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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 ptsb
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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