Anti-epidermal growth factor (EGFR) antibody cetuximab in patients with stage IV colorectal carcinoma who failed all standard therapy: An Access Protocol

Abstract

3753 Background: Cetuximab (Erbitux), an IgG1 monoclonal antibody, has shown activity against colorectal carcinoma (CRC), both as a single agent (ASCO 2002: A504) and in combination therapy (ASCO 2001: A7; ASCO 2003: A1012). Methods: This is an ongoing study to evaluate the safety of cetuximab in patients (pts) with metastatic CRC via an access program. Eligible pts have exhausted all standard therapies, having received at least two chemotherapy regimens for metastatic disease or adjuvant therapy plus one chemotherapy regimen for metastatic disease if the patient progressed within 6 months of completing adjuvant therapy. Prior chemotherapy must have included irinotecan, oxaliplatin and a fluoropyrimidine. Tumors must be EGFR+. Pts receive intravenous cetuximab therapy as 400 mg/m2 over 120 minutes (week 1 only) followed by 250 mg/m2 weekly over 60 minutes. Therapy continues until clinical evidence of disease progression. Results: As of December 15, 2003, 510 pts were enrolled with 331 in active treatment. Preliminary demographic data are available for the first 115 pts: M/F 61/54, mean age 60 years (range 31–81) and a mean duration of therapy 8 weeks (range 1–25). Reasons for discontinuation are available for 72 pts: progressive disease (51); toxicity (7), death (7), clinical deterioration (4), subject request (2), and other (1). Severe adverse event data is available on all 510 pts. Investigator-reported definitely and likely related grade 3/4 events include 14 hypersensitivity reactions. Grade 3/4 events deemed possibly related include headache, syncope, hypotension, diarrhea, asthenia, vomiting, abdominal pain, nausea, ventricular dysfunction, dehydration, dyskinesia and hypertension (1 pt each). Conclusions: Preliminary safety data from this access protocol demonstrate no unexpected toxicities. Single agent cetuximab is a viable option for colorectal cancer patients who have exhausted all standard therapies. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Bristol-Myers Squibb; Imclone Systems Imclone Systems Bristol-Myers Squibb Bristol-Myers Squibb, ImClone Systems Incorporated Bristol-Myers Squibb Bristol-Myers Squibb