Oncology Department, Hospital Universitario Reina Sofía, Av. Menéndez Pidal, Córdoba, 14004, Spain.
Oncology Department, Hospital Clínico San Carlos, Madrid, Spain.
BMC Cancer. 2024 Jul 5;24(1):803. doi: 10.1186/s12885-024-12577-z.
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.
曲贝替定联合聚乙二醇脂质体阿霉素（PLD）获批用于铂敏感复发性卵巢癌患者的治疗。然而，目前在真实世界环境中，关于老年卵巢癌患者使用该治疗方案的信息有限。
本观察性多中心研究回顾性评估了 15 家 GEICO 合作医院根据产品说明书（SmPC）在真实世界环境中使用曲贝替定联合 PLD 治疗铂敏感复发性卵巢癌老年患者的情况。起始治疗时年龄≥70 岁且铂类无进展间期（PFI）≥6 个月的患者符合入组条件。
2015 年 1 月 1 日至 2019 年 12 月 31 日，15 家西班牙中心共治疗了 43 例中位年龄为 74.0 岁的患者。4 例患者达到完全缓解（9.3%），14 例（32.6%）达到部分缓解，13 例（30.2%）疾病稳定为最佳影像学缓解。根据 CA125 血清水平（即 Rustin 标准）分析生物学总缓解率，14 例（32.6%）患者对治疗有反应，11 例（25.6%）患者有反应且正常化，3 例（7.0%）患者病情稳定，3 例（7.0%）患者进展。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 级不良事件为中性粒细胞减少（n=8，18.7%）和乏力（n=5，11.6%）。
本分析表明，曲贝替定联合 PLD 是铂敏感复发性卵巢癌老年患者的一种可行且有效的治疗方案，具有可接受的安全性特征，这对这些患者的姑息治疗至关重要。
