研究动态
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在现实环境中使用曲贝替定和聚乙二醇化脂质体阿霉素 (pld) 治疗的铂敏感复发性卵巢癌老年患者的回顾性多中心研究:一项 geico 研究。

Retrospective multicenter study of elderly patients with platinum-sensitive relapsed ovarian cancer treated with trabectedin and pegylated liposomal doxorubicin (pld) in a real-world setting: a geico study.

发表日期:2024 Jul 05
作者: María Jesús Rubio, Aránzazu Manzano, Luis Miguel de Sande, Purificación Estévez-García, María Del Mar Gordon, Diego Soto de Prado, Blanca Hernando Fernández de Aranguiz, Eva M Guerra-Alia, Anna Carbó-Bagué, Ignacio Romero, Miguel Corbellas, Alba González-Haba, Carlos E Robles-Barraza, Jerónimo Martínez-García, Antonio González-Martín
来源: PHARMACOLOGY & THERAPEUTICS

摘要:

曲贝替定与聚乙二醇化脂质体阿霉素 (PLD) 组合被批准用于治疗铂敏感的复发性卵巢癌患者。然而,目前关于现实世界中老年卵巢癌患者的这种治疗的信息有限。这项观察性多中心研究回顾性评估了曲贝替定加 PLD 在现实世界中治疗诊断为铂敏感复发性卵巢癌的老年患者的情况癌症,根据 15 家 GEICO 关联医院的产品特性摘要 (SmPC) 进行治疗。开始治疗时年龄≥70岁且无铂间隔≥6个月的患者被认为符合资格。2015年1月1日至2019年12月31日期间,在15个西班牙国家接受了43名中位年龄为74.0岁的患者的治疗。中心。 4 名患者获得完全缓解(9.3%),14 名患者(32.6%)获得部分缓解,13 名患者(30.2%)疾病稳定为最佳放射学反应。根据 CA125 血清水平(即 Rustin 标准)对生物学总体反应进行分析,14 名患者对治疗有反应(32.6%),11 名患者有反应并正常化(25.6%),3 名患者稳定(7.0%),3 名患者病情进展(7.0%)。 %)。研究人群的中位无进展生存期 (PFS) 和总生存期 (OS) 分别为 7.7 个月和 19.5 个月。最常见的 3/4 级不良事件是中性粒细胞减少症(n = 8,18.7%)和乏力(n = 5,11.6%)。该分析表明,曲贝替定联合 PLD 是老年铂类患者可行且有效的治疗方法。敏感的复发性卵巢癌,显示出可接受的安全性,这对于这些患者的姑息治疗至关重要。© 2024。作者。
Trabectedin in combination with pegylated liposomal doxorubicin (PLD) is approved for the treatment of patients with platinum-sensitive relapsed ovarian cancer. Nevertheless, there is currently limited information regarding this treatment in elderly patients with ovarian cancer in a real-world setting.This observational and multicentric study retrospectively evaluated trabectedin plus PLD in a real-world setting treatment of elderly patients diagnosed with platinum-sensitive relapsed ovarian cancer, treated according to the Summary of Product Characteristics (SmPC) from 15 GEICO-associated hospitals. Patients ≥ 70 years old at the time of treatment initiation and platinum-free intervals ≥ 6 months were considered eligible.Forty-three patients with a median age of 74.0 years were treated between January 1st, 2015, and December 31st, 2019 in 15 Spanish centers. Four patients achieved complete response (9.3%), 14 (32.6%) partial response, and 13 (30.2%) stable disease as the best radiological response. In the analysis of biological overall response according to CA125 serum levels (i.e., Rustin criteria), 14 responded to the treatment (32.6%), 11 responded and normalized (25.6%), three patients stabilized (7.0%) and three progressed (7.0%). Median progression-free survival (PFS) and overall survival (OS) in the study population were 7.7 and 19.5 months, respectively. The most common grade 3/4 adverse events were neutropenia (n = 8, 18.7%) and asthenia (n = 5, 11.6%).This analysis demonstrated that trabectedin combined with PLD is a feasible and effective treatment in elderly patients with platinum-sensitive relapsed ovarian cancer, showing an acceptable safety profile, which is crucial in the palliative treatment of these patients.© 2024. The Author(s).