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Table 7. Second-line Treatment With EGFR-TK Inhibitors for Advanced NSCLC
| 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.
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