Pegylated liposomal doxorubicin and carboplatin versus paclitaxel and carboplatin as first-line treatment for Chinese patients with ovarian cancer: A multi‑center, randomized, open‑label trial.

person Yuanming Shen Women's Hospital School of Medicine Zhejiang University, Hangzhou, Zhejiang, China info_outline Yuanming Shen, Beihua Kong, Bairong Xia, Fei Wang, Rutie Yin, Qingshui Li, Ying Yue, Shan Kang, Liping He, Ke Wang, Yuanguang Meng, Shixuan Wang, Pengpeng Qu, Xianghua Huang, Ruixia Guo, Ping Yan, Mei Pan, Ge Lou, Wenjun Cheng, Xing Xie

Authors person Yuanming Shen Women's Hospital School of Medicine Zhejiang University, Hangzhou, Zhejiang, China info_outline Yuanming Shen, Beihua Kong, Bairong Xia, Fei Wang, Rutie Yin, Qingshui Li, Ying Yue, Shan Kang, Liping He, Ke Wang, Yuanguang Meng, Shixuan Wang, Pengpeng Qu, Xianghua Huang, Ruixia Guo, Ping Yan, Mei Pan, Ge Lou, Wenjun Cheng, Xing Xie Organizations Women's Hospital School of Medicine Zhejiang University, Hangzhou, Zhejiang, China, Qilu Hospital of Shandong University, Jinan, China, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China, Shandong Provincial Hospital, Jinan, China, West China Second University Hospital, Sichuan University, Chengdu, Sichuan, China, Shandong Cancer Hospital and Institute, Jinan, China, First Affiliated Hospital of Jilin University, Changchun, China, The Fourth Hospital of Hebei Medical University and Hebei Tumor Hospital, Shijiazhuang, China, The Affiliated Cancer Hospital of Guizhou Medical University, Guizhou, China, Tianjin Medical University Cancer Institute & Hospital, Tianjin, China, Department of Gynecology and Obstetrics, Chinese PLA General Hospital, Beijing, China, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China, Tianjin Central Hospital of Gynecology and Obstetrics, Tianjin, China, The Second Hospital of Hebei Medical University, Shijiazhuang, China, The First Affiliated Hosital of Zhengzhou Universit, Zhengzhou, China, Hebei General Hospital, Shijiazhuang, China, Maternal and Child Health Hospital of Jiangxi Province, Nanchang, China, Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China, Jiangsu Province Hospital, Nanjing, China, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, China Abstract Disclosures Research Funding Pharmaceutical/Biotech Company CSPC Ouyi Pharmaceutical Group Co., Ltd Background: Paclitaxel combined with carboplatin is a standard first-line chemotherapy regimen for ovarian cancer. This study was designed to evaluate the efficacy and safety of pegylated liposomal doxorubicin (PLD) plus carboplatin (CD) compared with paclitaxel plus carboplatin (CP) as first-line treatment for epithelial ovarian cancer (EOC). Methods: Patients with stage IC to IV EOC, fallopian tube cancer, or primary peritoneal cancer were eligible for enrolment in this open-label, randomized controlled trial at 20 centers in China. Patients were randomly assigned 1:1 to CD group (carboplatin area under the curve [AUC] 5 plus PLD 30 mg/m 2 ) or CP group (carboplatin AUC 5 plus paclitaxel 175 mg/m 2 ) every 3 weeks for 3-6 cycles. The primary end point was progression free survival (PFS); secondary end points were overall survival (OS), objective response rate (ORR), disease control rate (DCR) and safety. Results: Between March, 2019 to December, 2021, 395 patients were enrolled, of whom 391 patients were analyzed (195 assigned to CD, 196 to CP). Baseline characteristics were balanced between the two treatment groups. The median follow-up was 21.6 months for the CD group and 22.5 months for the CP group. There was no significant difference in PFS between the two arms (P=0.516); the median PFS was 28.1 months and 30.1 months in the CD and CP arms, respectively. OS data were immature at data cutoff, with a total of 26 deaths in the two treatment groups. In patients with at least one measurable lesion at baseline, ORR was 65.5% in the CD arm and 66.2% in the CP arm (P= 0.941); DCR was 74.1% and 73.8% in the CD and CP arms, respectively (P= 0.971). Among patients who were evaluable by GCIG CA125 criteria, CA125 response was obtained in 86.0% and 88.5% of patients in the CD and CP arms, respectively (P=0.560). More frequent grade 1 to 3 alopecia (32.1% vs 12.3%) and neurotoxicity (20.4% vs 0%) were observed in the CP arm; more hand-foot syndrome (grade 1 to 3, 10.8% vs 2.6%), and oral mucositis (grade 1-3, 12.8% vs 5.1%) in the CD arm. Conclusions: The efficacy of CD regimen is comparable to that of CP, with less alopecia and neurotoxicity. CD may be an alternative first-line treatment for EOC. However, survival data are not yet mature, and longer follow-up is needed. Clinical trial information: NCT03794778.

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