Cetuximab Addition Produces High Rate of Complete Responses in Colorectal Cancer Patients With Resectable Liver Metastases: Presented at ESMO

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Title: Cetuximab Addition Produces High Rate of Complete Responses in Colorectal Cancer Patients With Resectable Liver Metastases: Presented at ESMO
URL: http://www.pslgroup.com/dg/22C9E6.htm
Doctor's Guide
September 17, 2008

By Ed Susman

STOCKHOLM, Sweden -- September 17, 2008 -- Addition of cetuximab to standard combination regimens for patients with advanced colorectal cancer results in a high rate of complete responses, researchers said here at the 33rd European Society for Medical Oncology Congress (ESMO).

"Among patients with initially nonresectable liver metastases, 42% had a liver resection and 35% had an R0 resection," said investigator Gunnar Folprecht, MD, University Hospital Carl Gustav Carus, Dresden, Germany, in a presentation on September 14.

The study randomised 56 patients to receive cetuximab 400 mg/m² as an initial dose and then 250 mg/m² weekly plus a combination of oxaliplatin 100 mg/m², 5-fluorouracil 400 mg/m² bolus, 5-fluorouracil 1,400 mg/m², and leucovorin 400 mg/m² (FOLFOX6). A second group of 55 patients was randomised to cetuximab 400 mg/m² plus a combination of irinotecan 100 mg/m², 5-fluorouracil 1,400 mg/m², and leucovorin 400 mg/m² (FOLFIRI). They underwent 8 cycles of treatment in about 4 months.

Patients in the study were enrolled if they had nonresectable, histologically confirmed colorectal liver metastases. The patients were an average of 63 years old; about 64% were men.

Dr. Folprecht said that among the 52 evaluable patients in the ongoing study who were on the FOLFOX regimen, 44 achieved a partial or complete response and 6 other patients achieved stable disease. Four patients had disease progression.

Among the 53 evaluable patients assigned to FOLFIRI, 35 achieved a partial or complete response and 12 achieved stable disease, while 6 had progressive disease.

"Cetuximab plus FOLFOX6 and cetuximab plus FOLFIRI are highly active regimens and induced high response rates," Dr. Folprecht reported in a poster presentation.

"The current data do not allow us to draw conclusions regarding differences between FOLFOX6 and FOLFIRI in the preoperative setting as final data are still pending," Dr. Folprecht said. He promised to present that data at future meetings.

Funding for this study was provided by Merck KGaA, sanofi-aventis, and Pfizer.

[Presentation title: Randomized Multicenter Study of Cetuximab Plus FOLFOX or Plus FOLFIRI in Neoadjuvant Treatment of Non-Resectable Colorectal Liver Metastases (CELIM-Study). Abstract 510PD]

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