Zhang Ying, Yuan Zhen, Zhang Guo-Nan, Li Qing-Shui, Cui Man-Hua, Cheng Wen-Jun, Meng Yuan-Guang, Wu Xiao-Hua, Yue Ying, Wang Li, Hou Jian-Qing, Li Chang-Zhong, Qu Peng-Peng, Sun Li-Xin, Tao Guang-Shi, Li Gui-Ling, Chen Ya-Qing, Ren Fang, Cao Dong-Yan, Shen Keng
Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Beijing, People's Republic of China.
Department of Gynaecologic Oncology, Sichuan Cancer Hospital, Chengdu, People's Republic of China.
Oncologist. 2025 Jan 17;30(1). doi: 10.1093/oncolo/oyae194.
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.
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/m2 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.
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.
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.
本研究旨在评估聚乙二醇化脂质体阿霉素（PLD）治疗部分铂敏感、铂耐药或铂难治性卵巢癌患者的疗效和安全性。
本前瞻性、开放标签、单臂、多中心研究招募了部分铂敏感、铂耐药或铂难治性卵巢癌患者。符合条件的患者接受4 - 6周期的PLD治疗（第1天40mg/m²，每4周一次）。主要终点为无进展生存期（PFS）。次要终点包括总生存期（OS）、客观缓解率（ORR）、疾病控制率（DCR）、生活质量和安全性。探索性终点包括CA125的变化趋势和无铂间期。
2017年6月至2020年11月期间，167例符合条件的患者纳入全分析集。中位PFS和OS分别为6.8个月（95%CI，4.4 - 9.3个月）和19.1个月（95%CI，15.0 - 23.3个月）。ORR和DCR分别为32.3%和60.5%。第一个周期后CA125下降的患者的ORR（62.3%对22.5%）和DCR（84.9%对60.7%）显著高于CA125未下降的患者（所有P < 0.05）。分别有9.9%和3.9%的患者报告了≥3级和严重不良事件。未观察到与治疗相关的死亡。
PLD在部分铂敏感、铂耐药或铂难治性卵巢癌患者中显示出有前景的疗效和可管理的耐受性。
临床试验.gov标识符：中国临床试验注册中心，ChiCTR1900022962 。
