Phase II study of cetuximab as first-line single-drug therapy in patients with unresectable squamous cell carcinoma of the skin
Journal of Clinical Oncology, 08/04/2011
Maubec E et al. – 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.
Methods- 36 patients received cetuximab (initial dose of 400 mg/m2 followed by subsequent weekly doses of 250 mg/m2) for at least 6 weeks with 48-week follow-up
- Primary end point was disease control rate (DCR) at 6 weeks (according to Response Evaluation Criteria in Solid Tumors [RECIST] criteria)
- Secondary end points included best response rate, OS, PFS, and toxicity assessment
- Association of treatment efficacy with RAS mutations or FcγR genotypes was investigated
- Median age of study population was 79 years
- DCR at 6 weeks obtained in 25 of 36 patients (69%; 95% CI, 52% to 84%) of the intention-to-treat population
- Best responses were 8 partial responses and 2 complete responses
- No cetuximab-related deaths
- 3 related serious AEs: 2 grade 4 infusion reactions and 1 grade 3 interstitial pneumopathy
- Grade 1 to 2 acne-like rash occurred in 78% of patients and was associated with prolonged PFS
- 1 HRAS mutation identified
- Combined FcγRIIa-131H/H and/or Fc?RIIIa-158V/V polymorphisms were not associated with clinical outcomes
