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美国一线仑伐替尼单药治疗碘难治性分化型甲状腺癌(RAI-R DTC)患者的真实世界治疗模式和临床结局。

Real-world treatment patterns and clinical outcomes in patients with radioiodine-refractory differentiated thyroid cancer (RAI-R DTC) treated with first line lenvatinib monotherapy in the United States.

机构信息

University of Michigan Health System, Ann Arbor, MI, USA.

Adelphi Real World, Bollington, UK.

出版信息

Endocrine. 2024 May;84(2):663-669. doi: 10.1007/s12020-023-03638-7. Epub 2023 Dec 16.

Abstract

PURPOSE

Lenvatinib was approved for the treatment of patients with radioiodine-refractory differentiated thyroid cancer (RAI-R DTC) in the United States (US) in 2015. The main objective of the current study was to assess real-world clinical effectiveness in RAI-R DTC patients treated with first line lenvatinib monotherapy in the US.

METHODS

A retrospective chart review was conducted in RAI-R DTC patients who initiated lenvatinib monotherapy as first line treatment between February 2015 and September 2020. Anonymized data were abstracted by prescribing physicians from individual patient's electronic health records. Clinical outcomes included provider-reported real-world best overall response (rwBOR), real-world progression-free survival (rwPFS), and overall survival (OS). Time-to-event endpoints were assessed using Kaplan-Meier methods.

RESULTS

Our study included 308 RAI-R DTC patients treated with first line lenvatinib. At lenvatinib initiation, patients' median age was 60 years, 51.6% were female, and 26.0% of patients had an ECOG performance score of ≥2. Over the follow-up period, 32.5% of patients discontinued first line lenvatinib permanently, with others remaining on treatment. The median duration of lenvatinib therapy was 17.5 months overall. Provider-reported rwBOR (complete or partial response) to lenvatinib was 72.4%. Median rwPFS was 49.0 months. Estimated rwPFS rates at 24 and 48 months were 68.5% and 55.0%, respectively. Estimated OS rates at 24 and 72 months were 78.4% and 57.0%, respectively; median OS was not reached.

CONCLUSION

The current study reinforces the clinical effectiveness of first line lenvatinib as standard of care in patients with RAI-R DTC in real-world clinical practice in the US.

摘要

目的

仑伐替尼于 2015 年在美国获批用于治疗放射性碘难治性分化型甲状腺癌(RAI-R DTC)患者。本研究的主要目的是评估在美国接受一线仑伐替尼单药治疗的 RAI-R DTC 患者的真实世界临床疗效。

方法

对 2015 年 2 月至 2020 年 9 月期间接受一线仑伐替尼单药治疗的 RAI-R DTC 患者进行回顾性病历审查。由处方医师从患者的电子健康记录中提取匿名数据。临床结局包括报告者评估的真实世界总缓解(rwBOR)、真实世界无进展生存期(rwPFS)和总生存期(OS)。采用 Kaplan-Meier 方法评估时间依赖性终点。

结果

本研究共纳入 308 例接受一线仑伐替尼治疗的 RAI-R DTC 患者。仑伐替尼起始时,患者的中位年龄为 60 岁,51.6%为女性,26.0%的患者 ECOG 表现评分为≥2 分。在随访期间,32.5%的患者永久停用一线仑伐替尼,其余患者仍在接受治疗。仑伐替尼治疗的中位总持续时间为 17.5 个月。报告者评估的仑伐替尼 rwBOR(完全或部分缓解)为 72.4%。中位 rwPFS 为 49.0 个月。估计的 24 个月和 48 个月 rwPFS 率分别为 68.5%和 55.0%。估计的 24 个月和 72 个月 rwOS 率分别为 78.4%和 57.0%;中位 OS 尚未达到。

结论

本研究证实了一线仑伐替尼作为美国 RAI-R DTC 患者标准治疗的临床疗效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2fe8/11076410/0544f79a17bd/12020_2023_3638_Fig1_HTML.jpg

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