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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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