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Clinical Trial
. 2020 May;42(5):828-838.
doi: 10.1002/hed.26053. Epub 2020 Jan 6.

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  1 , Esther van Meerten  2 , W Edward Fiets  3 , Laurens V Beerepoot  4 , Frank J F Jeurissen  5 , Marije Slingerland  6 , Marianne A Jonker  7 , Olga Husson  8   9 , Winette T A van der Graaf  1   10 , Carla M L van Herpen  1
Affiliations
Clinical Trial

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 et al. Head Neck. 2020 May.

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.

Keywords: cetuximab; first-line; methotrexate; palliative treatment; recurrent or metastatic squamous cell carcinoma of the head and neck.

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Figures

Figure 1
Figure 1
CONSORT flow diagram of the enrollment of patients in the phase II study [Color figure can be viewed at http://wileyonlinelibrary.com]
Figure 2
Figure 2
Kaplan–Meier estimates of progression free survival (A) and overall survival (B) according to the two treatment groups
See this image and copyright information in PMC

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