| 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.