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Japanese Journal of Clinical Oncology Advance Access originally published online on October 4, 2008
Japanese Journal of Clinical Oncology 2008 38(11):762-769; doi:10.1093/jjco/hyn102
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© The Author (2008). Published by Oxford University Press. All rights reserved

Multicenter Phase II Study of Cetuximab Plus Irinotecan in Metastatic Colorectal Carcinoma Refractory to Irinotecan, Oxaliplatin and Fluoropyrimidines

Makoto Tahara1, Kuniaki Shirao2, Narikazu Boku3, Kensei Yamaguchi4, Yoshito Komatsu5, Yoshitaka Inaba6, Tatsuhiro Arai7, Nobuyuki Mizunuma8, Taroh Satoh9, Hiroya Takiuchi10, Tomohiro Nishina11 and Yuh Sakata12

1 Division of Digestive Endoscopy and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Chiba
2 Department of Medical Oncology, Faculty of Medicine, Oita University, Yufu, Oita
3 Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Nagaizumi, Shizuoka
4 Department of Gastroenterology, Saitama Cancer Center Hospital, Ina-machi, Saitama
5 Department of Gastroenterology, Hokkaido University School of Medicine, Sapporo
6 Department of Diagnostic and Interventional Radiology, Aichi Cancer Center Hospital, Nagoya, Aichi
7 Department of Medical Oncology, Tochigi Cancer Center Hospital, Utsunomiya, Tochigi
8 Department of Medical Oncology, Ariake Cancer Institute Hospital, Tokyo
9 Department of Medical Oncology, Kinki University School of Medicine, Osakasayama, Osaka
10 Department of Gastroenterology, Osaka Medical College, Takatsuki, Osaka
11 Department of Medical Oncology, National Shikoku Cancer Center, Matsuyama, Ehime
12 Misawa Municipal Hospital, Misawa, Aomori, Japan

For reprints and all correspondence: Makoto Tahara, Division of Digestive Endoscopy and Gastrointestinal Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577, Japan. E-mail: matahara{at}east.ncc.go.jp

Received July 10, 2008; accepted September 1, 2008

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/m2 followed by weekly infusions at 250 mg/m2. Irinotecan was administered either weekly at a dose of 100 mg/m2 or every 2 weeks at 150 mg/m2.

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.

Key Words: cetuximab • irinotecan • colorectal cancer • multicenter phase II study


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