This study was designed to evaluate the efficacy and safety of irinotecan/cetuximab administeredas third- or fourth-line therapy in a retrospective series of patients with metastatic colorectal cancer refractoryto oxaliplatin and irinotecan.Patients and Methods:Most patients (90%) had been previously treated withadjuvant 5-fluorouracil/leucovorin, and all had received oxaliplatin-based regimens before receiving irinotecan-based second-line treatment. Sixty patients with irinotecan-refractory colorectal cancer received a regimencomprising weekly irinotecan 120 mg/m2as a 1-hour intravenous infusion and cetuximab 400 mg/m2infused over2 hours as the initial dose and 250 mg/m2infused over 1 hour for the subsequent administrations. A singletreatment cycle comprised 4 weekly infusions followed by 2 weeks of rest.Results:According to an intent-to-treat analysis, a partial response was exhibited in 12 of 60 enrolled patients (20%; 95% confidence interval, 11%-32%) with a median duration of 5.1 months (range, 3-7.4 months).The tumor growth control rate was 50% (95%confidence interval, 37%-63%). Objective responses did not correlate with performance status, number of sitesof disease, and pretreatments or epidermal growth factor receptor status. The median progression-free survivalwas 3.1 months (range, 1.2-9 months), whereas median overall survival was 6 months (range, 2-13 months). Bothsurvival parameters correlated with performance status at the beginning of treatment. The main grade 3/4toxicities were nausea (33%), diarrhea (27%), leukopenia (18%), asthenia (13%), and acne-like reaction (13%).Conclusion:Our data suggest that the weekly irinotecan/cetuximab regimen is feasible in an outpatient settingand tolerated by most patients.At present, combinations of chemotherapy with cetuximab are being evaluated inpatients with earlier-stage disease in a number of ongoing studies.
|Number of pages||7|
|Journal||Clinical Colorectal Cancer|
|Publication status||Published - 2006|