ETA2024 Oral Presentations Oral Session 12: Clinical thyroid cancer research (7 abstracts)
1University of Pavia, Department of Internal Medicine and Therapeutics, Pavia, Italy; 2Hospital Universitario de Ramon Y Cajal, Madrid, Spain; 3Gustave Roussy, Département Dimagerie Médicale, France; 4University Hospital Marburg, Department of Nuclear Medicine, Marburg, Germany; 5Adelphi Real World, Bollington, Cheshire, United Kingdom; 6Eisai Ltd, Hatfield, United Kingdom; 7Eisai Inc., Nutley, Nj, United States
Objectives: 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. This study investigated real-world clinical outcomes in patients with RAI-R DTC initiated with 24 mg lenvatinib once daily as first-line monotherapy in Europe and Canada.
Methods: A retrospective patient chart review was conducted. The study cohort comprised RAI-R DTC patients initiated with lenvatinib monotherapy as first line treatment between May 28, 2015, and January 31, 2022 (France, Germany, Italy, Spain, United Kingdom), or August 9, 2016, and January 31, 2022 (Canada). 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: 203 patients with RAI-R DTC were included; 54.2% of patients were male and 95.5% of patients were white. At lenvatinib initiation, median [IQR] patient age was 59 [50 66] years; 54.7% of patients had stage III or IV disease, with the proportion of patients with lung / lymph node / bone metastases in 54.2%, 47.8% and 42.4%, respectively. Over the available follow-up period (median [Range] 18.0 [0.1 48.1] months), 55 (27.1%) patients discontinued first line lenvatinib treatment, the majority (n = 34, 61.8%) due to disease progression, and 25 (12.3%) patients reduced their dosage, predominantly due to physician reported undesirable tolerability (n = 19, 76.0%) or impact on quality of life (n = 6, 24.0%). Second line treatment was initiated in 24 (11.8%) patients, the majority (n = 18, 75.0%) of whom received cabozantinib. Provider-reported best overall response with lenvatinib was reported to be complete (n = 47, 23.2%) or partial (n = 115, 56.7%) response in 79.8% of patients. Median [IQR] time to best response was 7.6 months [4.8 13.3]. Median PFS on first line lenvatinib was 41.7 months (95% CI: 26.5-NR). Median OS in patients treated with lenvatinib was not reached. Estimated OS rates were 96.1% (95% CI: 92.3-98.0) at 12 months and 85.6% (95% CI: 79.3-90.1) at 24 months. Median [IQR] duration of lenvatinib was 17.9 months [12.7 - 21.8].
Conclusions: The robust sample size of our study underscores the clinical effectiveness of first line lenvatinib among patients with RAI-R DTC, affirming its relevance in real world clinical settings across Europe and Canada, whilst also supporting the findings of the SELECT study.