Table 1.

Randomized clinical trials assessing molecular targeted therapies in recurrent and/or metastatic HNSCC targeting EGFR^*

Treatment arms	Systemic therapies given concomitantly		Phase	No.	ORR, %	PFS			OS			Reference
						Median, mo	HR	P	Median, mo	HR	P
Cetuximab	Cisplatin	—	III	57	26	4.2	0.78	NS	9.2	NA	—	(21)
	Cisplatin	—		60	10	2.7			8
Cetuximab	Platinum	5FU	III	222	36	5.6	0.54	<.001	10.1	0.9	.04	(5)
	Platinum	5FU		220	20	3.3			7.4
Panitumumab	Cisplatin	5FU	III	327	37	5.8	0.78	.004	11.1	0.87	NS	(22)
	Cisplatin	5FU		330	26	4.6			9
Panitumumab	Cisplatin	Docetaxel	II	56	44	6.9	0.63	.048	12.9	1.1	—	(23)
	Cisplatin	Docetaxel		57	37	5.5			13.8	NA
Zalutumumab	—	—	III	191	6	2.2	0.63	.001	6.7	0.77	NS	(24)
BSC	—	—		95	1	1.9			5.2
Gefitinib	Docetaxel	—	III	134	12.5	3.5	0.81	NS	7.3	0.93	NS	(25)
	Docetaxel	—		136	6.2	2.1			6
Gefitinib 500 mg	—	—	III	167	8	NA	NA	—	6	1.12	—	(26)
Gefitinib 250 mg	—	—		158	3	NA	NA	—	5.6	1.22	—
Methotrexate	—	—		161	4	NA	NA	—	6.7	—	—
Afatinib	—	—	III	322	10	2.6	0.8	.03	6.8	0.96	NS	(27)
Methotrexate	—	—		161	6	1.7			6
Afatinib	—	—	II	61	8	2.9	0.93	NS	8	1.06	NS	(28)
Cetuximab	—	—		60	10	3.3			10.5

^*BSC = best supportive care; EGFR = epidermal growth factor receptor; 5FU = 5-fluorouracil; HNSCC = head and neck squamous cell carcinoma; HR = hazard ratio; NA = not available; NS = not statistically significant; ORR = objective response rate; OS = overall survival; PFS = progression-free survival.