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Publications

Journal Article Ahead of print

PubMed: 41973603 DOI: 10.1530/ETJ-25-0301

Real-world efficacy of Lenvatinib/Pembrolizumab combination in anaplastic thyroid carcinoma: case series from two Italian referral centers.

Eur Thyroid J

Authors: Edoardo Talpacci, Manuela Macera, Giulia Maida, Silvia Morelli, Vincenzo Leone, Chiara Ingriccini, Antonella Ferrieri, Rachele Tortoriello, Miriam Paci, Monia Baldoni, Olivia Morelli, Samuele Barp, Marialuisa Sponziello, Marianna Maranghi, Cosimo Durante, Giorgio Grani, Efisio Puxeddu

Affiliations

  • Department of Medicine and Surgery, University of Perugia, Perugia.
  • Department of Translational and Precision Medicine, Sapienza University of Rome, Italy.
  • Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milano, Italy.

Abstract

OBJECTIVE

Anaplastic thyroid carcinoma (ATC) is an extremely aggressive cancer, traditionally refractory to conventional treatments. The combined therapy with Lenvatinib and Pembrolizumab (L+P) is supported by a preclinical rationale based on the distinctive immunological profile of ATC. We propose a real-life study to evaluate relevant clinical outcomes and identify survival predictors in a cohort of ATC patients treated with the combined therapy in two Italian referral centers.

METHODS

Sixteen ATC patients treated with the combination of L+P were retrospectively included. Overall survival (OS), progression-free survival (PFS), objective response rate (ORR) and disease control rate (DCR) were assessed according to RECIST 1.1 criteria. Baseline patient characteristics, including immuno-nutritional status (calculated using the CONUT score), were analyzed to identify potential predictors of response.

RESULTS

A median OS of 10 months (95% CI 4.2-15.9 months) and a median PFS of 6.0 months (95% CI 0-12.7 months) were observed after L+P therapy. Complete response was observed in 6.2% and partial response in 31.3% of patients, resulting in an ORR of 37.5%; the DCR was 68.8%. Progressive disease occurred in 25% of patients. Furthermore, a baseline CONUT score ≤ 2 resulted in a significantly longer OS (Log rank, p=0.001) and PFS (p=0.05) compared to CONUT score ≥ 3, while a non-significantly longer OS was observed between patients with a baseline ECOG PS of 0-2 and those with a baseline ECOG PS ≥ 3.

CONCLUSION

Our study confirms the efficacy and safety of L+P therapy, identifying the CONUT score as a prognostic factor.

MeSH

Thyroid Diseases, Thyroid Gland, Thyroid Carcinoma, Anaplastic, Therapeutics