| 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.