Medical Oncology, Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain.
Medical Oncology, Centro Integral Oncológico Clara Campal, Madrid, Spain.
BMC Cancer. 2022 Nov 8;22(1):1150. doi: 10.1186/s12885-022-10191-5.
Rucaparib is a poly(ADP-ribose) polymerase inhibitor approved in Europe as maintenance therapy for recurrent platinum-sensitive (Pt-S) ovarian cancer (OC). The Rucaparib Access Programme (RAP) was designed to provide early access to rucaparib for the above-mentioned indication, as well as for patients with BRCA-mutated Pt-S or platinum-resistant (Pt-R) OC and no therapeutic alternatives.
In this observational, retrospective study we analysed the efficacy and safety of rucaparib within the RAP in Spain. Hospitals associated with the Spanish Ovarian Cancer Research Group (GEICO) recruited patients with high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer treated with rucaparib 600 mg twice daily as maintenance or treatment (Pt-S/Pt-R) in the RAP. Baseline characteristics, efficacy, and safety data were collected.
Between July 2020 and February 2021, 51 patients treated in 22 hospitals in the RAP were included in the study. Eighteen patients with a median of 3 (range, 1-6) prior treatment lines received rucaparib as maintenance; median progression-free survival (PFS) for this group was 9.1 months (95% confidence interval [CI], 4.2-11.6 months). Among 33 patients (median 5 [range, 1-9] prior treatment lines) who received rucaparib as treatment, 7 and 26 patients had Pt-S and Pt-R disease, respectively. Median PFS was 10.6 months (95% CI, 2.5 months-not reached) in the Pt-S group and 2.2 months (95% CI, 1.1-3.2 months) in the Pt-R group. Grade ≥ 3 treatment-emergent adverse events were reported in 39% of all patients, the most common being anaemia (12% and 15% in the maintenance and treatment groups, respectively). At data cut-off, 5 patients remained on treatment.
Efficacy results in these heavily pre-treated patients were similar to those from previous trials. The safety profile of rucaparib in real life was predictable and manageable.
鲁卡帕尼是一种聚（ADP-核糖）聚合酶抑制剂，在欧洲被批准用于铂类敏感（Pt-S）复发性卵巢癌（OC）的维持治疗。鲁卡帕尼准入计划（RAP）旨在为上述适应症以及 BRCA 突变的 Pt-S 或铂耐药（Pt-R）OC 且无其他治疗选择的患者提供鲁卡帕尼的早期准入。
在这项观察性、回顾性研究中，我们分析了西班牙 RAP 中鲁卡帕尼的疗效和安全性。与西班牙卵巢癌研究小组（GEICO）相关的医院招募了接受鲁卡帕尼 600mg 每日两次维持或治疗（Pt-S/Pt-R）的高级别上皮性卵巢癌、输卵管癌或原发性腹膜癌患者。收集了基线特征、疗效和安全性数据。
2020 年 7 月至 2021 年 2 月，RAP 中 22 家医院共纳入 51 例患者。18 例患者中位既往治疗线数为 3 条（范围 1-6 条），接受鲁卡帕尼维持治疗；该组中位无进展生存期（PFS）为 9.1 个月（95%置信区间 [CI]：4.2-11.6 个月）。33 例（中位既往治疗线数为 5 条[范围 1-9 条]）患者接受鲁卡帕尼治疗，分别有 7 例和 26 例患者患有 Pt-S 和 Pt-R 疾病。Pt-S 组中位 PFS 为 10.6 个月（95%CI：2.5 个月-未达到），Pt-R 组为 2.2 个月（95%CI：1.1-3.2 个月）。所有患者中报告了 39%的治疗相关 3 级及以上不良事件，最常见的是贫血（维持治疗组和治疗组分别为 12%和 15%）。在数据截止时，5 例患者仍在接受治疗。
这些经大量预处理的患者的疗效结果与之前的试验相似。鲁卡帕尼在真实世界中的安全性可预测且可控。
