Wislez Marie, Giannopoulou Andromachi, Borget Isabelle, Lindsay Colin, Rothschild Sacha I, Vincent Bastien, Milce Joseph, Sultan Ihtisham, Stollenwerk Björn, Pless Miklos
Department of Respiratory Medicine, Thoracic Oncology Unit, AP-HP, INSERM U1138, Centre de Recherches des Cordeliers, Paris Cancer Institute CARPEM, Université Paris Cité, Paris, France.
HEOR, Bayer Consumer Care AG, Basel, Switzerland.
J Med Econ. 2025 Dec;28(1):1151-1167. doi: 10.1080/13696998.2025.2535225. Epub 2025 Jul 23.
To evaluate real-world patient characteristics, healthcare resource use (HRU), and clinical outcomes among patients with advanced or metastatic (A/M) non-small cell lung cancer (NSCLC) stratified by KRAS mutation status (KRAS G12C, KRAS non-G12C, and KRAS wild-type[WT]).
This retrospective chart review included adults with A/M NSCLC and known KRAS status who received second- or third-line non-targeted therapy (index therapy) in France, the UK, or Switzerland. Patient characteristics, HRU, and key clinical outcomes-including time to treatment discontinuation (TTD), progression-free survival (PFS), and overall survival (OS)-were analyzed using the Kaplan-Meier method and log-rank methods. Exploratory multivariate Cox models adjusted for clinical covariates.
The study included 211 patients (France: 192, UK: 13, Switzerland: 6), with 53.1% having KRAS G12C, 21.8% KRAS non-G12C, and 25.1% KRAS WT NSCLC. Median age was 66 years; 62.1% were male, and 95.8% were current/former smokers. Baseline characteristics were comparable across KRAS subgroups. HRU was high, including 125 unplanned healthcare provider visits, primarily to general practitioners (42.4%) and specialists (24.0%). Hospitalization was frequent (70.1% of patients), with 40.8% experiencing unplanned admissions, largely due to disease complications (54.2%) and grade 3/4 adverse events (24.4%). Median TTD, PFS, and OS were comparable across KRAS subgroups for second-line (4.4-4.7 months, 5.3-6.3 months, and 11.2-15.0 months) and third-line (3.2-4.1 months, 3.4-5.2 months, and 5.1-9.2 months) therapy. Multivariate analysis showed that KRAS status, performance status, histology, and comorbidities were not significantly associated with survival outcomes.
Patients with advanced NSCLC, regardless of KRAS mutation status, experience a substantial disease burden, frequent hospitalizations, and poor clinical outcomes. These findings highlight the urgent need for more effective treatment options for advanced NSCLC, including therapies tailored to KRAS-mutated disease.
评估按KRAS突变状态（KRAS G12C、KRAS非G12C和KRAS野生型[WT]）分层的晚期或转移性（A/M）非小细胞肺癌（NSCLC）患者的真实世界患者特征、医疗资源使用（HRU）和临床结局。
这项回顾性病历审查纳入了在法国、英国或瑞士接受二线或三线非靶向治疗（索引治疗）且已知KRAS状态的A/M NSCLC成年患者。使用Kaplan-Meier方法和对数秩检验方法分析患者特征、HRU和关键临床结局，包括治疗中断时间（TTD）、无进展生存期（PFS）和总生存期（OS）。探索性多变量Cox模型对临床协变量进行了调整。
该研究纳入了211例患者（法国：192例，英国：13例，瑞士：6例），其中53.1%为KRAS G12C、21.8%为KRAS非G12C、25.1%为KRAS野生型NSCLC。中位年龄为6岁；62.1%为男性，95.8%为当前/既往吸烟者。KRAS亚组间的基线特征具有可比性。HRU较高，包括125次非计划的医疗服务提供者就诊，主要是看全科医生（42.4%）和专科医生（24.0%）。住院频繁（70.1%的患者），40.8%的患者经历了非计划入院，主要原因是疾病并发症（54.2%）和3/4级不良事件（24.4%）。二线（TTD为4.4至4.7个月、PFS为5.3至6.3个月、OS为11.2至15.0个月）和三线（TTD为3.2至4.1个月、PFS为3.4至5.2个月、OS为5.1至9.2个月）治疗的KRAS亚组间的中位TTD,PFS和OS具有可比性。多变量分析显示，KRAS状态、体能状态、组织学和合并症与生存结局无显著相关性。
晚期NSCLC患者，无论KRAS突变状态如何，都承受着巨大的疾病负担、频繁住院且临床结局不佳。这些发现凸显了对晚期NSCLC更有效治疗方案的迫切需求，包括针对KRAS突变疾病的定制疗法。
