Table 4.

Table 4A. Clinical response and survival information within treatment and HER-2 subgroups
		FISH analysis of HER-2						IHC analysis of HER-2
		Not amplified			Amplified			0 or 1+				2+ or 3+
		AP	TAP		AP		TAP	AP		TAP		AP		TAP
Number of patients		72	76		9		12	58		72		55		49
Number of deaths		67	61		8		11	52		58		52		41
Median survival (months)		12.0	15.3		22.8		15.1	12.8		15.3		10.8		16.3
Number of responders		26	47		6		6	26		41		15		29
Proportion responding		0.36	0.62		0.67		0.50	0.45		0.57		0.27		0.59

Table 4B. Estimated treatment effects (odds ratio or hazard ratio with 95% confidence interval) of TAP relative to AP within FISH and within IHC subgroups using models with a treatment by HER-2 interaction for each endpoint and adjusted for performance status
	FISH analysis of HER-2			IHC analysis of HER-2
Endpoint	Not amplified	Amplified	Pinteraction	0 or 1+	2+ or 3+	Pinteraction
Survival (HR)	0.62 (0.44, 0.89)	1.27 (0.51, 3.16)	0.16	0.71 (0.49, 1.04)	0.64 (0.42, 0.97)	0.71
Response (OR)	2.75 (1.40, 5.40)	0.43 (0.17, 1.09)	0.06	1.54 (0.76, 3.14)	3.74 (1.63, 8.58)	0.11

HR: death hazard ratio; OR: response odds ratio; P_interaction: P-value for the test of the treatment by HER-2 interaction term