Abstract: Background: Molecular alterations (MA) may drive therapeutic approaches, however no data of thyroid carcinoma are available in Spain. We report next-generation sequencing (NGS) and fluorescence in situ hybridization (FISH) results. Methods: MOLTHY is an observational, retrospective, translational and multidisciplinary study aiming to characterize the MA of advanced radioiodine-refractory (RAI-R) differentiated thyroid carcinoma (DTC) and medullary thyroid carcinomas (MTC) from 12 Spanish referral centers. The primary objective characterizes the MA prevalence, demographic and prognostic characteristics of 150 patients (pts). MA were centrally analyzed by Oncomine focus (NGS), FISH for NTRK1/3 and RET genes, and NTRK by Results: From Nov 2021 to Feb 2023, 149 pts were included, 106 (71%) DTC and 43 (29%) MTC. The table shows pts characteristics, treatments, and MA. 1st-line systemic therapy (L) had been administered in 76 DTC pts (71.7%): 31.6% ORR (24/76), 18 months (mo) as median (m) EFS (95%CI:13.2-25) and mOS 293mo (95%CI:145.9-NR); and in 32 MTC pts (74.4%): 40.6% ORR (13/32), 41.5mo (16.4-NR) as mEFS with mOS not reached. RET fusions had no significant impact on the efficacy of 1st L in DTC. However, MTC pts Conclusions: MOLTHY is the first and larger Spanish cohort of RAI-R DTC and MTC. The prevalence of RET fusions, BRAF/RAS/PIK3CA mutations and NTRK fusions in DTC are consistent with reported studies. RET-mutant MTC correlates with better OS, as previous studies have demonstrated with RET M918T carriers. NGS, FISH and IHC comparison is underway.

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