Multicenter Phase II study of cetuximab plus irinotecan in metastatic colorectal carcinoma refractory to irinotecan, oxaliplatin and fluoropyrimidines.
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.
Division of Digestive Endoscopy and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Chiba, Japan. matahara@east.ncc.go.jp
Makoto
M
Tahara
Kuniaki
K
Shirao
Narikazu
N
Boku
Kensei
K
Yamaguchi
Yoshito
Y
Komatsu
Yoshitaka
Y
Inaba
Tatsuhiro
T
Arai
Nobuyuki
N
Mizunuma
Taroh
T
Satoh
Hiroya
H
Takiuchi
Tomohiro
T
Nishina
Yuh
Y
Sakata
D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D002277:Carcinoma / Q000188:drug therapy* / Q000556:secondary; D000068818:Cetuximab; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D000077146:Irinotecan; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009944:Organoplatinum Compounds / Q000627:therapeutic use*; D000077150:Oxaliplatin; D011743:Pyrimidines / Q000627:therapeutic use*; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; D011743:Pyrimidines; D000077150:Oxaliplatin; D000077146:Irinotecan; D000068818:Cetuximab; D002166:Camptothecin