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美国接受小分子激酶抑制剂治疗甲状腺癌患者的真实世界治疗模式。

Real-World Treatment Patterns Among Patients Initiating Small Molecule Kinase Inhibitor Therapies for Thyroid Cancer in the United States.

机构信息

Health Economics and Outcomes Research, Optum, Inc., Eden Prairie, MN, USA.

Health Economics & Outcomes Research, Eisai Inc., Woodcliff Lake, NJ, USA.

出版信息

Adv Ther. 2019 Apr;36(4):896-915. doi: 10.1007/s12325-019-0890-6. Epub 2019 Feb 28.

Abstract

INTRODUCTION

Little is known about real-world use of small molecule kinase inhibitors (SMKI) for advanced thyroid cancer in the United States. This study examined prescribing patterns of SMKI agents recommended by the National Comprehensive Cancer Center (NCCN).

METHODS

This retrospective study used a national health insurance database to identify patients diagnosed with thyroid cancer during 1/1/2006-6/30/2016 and with prescription claims for NCCN-recommended SMKI during 1/1/2010-5/31/2016 whose first claim date was the index date. Inclusion also required continuous enrollment in a health plan for 3 months pre-index (baseline) and ≥ 1 month post-index (follow-up) with no claims for SMKI during baseline. Lines of therapy (LOT) were defined by the date of SMKI claims and days of drug supply. Median time to SMKI discontinuation in each LOT was estimated by Kaplan-Meier method.

RESULTS

The study included 217 patients. During follow-up (mean duration 499.0 days), 35.5% of patients (n = 77) received a second or later LOT; among patients with ≥ 12 months follow-up after first LOT (LOT1) initiation, 53.1% (n = 60) received a second or later LOT. Median treatment duration was 5.0 months for LOT1 and 5.1 months for LOT2. Over the entire follow-up period (2010-2016), sorafenib was the most common regimen in LOT1 (36.9% of patients) and LOT2 (24.7%) followed by sunitinib and levantinib (13.4% each) in LOT1 and sunitinib (19.5%) in LOT2. Starting in 2015, the year lenvatinib was approved for differentiated thyroid cancer, lenvatinib was the most common first-line regimen among patients initiating LOT1 in 2015 (43.4%) and 2016 (66.7%).

CONCLUSION

Sorafenib was the most common first-line agent during 2010-2014 but was supplanted by lenvatinib starting in 2015. Approximately 36-53% of patients received a second-line treatment. Median treatment duration results suggested potential benefit of SMKI in second-line therapy. SMKI treatment after first-line failure may be considered for appropriately selected patients.

FUNDING

Eisai, Inc. (Woodcliff Lake, NJ).

摘要

简介

在美国,关于小分子激酶抑制剂(SMKI)在晚期甲状腺癌中的实际应用知之甚少。本研究调查了国家综合癌症网络(NCCN)推荐的 SMKI 药物的处方模式。

方法

这项回顾性研究使用国家健康保险数据库,确定了 2006 年 1 月 1 日至 2016 年 6 月 30 日期间被诊断为甲状腺癌的患者,并在 2010 年 1 月 1 日至 2016 年 5 月 31 日期间有 NCCN 推荐的 SMKI 处方的患者,且他们的首次索赔日期为索引日期。纳入标准还要求在索引前(基线)的 3 个月内连续参加健康计划,且在基线期间没有 SMKI 索赔。每一线治疗(LOT)的定义是根据 SMKI 索赔日期和药物供应天数。通过 Kaplan-Meier 法估计每个 LOT 中 SMKI 停药的中位时间。

结果

本研究共纳入 217 名患者。在随访期间(平均持续时间 499.0 天),35.5%(n=77)的患者接受了二线或以上的 LOT;在 LOT1 起始后至少有 12 个月随访的患者中,53.1%(n=60)接受了二线或以上的 LOT。LOT1 的中位治疗持续时间为 5.0 个月,LOT2 为 5.1 个月。在整个随访期间(2010-2016 年),索拉非尼是 LOT1(36.9%的患者)和 LOT2(24.7%)最常见的方案,紧随其后的是舒尼替尼和仑伐替尼(各 13.4%)在 LOT1 中,舒尼替尼(19.5%)在 LOT2 中。从 2015 年开始,仑伐替尼被批准用于分化型甲状腺癌,在 2015 年(43.4%)和 2016 年(66.7%)开始 LOT1 的患者中,仑伐替尼是最常见的一线方案。

结论

索拉非尼是 2010-2014 年最常用的一线药物,但从 2015 年开始被仑伐替尼取代。大约 36-53%的患者接受了二线治疗。中位治疗持续时间结果表明 SMKI 在二线治疗中可能具有潜在的益处。对于适当选择的患者,一线治疗失败后可以考虑 SMKI 治疗。

资金来源

卫材公司(新泽西州伍德克利夫湖)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e41c/6824453/8b191acaec7e/12325_2019_890_Fig1_HTML.jpg

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