1926MO - Radioiodine-refractory differentiated thyroid cancer (RAI-R DTC) patients treated with lenvatinib monotherapy: Real-world treatment patterns and clinical outcomes in Europe and Canada

Background

Lenvatinib was approved for the treatment of patients with radioiodine-refractory differentiated thyroid cancer (RAI-R DTC) in Europe in 2015 and Canada in 2016. The main objective of this study was to assess real-world clinical effectiveness in RAI-R DTC patients treated with first line lenvatinib monotherapy in UK, Spain, Germany, France, Italy, and Canada.

Methods

A retrospective patient chart review was conducted. The study cohort comprised RAI-R DTC patients who initiated lenvatinib monotherapy as first line treatment between May 28, 2015 (Europe), or August 9, 2016 (Canada) and January 31, 2022. Data were extracted by prescribing physicians from individual patients’ electronic health records and captured via an electronic case report form. All patient data were de-identified prior to analyses. Clinical outcomes assessed included provider-reported best overall response, progression-free survival (PFS), and overall survival (OS). Time to event endpoints were assessed using Kaplan-Meier methods.

Results

Of the 337 patients included, 45.1% were female and 94.7% were white/Caucasian. Patients’ median age was 60.0 years at lenvatinib initiation; 21.1% had ECOG performance status ≥2, 60.2% of patients had stage III or IV disease and 48.1% of patients had lung metastases. Over the available follow-up period (median [IQR] 17.9 months [13.7 – 22.0]), 32.3% of patients had discontinued lenvatinib. Provider-reported best overall response over the course of lenvatinib treatment was: complete in 21.1%, partial in 53.7%, with an overall response rate of 74.8% of patients. Median PFS on first line lenvatinib was 41.7 months (95%CI: 29.0-NR). Median OS was not reached. Estimated OS rates were 92.2% (95% CI: 88.8-94.7) at 12 months and 83.1% (95% CI: 78.3-86.9) at 24 months.

Conclusions

The current study reinforces the clinical effectiveness of first line lenvatinib in patients with RAI-R DTC in real-world clinical practice in Europe and Canada, including patients with PS ≥ 2. In addition, these results are consistent with the phase III SELECT trial and real-world evidence observed in the United States.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Eisai Inc.

Funding

Eisai Inc.

Disclosure

L.D. Locati: Financial Interests, Personal, Invited Speaker: Eisai, Ipsen, SunPharma, Bayer, Novartis, Seagen; Financial Interests, Personal, Advisory Board: MSD, Merck Serono, Eli Lilly, Roche; Financial Interests, Personal, Other, Scientific consultant: Istituto Gentili Srl; Financial Interests, Institutional, Local PI: Eisai; Financial Interests, Institutional, Funding: Pfizer; Non-Financial Interests, Leadership Role, Endocrine Tumor Group: EORTC; Non-Financial Interests, Advisory Board: AIOM (Italian Association of Medical Oncology), MSGS (Multidisciplinary Salivary Glands Society); Non-Financial Interests, Advisory Role: AIOCC (Associazione Italiana Oncologia Cervico Cefalica). T. Alonso Gordoa: Financial Interests, Personal, Advisory Board: Ipsen, Pfizer, Roche, Sanofi, Bayer, Eisai, Novartis Advanced Accelerator Applications, Lilly, Bristol Myers Squibb, Astellas; Financial Interests, Personal, Invited Speaker: Janssen-Cilag; Non-Financial Interests, Project Lead: Ipsen, Pfizer, Johnson & Johnson. L. Lamartina: Financial Interests, Personal, Advisory Board: Eisai, Bayer, Ipsen; Financial Interests, Personal, Invited Speaker: Lilly, Ipsen; Financial Interests, Institutional, Local PI: Exelixis, Eisai, Sanofi, Bayer. O. Rajkovic-Hooley, N. Reynolds, G. Milligan, C. Cooper: Financial Interests, Institutional, Full or part-time Employment: Adelphi Real World; Financial Interests, Institutional, Research Funding: Eisai. I. Brown: Financial Interests, Institutional, Full or part-time Employment: Eisai Ltd. H. Saal: Financial Interests, Institutional, Full or part-time Employment: Eisai Inc. J.R. Borbolla Escoboza: Financial Interests, Institutional, Full or part-time Employment: Eisai Inc. K. Newbold: Financial Interests, Institutional, Invited Speaker, 2023: Eisai; Financial Interests, Personal, Other, This is an initiative to provide guidelines online. It is a multinational advisory board of experts and I receive honoraria for this work: Thyroid International Recommendations Online; Non-Financial Interests, Advisory Role, chaired advisory board 2.11.21. No honorarium taken: Ipsen. All other authors have declared no conflicts of interest.