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🌱 來自: Metastatic Colon Cancer

CRYSTAL

Cetuximab and Chemotherapy as Initial Treatment for Metastatic Colorectal Cancer | NEJM

There was a significant interaction between treatment group and KRAS mutation status for tumor response (P=0.03) but not for progression-free survival (P=0.07) or overall survival (P=0.44). The hazard ratio for progression-free survival among patients with wild-type-KRAS tumors was 0.68 (95% CI, 0.50 to 0.94), in favor of the cetuximab-FOLFIRI group. The following grade 3 or 4 adverse events were more frequent with cetuximab plus FOLFIRI than with FOLFIRI alone: skin reactions (which were grade 3 only) (in 19.7% vs. 0.2% of patients, P<0.001), infusion-related reactions (in 2.5% vs. 0%, P<0.001), and diarrhea (in 15.7% vs. 10.5%, P=0.008).

1. Design: Randomized controlled trial.
2. Number of patients: Not reported.
3. Patients characteristics: Patients with metastatic colorectal cancer.
4. Agent: Cetuximab plus FOLFIRI or FOLFIRI alone.
5. Treatment line: 1L

Outcome	Cetuximab plus FOLFIRI	FOLFIRI alone	Hazard Ratio/Relative Risk (95% CI)	P-value
Tumor response	Not reported	Not reported	Not reported	0.03
Progression-free survival	Improved compared to FOLFIRI alone in wild-type-KRAS tumors	Not reported	0.68 (0.50-0.94)	0.07
Overall survival	Not different between the two groups	Not reported	Not reported	0.44

Adverse events:

Adverse Event	Cetuximab plus FOLFIRI	FOLFIRI alone	P-value
Skin reactions (grade 3 only)	19.7%	0.2%	<0.001
Infusion-related reactions	2.5%	0%	<0.001
Diarrhea	15.7%	10.5%	0.008