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Title Durvalumab with or without tremelimumab versus the EXTREME regimen as first-line treatment for recurrent or metastatic squamous cell carcinoma of the head and neck: KESTREL, a randomized, open-label, phase III study
Authors Psyrri, A.
Fayette, J. Vynnychenko
Harrington, K.
Gillison, M.
Ahn, M.-J.
Takahashi, S.
Weiss, J.
Machiels, J.-P.
Baxi, S.
Vasilyev, A.
Karpenko, A.
Dvorkin, M.
Hsieh, C.-Y.
Thungappa, S.C.
Segura, P.P.
Vynnychenko, Ihor Oleksandrovych  
Haddad, R.
Kasper, S.
Mauz, P.-S.
Baker, V.
He, P.
Evans, B.
Wildsmith, S.
Olsson, R.F.
Yovine, A.
Kurland, J.F.
Morsli, N.
Seiwert, T.Y.
ORCID http://orcid.org/0000-0002-2339-6509
Keywords Durvalumab
tremelimumab
kestrel
randomized
Type Article
Date of Issue 2023
URI https://essuir.sumdu.edu.ua/handle/123456789/93786
Publisher Elsevier
License Creative Commons Attribution - NonCommercial - NoDerivatives 4.0 International
Citation Durvalumab with or without tremelimumab versus the EXTREME regimen as first-line treatment for recurrent or metastatic squamous cell carcinoma of the head and neck: KESTREL, a randomized, open-label, phase III study / A. Psyrri et al. // Annals of Oncology. 2023. Vol. 34, Issue 3. P. 262-274. DOI: https://doi.org/10.1016/j.annonc.2022.12.008
Abstract Patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) have a poor prognosis. The phase III KESTREL study evaluated the efficacy of durvalumab [programmed death-ligand 1 (PD-L1) antibody] with or without tremelimumab [cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) antibody], versus the EXTREME regimen in patients with R/M HNSCC. Patients and methods: Patients with HNSCC who had not received prior systemic treatment for R/M disease were randomized (2 : 1 : 1) to receive durvalumab 1500 mg every 4 weeks (Q4W) plus tremelimumab 75 mg Q4W (up to four doses), durvalumab monotherapy 1500 mg Q4W, or the EXTREME regimen (platinum, 5-fluorouracil, and cetuximab) until disease progression. Durvalumab efficacy, with or without tremelimumab, versus the EXTREME regimen in patients with PD-L1-high tumors and in all randomized patients was assessed. Safety was also assessed. Results: Durvalumab and durvalumab plus tremelimumab were not superior to EXTREME for overall survival (OS) in patients with PD-L1-high expression [median, 10.9 and 11.2 versus 10.9 months, respectively; hazard ratio (HR) 1⁄4 0.96; 95% confidence interval (CI) 0.69-1.32; P 1⁄4 0.787 and HR 1⁄4 1.05; 95% CI 0.80-1.39, respectively]. Durvalumab and durvalumab plus tremelimumab prolonged duration of response versus EXTREME (49.3% and 48.1% versus 9.8% of patients remaining in response at 12 months), correlating with long-term OS for responding patients; however, median progression-free survival was longer with EXTREME (2.8 and 2.8 versus 5.4 months). Exploratory analyses suggested that subsequent immunotherapy use by 24.3% of patients in the EXTREME regimen arm contributed to the similar OS outcomes between arms. Grade 3/4 treatment-related adverse events (TRAEs) for durvalumab, durvalumab plus tremelimumab, and EXTREME were 8.9%, 19.1%, and 53.1%, respectively.
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