Tables--Technology Assessment: Report on the Relative Efficacy of Oral Cancer Therapy for Medicare Beneficiaries Versus Currently Covered Therapy, Part 1. Table 5

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Table 5. First-line Treatment With EGFR-TK Inhibitors (Single Agent) for Advanced NSCLC

Study ID	No. of Patients, Age (median [range]), Sex	Histology	Stage	PS	Smoking Status	EGFR-TK Inhibitor Dose/day	Outcomes Sought
All NSCLC
Niho, et al., 2004¹¹ Phase II	37 pts 61 (44-74) 35% F	Adeno n = 27 Squamous n = 3 Large cell n = 7	IIIB: n = 3 IV: n = 34	0: n = 14 1: n = 23	NR	Gefitinib 250 mg	Response Toxicity
Giaccone, et al., 2005¹² Phase II	53 pts 61 (NR) 62% F	Adeno n = 23 Squamous n = 9 BAC n = 6 Large cell n = 8 Other n = 7	NR	NR	Current: n = 10 Former: n = 25 Never: n = 18	Erlotinib 150 mg	Response Survival TTP Safety
Kasahara, et al., 2005¹³ Phase II	30 pts 64 (44-87) 40% F	Adeno n = 25 Squamous n = 3 Large cell n = 2	IIIb n = 4 IV n = 26	0: n = 20 1: n = 6 2: n = 4	Yes n = 20 No n = 10	Gefitinib 250 mg	Response Survival TTP Safety
Suzuki, et al., 2005¹⁴ Phase II	34 pts 64 (43-73) 38% F	Adeno n = 25 Squamous n = 5 Other n = 4	IV all	0: n = 16 1: n = 18	NR	Gefitinib 250 mg	Response QoL Toxicity
Reck, et al., 2005¹⁵ Phase II	58 pts 67 (41-84) NR	Adeno n = 32 BAC n = 10 Squamous n = 8 Large cell n = 4 Other n = 4	NR	0: 10% 1: 66% 2: 24%	Current: 33% Former: 48% Never: 19%	Gefitinib 250 mg	Response PFS Toxicity
D'Addario, et al., 2005¹⁶ Phase II	63 pts 62 (39-85) 38% F	Adeno n = 31 BAC n = 6 Squamous n = 17 Large cell n = 6 Other n = 3	IIIb n = 15 IV n = 47	0: 57% 1: 43%	Never: n = 9	Gefitinib 250 mg	Response Survival
Lee, et al., 2005¹⁷ Phase II	55 pts 55 (40-74) 93% F	Adeno n = 44 Adeno w/ BAC n = 11	IIIb n = 5 IV n = 50	0: n = 19 1: n = 32 2: n = 3	Never: 100%	Gefitinib 250 mg	Response
BAC
West, et al., 2004¹⁸ Phase II	138 pts^b 68 (34-89) 51% F	BAC 100%	NR	PS 0/1: 86%	NR	Gefitinib 500 mg	Response Survival Predictors
Kris, et al., 2004¹⁹ Phase II	69 pts ^b 65 (33-85) 64% F	Pure BAC 25% Adeno/BAC 74%	NR	KPS > or = 80: 91%	Never: 29%	Erlotinib 150 mg	Response Survival
Elderly
Jackman, et al., 2005²¹ Phase II	58 pts 75 (70-91) 47% F	Adeno n = 39 Adeno/BAC n = 9 Squamous n = 7 Large cell n = 2 NSCLC NOS n = 19	NR	0: 17% 1: 72% 2: 11%	Current: n = 3 Former: n = 49 Never: n = 6	Erlotinib 150 mg	Survival Response
Poor PS
Dickson, et al., 2004²² Phase II	25 pts 64 (58-84) 32% F	BAC n = 2 Adeno n = 8 Squamous n = 8 Large cell n = 6 Other n = 1	IIIB: 28% IV: 72%	2: 80% 3: 20%	NR	Gefitinib 250 mg	Feasibility/toxicity Response rate Symptom response

^b 26% of patients in both studies had previous chemotherapy.

Abbreviations: Adeno = adenocarcinoma; Adeno/BAC = adenocarcinoma with bronchoalveolar carcinoma features; BAC = bronchoalveolar carcinoma; EGFR-TK = epidermal growth factor receptor tyrosine kinase; F = female; LCSS = Lung Cancer Symptom Scale; No. = number; NSCLC = non-small cell lung cancer; NSCLC NOS = non-small cell lung cancer not otherwise specified; PS = performance status; pts = patients; QoL = quality of life.

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