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Phase II study of cetuximab as first-line single-drug therapy in patients with unresectable squamous cell carcinoma of the skin.
- Source :
-
Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2011 Sep 01; Vol. 29 (25), pp. 3419-26. Date of Electronic Publication: 2011 Aug 01. - Publication Year :
- 2011
-
Abstract
- 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).<br />Patients and Methods: Thirty-six patients received cetuximab (initial dose of 400 mg/m(2) followed by subsequent weekly doses of 250 mg/m(2)) 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.<br />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.<br />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.
- Subjects :
- Adult
Aged
Aged, 80 and over
Antibodies, Monoclonal, Humanized
Carcinoma, Squamous Cell secondary
Carcinoma, Squamous Cell surgery
Cetuximab
Female
Follow-Up Studies
Humans
Lymphatic Metastasis
Male
Middle Aged
Skin Neoplasms pathology
Skin Neoplasms surgery
Survival Rate
Treatment Outcome
Antibodies, Monoclonal therapeutic use
Antineoplastic Agents therapeutic use
Carcinoma, Squamous Cell drug therapy
Skin Neoplasms drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1527-7755
- Volume :
- 29
- Issue :
- 25
- Database :
- MEDLINE
- Journal :
- Journal of clinical oncology : official journal of the American Society of Clinical Oncology
- Publication Type :
- Academic Journal
- Accession number :
- 21810686
- Full Text :
- https://doi.org/10.1200/JCO.2010.34.1735