Department of Obstetrics and Gynecology, Pusan National University College of Medicine, Busan 49241, Republic of Korea.
Department of Obstetrics and Gynecology, Pusan National University Yangsan Hospital, Yangsan-si 50612, Republic of Korea.
Curr Oncol. 2024 Oct 28;31(11):6711-6722. doi: 10.3390/curroncol31110495.
In this study, we aimed to retrospectively investigate the real-world clinical efficacy and adverse events of poly(adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitors in real-world clinical practice among patients with newly diagnosed epithelial ovarian cancer.
We retrospectively reviewed the medical records from hospitals. Patients with epithelial ovarian cancer treated with olaparib or niraparib as frontline maintenance treatment between 1 January 2014 and 31 December 2022 were included. Progression-free survival (PFS) was analyzed using the Kaplan-Meier method, and adverse events associated with PARP inhibitor treatment were investigated.
Ninety-six patients treated with PARP inhibitors were identified. The median follow-up period was 21.8 months (95% confidence interval [CI] 19.4-24.0). Twenty (20.1%) patients experienced disease progression, and two patients died. The median PFS was 45.3 months (95% CI 39.4-NA). or gene mutations and primary cytoreductive surgery were associated with better PFS. Adverse events of any grade occurred in 74 (77.1%) patients. Nineteen (19.8%) patients experienced PARP inhibitor therapy interruptions, and 35 (36.5%) patients experienced dose reductions. Only three patients discontinued the drug due to adverse events.
In a real-world setting, PARP inhibitors showed efficacy comparable to that reported in published randomized controlled trials and had acceptable safety profiles.
本研究旨在回顾性调查聚（二磷酸腺苷[ADP]-核糖）聚合酶（PARP）抑制剂在新诊断的上皮性卵巢癌患者真实世界临床实践中的实际临床疗效和不良事件。
我们回顾性地审查了医院的病历。纳入 2014 年 1 月 1 日至 2022 年 12 月 31 日期间接受奥拉帕利或尼拉帕利作为一线维持治疗的上皮性卵巢癌患者。采用 Kaplan-Meier 法分析无进展生存期（PFS），并研究与 PARP 抑制剂治疗相关的不良事件。
确定了 96 例接受 PARP 抑制剂治疗的患者。中位随访时间为 21.8 个月（95%置信区间[CI] 19.4-24.0）。20 例（20.1%）患者发生疾病进展，2 例患者死亡。中位 PFS 为 45.3 个月（95%CI 39.4-N/A）。BRCA1/2 基因突变和初次细胞减灭术与更好的 PFS 相关。任何等级的不良事件发生在 74 例（77.1%）患者中。19 例（19.8%）患者中断 PARP 抑制剂治疗，35 例（36.5%）患者减少剂量。仅 3 例患者因不良事件停止用药。
在真实环境中，PARP 抑制剂显示出与已发表的随机对照试验相当的疗效，且具有可接受的安全性。
