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Adding Cetuximab to Standard Chemotherapy Improves Response Rates in Patients With Nonresectable Colorectal Liver Metastases: Presented at ESMO-GI

By Jenny Powers

BARCELONA, Spain -- June 26, 2009 -- Tumour response and resectability rates in patients with nonresectable colorectal liver metastases are favourably increased when cetuximab is added to 2 standard chemotherapy regimens, according to a study presented here at the 11th World Gastrointestinal Cancer Congress of the European Society for Medical Oncology (ESMO-GI).

Claus-Henning Köhne, MD, Klinicum Oldenburg, Oldenburg, Germany, and colleagues presented the results of the Cetuximab in Neoadjuvant Treatment of Non-Resectable Colorectal Liver Metastases (CELIM) study on June 25.

The study compared response rates in 111 patients with nonresectable colorectal liver metastases in response to the addition of cetuximab to either folinic acid, fluorouracil, and irinotecan (FOLFIRI) or folinic acid, fluorouracil, and oxaliplatin (FOLFOX6).

Patients (median age 63 years) were randomised to receive cetuximab 400 mg/m², then 250 mg/m² weekly plus either FOLFOX6 (n = 56) or FOLFIRI (n = 55) for 8 cycles as preoperative therapy.

Responses were confirmed according to Response Evaluation Criteria in Solid Tumours or by resection and by a central blinded imaging review.

Of the patients, 55% were technically nonresectable, 18% were initially staged with positron emission tomography (PET), and 73% had epidermal growth factor receptor-positive tumours. Of 99 patients evaluable for KRAS, 71% had KRAS wild-type tumours.

Grade 3 or higher toxicities were reported in 72% of patients, the most frequent being skin toxicity (33%), neutropenia (23%), and diarrhoea (14%). Neuropathy (grade >=2) occurred in 10% of patients in the FOLFIRI arm and in 20% of patients in the FOLFOXX6 arm.

Two preoperative and 3 postoperative deaths occurred.

The confirmed response rate was 62% overall: 70% in patients with KRAS wild-type tumours and 43% in patients with KRAS mutant tumours (68% FOLFOX6, 57% FOLFIRI).

R0 resection was performed in 34% of patients, and 46% had macroscopically complete liver resection and/or radiofrequency ablation.

Scans from baseline and 4 months were available for 75 patients (68%) for retrospective surgical review that showed that 32% of patients had changed from nonresectable to resectable and 6% from resectable to nonresectable status during this interval. The status of 61% of the patients remained unchanged.

The researchers concluded that the combination of standard chemotherapy plus cetuximab increases response rates, especially in patients with KRAS wild-type tumours, and that resectability was improved.

Funding for this study was provided by Merck Serono, Sanofi-Aventis, and Pfizer

[Presentation title: Results From the CELIM Study: Cetuximab Plus FOLFOX6 or Cetuximab Plus FOLFIRI as Neoadjuvant Treatment for Nonresectable Colorectal Cancer Liver Metastases. Abstract 22]

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