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Table 2. First-line Treatment With EGFR-TK Inhibitors Combined With Cytotoxic Agents for Patients With Advanced NSCLC

Study ID EGFR-TK Inhibitor Dose [length of followup] Chemo-therapy No. of Patients, Age (median [range]), Sexa Histology Stage PS Smoking Status Outcomes Sought
Phase III
Herbst, et al., 20066 Gefitinib 250-500 mg/day
[12 months]
Carboplatin
AUC 6 mg/ml-min &
paclitaxel 225 mg/m2 x 6 cycles
1037 pts
62 (26-86)
40% F
Squamous 19.4%
Adeno 51.9%
Adenosquamous 1.7%
BAC 3.2%
NSCLC NOS 11.3%
Large cell 11.0
IIIA 3.8%
IIIB 17.1%
IIIB no pl eff 5.2%
IIIB pl eff 11.9%
IV 78.3%
0: 38.8%
1: 51.9%
2: 9.3%
NR 1. Overall survival
2. TTP
Others: response rate, disease-related symptoms and QoL, toxicity
Giaccone, et al., 20047 Gefitinib 250-500 mg/day
[16 months]
Cisplatin 80
mg/m2 &
gemcitabine
1250 mg/m2
x 6 cycles
1093 pts
60 (31-85)
26% F
Squamous 29.2%
Adeno 46.6%
Adenosquamous 1.4%
BAC 0.3%
NSCLC NOS 11.8%
Large cell 8.8%
IIIA 1.9%
IIIB 28.4%
IIIB no pl eff 6.6%
IIIB pl eff 21.8%
IV 68.6%
0: 33.9%
1: 55.6%
2: 9.6%
NR 1. Survival
2. TTP, response, toxicity
Miller, et al., 20048 Erlotinib 150
mg/day
[22 months]
Carboplatin/
paclitaxel
(6 cycles)
1059 pts
62.6 (24-84)
38% F
Squamous 16%
Adeno 61%
Large cell 10%
NSCLC NOS 12%
IV 82% 0: 36.2%
1: 63.6%
2: 0.2%
Never: 8% 1. Overall survival;
Others: TTP,
response rate,
duration of
response
Gatzemeier, et al., 20049 Erlotinib 150
mg/day
[NR]
Cisplatin 80
mg/m2 and
gemcitabine
1250 mg/m2 x 6 cycles
~1150
NR
NR
NR NR 0/1: 100% NR 1. Survival
Others: TTP,
toxicity
Phase II
Williams, et al., 200410 Gefitinib
250 mg/day
[NR]
Docetaxel
75 mg/m2
every 3 weeks
12 pts
74 (70-82)
25% F
NR NR NR NR Response,
survival

a Patient characteristics based on placebo group when not reported for all patients in randomized controlled trial.

Abbreviations: Adeno = adenocarcinoma; AUC = area under the curve; BAC = bronchoalveolar carcinoma; EGFR-TK = epidermal growth factor receptor tyrosine kinase; F = female; No. = number; NR = not reported; NSCLC NOS = non-small cell lung cancer not otherwise specified; pl eff = pleural effusion; PS = performance status; pts = patients; TTP = time to progression.

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