Table 2.

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

StudyDesign/PopulationSmoking status (No. Subjects)Response rate (95% CI)Time to progression (95% CI)Overall survivalHR (95% CI)
Gefitinib Therapy
Cohen et al (24)Prospective, retrospective subgroup: 142 male and female patients with NSCLC; Study location: United States; Study years: not statedEver smoked (n = 108)4.6% (1.5-10.6%)
Never smoked (n = 34)29.4% (14.6-46.3%)
Miller et al (19)Retrospective: 139 male and female patients with NSCLC; Study location: NY; Study years: 1998-2002Ever smoked (n = 103)8%
Never smoked (n = 36)36%
Han et al (144)Retrospective: 90 male and female patients with NSCLC; Study location: Korea; Study years: 2001-2004Ever smoked (n = 47)7.3%
Never smoked (n = 43)21.9%
Kim et al (145)Retrospective: 80 male and female patients with NSCLC; Study location: Korea; Study years: not statedEver smoked (n = 66)15.9%243 days (29-457 days)
Never smoked (n = 17)58.8%382 days (91-673 days)
Konishi (146)Retrospective: 122 male and female patients with NSCLC; Study location: Japan; Study years: 2002-2004Ever smoked (n = 74)13.5%1
Never smoked (n = 48)41.7%0.39
Lee (27) (168)Prospective first-line: 36 male and female patients with adenocarcinomas (all never smokers); Study location: Korea; Study years: 2003-2004Never smoked (n = 36)69%33 weeks (4-54 weeks)
Lim et al (147)Retrospective: 110 male and female patients with NSCLC; Study location: Singapore; Study years: 2001-2003Ever smoked (n = 44)9%7.6 months1
Never smoked (n = 66)47%13.6 months0.61 (0.38-0.99)
Mitsudomi et al (148)Retrospective: 59 male and female patients with NSCLC; Study location: Japan; Study years: 1999-2003Ever smoked (n = 31)36%1
Never smoked (n = 28)68%0.511 (0.092-2.854)
Thatcher et al (12)Prospective: 1694 male and female patients with NSCLC; 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 armSame as placebo arm (not stated)0.92 (0.79-1.06)
Never smoked, gefitinib arm (n = 250)18.1%5.6 months8.9 months0.67 (0.49-0.92)
Ever smoked, placebo arm (n = 437)Same as gefitinib armSame as gefitinib arm (not stated)1
Never smoked, placebo arm (n = 125)2.8 months6.1 months1
Shih et al (149)Retrospective: 62 male and female patients with NSCLC Study location: Taiwan; Study years: 2001-2004Ever smoked (n = 21)10%2.4 (1.1-4.9)
Never smoked (n = 41)51%1
Veronese et al (150) Retrospective: 112 male and female patients with NSCLC; Study location: PA; Study years: 2001-2003Ever smoked (n = 93)
Never smoked (n = 18)
Erlotinib Therapy:
Herbst et al (31)Prospective: 1,059 male and female patients with NSCLC; Study location: United States; Study years: 2001-2002Ever smoked, erlotinib arm (n = 467)Current smokers: 8.4 months; Former smokers: 10.0 months
Never smoked, erlotinib arm (n = 72)6.0 months22.5 months0.49 (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 months10.1 months1