Impact of KRAS Mutations on Management of Colorectal Carcinoma

Table 1

Clinical trials of antiEGFR monoclonal antibodies in metastatic CRC.

Study	Setting	Treatment	No. of patients	ORR (%)	mTTP (mos)	mPFS (mos)	mOS (mos)
Single Arm phase II [12]	Irinotecan-refractory	Cetuximab monotherapy	57	9	1.4	N.R.	6.4
Randomized phase II [13]	Refractory disease to 5-FU and Irinotecan	Cetuximab monotherapy vs. Cetuximab + Irinotecan	111 vs. 218	10.8* vs. 22.9	1.5* vs. 4.1	N.R.	6.9 vs. 8.6
Single Arm phase II [14]	Refractory disease to 5-FU, Irinotecan, and Oxaliplatin	Cetuximab monotherapy	346	12.4	1.4	N.R.	6.6
Single Arm phase II [15]	First-line treatment	Cetuximab + Irinotecan + 5-FU/FA	21	67	9.9	N.R.	33.0
Randomized phase III [16]	Refractory disease to 5-FU, Irinotecan and Oxaliplatin	Cetuximab monotherapy vs. BSC	287 vs. 285	8* vs. 0	N.R.	1.9* vs. 1.8	6.1* vs. 4.6
Single Arm phase II [17]	First-line treatment	Cetuximab + FOLFOX-4	43	72	N.R.	12.3	30
Randomized phase III [18]	Refractory to Oxaliplatin	Cetuximab + Irinotecan vs. Irinotecan	648 vs. 650	16.4* vs. 4.2	N.R.	4.0* vs. 2.6	10.7 vs. 10.0
Randomized phase III [19]	First-line treatment	Cetuximab + FOLFIRI vs. FOLFIRI	602 vs. 600	46.9* vs. 38.7	N.R.	8.9* vs. 8.0	N.R.
Randomized phase III [20]	Refractory disease to 5-FU, Irinotecan and Oxaliplatin	Panitumumab monotherapy versus BSC	231 vs. 232	10.0* vs. 0	N.R.	8 weeks* vs. 7.3 weeks	6.5 vs. 6.5
Randomized phase II [21]	Refractory to Irinotecan	Irinotecan + Cetuximab+ Bevacizumab vs. Cetuximab + Bevacizumab	43 vs. 40	37 vs. 20	7.3 vs. 4.9	N.R.	14.5 vs. 11.4
Single Arm phase II [22]	Refractory to Irinotecan + Bevacizumab	Cetuximab + Bevacizumab + Irinotecan	33	9	3.9	N.R.	10.6

*Statistically significant improvement.
ORR: overall response rate; mTTP: median time to progression; mPFS: median progression-free survival; mOS: median overall survival; N.R.: not reported; 5-FU: 5-fluorouracil; BSC: best supportive care; FA: folinic acid; NS: not significant.