| Study ID | No. of Patients, Age (median [range]), Sex |
Previous Treatments | Histology | Stage | PS | Smoking Status | EGFR-TK Inhibitor Dose/day |
Outcomes Sought |
|---|---|---|---|---|---|---|---|---|
| Phase III | ||||||||
| Shepherd, et al., 200525 | 731 pts 62 (32-89) 35% F |
1 prior chemo: 50% 2 prior chemo: 49% chemo incl plat 92% |
Adeno 50% Other 50% |
NR | 0-1: 65% 2-3: 35% |
Never 21% Current or former 73% Unk 5% |
Erlotinib 150 mg | Survival, PFS, QoL, response, response duration, toxicity |
| ISEL press release, 200426 | 1692 pts NR NR |
NR | NR | NR | NR | NR | Gefitinib 250 mg | Survival |
| Phase II | ||||||||
| Kris, et al., 200329 | 216 pts 61 (30-84) 46% F |
2 prior chemo: 40% 3 prior chemo: 30% > or = 4 prior chemo: 28% |
Adeno 69% Squamous 30% |
IIIB: 15% IV: 85% |
NR | NR | Gefitinib 250 mg vs. 500 mg |
Response: bidimensional; Symptoms: FACT-L; Adverse events: NCI CTC 2.0 |
| Fukuoka, et al., 200330 | 209 pts 61 (28-85) 29% F |
Surgery: 31% XRT: 50% 1 prior chemo: 56% 2 prior chemo: 44% Immuno/hormonal treatment: 4% |
Adeno 64% Squamous 24% Large cell 9% Undiff 3% |
IIIA: 4% IIIB: 18% IV: 78% |
NR | NR | Gefitinib 250 mg (500 mg on day 1) |
Response: WHO criteria; Toxicity: NCI CTC; QoL: LCS |
| Perez-Soler, et al., 200431 | 57 pts 62 (31-83) 60% F |
Surgery: 89% XRT: 74% Immuno/hormonal treatment: 9% 1 prior chemo: 18% 2 prior chemo: 42% > or = 3 prior chemo: 40% |
Adeno 61% Squamous 16% Large cell 19% Undiff 4% |
IIIB: 16% IV: 84% |
NR | NR | Erlotinib 150 mg | 1. Response rate 2. SD, duration of response, TTP, overall and 1-yr survival, QoL (EORTC QLQ-C30 v 3.0 & EORTC QLQ-LC13), safety |
| Cappuzzo, et al., 200445 | 40 pts 74 (70-88) 18% F |
1 prior chemo: 53% 2 prior chemo: 40% > or = 3 prior chemo: 7.5% Chemo included platinum: 48% |
Squamous 35% Adeno 45% BAC 10% NSCLC undiff 10% |
IIIB: 27.5% IV: 72.5% |
0: 25% 1: 67.5% 2: 7.5% |
NR | Gefitinib 250 mg | Response: RECIST Toxicity: NCI CTC 2.0 |
| Barlesi, et al., 200546 | 51 pts 60 (38-78) 31% F |
2 prior chemo 60% 3 prior chemo 29% > or =4 prior chemo 12% |
Adeno 47% Squamous 29% Large cell 24% |
IIIb 26% IV 74% |
0/1 72% > or =2 28% |
Current or former 100% |
Gefitinib dose NR |
Survival Response Toxicity |
| Felip, et al., 200528 | 59 pts 56 (35-78) 29% F |
NR | Adeno 49% Large cell 32% Squamous 17% Other 3% |
NR | NR | NR | Erlotinib 150 mg | Response Toxicity |
Abbreviations: Adeno = adenocarcinoma; BAC = bronchoalveolar carcinoma; chemo = chemotherapy; EORTC QLQ-C30 = European Organization for Research and Treatment of Cancer Quality of Life Questionnaire; EORTC QLQ-LC13 = European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module; NCI CTC = National Cancer Institute Common Toxicity Criteria; EGFR-TK = epidermal growth factor receptor tyrosine kinase; F = female; FACT-L = Functional Assessment of Cancer Therapy-Lung; ISEL = Iressa Survival Evaluation in Lung cancer trial; LCS = Lung Cancer Symptom Scale; NCI CTC = National Cancer Institute Common Toxicity Criteria; No. = number; NR = not reported; PFS = progression-free survival; PS = performance status; pts = patients; QoL = quality of life; RECIST = Response Evaluation Criteria in Solid Tumors; SD = stable disease; TTP = time to progression; undiff = undifferentiated; WHO = World Health Organization; XRT = radiation therapy.