Health Economics and Outcomes Research, Amgen, Thousand Oaks, CA, USA.
SCRI Research Network, OHC (Oncology Hematology Care), Cincinnati, OH, USA.
Adv Ther. 2024 Dec;41(12):4648-4659. doi: 10.1007/s12325-024-03020-7. Epub 2024 Oct 29.
Sotorasib was the first drug approved for adults with Kirsten rat sarcoma G12C-mutated locally advanced/metastatic non-small cell lung cancer (NSCLC) who received prior systemic therapy in the US. This study aimed to provide initial real-world evidence on patient characteristics, treatment patterns, healthcare resource utilization (HCRU), and healthcare costs (HCC) associated with sotorasib in US clinical practice.
A retrospective observational study was conducted using the Optum Clinformatics Data Mart US claims database spanning January 2016 to March 2023. The study population included adults with a diagnosis of lung cancer (diagnosis (Dx) date), claims for sotorasib on/post-Dx date (index date), Continuous enrollment for medical/pharmacy benefits from 180 days pre-Dx date to ≥ 30 days post-index date was required. Patients receiving treatments for small-cell lung cancer (SCLC) pre-index were excluded. Outcomes were analyzed for patients receiving sotorasib as second or subsequent line (2L+) treatment and included adherence [proportion of days covered (PDC)], treatment duration, time to next treatment (TTNT), HCRU, and HCC during sotorasib treatment.
Among 169 patients with lung cancer that met all inclusion criteria, 140 patients received sotorasib as 2L+ treatment (mean age: 71 years; 67.1% females). Mean PDC for sotorasib was 94.9%. Kaplan-Meier median treatment duration was 4.3 months. Median TTNT in patients with subsequent treatment (n = 31) was 6.8 months. During sotorasib treatment, patients had a mean 3.87 outpatient, 0.09 inpatient, and 0.11 emergency visits per month. Mean monthly HCC during sotorasib treatment were US$23,063 versus $25,541 during the 180-day pre-index period.
Patients in the US receiving sotorasib as 2L+ therapy for NSCLC in real-world clinical practice showed high adherence, TTNT comparable to progression-free survival observed in clinical trials, and HCC similar to those immediately prior to treatment demonstrating real-world benefits with no additional impact on healthcare resources with sotorasib.
Sotorasib 是首款获美国批准用于既往接受过系统治疗的携带 Kirsten 大鼠肉瘤 G12C 突变的局部晚期/转移性非小细胞肺癌（NSCLC）成人患者的药物。本研究旨在提供美国临床实践中使用 Sotorasib 治疗相关的患者特征、治疗模式、医疗资源利用（HCRU）和医疗保健成本（HCC）的初步真实世界证据。
本回顾性观察性研究使用 Optum Clinformatics Data Mart 美国索赔数据库进行，该数据库涵盖 2016 年 1 月至 2023 年 3 月期间的数据。研究人群包括诊断为肺癌（诊断日期）的成年人，有 Sotorasib 索赔记录（诊断日期后/当日）（索引日期），要求在索引日期前 180 天至索引日期后 30 天内，连续参加医疗/药房福利。索引日期前接受小细胞肺癌（SCLC）治疗的患者被排除在外。分析了接受 Sotorasib 二线或二线以上（2L+）治疗的患者的结局，包括依从性[比例天数覆盖（PDC）]、治疗持续时间、至下一治疗时间（TTNT）、HCRU 和 Sotorasib 治疗期间的 HCC。
在符合所有纳入标准的 169 名肺癌患者中，有 140 名患者接受了 Sotorasib 作为 2L+治疗（平均年龄：71 岁；67.1%为女性）。Sotorasib 的平均 PDC 为 94.9%。Kaplan-Meier 中位治疗持续时间为 4.3 个月。在有后续治疗的患者（n=31）中，中位 TTNT 为 6.8 个月。在 Sotorasib 治疗期间，患者每月平均有 3.87 次门诊就诊、0.09 次住院就诊和 0.11 次急诊就诊。在 Sotorasib 治疗期间，每月的 HCC 平均为 23063 美元，而在索引日期前的 180 天内为 25541 美元。
在真实世界的临床实践中，美国接受 Sotorasib 作为二线或二线以上治疗 NSCLC 的患者具有较高的依从性，TTNT 与临床试验中观察到的无进展生存期相当，并且 HCC 与治疗前即刻的 HCC 相似，证明了真实世界的获益，并且在使用 Sotorasib 治疗时对医疗资源没有额外影响。
