Efficacy and Safety of Cetuximab/Irinotecan in Chemotherapy-Refractory Metastatic Colorectal Adenocarcinomas: A Clinical Practice Setting, Multicenter Experience

摘要: Abstract Background This study was designed to evaluate the efficacy and safety of irinotecan/cetuximab administered as third- or fourth-line therapy in a retrospective series patients with metastatic colorectal cancer refractory oxaliplatin irinotecan. Patients Methods Most (90%) had been previously treated adjuvant 5-fluorouracil/leucovorin, all received oxaliplatin-based regimens before receiving irinotecanbased second-line treatment. Sixty irinotecan-refractory regimen comprising weekly irinotecan 120 mg/m2 1-hour intravenous infusion cetuximab 400 infused over 2 hours initial dose 250 1 hour for subsequent administrations. A single treatment cycle comprised 4 infusions followed by weeks rest. Results According an intent-totreat analysis, partial response exhibited 12 60 enrolled (20%; 95% confidence interval, 11%-32%) median duration 5.1 months (range, 3–7.4 months). The tumor growth control rate 50% (95% 37%-63%). Objective responses did not correlate performance status, number sites disease, pretreatments epidermal factor receptor status. progression-free survival 3.1 1.2–9 months), whereas overall 6 2–13 Both parameters correlated status at beginning main grade 3/4 toxicities were nausea (33%), diarrhea (27%), leukopenia (18%), asthenia (13%), acne-like reaction (13%). Conclusion Our data suggest that is feasible outpatient setting tolerated most patients. At present, combinations chemotherapy are being evaluated earlier-stage disease ongoing studies.