Table 1.

Clinical outcome according to clinical characteristics

CharacteristicPatients n (%)Response n (%)*PTTP mo (95% CI)POS mo (95% CI)P
No. Patients9617 (17.7)3.2 (2.6–3.8)7.7 (6.8–8.6)
Baseline demographic characteristics
Age, median y64.0
    <6447 (49.0)8 (17.0)0.873.0 (2.6–3.3)0.026.8 (4.1–9.5)0.07
    >6449 (51.0)9 (18.4)5.7 (3.3–8.1)8.0 (3.5–12.6)
Sex
    Male55 (57.3)3 (5.5)<0.013.0 (2.8–3.2)0.087.0 (4.3–9.7)0.19
    Female41 (42.7)14 (34.1)5.8 (3.7–7.9)10.5 (5.7–15.3)
Smoking history
    Smokers66 (68.8)4 (6.1)<0.013.0 (2.7–3.3)0.017.6 (6.6–8.7)0.11
    Never smokers29 (31.2)13 (44.8)5.7 (3.4–8.0)8.0 (6.2–9.7)
Clinical stage
    IIIB9 (9.4)0 (0.0)0.353.0 (2.7–3.2)0.097.0 (4.1–9.9)0.54
    IV87 (90.6)17 (19.5)3.3 (2.3–4.3)7.7 (6.8–8.6)
ECOG PS
    0–176 (79.2)12 (15.8)0.343.3 (1.6–5.0)0.848.0 (5.9–10.1)0.37
    2–320 (21.8)5 (25.0)2.0 (1.9–2.1)2.2 (1.0–3.5)
Histology
    Adenocarcinoma54 (56.3)10 (18.5)0.814.5 (2.8–6.2)0.7815.0 (12.3–17.7)0.62
    Other histology42 (43.7)7 (16.7)3.0 (2.8–3.2)16.0 (0.0–32.8)
    BAC13 (13.5)4 (30.8)0.188.0 (4.5–11.5)0.0214.0 (3.2–24.8)0.03
    Other histology83 (86.5)13 (15.7)3.0 (2.7–3.2)7.0 (5.3–8.7)
Previous treament
    No14 (14.6)2 (14.3)0.725.7 (2.3–9.1)0.407.2 (6.8–8.6)0.62
    Yes82 (85.4)15 (18.3)3.1 (2.5–3.7)7.7 (6.8–19.2)
Treatment effects
Response
    PR17 (17.7)//12.0 (8.0–16.0)<0.0118.8 (13.4–14.1)<0.01
    SD+PD79 (82.3)//3.0 (2.8–3.2)7.0 (5.2–8.8)
Clinical benefit
    PR+SD54 (56.3)//6.6 (5.7–7.5)<0.0111.3 (8.2–14.5)<0.01
    PD42 (43.7)//2.0 (1.9–2.1)4.1 (2.9–5.4)
Skin rash (grade)
    0–165 (73.0)11 (16.9)0.183.1 (2.8–3.4)0.837.7 (6.6–8.8)0.60
    2–324 (27.0)5 (20.8)4.0 (1.5–6.5)7.4 (5.8–9.1)
Diarrhea (grade)
    0–181 (93.1)13 (16.0)0.383.2 (2.5–3.8)0.487.7 (6.8–8.6)0.74
    2–36 (6.9)2 (33.0)1.9 (0.7–3.1)6.0 (1.0–11.)

Abbreviation: 95% CI, 95% confidence interval; ECOG, Eastern Cooperative Oncology Group.

  • *% were calculated with respect to n of the correspondent characteristic.

  • Never (<100 cigarettes/lifetime) vs former (quit smoking >12 mo before starting gefitinib) + current smokers.