Table 5 K-ras mutational analysis in randomised studies evaluating EGFR antibodies

From: Treatment in advanced colorectal cancer: what, when and how?

Study	No. of patients evaluable for *K-ras* mutation/No. of patients in the ITT study population	Proportion of patients with *K-ras* mutations	Treatment by mutation status	Response rates (%)	P -value	Median progression-free survival	P -value	Median overall survival	P -value
First line
Van Cutsem et al (2009)	540/1198 (45%)	35.6% mutant	Wild type
CRYSTAL			FOLFIRI	43.2	0.0025	8.7 months	0.02	21.0 months	HR: 0.84 (95% CI: 0.64–1.11)
			FOLFIRI +cetuximab	59.3		9.9 months		24.9 months
			Mutant
			FOLFIRI	40.2	0.46	8.1 months	0.75	17.7 months	HR: 1.03 (95% CI: 0.74–1.44)
			FOLFIRI +cetuximab	36.2		7.6 months		17.5 months
Bokemeyer et al (2009)	233/337 (69%)	42% mutant	Wild type
OPUS			FOLFOX	37	0.011	7.2 months	0.0163	NR	NR
			FOLFOX +cetuximab	61		7.7 months		NR
			Mutant
			FOLFOX	49	0.106	8.6 months	0.0192	NR	NR
			FOLFOX +cetuximab	33		5.5 months		NR
Hecht et al (2009)	865/1053 (82%)	40% mutant	Wild type
PACCE			FOLFOX + bevacizumab	56	NR	11.5 months	HR: 1.36 (95% CI: 1.04–1.77)	24.5	0.045
			FOLFOX + bevacizumab + panitumumab	50		9.8 months		20.7
			Mutant
			FOLFOX + bevacizumab	44	NR	11.0 months		19.3
			FOLFOX + bevacizumab + panitumumab	47		10.4 months		19.3
Tol et al (2009)	528/736 (72%)	39.6% mutant	Wild type
CAIRO 2			CAPOX + bevacizumab	50.0	0.06	10.6 months	0.030	22.4 months	0.64
			CAPOX + bevacizumab +cetuximab	61.4		10.5 months		21.8 months
			Mutant
			CAPOX + bevacizumab	59.2	0.03	12.5 months	0.003	24.9 months	0.03
			CAPOX + bevacizumab +cetuximab	45.9		8.1 months		17.2 months
Hecht et al (2009)	865/1053 (82%)	40% mutant	Wild type
PACCE			FOLFIRI + bevacizumab	48	NR	12.5 months	NR	19.8	NR
			FOLFIRI + bevacizumab + panitumumab	54		10.0 months		NE
			Mutant
			FOLFIRI + bevacizumab	38	NR	11.9 months		20.5 months
			FOLFIRI + bevacizumab + panitumumab	30		8.3 months		17.8 months
Subsequent lines
Tejpar et al (2008)	148/157 (94%)	39% mutant	Wild type
EVEREST			Irinotecan +cetuximab (standard dose)	30.4	0.396	5.7 months for all wild-type patients	0.014 (in favour of wild type in standard dose)	NR	NR
			Irinotecan +cetuximab (escalating dose)	41.9				NR
			Mutant				<0.0001
			Irinotecan +cetuximab (standard dose)	0	NR	2.7 months for all mutant patients	(in favour of wild type in escalating dose)	NR	NR
			Irinotecan +cetuximab (escalating dose)	0				NR
Amado et al (2008)	427/463 (92%)	43% mutant	Wild type
			Panitumumab	17	NR	12.3 weeks	<0.0001	8.1 months	NS
			BSC	0		7.3 weeks		7.6 months
			Mutant
			Panitumumab	0	NR	7.4 weeks	0.99	4.9 months	NS
			BSC	0		7.3 weeks		4.4 months
Karapetis et al (2008)	394/572 (69%)	42.3% mutant	Wild type
NCIC CO.17			Cetuximab	12.8	NR	3.7 months	<0.001	9.5 months	<0.00
			BSC	0		1.9 months		4.8 months	1
			Mutant
			Cetuximab	1.2	NR	1.8 months	0.96	4.5 months	0.89
			BSC	0		1.8 months		4.6 months

ITT=intension to treat; FOLFOX=oxaliplatin-infused 5-FU/LV; FOLFIRI=irinotecan-infused 5-FU/LV; BSC=best supportive care; NR=not reported; NS=not significant; NE=not estimable.

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Table 5 K-ras mutational analysis in randomised studies evaluating EGFR antibodies

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