Real-World Evidence and Insights, Cardinal Health Specialty Solutions, Dublin, OH, USA.
US Health Economics and Outcomes Research & Real-World Evidence, Formerly of Eisai Inc., Woodcliff Lake, NJ, USA.
Adv Ther. 2020 Jun;37(6):2841-2852. doi: 10.1007/s12325-020-01362-6. Epub 2020 May 7.
Lenvatinib has become the most commonly prescribed first-line (1L) agent for the treatment of radioactive iodine-refractory differentiated thyroid cancer (RAI-r DTC) since its approval in 2015. With no real-world studies describing clinical outcomes of 1L lenvatinib and subsequent therapy, the current study aimed to assess treatment sequencing and related clinical outcomes in patients treated with 1L lenvatinib in the USA METHODS: We conducted a multisite, retrospective chart review of US patients with a diagnosis of RAI-r DTC who had initiated 1L therapy with lenvatinib from January 1, 2016 through May 31, 2017 with follow-up through October 17, 2018. Physicians completed electronic case report forms for two patient cohorts: patients still receiving 1L lenvatinib (cohort 1) and those who had initiated second-line (2L) therapy prior to data cutoff (cohort 2). Real-world objective response rate (ORR) was assessed for both cohorts. Progression-free survival (PFS) and overall survival (OS) were assessed for cohort 2.
A total of 252 patients met the study criteria with 71 in cohort 1 and 181 in cohort 2. Patients were predominantly female, had papillary DTC, and had lung metastases. The ORR was 64.8% for cohort 1 and 53.6% for cohort 2. In cohort 2, median PFS from 1L lenvatinib initiation was 14.0 months (95% CI 12.7-15.0). Second-line treatments included sorafenib (49.7%), cabozantinib (19.3%), and other targeted/chemotherapy/immuno-oncology agents. The ORR in 2L therapy was 15.5%. For cohort 2, the 12-, 18-, and 24-month OS from initiation of 1L lenvatinib was 92.8%, 81.5%, and 66.9%, respectively.
In this first real-world examination of clinical effectiveness of 1L lenvatinib and subsequent therapy among patients in the US, the results demonstrated that treatment with 1L lenvatinib followed by another 2L therapy may deliver a clinical benefit, thus allowing a number of potential 2L options following 1L lenvatinib for patients with RAI-r DTC.
自 2015 年批准以来，乐伐替尼已成为治疗放射性碘难治性分化型甲状腺癌（RAI-r DTC）的最常用一线（1L）药物。由于没有真实世界的研究描述接受 1L 乐伐替尼治疗的患者的临床结局和后续治疗，本研究旨在评估美国接受 1L 乐伐替尼治疗的患者的治疗方案和相关临床结局。
我们对 2016 年 1 月 1 日至 2017 年 5 月 31 日期间在美国开始接受 1L 乐伐替尼治疗的 RAI-r DTC 患者进行了多地点、回顾性病历审查，并随访至 2018 年 10 月 17 日。医生为两组患者填写了电子病例报告表：仍在接受 1L 乐伐替尼治疗的患者（队列 1）和在数据截止日期前开始二线（2L）治疗的患者（队列 2）。对两组患者的真实世界客观缓解率（ORR）进行了评估。对队列 2 进行了无进展生存期（PFS）和总生存期（OS）评估。
共有 252 名患者符合研究标准，其中队列 1 有 71 名，队列 2 有 181 名。患者主要为女性，患有乳头状 DTC，并有肺转移。队列 1 的 ORR 为 64.8%，队列 2 为 53.6%。在队列 2 中，从开始接受 1L 乐伐替尼治疗到进展的中位 PFS 为 14.0 个月（95%CI 12.7-15.0）。二线治疗包括索拉非尼（49.7%）、卡博替尼（19.3%）和其他靶向/化疗/免疫肿瘤学药物。二线治疗的 ORR 为 15.5%。对于队列 2，从开始接受 1L 乐伐替尼治疗到 12、18 和 24 个月的 OS 分别为 92.8%、81.5%和 66.9%。
这是第一项关于美国患者接受 1L 乐伐替尼治疗及其后续治疗的临床疗效的真实世界研究，结果表明，接受 1L 乐伐替尼治疗后再接受另一种二线治疗可能会带来临床获益，从而为 RAI-r DTC 患者在接受 1L 乐伐替尼治疗后提供了多种潜在的二线治疗选择。
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