EMD Serono, Rockland, MA, USA.
The Healthcare Business of Merck KGaA, Darmstadt, Germany.
Value Health. 2023 Aug;26(8):1155-1163. doi: 10.1016/j.jval.2023.02.007. Epub 2023 Feb 18.
The VISION trial showed durable activity of tepotinib in MET exon 14 (METex14) skipping non-small cell lung cancer. We analyzed health state utilities using patient-reported outcomes from VISION.
5-level version of EQ-5D (EQ-5D-5L) and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 responses were collected at baseline, every 6 to 12 weeks during treatment, and at the end of treatment and safety follow-up. EQ-5D-5L and European Organisation for Research and Treatment of Cancer Quality of Life Utility Measure-Core 10 Dimensions (QLU-C10D) utilities were derived using United States, Canada, United Kingdom, and Taiwan value sets, where available. Utilities were analyzed with linear mixed models including covariates for progression or time-to-death (TTD).
Utilities were derived for 273/291 patients (EQ-5D-5L, 1545 observations; QLU-C10D, 1546 observations). Mean (± SD) US EQ-5D-5L utilities increased after tepotinib initiation, from 0.687 ± 0.287 at baseline to 0.754 ± 0.250 before independently assessed progression, and decreased post progression (0.704 ± 0.288). US QLU-C10D utilities showed similar trends (0.705 ± 0.215, 0.753 ± 0.195, and 0.708 ± 0.209, respectively). Progression-based models demonstrated a statistically significant impact of progression on utilities and predicted higher utilities pre versus post progression. TTD-based models showed statistically significant associations of TTD with utilities and predicted declining utilities as TTD decreased. Prior treatment (yes/no) did not significantly predict utilities in progression- or TTD-based models. Utilities for Canada, United Kingdom, and Taiwan showed comparable trends.
In this first analysis of health state utilities in patients with METex14 skipping non-small cell lung cancer, who received tepotinib, utilities were significantly associated with progression and TTD, but not prior treatment.
VISION 试验表明，特泊替尼在 MET 外显子 14（METex14）跳跃型非小细胞肺癌中具有持久的疗效。我们使用 VISION 中的患者报告结果来分析健康状态效用。
在基线时、治疗期间每 6-12 周以及治疗结束和安全性随访时，收集 5 级版 EQ-5D（EQ-5D-5L）和欧洲癌症研究与治疗组织生活质量问卷核心 30 项的反应。在有可用美国、加拿大、英国和中国台湾地区价值量表的情况下，从 EQ-5D-5L 和欧洲癌症研究与治疗组织生命质量测定量表核心 10 维度（QLU-C10D）中得出效用。使用包括进展或至死亡时间（TTD）的协变量的线性混合模型分析效用。
为 273/291 例患者（EQ-5D-5L，1545 次观察；QLU-C10D，1546 次观察）得出了效用。特泊替尼起始后，美国 EQ-5D-5L 效用平均（±标准差）增加，从基线时的 0.687 ± 0.287 增加到独立评估进展前的 0.754 ± 0.250，并且在进展后降低（0.704 ± 0.288）。美国 QLU-C10D 效用显示出相似的趋势（0.705 ± 0.215、0.753 ± 0.195 和 0.708 ± 0.209）。基于进展的模型显示，进展对效用有统计学显著影响，预测进展前优于进展后。基于 TTD 的模型显示 TTD 与效用的统计学显著关联，并预测随着 TTD 减少而效用下降。基于进展的模型中，先前治疗（是/否）与效用无显著相关性。加拿大、英国和中国台湾的效用显示出类似的趋势。
在接受特泊替尼治疗的 METex14 跳跃型非小细胞肺癌患者中，这是首次对健康状态效用进行分析，结果表明，效用与进展和 TTD 显著相关，但与先前治疗无关。
