Technology Assessment: Report on the Relative Efficacy of Oral Cancer Therapy for Medicare Beneficiaries Versus Currently Covered Therapy, Part 1. Table 9

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Table 9. Summary of Survival in Studies of Second-line Treatment With EGFR Inhibitors for Advanced NSCLC

Study ID	Diagnosis (no. of patients)	Sub-groups	Survival from Start of Treatment			Progression-free Survival
Study ID	Diagnosis (no. of patients)	Sub-groups	Median (months)	1-year (%)	HR (95% CI) [p-value]	Median TTP (months)	1-year (%)	HR (95% CI) [p-value]
Phase III
Shepherd, et al., 2004^24,25	NSCLC (~750)	Placebo Erlotinib	4.7 6.7	22 31	0.70 (0.58- 0.85) [p = 0.001]	1.8 2.2	- - - -	0.61 (0.51- 0.74) [p < 0.001]
ISEL press release, 2004²⁶	NSCLC (1692)	Placebo—all Gefitinib—all Placebo—adeno Gefitinib—adeno	5.1 5.6 5.4 6.3	- - - - - - - -	0.89 [p = 0.11] 0.83 [p = 0.07]	- - - - - - - -	- - - - - -	- - - -
Phase II
Kris, et al., 2003²⁹	NSCLC (216) [Gefitinib]	250-mg dose 500-mg dose	7 6	27 25	- -	- - - -	- - - -	- -
Fukuoka, et al., 2003³⁰	NSCLC (210) [Gefitinib]	250-mg dose 500-mg dose	7.6 8	35 29	- -	2.7 2.8	- - - -	- -
Perez-Soler, et al., 2004³¹	NSCLC (57) [Erlotinib]	- -	8.4	40	- -	2.1	- -	- -
Cappuzzo, et al., 2004⁴⁵	NSCLC (40) [Gefitinib]	- -	5	- -	- -	3	- -	- -
Barlesi, et al., 2005⁴⁶	NSCLC (51) [Gefitinib]	- -	4	- -	- -	- -	- -	- -

Abbreviations: adeno = adenocarcinoma; EGFR = epidermal growth factor receptor; HR = hazard ratio; ISEL = Iressa Survival Evaluation in Lung cancer trial; no. = number; NSCLC = non-small cell lung cancer; TTP = time to progression.

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