Phase II study of cetuximab as first-line single-drug therapy in patients with unresectable squamous cell carcinoma of the skin

Eve Maubec, Peter Petrow, Isabelle Scheer-Senyarich, Pierre Duvillard, Ludovic Lacroix, Julien Gelly, Agnès Certain, Xavier Duval, Béatrice Crickx, Valérie Buffard, Nicole Basset-Seguin, Pierre Saez, Anne Bénédicte Duval-Modeste, Henri Adamski, Sandrine Mansard, Florent Grange, Anne Dompmartin, Sandrine Faivre, France Mentré, Marie Françoise Avril

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    Résumé

    Purpose: To evaluate the efficacy and safety of cetuximab, a monoclonal antibody that inhibits the epidermal growth factor receptor (EGFR), as a first-line monotherapy in patients with unresectable squamous cell carcinoma of the skin (SCCS). Patients and Methods: Thirty-six patients received cetuximab (initial dose of 400 mg/m2 followed by subsequent weekly doses of 250 mg/m2) for at least 6 weeks with a 48-week follow-up. The primary end point was the disease control rate (DCR) at 6 weeks (according to Response Evaluation Criteria in Solid Tumors [RECIST] criteria). Secondary end points included best response rate, overall survival, progression-free survival (PFS), and toxicity assessment. Association of treatment efficacy with RAS mutations or FcγR genotypes was investigated. Results: Median age of the study population was 79 years. DCR at 6 weeks was obtained in 25 of 36 patients (69%; 95% CI, 52% to 84%) of the intention-to-treat population. The best responses were eight partial responses and two complete responses. There were no cetuximab-related deaths. There were three related serious adverse events: two grade 4 infusion reactions and one grade 3 interstitial pneumopathy. Grade 1 to 2 acne-like rash occurred in 78% of patients and was associated with prolonged PFS. One HRAS mutation was identified. Combined FcγRIIa-131H/H and/or FcγRIIIa-158V/V polymorphisms were not associated with the clinical outcomes. Conclusion: As a first-line treatment in patients with unresectable SCCS, cetuximab achieved 69% DCR. A randomized phase III trial is warranted to confirm that cetuximab may be considered as a therapeutic option especially in elderly patients. The low frequency of RAS mutations in SCCS makes SCCS tumors attractive for EGFR inhibition.

    langue originaleAnglais
    Pages (de - à)3419-3426
    Nombre de pages8
    journalJournal of Clinical Oncology
    Volume29
    Numéro de publication25
    Les DOIs
    étatPublié - 1 sept. 2011

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