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. Author manuscript; available in PMC: 2010 Oct 6.
Published in final edited form as: Clin Cancer Res. 2009 Sep 15;15(18):5646–5661. doi: 10.1158/1078-0432.CCR-09-0377

Table 2.

Results from studies of treatment with EGFR inhibitors and outcome by smoking status

Study Design/population Smoking
Status (No.
subjects)
Response Rate
(95% CI)
Time to
Progression
(95% CI)
Overall Survival Hazard Ratio
(95% CI)
Gefitinib Therapy
Cohen et al. (2003) (24) Prospective, retrospective subgroup:
142 male and female patients with with non-small cell lung cancer
Study location: USA
Study years: not stated
Ever smoked
(n = 108)
4.6%
(1.5%–10.6%)
Never smoked
(n = 34)
29.4%
(14.6%–46.3%)

Miller et al. (2004) (19) Retrospective:
139 male and female patients with with non-small cell lung cancer
Study location: USA (NY)
Study years: 1998–2002
Ever smoked
(n = 103)
8%
Never smoked
(n = 36)
36%

Han et al. (2005) (144) Retrospective:
90 male and female patients with with non-small cell lung cancer
Study location: Korea
Study years: 2001–2004
Ever smoked
(n = 47)
7.3%
Never smoked
(n = 43)
21.9%

Kim et al. (2005) (145) Retrospective:
80 male and female patients with with non-small cell lung cancer
Study location: Korea
Study years: not stated
Ever smoked
(n = 66)
15.9% 243 days
(29–457 days)
Never smoked
(n = 17)
58.8% 382 days
(91–673 days)

Konishi et al. (2005) (146) Retrospective:
122 male and female patients with with non-small cell lung cancer
Study location: Japan
Study years: 2002–2004
Ever smoked
(n = 74)
13.5% 1
Never smoked
(n = 48)
41.7% 0.39

Lee et al. (27) (168) Prospective first-line:
36 male and female patients with adenocarcinomas (all never smokers)
Study location: Korea
Study years: 2003–2004
Never smoked
(n=36)
69% 33 weeks
(4–54 weeks)

Lim et al. (2005) (147) Retrospective:
110 male and female patients with with non-small cell lung cancer
Study location: Singapore
Study years: 2001–2003
Ever smoked
(n = 44)
9% 7.6 months 1
Never smoked
(n = 66)
47% 13.6 months 0.61
(0.38–0.99)

Mitsudomi et al. (2005) (148) Retrospective:
59 male and female patients with with non-small cell lung cancer
Study location: Japan
Study years: 1999–2003
Ever smoked
(n = 31)
36% 1
Never smoked
(n = 28)
68% 0.511
(0.092–2.854)

Thatcher et al. (2005) (12) Prospective:
1694 male and female patients with with non-small cell lung cancer
Study location: Asia, Europe, Central and South America, Canada, Australia
Study years: up to October 2004 (start date not stated)
Ever smoked,
gefitinib arm
(n = 879)
5.3% same as placebo arm same as placebo arm (not stated) 0.92
(0.79–1.06)
Never smoked,
gefitinib arm
(n = 250)
18.1% 5.6 months 8.9 months 0.67
(0.49–0.92)
Ever smoked,
placebo arm
(n = 437)
same as gefitinib arm same as gefitinib arm (not stated) 1
Never smoked,
placebo arm
(n = 125)
2.8 months 6.1 months 1

Shih et al. (2006) (149) Retrospective:
62 male and female patients with with non-small cell lung cancer
Study location: Taiwan
Study years: 2001–2004
Ever smoked
(n = 21)
10% 2.4
(1.1–4.9)
Never smoked
(n = 41)
51% 1

Veronese et al. (2005) (150) Retrospective:
112 male and female patients with with non-small cell lung cancer
Study location: USA (PA)
Study years: 2001–2003
Ever smoked
(n = 93)
Never smoked
(n = 18)

Erlotinib Therapy:
Herbst et al.(2005) (31) Prospective:
1059 male and female patients with with non-small cell lung cancer
Study location: USA
Study years: 2001–2002
Ever smoked,
erlotinib arm
(n = 467)
current smokers:
8.4 months
former smokers:
10.0 months
Never smoked,
erlotinib arm
(n = 72)
6.0 months 22.5 months 0.49
(0.28–0.85)
Ever smoked,
placebo arm
(n = 495)
current smokers:
9.1 months
former smokers:
10.9 months
Never smoked,
placebo arm
(n = 44)
4.3 months 10.1 months 1