Table 1 Summary of efficacy end-points for gefitinib from the IPASS, INTEREST and ISEL studies

Study	Population	Subjects n	Objective response rates	Progression-free survival^#	Overall survival^#,¶
IPASS⁺
Gefitinib versus carboplatin/paclitaxel in chemo-naïve, never- or former light-smokers with adenocarcinoma in East Asia	Overall	1217	43.0% versus 32.2%	HR 0.74	HR 0.91
			OR 1.59	95% CI 0.65–0.85	95% CI 0.76–1.10
			95% CI 1.25–2.01	5.7 versus 5.8 months	18.6 versus 17.3 months
			p<0.001	p<0.001
	EGFR mutation-positive	261	71.2% versus 47.3%	HR 0.48	HR 0.78
			OR 2.75	95% CI 0.36–0.64	95% CI 0.50–1.20
			95% CI 1.65–4.60	9.5 versus 6.3 months	NR versus 19.5 months
			p = 0.0001	p<0.001
	EGFR mutation-negative	176	1.1% versus 23.5%	HR 2.85	HR 1.38
			OR 0.04	95% CI 2.05–3.98	95% CI 0.92–2.09
			95% CI 0.01–0.27	1.5 versus 5.5 months	12.1 versus 12.6 months
			p = 0.0013	p<0.001
INTEREST^§
Gefitinib versus docetaxel in previously treated patients	Overall	1466	9.1% versus 7.6%	HR 1.04	HR 1.020
			OR 1.22	95% CI 0.93–1.18	96% CI 0.905–1.150^##
			95% CI 0.82–1.84	2.2 versus 2.7 months	7.6 versus 8.0 months
			p = 0.33	p = 0.47	p = 0.7332
	EGFR mutation-positive	44	42.1% versus 21.1%	HR 0.16	HR 0.83
			OR 25.22	95% CI 0.05–0.49	95% CI 0.41–1.67
			95% CI 1.23–515.53	7.0 versus 4.1 months	14.2 versus 16.6 months
			p = 0.0361	p = 0.001	p = 0.60
	EGFR mutation-negative	253	6.6% versus 9.8%	HR 1.24	HR 1.02
			OR 0.63	95% CI 0.94–1.64	95% CI 0.78–1.33
			95% CI 0.23–1.73	1.7 versus 2.6 months	6.4 versus 6.0 months
			p = 0.3720	p = 0.14	p = 0.91
ISEL^ƒ
Gefitinib versus best supportive care in previously treated patients	Overall	1692	8.0% versus 1.3%	TTF HR 0.82	HR 0.89
			OR 7.28	95% CI 0.73–0.92	95% CI 0.77–1.02
			95% CI 3.1–16.9	3.0 versus 2.6 months	5.6 versus 5.1 months
			p<0.0001	p = 0.0006	p = 0.087
	EGFR mutation-positive	26	37.5% versus 0%	NC	NC
			NC
	EGFR mutation-negative	189	2.6% versus 0%	NC	HR 1.16
			NC		95% CI 0.79–1.72
					3.7 versus 5.9 months
					p = 0.4449

Odds ratios >1 favour gefitinib. Hazard ratios <1 favour gefitinib. IPASS: IRESSA Pan-Asia Study; INTEREST: IRESSA NSCLC Trial Evaluating Response and Survival versus Taxotere; ISEL: IRESSA Survival Evaluation in Lung cancer; EGFR: epidermal growth factor receptor; NR: not reached; NC: not calculated; TTF: time to treatment failure. ^#: median month values are presented; ^¶: IPASS overall survival follow-up is ongoing;⁺: values presented for IPASS are for gefitinib versus carboplatin/paclitaxel; ^§: INTEREST values are for gefitinib versus docetaxel; ^ƒ: ISEL values are for gefitinib versus placebo; ^##: confidence interval entirely below non-inferiority margin of 1.154. Data are taken from [7, 28, 37, 38, 39] and previously unpublished studies.