尼拉帕利维持治疗铂敏感复发性卵巢癌的真实世界安全性和有效性：西班牙扩大可及性项目中的一项GEICO回顾性观察研究
Real-world safety and effectiveness of maintenance niraparib for platinum-sensitive recurrent ovarian cancer: A GEICO retrospective observational study within the Spanish expanded-access programme.
作者信息
Cueva Juan F, Palacio Isabel, Churruca Cristina, Herrero Ana, Pardo Beatriz, Constenla Manuel, Santaballa Ana, Manso Luis, Estévez Purificación, Maximiano Constanza, Legerén Marta, Marquina Gloria, de Juan Ana, Quindós María, Sánchez Luisa, Barquin Arantzazu, Fernández Isaura, Martín Cristina, Juárez Asunción, Martín Teresa, García Yolanda, Yubero Alfonso, Gallego Alejandro, Martínez Bueno Alejandro, Guerra Eva, González-Martín Antonio
机构信息
Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain.
Hospital Universitario Central de Asturias, Oviedo, Spain.
出版信息
Eur J Cancer. 2023 Mar;182:3-14. doi: 10.1016/j.ejca.2022.12.023. Epub 2022 Dec 29.
AIM
To describe patient characteristics, effectiveness and safety in a real-world population treated with niraparib in the Spanish expanded-access programme.
PATIENTS AND METHODS
This retrospective observational study included women with platinum-sensitive recurrent high-grade serous ovarian cancer who received maintenance niraparib within the Spanish niraparib expanded-access programme. Eligible patients had received ≥2 previous lines of platinum-containing therapy, remained platinum-sensitive after the penultimate line of platinum and had responded to the most recent platinum-containing therapy. Niraparib dosing was at the treating physician's discretion (300 mg/day fixed starting dose or individualised starting dose [ISD] according to baseline body weight and platelet count). Safety, impact of dose adjustments, patient characteristics and effectiveness were analysed using data extracted from medical records.
RESULTS
Among 316 eligible patients, 80% had BRCA wild-type tumours and 66% received an ISD. Median niraparib duration was 7.8 months. The most common adverse events typically occurred within 3 months of starting niraparib. Median progression-free survival was 8.6 (95% confidence interval [CI] 7.6-10.0) months. One- and 2-year overall survival rates were 86% (95% CI 81-89%) and 65% (95% CI 59-70%), respectively. Dose interruptions, dose reductions, haematological toxicities and asthenia/fatigue were less common with ISD than fixed starting dose niraparib, but progression-free survival was similar irrespective of dosing strategy. Subsequent therapy included platinum in 71% of patients who received further treatment.
CONCLUSION
Outcomes in this large real-world dataset of niraparib-treated patients are consistent with phase III trials, providing reassuring evidence of the tolerability and activity of niraparib maintenance therapy for platinum-sensitive recurrent ovarian cancer.
GOV REGISTRATION
NCT04546373.
目的
描述在西班牙扩大准入项目中接受尼拉帕利治疗的真实世界人群的患者特征、有效性和安全性。
患者与方法
这项回顾性观察性研究纳入了在西班牙尼拉帕利扩大准入项目中接受尼拉帕利维持治疗的铂敏感复发性高级别浆液性卵巢癌女性患者。符合条件的患者此前接受过≥2线含铂化疗，在倒数第二线铂类治疗后仍对铂敏感，并且对最近一次含铂治疗有反应。尼拉帕利的给药由治疗医生决定（固定起始剂量300mg/天或根据基线体重和血小板计数确定的个体化起始剂量[ISD]）。使用从医疗记录中提取的数据对安全性、剂量调整的影响、患者特征和有效性进行分析。
结果
在316例符合条件的患者中，80%为BRCA野生型肿瘤，66%接受了个体化起始剂量。尼拉帕利的中位治疗持续时间为7.8个月。最常见的不良事件通常在开始使用尼拉帕利的3个月内出现。中位无进展生存期为8.6（95%置信区间[CI]7.6 - 10.0）个月。1年和2年总生存率分别为86%（95%CI 81 - 89%）和65%（95%CI 59 - 70%）。与固定起始剂量的尼拉帕利相比，个体化起始剂量组的剂量中断、剂量减少、血液学毒性和乏力/疲劳情况较少见，但无论给药策略如何，无进展生存期相似。后续治疗中，71%接受进一步治疗的患者使用了铂类药物。
结论
这个大型的尼拉帕利治疗患者真实世界数据集的结果与III期试验一致，为尼拉帕利维持治疗铂敏感复发性卵巢癌的耐受性和活性提供了可靠证据。
政府注册号
NCT04546373
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