Efficacy and safety of cetuximab/irinotecan in chemotherapy-refractory metastatic colorectal adenocarcinomas: a clinical practice setting, multicenterexperience

Vittorio Gebbia, Vincenza Leonardi, Elena Capasso, Nicolò Borsellino, Paolo Tralongo, Francesco Ferraù, Francesco Ferraù, Biagio Agostara, Roberto Bordonaro, Francesco Verderame, Evaristo Maiello, Vita Leonardi, Salvatore Del Prete, Carlo Barone

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30 Citations (Scopus)


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.
Original languageEnglish
Pages (from-to)422-428
Number of pages7
JournalClinical Colorectal Cancer
Publication statusPublished - 2006

All Science Journal Classification (ASJC) codes

  • Oncology
  • Gastroenterology


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