Table 1.

Randomized clinical trials examining the prognostic impact of KRAS codon 12 and 13 mutations in colorectal cancer

Cohort	No. of Tumors Total (Codon 12 / 13)	% of Total Cohort	Tumor, Stage	Treatment	Findings
					Multivariate HRs for KRAS mutations		Reference Group a
					Codon 12	Codon 13
Co.17, BOND, MABEL, EMR202600, EVEREST, BABEL, SALVAGE (5)	579 (~260 / 45)		CRC IV	BSC +/− cetuximab; Cetuximab +/− chemotherapy		c.38G>A HR 1.82 (p =.053) for overall survival b	BRAF/KRAS wild type or BRAF mutated
OPUS, CRYSTAL (13)	1378 (125 / 83)	90%	CRC IV	FOLFIRI or FOLFOX +/− cetuximab	c.35G>T, HR 1.11 (p =.53) for overall survival c	c.38G>A, HR 1.39 (p=.079) for overall survival c	BRAF/KRAS wild type or BRAF mutated
NSABP C07, C08 (9)	2299 ( - / - )	48%	Colon II—III	5FU +/− oxaliplatin, FOLFOX +/− bevacizumab	c.35G>T, HR 1.22 (p=.16) for time to recurrence d		BRAF/KRAS wild type or BRAF mutated
PETACC-3 (18)	1321 (368 / 102)	40%	Colon II—III	5FU +/− irinotecan	c.35G>A, HR 0.98 (p =.91) c.35G>C, HR 0.97 (p =.92) c.35G>T, HR 1.09 (p =.64) c.34G>T, HR 1.40 (p =.15) c.34G>A, HR 0.99 (p =.97) for relapse-free survival d	c.38G>A, HR 0.99 (p =.97) for relapse-free survival d	BRAF/KRAS wild type or BRAF mutated
CALGB 89803 (21)	506 (123 / 53)	40%	Colon III	5FU +/− irinotecan	Any Codon 12, HR 1.09 (NS) for disease-free survival d	c.38G>A, HR 0.82 (NS) for disease-free survival d	BRAF/KRAS wild type or BRAF mutated
NCCTG N0147 (Alliance); Current Study	2478 (779 / 220) BRAF wild type only	82%	Colon III	FOLFOX +/− cetuximab	Any Codon 12, HR 1.52 (p <.0001) for disease- free survival d	c.38G>A, HR 1.36 (p =.025) for disease-free survival d	BRAF/KRAS wild type only

BSC, best supportive care; CRC, colorectal; HR, hazard ratio; 5FU, fluorouracil; NS, not statistically significant

^aRefers to the patient reference group used for prognostic analysis.

^bBSC-alone arm

^cChemotherapy-alone arms across both trials

^dData pooled across both arms