TABLE 1.

Demographics of patients treated with afatinib in the named patient use (NPU) program

	Total	Final dose 50 mg n = 25 (41.7%)	Final dose <50 mg n = 35 (58.3%)	p‐value
Age (years) mean ± SD a	64.3 ± 10.5	64.2 ± 10.5	64.3 ± 10.7	NS b
Sex, female/male	39/21	15/10	24/11	NS
Histology, adeno/squamous	59/1	24/1	35/0	NS
Stage, III/ IV	4/56	2/23	2/33	NS
EGFR mutation				NS
Ex 19 del/L858R	11/7	4/2	7/5
Negative	19	7	12
Not tested	23	12	11
Final dose (50/40/30)	25/25/10	25/0/0	0/25/10
Prior TKI, gefitinib/erlotinib	43/17	18/7	25/10	NS
Line of afatinib treatment				NS
3/4/5	2/27/19	0/8/9	2/19/10
6/7/8/9/10	6/1/3/1/1	3/1//1/1	3/0/1/0/0
Subsequent treatment				NS
Supportive care only	32	15	17
One more regimen	17	7	10
Two or three regimens	11	3	8
Response rate (%)	21.7	16.0	25.7	NS
Disease control rate (%)	76.7	64.0	85.7
PR/SD/PD/NE (number) c	13/33/12/2	4/12/7/2	9/21/5/0

^aSD, standard deviation.

^bNS, not significant.

^cPR, partial remission; SD, stable disease; PD, progressive disease; NE, not evaluable.