Table 2 Univariate analyses of biomarker and treatment outcomes

	Criteria (No. of patients)	Responders (%)	P -value	Median TTP (mo)	P -value	Median OS (mo)	P -value
Tumour expression (IHC)
TS^a	<25 (13)	9 (69.2)	0.21	4.8	0.78	N/R	0.15
	>25 (25)	12 (48)		5.5		8.2
TP^a	<25 (20)	13 (65)	0.20	7.2	0.10	N/R	0.021
	>25 (18)	8 (44.4)		3.8		7.0
ERCC1^a	<130 (16)	11 (68.8)	0.15	7.2	0.60	N/R	0.022
	>130 (22)	10 (45.5)		5.0		7.0
EGFR^b	(−) (12)	5 (41.7)	0.25	2.8	0.18	6.1	0.33
	1+ in ⩾10% (26)	16 (61.5)		5.9		N/R
HER2^b	0/1+ (32)	16 (50)	0.20	5.3	0.20	9.9	0.47
	2+/3+ (6)	5 (83.3)		7.2		N/R
Gene copy number (FISH)
HER2/CEP17	<2.0 (33)	18 (54.5)	1.0	5.3	0.18	9.9	0.66
	>2.0 (5)	3 (60)		N/R		N/R
Serum protein level (ELISA)
EGFR (ng ml⁻¹)	<41.9 (13)	6 (46.2)	0.42	5.5	0.73	5.6	0.12
	>41.9 (25)	15 (60)		5.5		N/R
EGF (pg ml⁻¹)	<667 (20)	15 (75)	0.01	7.6	0.88	N/R	0.51
	>667 (18)	6 (33.3)		5.0		7.6
TGF-α (pg ml⁻¹)	<14 (21)	15 (71.4)	0.03	5.9	0.47	N/R	0.31
	>14 (17)	6 (35.3)		4.8		7.6
Amphiregulin (pg ml⁻¹)	<1.14 (16)	7 (43.8)	0.22	5.0	0.89	6.1	0.34
	>1.14 (22)	14 (63.6)		7.2		N/R

CEP, chromosome enumerator probe; EGF, epidermal growth factor; EGFR, epidermal growth factor receptor; ELISA, enzyme-linked immunosorbent assay; ERCC1, excision repair cross-complementation group 1; FISH, fluorescence in situ hybridization; HER2, human epidermal growth factor receptor 2; IHC, immunohistochemistry; mo, months; N/R, not reached; OS, overall survival; TGF, transforming growth factor; TP, thymidine phosphorylase; TS, thymidylate synthase; TTP, time-to-progression.
^aNumbers in the criteria denote IHC scores derived from staining intensity and percentage of positive cells.
^bIHC score cutoff for EGFR was 7.5 which was identical to 1+ staining in 10% or more cancer cells. The cutoff for HER2 was 15, which was identical to 2+ staining in at least 10% of cells.

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