| General information |
| Database: | DB00884 |
| Objective: | To evaluate the efficacy and safety of cetuximab, a monoclonal antibody that inhibits the epidermal growth factor receptor (EGFR), as a firstline monotherapy in patients with unresectable squamous cell carcinoma of the skin (SCCS). |
| Authors: | Maubec E, et al |
| Title: | Phase II study of cetuximab as firstline singledrug therapy in patients with unresectable squamous cell carcinoma of the skin. |
| Journal: | J Clin Oncol. |
| Year: | 2011 |
| PMID: | 21810686 |
| Trial Design |
| Clinical Trial Id: | NCT00240682 |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | melanoma |
| Cancer Subtype: | squamous cell carcinoma of the skin |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | an openlabel, uncontrolled, multicenterphase II study |
| Key Patients Feature: | pathologically confirmed SCCS as well as immunohistochemical evidence of strong or moderate EGFR expression, locally advanced SCCS that was surgically unresectable, or metastatic SCCS, with documented progression. Patients had to be chemotherapyna ve |
| Biomarker: | RAS mutations or Fc¦ÃR genotypes |
| Biomark Analysis: | One HRAS mutation was identified. Combined Fc¦ÃRIIa131H/H and/or Fc¦ÃRIIIa158V/V polymorphisms were not associated with the clinical outcomes |
| Control Group Info: | single arm |
| Treatment Info: | patients received cetuximab (initial dose of 400 mg/m(2) follotheyd by subsequent weekly doses of 250 mg/m(2)) for at least 6 weeks with a 48week followup. |
| Primary End Point: | the disease control rate (DCR) at 6 weeks (according to Response Evaluation Criteria in Solid Tumors [RECIST] criteria). |
| Secondary End Point: | best response rate, overall survival, progression free survival (PFS), and toxicity assessment |
| Patients Number: | 36 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 28% (95% CI, 14% to 45%). |
| Disease Control Rate: | 69% (95% CI, 52% to 84%) in the ITT population and 81% (95% CI, 63% to 93%) in the PP population |
| Median Time to Progression: | 6.8 months (95% CI, 4.1 to 8.3 months). |
| Median PFS A vs. C: | 4.1 months (95% CI, 1.7 to 5 months |
| Median OS A vs. C: | 8.1 months (95% CI, 6.9 to 9.3 months) |
| Adverse Event(agent arm): | Grade 3 or 4 SAEs were reported in 61% of patients. Of the 29 SAEs, 62% were considered to be unrelated to cetuximab, 28% were not assessable, and 10% were related to cetuximab |
| Conclusions: | As a firstline treatment in patients with unresectable SCCS, cetuximab achieved 69% DCR. A randomizedphase 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. |