Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, Zip code: 100730, China.
Department of Gynecologic Oncology, Shandong Cancer Hospital & Institute, Shandong, China.
J Ovarian Res. 2021 Jan 11;14(1):12. doi: 10.1186/s13048-020-00736-2.
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.
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.
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.
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.
评估 PLD 治疗在一线铂类化疗后 12 个月内发生上皮性卵巢癌、输卵管癌和腹膜癌进展的患者的疗效和安全性。
这是一项开放标签、单臂和多中心临床试验。ORR 是中期主要终点，DCR、AE 和 QOL 是次要终点。疗效结果的影响因素、CA125 的变化趋势和人工无铂间期是探索性终点。
共有 115 例患者入组本研究并纳入意向性治疗人群。另外，101 例患者纳入安全性人群。中位随访时间为 4 个月（IQR 2-6）。在意向性治疗人群中，确认的 ORR 为 37.4%（95%CI，28.4-46.4%），DCR 为 65.2%（95%CI，56.4-74.1%）。既往铂类化疗的反应状态和基线 CA125 水平与 ORR 显著相关。在第一个周期 CA125 下降的患者中，ORR 明显高于 CA125 升高的患者。最常见的 3 级或更高级别的 AE 是手足综合征（3[3.0%]例 101 例患者）。基线和基线后问卷之间没有统计学上的显著差异。
对于铂类耐药和铂类难治性复发的患者，PLD 的使用可能是可以接受的，因为其疗效令人满意，AE 发生率低，患者 QOL 高。此外，基线时 CA125 水平低和第一个周期后 CA125 降低是疗效满意的预测因素。
