Musicco Felice, Fulgenzio Chiara, Malfa Antonia La, Jannitti Nicoletta, Vitiello Antonietta, Carpano Silvia, Fusco Francesca, Cappuzzo Federico, Terrenato Irene, Sperduti Isabella, Polidori Piera, Tarantino Domenico, Cerbo Lidia Di, Pani Marcello, Isgrò Valentina, Lasala Ruggero
Hospital Pharmacy, IRCCS Regina Elena National Cancer Institute, Rome, Italy.
Medical Oncology 2, IRCCS Regina Elena National Cancer Institute, Rome, Italy.
J Oncol Pharm Pract. 2025 Apr;31(3):430-437. doi: 10.1177/10781552241242096. Epub 2024 Mar 27.
IntroductionThe aim of this study was to analyze real-life data from a cohort of adult patients receiving atezolizumab in combination with carboplatin and etoposide for first-line treatment of ES-SCLC, in order to assess relative dose intensity (RDI), time-to-treatment discontinuation (TTD), time-to-treatment failure (TTF), progression-free survival (PFS), overall survival (OS) of treatments as well as the correlation between these outcomes.MethodsAn observational retrospective study was conducted. All patients treated with atezolizumab combined with carboplatin and etoposide for first-line treatment of ES-SCLC were included. Median TTD, TTF, PFS and OS were calculated in our cohort of patient by the Kaplan Meier method.ResultsThe curves obtained with the Kaplan Meier method of TTF and TTD are substantially similar, indicating a good concordance of the information extracted by the two different data sources. This tendency was confirmed also when the TTD versus PFS curves were compared. The median OS registered was 11.8 months. Patients with no liver metastases showed a longer median time of OS than patients with liver metastases. The mean value of RDI for the entire cohort was 87.4%.ConclusionsOur study showed that TTD, calculated from the administration data is a useful proxy of TTF as registered in the clinical chart. TTD is a real-world outcome that can be used to demonstrate the efficacy of drugs used for administered therapies. It can be used as an end point for RWE studies, where the evaluation is less structured and standardized.
引言
本研究旨在分析一组接受阿替利珠单抗联合卡铂和依托泊苷一线治疗广泛期小细胞肺癌(ES-SCLC)的成年患者的真实世界数据,以评估相对剂量强度(RDI)、治疗中断时间(TTD)、治疗失败时间(TTF)、无进展生存期(PFS)、总生存期(OS)以及这些结果之间的相关性。
方法
进行了一项观察性回顾性研究。纳入所有接受阿替利珠单抗联合卡铂和依托泊苷一线治疗ES-SCLC的患者。通过Kaplan-Meier方法计算我们患者队列的中位TTD、TTF、PFS和OS。
结果
用Kaplan-Meier方法得到的TTF和TTD曲线基本相似,表明两个不同数据源提取的信息具有良好的一致性。比较TTD与PFS曲线时也证实了这种趋势。记录的中位OS为11.8个月。无肝转移患者的中位OS时间比有肝转移患者更长。整个队列的RDI平均值为87.4%。
结论
我们的研究表明,根据给药数据计算的TTD是临床记录中登记的TTF的有用替代指标。TTD是一种真实世界的结果,可用于证明用于给药治疗的药物的疗效。它可以用作真实世界证据(RWE)研究的终点,在这类研究中评估的结构化和标准化程度较低。