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A phase II, multicenter study of cetuximab monotherapy in patients with refractory, metastatic colorectal carcinoma with absent epidermal growth factor receptor immunostaining
Investigational New Drugs, 10/28/09

Wierzbicki R et al. – Cetuximab monotherapy produces objective antitumor activity in patients with mCRC that does not express EGFR as determined by IHC. The activity and safety profiles of cetuximab monotherapy in mCRC lacking EGFR immunostaining are similar to previous observations in EGFR IHC-positive disease that was not selected based on K-ras mutation status.

Methods

Patients had immunohistochemical (IHC)-determined mCRC with absent EGFR immunostaining that progressed after receiving at least one standard, fluoropyrimidine-containing chemotherapeutic regimen
Absent EGFR immunostaining defined as IHC absence of specific membrane staining in ≥ 500 cancer cells examined in well-preserved tissue
Patients received 400 mg/m2 of intravenous (i.v.) cetuximab followed by once-weekly i.v. cetuximab 250 mg/m2 until disease progression or unacceptable toxicity
Patients evaluated for objective response at least every 6 weeks
Kaplan-Meier estimates calculated for duration of response, time to progression (TTP), and overall survival (OS)

Results

(8.2%) of 85 mCRC patients whose tumors lacked EGFR immunostaining had major responses following cetuximab treatment
Median duration of response 5.1 months
Median TTP and OS 2.5 months and 10.0 months, respectively; the 1-year survival rate was 39.6%
Most frequently reported cetuximab-related adverse events were acneiform dermatitis, fatigue, headache, and dry skin

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