46.9) in the experimental group and 35.0 months (95% CI, 26.9–43.1) in the control group (hazard ratio = 0.99, 95% CI, 0.73–1.35; p = 0.94). There were no statistically significant differences between the two groups in median ORR (80.5% vs 79.2%), DCR (90.2% vs 83.3%), 2-year OS rate (96.2% vs 92.4%), or 4-year OS rate (87.6% vs 82.4%; all p > 0.05). In the experimental and control groups, 165 (84.6%) and 169 (86.2%) patients experienced at least one adverse event (AEs). Alopecia (9.2% vs 28.1%, p < 0.001), peripheral sensory neuropathy (2.1% vs 17.9%, p < 0.001), and febrile neutropenia (1.0% vs 6.1%, p = 0.01) were less common in the PLD-carboplatin group compared to the paclitaxel-carboplatin group. Conclusion: The superior tolerability and comparable efficacy of PLD plus carboplatin over paclitaxel plus carboplatin as a first-line treatment for epithelial ovarian cancer suggest that substituting paclitaxel with PLD is both feasible and potentially more beneficial. Trial registration: This trial is registered with ClinicalTrials.gov, NCT03794778.
Institutions: Women's Hospital, School of Medicine, Zhejiang University, Zhejiang University, Shandong University, Qilu Hospital of Shandong University, Shandong Provincial Hospital, Sichuan University, West China Second University Hospital of Sichuan University, Shandong Tumor Hospital, Shandong First Medical University, First Hospital of Jilin University, First Bethune Hospital of Jilin University, Hebei Medical University, Fourth Hospital of Hebei Medical University, Tianjin Medical University Cancer Institute and Hospital, Guiyang Medical University, Guizhou Cancer Hospital, Tongji Hospital, Huazhong University of Science and Technology, Chinese PLA General Hospital, Tianjin Central Hospital of Gynecology Obstetrics, Second Hospital of Hebei Medical University, First Affiliated Hospital of Zhengzhou University, Hebei General Hospital, Jiangxi Maternal and Child Health Hospital, Jiangsu Province Hospital, Third Affiliated Hospital of Harbin Medical University, Wuhan Union Hospital
Language: English
Subfield: Reproductive Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,800
OpenAlex ID: W7129102837