AO Ordine Mauriziano Torino and Department of Oncology, University of Torino, Torino, Italy.
GOG Foundation and Departments of Obstetrics/Gynecology and Medicine, Division of Gynecologic Oncology, Laura & Isaac Perlmutter Cancer Center, NYU Langone Health, New York, NY, USA.
Gynecol Oncol. 2024 Aug;187:128-138. doi: 10.1016/j.ygyno.2024.03.009. Epub 2024 Jun 3.
To evaluate the impact of age on the efficacy and safety of niraparib first-line maintenance therapy in patients with newly diagnosed advanced ovarian cancer with a complete/partial response to first-line platinum-based chemotherapy.
Post hoc analysis of the phase 3 PRIMA/ENGOT-OV26/GOG-3012 study (NCT02655016). Patients in the intent-to-treat population were categorized according to age at baseline (<65 years vs ≥65 years), and progression-free survival (PFS), safety, and health-related quality of life (HRQOL) were evaluated for each age subgroup (clinical cutoff date, May 17, 2019). Safety findings were also evaluated according to a fixed starting dose (FSD) or an individualized starting dose (ISD).
Of 733 randomized patients, 289 (39.4%) were ≥65 years (190 niraparib, 99 placebo) at baseline. Median PFS (niraparib vs placebo) and hazard ratios (95% CI) were similar in patients aged <65 years (13.9 vs 8.2 months; HR, 0.61 [0.47-0.81]) and ≥65 years (13.7 vs 8.1 months; HR, 0.53 [0.39-0.74]). The incidences of any-grade and grade ≥3 treatment-emergent adverse events (TEAEs) were similar across age subgroups; in the niraparib arm, TEAEs leading to dose discontinuation occurred in 7.8% of patients <65 years and 18.4% of patients ≥65 years. ISD use lowered the incidence of grade ≥3 thrombocytopenia events in niraparib-treated patients compared with the FSD (<65 years: 42.8% vs 18.0%; ≥65 years 57.0% vs 26.1%). HRQOL was comparable across age subgroups.
Niraparib efficacy, safety, and HRQOL were generally comparable across age subgroups, although patients ≥65 years had a higher rate of discontinuations due to TEAEs. ISD use reduced grade ≥3 thrombocytopenia events regardless of age.
评估年龄对一线维持治疗尼拉帕利治疗对一线含铂化疗完全/部分缓解的新诊断晚期卵巢癌患者疗效和安全性的影响。
这是一项 III 期 PRIMA/ENGOT-OV26/GOG-3012 研究（NCT02655016）的事后分析。意向治疗人群的患者根据基线时的年龄（<65 岁与≥65 岁）进行分类，并评估每个年龄亚组的无进展生存期（PFS）、安全性和健康相关生活质量（HRQOL）（临床截止日期为 2019 年 5 月 17 日）。还根据固定起始剂量（FSD）或个体化起始剂量（ISD）评估安全性发现。
在 733 名随机患者中，289 名（39.4%）患者在基线时年龄≥65 岁（190 名尼拉帕利，99 名安慰剂）。年龄<65 岁（13.9 个月比 8.2 个月；HR，0.61 [0.47-0.81]）和年龄≥65 岁（13.7 个月比 8.1 个月；HR，0.53 [0.39-0.74]）的患者 PFS（尼拉帕利比安慰剂）和危险比（95%CI）相似。任何等级和等级≥3 级治疗相关不良事件（TEAEs）的发生率在年龄亚组中相似；在尼拉帕利组中，7.8%的<65 岁患者和 18.4%的≥65 岁患者因 TEAEs 而停药。与 FSD 相比，尼拉帕利治疗患者中使用 ISD 降低了等级≥3 级血小板减少事件的发生率（<65 岁：42.8%比 18.0%；≥65 岁：57.0%比 26.1%）。HRQOL 在年龄亚组中相似。
无论年龄大小，尼拉帕利的疗效、安全性和 HRQOL 总体上相似，但≥65 岁的患者因 TEAEs 导致停药率较高。ISD 的使用降低了无论年龄大小的等级≥3 级血小板减少事件的发生率。
