Table 1.

Patient demographics and disease characteristics at baseline (intent-to-treat population)

Gefitinib (n = 82)Docetaxel (n = 79)
Median age (range), y57 (21-74)58 (20-73)
Sex, n (%)
    Male55 (67.1)45 (57.0)
    Female27 (32.9)34 (43.0)
WHO PS, n (%)
    02 (2.4)3 (3.8)
    174 (90.2)71 (89.9)
    26 (7.3)5 (6.3)
Smoking history, n (%)
    Never smoker30 (36.6)36 (45.6)
    Exsmoker51 (62.2)43 (54.4)
    Regular smoker1 (1.2)0 (0.0)
Tumor histology, n (%)
    Adenocarcinoma54 (65.9)55 (69.6)
    Squamous cell17 (20.7)11 (13.9)
    Undifferentiated7 (8.5)9 (11.4)
    Bronchioloalveolar1 (1.2)0 (0.0)
    Mixed squamous and adenocarcinoma1 (1.2)1 (1.3)
    Other2 (2.4)3 (3.8)
Best response to previous therapy, n (%)
    CR0 (0.0)0 (0.0)
    PR28 (34.1)30 (38.0)
    SD33 (40.2)29 (36.7)
    Progression20 (24.4)19 (24.1)
    Unknown0 (0.0)1 (1.3)
    Nonevaluable1 (1.2)0 (0.0)
Disease stage
    Locally advanced11 (13.4)14 (17.7)
    Metastatic71 (86.6)65 (82.3)

Abbreviations: PS, performance status; CR, complete response; PR, partial response; SD, stable disease.