Anti-EGFR and anti-VEGF agents: Important targeted therapies of colorectal liver metastases

doi:10.3748/wjg.v20.i15.4263

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World Journal of Gastroenterology

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World J Gastroenterol. Apr 21, 2014; 20(15): 4263-4275
Published online Apr 21, 2014. doi: 10.3748/wjg.v20.i15.4263

Table 1 Phase II/III clinical trials of targeted agents in combination with chemotherapy as first-line treatments for metastatic colorectal cancer

Clinical trial(reporters)	Year	Primary end point	Population	Regimen	Patient number	Median PFS(mo)	HRP value (95%CI)	Median OS(mo)	HRP value (95%CI)	Response rates	ORP value (95%CI)
CRYSTAL[26]	2009	PFS	ITT	FOLFIRI + Cet	599	8.9	HR = 0.85 ^aP = 0.048	19.9	HR = 0.93 P = 0.31	46.90%	OR = 1.403 ^aP = 0.0038
			ITT	FOLFIRI	599	8.0	HR = 0.85 ^aP = 0.048	18.6	HR = 0.93 P = 0.31	38.70%	OR = 1.403 ^aP = 0.0038
			KRAS WT subgroup	FOLFIRI + Cet	316	9.9	HR = 0.696 ^aP = 0.0012	23.5	HR = 0.796 ^aP = 0.0093	57.30%	OR = 2.069 ^aP < 0.001
			KRAS WT subgroup	FOLFIRI	350	8.4	HR = 0.696 ^aP = 0.0012	20	HR = 0.796 ^aP = 0.0093	39.70%	OR = 2.069 ^aP < 0.001
			KRAS MT subgroup	FOLFIRI + Cet	214	7.4	HR = 1.171 P = 0.26	16.2	HR = 1.035 P = 0.75	31.30%	OR = 0.822 P = 0.35
			KRAS MT subgroup	FOLFIRI	183	7.7	HR = 1.171 P = 0.26	16.7	HR = 1.035 P = 0.75	36.10%	OR = 0.822 P = 0.35
OPUS[27]	2009	Response rates	ITT	FOLFOX4 + Cet	169	7.2	HR = 0.931 P = 0.62	18.3	HR = 1.015 P = 0.91	46%	OR = 1.516 P = 0.064
			ITT	FOLFOX4	168	7.2	HR = 0.931 P = 0.62	18.0	HR = 1.015 P = 0.91	36%	OR = 1.516 P = 0.064
			KRAS WT subgroup	FOLFOX4 + Cet	82	8.3	HR = 0.567 ^aP = 0.0064	22.8	HR = 0.855 P = 0.39	57%	OR = 2.551 ^aP = 0.0027
			KRAS WT subgroup	FOLFOX4	97	7.2	HR = 0.567 ^aP = 0.0064	18.5	HR = 0.855 P = 0.39	34%	OR = 2.551 ^aP = 0.0027
			KRAS MT subgroup	FOLFOX4 + Cet	77	5.5	HR = 1.72 ^aP = 0.0153	13.4	HR = 1.290 P = 0.20	34%	OR = 0.459 ^aP = 0.029
			KRAS MT subgroup	FOLFOX4	59	8.6	HR = 1.72 ^aP = 0.0153	17.5	HR = 1.290 P = 0.20	53%	OR = 0.459 ^aP = 0.029
COIN[24]	2011	OS	KRAS WT	FOLFOX/XELOX + Cet	362	8.6	HR = 0.96 P = 0.60	17.0	HR = 1.04 P = 0.68	64%	OR = 1.35 ^aP = 0.049
			KRAS WT	FOLFOX/XELOX	367	8.6	HR = 0.96 P = 0.60	17.9	HR = 1.04 P = 0.68	57%	OR = 1.35 ^aP = 0.049
			KRAS WT	FOLFOX + Cet	117	9.0	HR = 0.77 P = 0.056	-	-	-	-
			KRAS WT	FOLFOX	127	9.2	HR = 0.77 P = 0.056	-	-	-	-
			KRAS WT	XELOX + Cet	245	8.4	HR = 1.06 P = 0.56	-	-	-	-
			KRAS WT	XELOX	240	8.0	HR = 1.06 P = 0.56	-	-	-	-
			KRAS MT	FOLFOX/XELOX + Cet	297	-	-	13.6	HR = 0.98 P = 0.80	-	-
			KRAS MT	FOLFOX/XELOX	268	-	-	14.8	HR = 0.98 P = 0.80	-	-
NORDIC-VII[29]	2012	PFS	ITT	FLOX + Cet	194	8.3	HR = 0.89 P = 0.31	19.7	HR = 1.06 P = 0.67	49%	OR = 1.35 P = 0.15
				Intermittent FLOX + Cet	187	7.3	Not reported	20.3	HR = 1.03 P = 0.79	47%	Not report
				Nordic FLOX	185	7.9	Control	20.4	Control	41%	Control
			KRAS WT subgroup	FLOX + Cet	97	7.9	HR = 1.07 P = 0.66	20.1	HR = 1.14 P = 0.48	46%	OR = 0.96 P = 0.89
				Intermittent FLOX + Cet	109	7.5	Not reported	21.4	HR = 1.08 P = 0.66	51%	OR = 0.96 P = 0.89
				Nordic FLOX	97	8.7	Control	22.0	Control	47%	Control
			KRAS MT subgroup	FLOX + Cet	72	9.2	HR = 0.71 P = 0.07	21.1	HR = 1.03 P = 0.89	49%	OR = 1.44 P = 0.31
				Intermittent FLOX + Cet	65	7.2	Not reported	20.5	HR = 1.04 P = 0.84	42%	Not report
				Nordic FLOX	58	7.8	Control	20.4	Control	40%	Control
PRIME[30]	2010	PFS	KRAS WT	FOLFOX4 + Pan	325	9.6	HR = 0.80 ^aP = 0.02	23.9	HR = 0.83 P = 0.072	55%	OR = 1.35 P = 0.068
			KRAS WT	FOLFOX4	331	8.0	HR = 0.80 ^aP = 0.02	19.7	HR = 0.83 P = 0.072	48%	OR = 1.35 P = 0.068
			KRAS MT	FOLFOX4 + Pan	221	7.3	HR = 1.29 ^aP = 0.02	15.5	HR = 1.24 P = 0.068	40%	-
			KRAS MT	FOLFOX4	219	8.8	HR = 1.29 ^aP = 0.02	19.3	HR = 1.24 P = 0.068	40%	-
AVF2107g[32]	2004	OS	ITT	IFL + Bev	402	10.6	HR = 0.54 ^aP < 0.001	20.3	HR = 0.66 ^aP < 0001	44.80%	^aP = 0.004
AVF2107g[32]	2004	OS	ITT	IFL	411	6.2	HR = 0.54 ^aP < 0.001	15.6	HR = 0.66 ^aP < 0001	34.80%	^aP = 0.004
NO16966[33]	2008	PFS	ITT	FOLFOX4/XELOX + Bev	699	9.4	HR = 0.83 ^aP = 0.0023	21.3	HR = 0.89 P = 0.0769	38%	OR = 1.00 P = 0.99
			ITT	FOLFOX4/XELOX	701	8.0	HR = 0.83 ^aP = 0.0023	19.9	HR = 0.89 P = 0.0769	38%	OR = 1.00 P = 0.99
			Subgroup	FOLFOX4 + Bev	349	9.4	HR = 0.89 97.5%CI: 0.73-1.08	21.2	HR = 0.94 97.5%CI: 0.75-1.16	-	-
			Subgroup	FOLFOX4	351	8.6	HR = 0.89 97.5%CI: 0.73-1.08	20.3	HR = 0.94 97.5%CI: 0.75-1.16	-	-
			Subgroup	XELOX + Bev	350	9.3	HR = 0.77 97.5%CI: 0.63-0.94	21.4	HR = 0.84 97.5%CI: 0.68-1.04	-	-
			Subgroup	XELOX	350	7.4	HR = 0.77 97.5%CI: 0.63-0.94	19.2	HR = 0.84 97.5%CI: 0.68-1.04	-	-
CAIRO-2[67]	2009	PFS	ITT	XELOX + Bev + Cet	368	9.4	HR = 1.22 ^aP = 0.01	19.4	HR = 1.15 P = 0.16	52.70%	P = 0.49
			ITT	XELOX + Bev	368	10.7	HR = 1.22 ^aP = 0.01	20.3	HR = 1.15 P = 0.16	50%	P = 0.49
			KRAS WT subgroup	XELOX + Bev + Cet	158	10.5	P = 0.30	21.8	P = 0.64	61.40%	P = 0.06
			KRAS WT subgroup	XELOX + Bev	156	10.6	P = 0.30	22.4	P = 0.64	50.00%	P = 0.06
			KRAS MT subgroup	XELOX + Bev + Cet	98	8.1	^aP = 0.003	17.2	^aP = 0.03	45.90%	^aP = 0.03
			KRAS MT subgroup	XELOX + Bev	108	12.5	^aP = 0.003	24.9	^aP = 0.03	59.20%	^aP = 0.03
PACCE[68]	2009	PFS	ITT	Ox-CT + Bev + Pan	413	10.0	HR = 1.27 95%CI: 1.06-1.52	19.4	HR = 1.43 95%CI: 1.11-1.83	46%	OR = 0.92 95%CI: 0.70-1.22
			ITT	Ox-CT + Bev	410	11.4	HR = 1.27 95%CI: 1.06-1.52	24.5	HR = 1.43 95%CI: 1.11-1.83	48%	OR = 0.92 95%CI: 0.70-1.22
			KRAS WT subgroup	Ox-CT + Bev + Pan	201	9.8	HR = 1.36 95%CI: 1.04-1.77	20.7	HR = 1.89 95%CI: 1.30-2.75 ^aP = 0.045	50%	-
			KRAS WT subgroup	Ox-CT + Bev	203	11.5	HR = 1.36 95%CI: 1.04-1.77	24.5	HR = 1.89 95%CI: 1.30-2.75 ^aP = 0.045	56%	-
			KRAS MT subgroup	Ox-CT + Bev + Pan	135	10.4	HR = 1.25 95%CI: 0.91-1.71	19.3	HR = 1.02 95%CI: 0.67-1.54	47%	-
			KRAS MT subgroup	Ox-CT + Bev	125	11.0	HR = 1.25 95%CI: 0.91-1.71	19.3	HR = 1.02 95%CI: 0.67-1.54	44%	-
			ITT	Iri-CT + Bev + Pan	115	10.1	HR = 1.19 95%CI: 0.79-1.79	20.7	HR = 1.42 95%CI: 0.77-2.62	43%	OR = 1.11 95%CI: 0.65- 1.90
			ITT	Iri-CT + Bev	115	11.7	HR = 1.19 95%CI: 0.79-1.79	20.5	HR = 1.42 95%CI: 0.77-2.62	40%	OR = 1.11 95%CI: 0.65- 1.90
			KRAS WT subgroup	Iri-CT + Bev + Pan	57	10.0	HR = 1.50 95%CI: 0.82-2.76	NE	HR = 1.28 95%CI: 0.50-3.25 P = 0.445	54%	-
				Iri-CT + Bev	58	12.5		19.8		48%
				Iri-CT + Bev	58	12.5		19.8		KRAS MT subgroup		Iri-CT + Bev + Pan	47	8.3	HR = 1.19 95%CI: 0.65-2.21	17.8	HR = 2.14 95%CI: 0.82-5.59	30%	-
			Iri-CT + Bev	39	11.9	20.5	38%			KRAS MT subgroup					HR = 1.19 95%CI: 0.65-2.21		HR = 2.14 95%CI: 0.82-5.59		-

^aP < 0.05. PFS: Progress-free survival; OS: Overall survival; ITT: Intent to treat; WT: Wild type; MT: Mutant type; NE: Not estimatable; KRAS: KRAS exon 2, codons 12 and 13; FOLFOX: Fluorouracil, leucovorin, and oxaliplatin; XELOX: Capecitabine and oxaliplatin; FLOX: Fluorouracil, leucovorin, and oxaliplatin; Ox-CT: Oxaliplatin-based chemotherapy; FOLFIRI: Irinotecan, fluorouracil, and leucovorin; IFL: Irinotecan, fluorouracil, and leucovorin; Iri-CT: Irinotecan-based chemotherapy; Cet: Cetuximab; Pan: Panitumumab; Bev: Bevacizumab.

Citation: Feng QY, Wei Y, Chen JW, Chang WJ, Ye LC, Zhu DX, Xu JM. Anti-EGFR and anti-VEGF agents: Important targeted therapies of colorectal liver metastases. World J Gastroenterol 2014; 20(15): 4263-4275
URL: https://www.wjgnet.com/1007-9327/full/v20/i15/4263.htm
DOI: https://dx.doi.org/10.3748/wjg.v20.i15.4263