Multicenter Phase II study of cetuximab plus irinotecan in metastatic colorectal carcinoma refractory to irinotecan, oxaliplatin and fluoropyrimidines.

Autor: Tahara M; Division of Digestive Endoscopy and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Chiba, Japan. matahara@east.ncc.go.jp, Shirao K, Boku N, Yamaguchi K, Komatsu Y, Inaba Y, Arai T, Mizunuma N, Satoh T, Takiuchi H, Nishina T, Sakata Y
Jazyk: angličtina
Zdroj: Japanese journal of clinical oncology [Jpn J Clin Oncol] 2008 Nov; Vol. 38 (11), pp. 762-9. Date of Electronic Publication: 2008 Oct 04.
DOI: 10.1093/jjco/hyn102
Abstrakt: Objective: Cetuximab is a chimeric IgG1 monoclonal antibody that specifically blocks the epidermal growth factor receptor. We evaluated the efficacy and safety of cetuximab in combination with irinotecan in patients with metastatic colorectal cancer (CRC) refractory to irinotecan, oxaliplatin and fluoropyrimidines.
Methods: Cetuximab was administered initially at a dose of 400 mg/m(2) followed by weekly infusions at 250 mg/m(2). Irinotecan was administered either weekly at a dose of 100 mg/m(2) or every 2 weeks at 150 mg/m(2).
Results: Between October 2005 and February 2006, 39 consecutive patients were enrolled. The response and disease control rates (complete or partial response, or stable disease) were 30.8% (95% CI, 17.0-47.6) and 64.1% (95% CI, 47.2-78.8), respectively. With a median follow-up of 14.4 months, median time to progression was 4.1 months (95% CI, 2.7-5.1) and median survival time was 8.8 months (95% CI, 5.9-12.8). Patients (5.1%) developed Grade 3 acne-like rash.
Conclusions: Combination therapy of cetuximab and irinotecan is effective and well-tolerated in patients with metastatic CRC refractory to irinotecan, oxaliplatin and fluoropyrimidines.
Databáze: MEDLINE