Source: Blood  |  Posted 5 years ago

By Jill Stein

ISTANBUL, TURKEY -- October 4, 2006 -- Cetuximab (Erbitux) appears to improve tumor response and disease control in first-line treatment of metastatic colorectal cancer (mCRC) when added to 2 different chemotherapy regimens.

Volker Heinemann, MD, Director of Klinikum Grosshadern, Medizinische Klinik III, Munich, Germany, presented updated interim results of the ongoing trial during an oral session on October 2[^]nd[] at the 31[^]st[] European Society of Medical Oncology (ESMO) Scientific Congress.

The study randomized 84 patients with mCRC and a median Karnofsky Performance Status of more than 70% to cetuximab -- epidermal growth factor receptor (EGFR)-targeting antibody -- in combination with either XELIRI or XELOX.

The XELIRI regimen consisted of capecitabine 2 x 800 mg/m[^]2[] orally on days 1 to 14 plus irinotecan 200 mg/m[^]2[] intravenously on day 1. The XELOX regimen involved oral capecitabine 2 x 1000 mg/m[^]2[] on days 1 to 14 plus intravenous (IV) oxaliplatin 130 mg/m[^]2[] on day 1.

In both treatment arms, IV cetuximab was given at a dose of 400 mg/m[^]2[] on day 1 of the first 3-week cycle followed by 250 mg/m[^]2[] during each subsequent cycle.

The primary endpoint of objective response rate was 42% in the XELIRI arm and 65.5% in the XELOX arm. Disease-control rates were 90.9% and 93.1%, respectively.

"Both treatments were highly effective, and the disease-control rates were high," Dr. Heinemann commented.

Without cetuximab, these regimens would be more likely to show disease-control rates in the region of 40% and 50%, respectively, according to previous studies, Dr. Heinemann noted.

"There was more hematological toxicity in the XELIRI arm but more neurotoxicity in the oxaliplatin arm, as would be expected," Dr. Heinemann added.

"These are promising results in the first-line setting," Dr. Heinemann concluded. The trial is continuing to recruit patients until November, 2006.

[Presentation title: Cetuximab Plus Capecitabine/Irinotecan (XELIRI) versus Cetuximab Plus Capecitabine/Oxaliplatin (XELOX) as First-Line Treatment for Patients With Metastatic Colorectal Cancer (CRC): A Randomized Trial of the AIO CRC Study Group. Abstract 327O]