Abstract 1659TiP
Background
Thyroid cancer (TC) is the most frequent endocrine cancer. Treatment is generally based on surgery +/- radioactive iodine (RAI) and TSH suppression in Differentiated TC (DTC) and surgery and levothyroxine suppression in Medullary TC (MTC). Multiple kinase inhibitor drugs have become the standard therapy for advanced TC. New molecular-driven alterations therapies have raised such as neurotrophic tyrosine kinase receptor (NTRK) and rearranged during transfection (RET) inhibitors. The availability of molecular profiling test at cancer centers provides precision medicine in clinical routine and new treatment opportunities. To date, there is no information of molecular alterations prevalence in Spain of patients with advanced RAI-R DTC and MTC.
Trial design
MOLTHY (NCT04970134) is a multicenter multidisciplinary translational project aiming to characterize the molecular profiling of advanced MTC and DTC in a Spanish cohort, identify potential molecular-driven alterations and the impact on survival, and compare with different molecular testing techniques in a retrospective cohort of 150 patients diagnosed of advanced RAI refractory DTC and MTC at the thyroid cancer units of 12 Spanish sites, belonging to both Spanish Cooperative groups TTCC and GETNE (H. Clinic Barcelona, H. Vall Hebron, ICO Hospitalet, ICO Girona, H.U. Ramón y Cajal, H.U.M. Valdecilla, H.U. La Paz, H.U. Miguel Servet Zaragoza, H.U. General Valencia, Fundacion Althaia, H. Parc Tauli and H.U. La Fe Valencia). Demographic, clinicopathologic, survival data will be collected for two years. Surgical tumor samples (FFPE) will be analyzed for molecular profiling, including different diagnostic techniques: oncomine focus assay (52-gene NGS panel to detect mutations, copy number alterations, gene rearrangements), NTRK1, NTRK3 and RET alterations by fluorescence in situ hybridization (FISH) and NTRK expression by immunohistochemistry staining (IHC). A comparison of different molecular testing technique will be explored, with the aim to propose a diagnostic decision-making in advanced TC, especially for NTRK and RET alterations.
Clinical trial identification
NCT04970134.
Editorial acknowledgement
Legal entity responsible for the study
TTCC-Grupo Español de Tratamiento de Tumores de Cabeza y Cuello.
Funding
TTCC-Grupo Español de Tratamiento de Tumores de Cabeza y Cuello (academic group) with partial funding from Roche Diagnostics S.L.U. Spain and Roche Farma S.A. Spain.
Disclosure
N. Baste Rotllan: Non-Financial Interests, Advisory Role: Eisai, MSD, Merck Serono, BioNTech, Roche, BMS, Exelixis. J. Martinez Trufero: Financial Interests, Personal, Advisory Board, Advisory Board meeting: PharmaMar, Eisai; Financial Interests, Personal, Invited Speaker: Roche, Eisai, Merck, Medicamenta; Financial Interests, Institutional, Invited Speaker, Clinical trial: RAIN Therapeutics, Blueprint, Lilly, Kariopharm Therapeutics, Syneos Health; Non-Financial Interests, Invited Speaker, Spanish group of Sarcoma Research: GEIS Group; Non-Financial Interests, Invited Speaker, Spanish Group of Head and Neck cancer Research: TTCC Group. C. Alvarez Escola: Financial Interests, Personal, Invited Speaker, I received honoraria from Ipsen, Novartis and Pfizzer as speaker fees, has served on an advisory board, received lecture fees and sponsorship for travel and accommodation in international scientific meetings: Ipsen, Novartis, Pfizer, HRA Pharma, Recordati, Sanofi, AAA. T. Alonso Gordoa: Financial Interests, Personal, Advisory Board: Ipsen, Sanofi, Bayer, Eisai, Novartis Advanced Accelerator Applications, Lilly; Financial Interests, Personal, Invited Speaker: Pfizer, Roche, Janssen-Cilag; Financial Interests, Institutional, Advisory Board: Bristol Myers Squibb; Non-Financial Interests, Project Lead: Pfizer, Ipsen. E. Gallardo Diaz: Financial Interests, Personal, Advisory Board: Sanofi, Janssen, Astellas, Pfizer, Bayer, Roche, Ipsen, Eisai, EUSA Pharma, BMS, AstraZeneca, Merck, Daiichi Sankyo, Techdow, Lilly; Financial Interests, Personal, Invited Speaker: Sanofi, Janssen, Astellas, Pfizer, Bayer, Roche, Ipsen, Eisai, EUSA Pharma, BMS, Merck, Daiichi Sankyo, MSD, Menarini, Rovi, Leo Pharma, Boehringer Ingelheim; Financial Interests, Personal, Expert Testimony: Merck, Novartis, Pfizer; Financial Interests, Institutional, Invited Speaker: Astellas, Medivation, Ipsen, Janssen, Pfizer, Lilly, Pfizer-Merck, MSD, BMS, Bayer, Daiichi Sankyo, Roche, AstraZeneca, Novartis, Seattle Genetics, Incyte, Aveo, Exelixis, Immunicum, Mediolanum, Clovis, QED Therapeutics; Non-Financial Interests, Leadership Role, Member of the Board: SOGUG; Non-Financial Interests, Leadership Role, Member of the Board of Thrombosis and Cancer Section: SEOM. J. Rubió-Casadevall: Financial Interests, Personal, Advisory Board, Advisory board meeting in 2021: Sanofi. C.M. Vila: Financial Interests, Personal, Invited Speaker, Melanoma Rising Stars Conference: Novartis; Financial Interests, Personal, Invited Speaker, Head and neck cancer Invited Speaker: BMS. M. Plana Serrahima: Financial Interests, Institutional, Other: Nanobiotix; Financial Interests, Personal, Invited Speaker, X: MSD; Financial Interests, Personal, Other: BMS. A.J. Cunquero Tomas: Financial Interests, Personal, Invited Speaker: Pierre-Fabre, Sanofi, BMS, Fundación ECO; Financial Interests, Personal, Other, Meeting expenses: Sanofi, MSD, Novartis; Non-Financial Interests, Other, Member of the QOPI Steering Group: American Society of Clinical Oncology; Non-Financial Interests, Other, Member of the Practising Oncologists Working Group: European Society for Medical Oncology. C. Lopez Lopez: Financial Interests, Personal, Invited Speaker: Ipsen, Roche, Eisai, Novartis, Pfizer, Aaa, Bayer, Lilly, Ipsen, Ipsen, Roche, Ipsen, Eisai; Financial Interests, Personal, Advisory Board: Ipsen, Roche, Eisai, Pfizer, Bayer, Lilly; Financial Interests, Personal, Funding: Roche, Pfizer, Novartis, Bayer, Lilly, Eisai. J. Hernando Cubero: Financial Interests, Personal, Expert Testimony: Eisai, Ipsen, Novartis, Aaa, Angelini, Pfizer, Roche. C. Teixido: Financial Interests, Personal, Invited Speaker: AstraZeneca, Takeda, MSD, Roche, Diaceutics, Pfizer; Financial Interests, Institutional, Research Grant: Novartis. E.M. Ortega Izquierdo: Financial Interests, Personal, Expert Testimony: gsk; Financial Interests, Personal, Invited Speaker: Clovis, AstraZeneca, PharmaMar. I. Ruz-Caracuel: Non-Financial Interests, Personal, Training, Tuition fee in: Ipsen. T. Bonfill Abella: Financial Interests, Personal, Advisory Board: Merck, Astellas. R. Mesia Nin: Financial Interests, Personal, Advisory Board: Merck, MSD, BMS, Bayer, Seattle Genetics, Nanobiotix, Boehringer; Financial Interests, Personal, Invited Speaker: Merck, MSD, BMS; Non-Financial Interests, Principal Investigator, Clinical Trial PI: BMS; Non-Financial Interests, Principal Investigator, Observational trial PI: Merck. All other authors have declared no conflicts of interest.