Anti-epidermal growth factor (EGFR) antibody, cetuximab, in patients with stage IV colorectal carcinoma who failed all standard therapy: Final report of an access protocol

Abstract

3646 Background: Irinotecan, oxaliplatin, and fluoropyrimidine based regimens have been the mainstay of therapy for metastatic colorectal cancer (mCRC) and options are limited in patients who fail the standard regimens. Final data from a previously reported access study with single agent cetuximab for mCRC patients failing all standard therapy (Zehngebot et al, abstract 3753, ASCO 2004) is now available. Methods: Safety was evaluated in patients with EGFR detectable mCRC and an ECOG PS of ≤ 2. Patients must have exhausted all standard therapies and 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. Patients received an initial cetuximab dose of 400 mg/m2 on Day 1 followed by 250 mg/m2 weekly until disease progression or unacceptable toxicity. Results: : A total of 743 patients were enrolled in the study in approximately 30 sites across the country. The median age was 60 years (range 26–90), 35.9% of pts were ≥ 65 yrs, and 56.1% were male. The median duration of disease from the time of initial diagnosis to study entry was 30 months. The median number of infusions was 11 (range 1–56) and the median duration of therapy was 11.4 weeks (range 1–56), with 11.7% of patients continuing on therapy beyond six months. 44% of the patients experienced no cetuximab delay. Reasons for discontinuation included: progressive disease (61.6%); clinical deterioration (8.0%), patient request (6.9%), death (5.6%), toxicity (2.8%), and other (10.3%). The most commonly reported adverse event was rash 69% (5.5% grade 3/4). Grade 3/4 events included asthenia/malaise (7.9%), fatigue (5.8%), dyspnea (3.8%), nausea/vomiting (3.4%), dehydration (3.4%), and infusion reactions (2.4%). Conclusions: This study identified no unexpected toxicities related to single agent cetuximab and showed cetuximab to be an option for this pretreated population with mCRC who had exhausted all standard therapies. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Bristol-Myers Squibb ImClone Bristol-Myers Squibb