Methotrexate plus or minus cetuximab as first-line treatment in a recurrent or metastatic (R/M) squamous cell carcinoma population of the head and neck (SCCHN), unfit for cisplatin combination treatment, a phase Ib-randomized phase II study Commence

Ham, J.C.; Meerten, E. van; Fiets, W.E.; Beerepoot, L.V.; Jeurissen, F.J.F.; Slingerland, M.; ... ; Herpen, C.M.L. van (2020)

Article / Letter to editor

Background Methotrexate in recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN) has limited progression-free survival (PFS) benefit. We hypothesized that adding cetuximab to methotrexate improves PFS. Methods In the phase-Ib-study, patients with R/M SCCHN received methotrexate and cetuximab as first-line treatment. The primary objective was feasibility. In the phase-II-study patients were randomized to this combination or methotrexate alone (2:1). The primary endpoint was PFS. Secondary endpoints were overall survival (OS), toxicity, and quality of life (QoL). Results In six patients in the phase-Ib-study, no dose limiting toxicities were observed. In the phase II study, 30 patients received the combination and 15 patients methotrexate. In the phase-II-study median PFS was 4.5 months in the combination group vs 2.0 months in the methotrexate group (HR 0.37; P = .002). OS, toxicity, and QoL were not significantly different. Conclusion Cetuximab with methotrexate improved PFS without increased toxicity in R/M SCCHN-patients.

• cetuximab
• first-line
• methotrexate
• palliative treatment
• recurrent or metastatic squamous cell carcinoma of the head and neck

• All authors: Ham, J.C.; Meerten, E. van; Fiets, W.E.; Beerepoot, L.V.; Jeurissen, F.J.F.; Slingerland, M.; Jonker, M.A.; Husson, O.; Graaf, W.T.A. van der; Herpen, C.M.L. van
• Date: 2020-01-06
• Journal: Head and Neck
• Volume: 42
• Issue: 5
• Pages: 828 - 838
• DOI: doi:10.1002/hed.26053
• Link: https://onlinelibrary.wiley.com/doi/10.1002/hed.26053