Schneeweiss Andreas, Fasching Peter A, Thill Marc, van Mackelenbergh Marion, Marme Frederik, Tesch Hans, Fehm Tanja N, Park-Simon Tjoung-Won, Häberle Lothar, Uhrig Sabrina, Tome Oliver, Spall Thomas, Theuser Anna-Katharin, Ruebner Matthias, Belleville Erik, Wallwiener Diethelm, Brucker Sara Y, Hartkopf Andreas D
National Center for Tumor Diseases (NCT), University Hospital and German Cancer Research Center, Heidelberg, Germany.
Department of Gynecology and Obstetrics, Universitätsklinikum Erlangen, Friedrich- Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany.
J Cancer Res Clin Oncol. 2025 Jun 19;151(6):192. doi: 10.1007/s00432-025-06246-2.
Chemotherapies are still widely used in advanced breast cancer, specifically in patients with HER2-negative disease. This non-interventional real-world study assessed the utilization of nab-paclitaxel in a broad patient population with advanced breast cancer.
SERAPHINA (NCT02642406) was a single arm, non-interventional study performed in Germany. Patients were eligible if they were treated with nab-paclitaxel according to the Summary of Product Characteristics (SmPC) as indicated by their physician. Progression-free survival (PFS), overall survival (OS), safety and quality of life were evaluated. Additionally, efficacy was assessed in patient subgroups based on age, metastasis pattern, performance status and therapy line.
A total of 432 patients were treated with nab-paclitaxel. The majority of patients had HER2-negative disease (94.2%). Furthermore, 30.1% of patients were treated in the first line and 48.3% in the third or later therapy line. Median PFS was 6.0 months (95% CI: 5.6-6.9) and median OS was 15.3 months (95% CI: 12.5-17.5). Although no clear predictors of PFS and OS in multivariable Cox models could be identified, patients with brain metastases had the shortest PFS (3.0 months; 95% CI: 2.2-4.3). Adverse events occurred in 83.1% of patients, with high-grade adverse events being rare (< 8% of patients). Quality of life did not change under therapy.
Nab-paclitaxel is used in patients with advanced breast cancer. In this real-world, non-interventional study, prognosis was favorable and safety profile manageable, which is comparable to previous clinical trials and real-world studies.
化疗仍广泛应用于晚期乳腺癌，特别是HER2阴性疾病患者。这项非干预性真实世界研究评估了纳布紫杉醇在广泛的晚期乳腺癌患者群体中的使用情况。
SERAPHINA（NCT02642406）是在德国进行的一项单臂、非干预性研究。如果患者根据其医生指示按照产品特性摘要（SmPC）接受纳布紫杉醇治疗，则符合入选条件。评估无进展生存期（PFS）、总生存期（OS）、安全性和生活质量。此外，还根据年龄、转移模式、体能状态和治疗线对患者亚组的疗效进行了评估。
共有432例患者接受了纳布紫杉醇治疗。大多数患者患有HER2阴性疾病（94.2%）。此外，30.1%的患者接受一线治疗，48.3%的患者接受三线或更晚的治疗。中位PFS为6.0个月（95%CI：5.6-6.9），中位OS为15.3个月（95%CI：12.5-17.5）。尽管在多变量Cox模型中未发现PFS和OS的明确预测因素，但有脑转移的患者PFS最短（3.0个月；95%CI：2.2-4.3）。83.1%的患者发生了不良事件，高级别不良事件很少见（<8%的患者）。治疗期间生活质量没有变化。
纳布紫杉醇用于晚期乳腺癌患者。在这项真实世界的非干预性研究中，预后良好，安全性可控，这与先前的临床试验和真实世界研究相当。
