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

Janneke C. Ham, Esther van Meerten, W. Edward Fiets, Laurens V. Beerepoot, Frank J.F. Jeurissen, Marije Slingerland, Marianne A. Jonker, Olga Husson, Winette T.A. van der Graaf, Carla M.L. van Herpen*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

9 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)828-838
Number of pages11
JournalHead and Neck
Volume42
Issue number5
DOIs
Publication statusPublished - 1 May 2020

Bibliographical note

Funding Information:
We would like to thank all participating patients and their families. Furthermore we would like to thank all collaborating hospitals; Erasmus MC Cancer Institute, Medical Center Leeuwarden, Elisabeth TweeSteden Hospital, Medical Center Haaglanden, Leiden University Medical Center. Merck KGaA, Darmstadt, Germany provided a grant to perform the study, and provided cetuximab as study medication. Merck KGaA, Darmstadt, Germany reviewed the manuscript for medical accuracy only before journal submission. The authors are fully responsible for the content of this manuscript, and the views and opinions described in the publication reflect solely those of the authors.

Publisher Copyright:
© 2020 The Authors. Head & Neck published by Wiley Periodicals, Inc.

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