Sistema de Salut de Catalunya
Institut Català de la Salut
[Brose MS] Department of Medical Oncology, Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, Pennsylvania, USA. [Capdevila J] Servei d’Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Gastrointestinal and Endocrine Tumor Unit, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Elisei R] Unit of Endocrinology, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy. [Bastholt L] Department of Clinical Oncology, Odense University Hospital, Odense, Denmark. [Führer-Sakel D] Department of Endocrinology, Diabetes and Metabolism and Clinical Chemistry, University Hospital Essen, Essen, Germany. [Leboulleux S] Department of Nuclear Medicine and Endocrine Oncology, Gustave Roussy and Université Paris Saclay, Villejuif, France. Department of Endocrinology, Diabetology, Nutrition and Therapeutic Education, Hôpitaux Universitaires de Genève, Geneve, Switzerland
Vall d'Hebron Barcelona Hospital Campus
2024-07-09T11:25:53Z
2024-07-09T11:25:53Z
2024-07-02
Differentiated thyroid cancer; Multikinase inhibitor; Progression-free survival
Cáncer de tiroides diferenciado; Inhibidor de multiquinasa; Supervivencia libre de progresión
Càncer de tiroides diferenciat; Inhibidor de multiquinasa; Supervivència lliure de progressió
The VERIFY study aimed to determine the efficacy of vandetanib in patients with differentiated thyroid cancer (DTC) that is either locally advanced or metastatic and refractory to radioiodine (RAI) therapy. Specifically, VERIFY is a randomized, double-blind, multicenter phase III trial aimed to determine the efficacy and safety of vandetanib in tyrosine kinase inhibitor-naive patients with locally advanced or metastatic RAI-refractory DTC with documented progression (NCT01876784). Patients were randomized 1:1 to vandetanib or placebo. The primary endpoint was progression-free survival (PFS). Secondary endpoints included best objective response rate, overall survival (OS), safety, and tolerability. Patients continued to receive randomized treatment until disease progression or for as long as they were receiving clinical benefit unless criteria for treatment discontinuation were met. Following randomization, 117 patients received vandetanib, and 118 patients received a placebo. Median PFS was 10.0 months in the vandetanib group and 5.7 months in the placebo group (hazard ratio: 0.75; 95% CI: 0.55–1.03; P = 0.080). OS was not significantly different between treatment arms. Common Terminology Criteria for Adverse Events (CTCAE) of grade ≥3 were reported in 55.6% of patients in the vandetanib arm and 25.4% in the placebo arm. Thirty-three deaths (28.2%; one related to study treatment) occurred in the vandetanib arm compared with 16 deaths (13.6%; two related to treatment) in the placebo arm. No statistically significant improvement was observed in PFS in treatment versus placebo in patients with locally advanced or metastatic, RAI-refractory DTC. Moreover, active treatment was associated with more adverse events and more deaths than placebo, though the difference in OS was not statistically significant.
This study was sponsored by Sanofi.
Article
Published version
English
Avaluació de resultats (Assistència sanitària); Tiroide - Càncer -Tractament; Medicaments antineoplàstics - Ús terapèutic; Isòtops radioactius en farmacologia; DISEASES::Neoplasms::Neoplasms by Site::Endocrine Gland Neoplasms::Thyroid Neoplasms; Other subheadings::Other subheadings::Other subheadings::/drug therapy; CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Antineoplastic Agents; CHEMICALS AND DRUGS::Inorganic Chemicals::Elements::Halogens::Iodine::Iodine Isotopes::Iodine Radioisotopes; ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Prognosis::Treatment Outcome; ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias de las glándulas endocrinas::neoplasias de la tiroides; Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia; COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antineoplásicos; COMPUESTOS QUÍMICOS Y DROGAS::compuestos inorgánicos::elementos::halógenos::yodo::isótopos del yodo::radioisótopos del yodo; TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::pronóstico::resultado del tratamiento
Bioscientifica
Endocrine-Related Cancer;31(8)
https://doi.org/10.1530/ERC-23-0354
Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
