In patients with unresectable squamous cell carcinoma of the skin (SCCS), first-line treatment with single-agent cetuximab has an overall disease control rate (DCR) of 69 percent, according to a study published online Aug. 1 in the Journal of Clinical Oncology.
Eve Maubec, M.D., from the Hôpital Bichat in Paris, and colleagues evaluated the efficacy and safety of cetuximab as a first-line monotherapy in 36 patients with unresectable SCCS, with a median age of 79 years. Patients received cetuximab (initial dose of 400 mg/m² and subsequent weekly doses of 250 mg/m²) for a minimum of six weeks, and were followed up for 48 weeks. The end points were DCR at six weeks, best response rate, overall survival, progression-free survival (PFS), and toxicity assessment. Correlation between treatment effectiveness and RAS mutations or FcγR genotypes was also analysed.
The investigators found that cetuximab therapy achieved a 69 percent DCR (obtained in 25 patients). Two complete and eight partial responses were the best responses. No cetuximab-related deaths occurred, and there were three related serious adverse events identified: one grade-3 interstitial pneumopathy and two grade-4 infusion reactions. Seventy-eight percent of patients had grade 1 to 2 acne-like rashes, which were associated with prolonged PFS. One case of HRAS mutation was found. Clinical outcomes were not correlated with combined FcγRIIa-131H/H and/or FcγRIIIa-158V/V polymorphisms.
"As a first-line treatment in patients with unresectable SCCS, cetuximab achieved 69 percent DCR," the authors write. "The low frequency of RAS mutations in SCCS makes SCCS tumors attractive for EGFR inhibition."
Several authors disclosed financial relationships with the pharmaceutical industry. The study was supported by grants from Merck, which also supplied the cetuximab.
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