Table 2 Univariate and multivariate analysis of factors affecting the development of hepatotoxicity with gefitinib

Age (years)

 Median [range]

72 [47–90]

72 [37–85]

0.700 ^d

 <  75

43 (60)

17 (57)

0.827 ^e

 ≥ 75

29 (40)

13 (43)

Sex

 Male

34 (47)

12 (40)

0.522 ^e

 Female

38 (53)

18 (60)

ECOG PS

 0–1

60 (83)

26 (87)

0.773 ^e

 2–3

12 (17)

4 (13)

Stage

 I - III

35 (49)

14 (47)

1.000 ^e

 IV

37 (51)

16 (53)

BSA (m²)

 Median [range]

1.5 [1.1–1.8]

1.5 [1.1–1.9]

0.467 ^d

 <  1.6

52 (72)

18 (60)

0.248 ^e

 ≥ 1.6

20 (28)

12 (40)

BMI (kg/m²)

 Median [range]

21.1 [14.9–31.3]

23.9 [16.2–28.5]

0.016 ^d

 < BMI 25

63 (88)

20 (67)

0.024 ^e

4.571 (1.486–14.056)

0.008

 ≥ BMI 25

9 (12)

10 (33)

Recurrence

 Yes

28 (39)

13 (43)

0.825 ^e

 No

44 (61)

17 (57)

Metastasis

 Yes

64 (89)

27 (90)

1.000 ^e

 No

8 (11)

3 (10)

Line of therapy

 First line

38 (53)

21 (70)

0.127 ^e

 Second line and later line

34 (47)

9 (30)

EGFR mutation

 Exon 19 Deletion

  Yes

27 (38)

17 (57)

0.084 ^e

2.327 (0.918–5.895)

0.075

  No

45 (63)

13 (43)

 Exon 21 L858R point mutation

  Yes

38 (53)

13 (43)

0.515 ^e

  No

34 (47)

17 (57)

Smoking history

 Yes

32 (44)

7 (23)

0.073 ^e

 No

40 (56)

23 (77)

Grade 1 liver dysfunction ^b

 Yes

24 (33)

13 (43)

0.372 ^e

 No

48 (67)

17 (57)

Concomitant medication ^c

 AS

  Yes

33 (46)

8 (27)

0.081 ^e

0.394 (0.145–1.070)

0.068

  No

39 (54)

22 (73)

CYP1A2 inducer

 Yes

1 (1.0)

0 (0.0)

1.000 ^e

 No

71 (99)

30 (100)

CYP3A4 inducer

 Yes

1 (1.0)

0 (0.0)

1.000 ^e

 No

71 (99)

30 (100)

CYP3A4 inhibitor

 Yes

5 (7.0)

0 (0.0)

0.318 ^e

 No

67 (93)

30 (100)