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. Issue 5 (6th January 2020)

• Record Type: Journal Article
• Authors: Ham, Janneke C.; van Meerten, Esther; Fiets, W. Edward; Beerepoot, Laurens V.; Jeurissen, Frank J. F.; Slingerland, Marije; Jonker, Marianne A.; Husson, Olga; van der Graaf, Winette T. A.; van Herpen, Carla M. L.
• Is Part Of: Head & neck. Volume 42:Issue 5(2020)
• Page Start: 828
• Page End: 838
• Publication Date: 2020-01-06
• Subjects: cetuximab -- first‐line -- methotrexate -- palliative treatment -- recurrent or metastatic squamous cell carcinoma of the head and neck; Head -- Diseases -- Periodicals; Neck -- Diseases -- Periodicals; Head -- Periodicals; Neck -- Periodicals; Face -- Periodicals; 617.51059
• DOI: 10.1002/hed.26053
• Languages: English
• ISSNs: 1043-3074

Abstract

Abstract: 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.