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Annals of Oncology Advance Access published online on November 22, 2005
Annals of Oncology, doi:10.1093/annonc/mdj084
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© 2005 European Society for Medical Oncology
Received August 23, 2005
Revised October 14, 2005
Accepted October 17, 2005

original article

Cetuximab and irinotecan/5-fluorouracil/folinic acid is a safe combination for the first-line treatment of patients with epidermal growth factor receptor expressing metastatic colorectal carcinoma

G. Folprecht 1, M. P. Lutz 2, P. Schöffski 3, T. Seufferlein 2, A. Nolting 4, P. Pollert 4, and C.-H. Köhne 5 *

1 University Hospital, Dresden, Germany
2 University Hospital, Ulm, Germany
3 Hannover Medical School, Hannover, Germany
4 Merck KGaA, Darmstadt, Germany
5 Klinikum Oldenburg gGmbH, Oldenburg, Germany

* To whom correspondence should be addressed.
C.-H. Köhne, E-mail: onkologie{at}klinikum-oldenburg.de


  Abstract

Background: To investigate the safety/tolerability of the EGFR-antibody cetuximab when added to irinotecan/5-fluorouracil (5-FU)/folinic acid (FA) for first-line treatment in patients with metastatic colorectal cancer (mCRC).

Patients and methods: Twenty-one patients with untreated, metastatic, EGFR-expressing CRC received cetuximab 400 mg/m2 as an initial dose, and thereafter 250 mg/m2 weekly. In addition, patients received infusional 5-FU (24 h) in two dose levels (1500 mg/m2, low 5-FU group, n = 6 or 2000 mg/m2, high 5-FU group, n = 15), plus FA at 500 mg/m2 and irinotecan at 80 mg/m2, weekly x6 q50d.

Results: Twenty patients were assessable for tolerability after the first cycle. There were no dose limiting toxicities (DLTs) in the low 5-FU group and three DLTs (20%) in the high 5-FU group (two patients with diarrhea grade 3 and one patient with diarrhea grade 4). In the low 5-FU group all six patients received >80% of the planned dose. In the high 5-FU group, seven of 14 patients (50%) received ≤80% of the planned chemotherapy dose during the first cycle due to dosage reductions whilst treatment delays occurred in 10/14 patients. During the whole study period, the common grade 3/4 adverse events were acne-like rash (38%) and diarrhea (29%). Chemotherapy did not affect the pharmacokinetics of cetuximab determined at weeks 1 and 4. Fourteen patients (67%, 95% CI 47% to 87%) had a confirmed response, and six (29%) had stable disease. Median time to progression was 9.9 months [lower 95% confidence limit (CL) 7.9, upper 95% CL not reached]. Median survival time was 33 months (lower CL 20, upper CL not reached). Four patients received secondary surgery with curative intent, and a fifth was potentially eligible for surgery but declined.

Conclusions: Addition of cetuximab to weekly infusional 5-FU/FA plus irinotecan is safe and first data suggest a promising activity. The 5-FU dose of 1500 mg/m2 is recommended for further studies.

Keywords: cetuximab; irinotecan; chemotherapy; metastatic colorectal cancer.
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