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KRAS Status Predicts Survival to Cetuximab Plus FOLFOX6 in Patients With Metastatic CRC: Presented at ESMO-GI

By Jenny Powers

BARCELONA, Spain -- June 29, 2009 -- Patients with metastatic colorectal cancer (mCRC) whose tumours express wild-type (wt) KRAS experience longer survival times after treatment with cetuximab plus either folinic acid, fluorouracil, and irinotecan (FOLFIRI) or folinic acid, fluorouracil, and oxaliplatin (FOLFOX6) than patients whose tumours express mutant KRAS.

Janja Ocvirk, MD, Institute of Oncology, Lujbljana, Slovenia, presented the results of a multivariate Cox proportional hazard analysis here at the 11th World Gastrointestinal Cancer Congress of the European Society for Medical Oncology (ESMO-GI).

The analysis included 117 (77%) of the 151 patients in the intent-to-treat population of a randomised phase 2 trial investigating the influence of KRAS status on the efficacy of cetuximab in combination with FOLFOX or FOLFIRI as first-line treatment for mCRC (CECOG/CORE1.2.001 trial).

Wild-type KRAS was expressed in 53% (n = 62) of tumours, of which 34 were in the FOLFOX6 plus cetuximab arm and 28 were in the FOLFIRI plus cetuximab arm.

At 29 months after treatment, overall survival was significantly prolonged in patients with tumours expressing wild-type KRAS compared with patients with tumours expressing mutant KRAS (20.8 vs 15.9 months, respectively; hazard ratio [HR] = 1.62; P = .0296.

The FOLFOX6 treatment arm demonstrated significantly longer survival times for patients with KRAS wild-type tumours than for those with KRAS mutant tumours (22.5 vs 15.2 months; HR = 2.06; P = .0201). No significant survival difference based on KRAS mutation status was seen in the FOLFIRI plus cetuximab arm.

Other independent predicting factors for prolonged survival included the appearance of a grade 2/3 acnelike rash during the first 6 weeks of treatment (HR = 0.465; 95% confidence interval [CI], 0.274-0.788; P = .0044) and no previous treatment versus previous neoadjuvant treatment (HR = 0.321; 95% CI, 0.170-0.605; P = .0004).

The researchers concluded that wild-type KRAS status is predictive for prolonged overall survival after treatment with cetuximab plus standard FOLFOX6, confirming results obtained from previous studies.

[Presentation title: Relationship Between KRAS Status and Efficacy of FOLFOX6 + Cetuximab or FOLFIRI + Cetuximab in First-Line Treatment of Patients With Metastatic Colorectal Cancer (mCRC): The CECOG/CORE1.2.001 Trial. Abstract PD0001]

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