Real-world efficacy of Lenvatinib/Pembrolizumab combination in anaplastic thyroid carcinoma: case series from two Italian referral centers.
[OBJECTIVE] Anaplastic thyroid carcinoma (ATC) is an extremely aggressive cancer, traditionally refractory to conventional treatments.
- p-value p=0.001
- p-value p=0.05
- 95% CI 4.2-15.9
APA
Talpacci E, Macera M, et al. (2026). Real-world efficacy of Lenvatinib/Pembrolizumab combination in anaplastic thyroid carcinoma: case series from two Italian referral centers.. European thyroid journal. https://doi.org/10.1530/ETJ-25-0301
MLA
Talpacci E, et al.. "Real-world efficacy of Lenvatinib/Pembrolizumab combination in anaplastic thyroid carcinoma: case series from two Italian referral centers.." European thyroid journal, 2026.
PMID
41973603
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.
[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.