Observational, prospective, phase 4 study in patients with first-line recurrent and/or metastatic squamous cell carcinoma of the head and neck treated with cetuximab and platinum-based therapy: DIRECT.

Autor: Guigay J; Comprehensive Cancer Center Antoine Lacassagne, FHU OncoAge, Université Côte d'Azur, Nice, France., Chamorey E; Comprehensive Cancer Center Antoine Lacassagne, FHU OncoAge, Université Côte d'Azur, Nice, France., Lefebvre G; Centre Oscar Lambret, Lille, France., Rotarski M; Centre d'Oncologie et de Radiothérapie de Haute Énergie du Pays Basque, Bayonne, France., Wagner JP; Institut Andrée Dutreix, Dunkerque, France., Blot E; Elsan Hôpital Privé Océane, Vannes, France.; Centre Hospitalier Bretagne Atlantique, Vannes, France., Alfonsi M; Clinique Sainte Catherine, Avignon, France., Seronde A; Department of Medical Affairs, Merck Biopharma, Lyon, France., Schulten J; Merck KGaA, Darmstadt, Germany., Peyrade F; Comprehensive Cancer Center Antoine Lacassagne, FHU OncoAge, Université Côte d'Azur, Nice, France., Le Tourneau C; Department of Drug Development and Innovation (D3i), Institut Curie, Saint-Cloud, France.; INSERM U900 Research Unit, Institut Curie, Saint-Cloud, France.; Espace Technologique, Bat. Discovery, Paris-Saclay University, Paris, France.
Jazyk: angličtina
Zdroj: Cancer reports (Hoboken, N.J.) [Cancer Rep (Hoboken)] 2022 Feb; Vol. 5 (2), pp. e1467. Date of Electronic Publication: 2021 Jun 22.
DOI: 10.1002/cnr2.1467
Abstrakt: Background: Cetuximab plus platinum-based therapy (PBT) followed by cetuximab maintenance until progression (EXTREME) is a guideline-recommended first-line treatment option in recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). DIRECT (Dose Intensity RElative to CeTuximab) was the first phase 4 observational study evaluating EXTREME administration in the real-world setting.
Aims: The primary aim of this study was to assess the relative dose intensity of cetuximab in patients with R/M SCCHN treated with first-line cetuximab according to the EXTREME regimen.
Methods and Results: Patients were ≥18 years old and eligible to receive cetuximab/PBT. Primary endpoint was cetuximab relative dose intensity (RDI). Of prospectively enrolled patients (n = 157), 119 received ≥1 cycle of EXTREME. Practices differing from the EXTREME trial were 5-fluorouracil omission (14%), maintenance cetuximab given every other week (54%), prior cetuximab, disease-free interval <6 months. 64% of patients reached cetuximab RDI ≥80%; mean cetuximab RDI was 88%. 46% of patients received maintenance cetuximab (mean RDI, 91%). Median progression-free survival and overall survival were 4.5 and 9.4 months. No new/unexpected safety findings were observed.
Conclusions: The DIRECT study showed that first-line cetuximab plus PBT was a feasible, beneficial first-line treatment regimen in patients with R/M SCCHN in the real-world setting.
(© 2021 The Authors. Cancer Reports published by Wiley Periodicals LLC.)
Databáze: MEDLINE
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