Disruptions in Liver Function among Cancer Patients and Patients Treated with Tyrosine Kinase Inhibiting Drugs: Comparisons of Two Population-Based Databases
Table 4
Incidence of first occurrence of each degree of elevation for multiple liver function tests, TKI cohorts.
Liver function tests (LFTs)
EMR database
Insurance claims database
Patients with elevation
Patients with elevation
Patients evaluated ()*
**
%†
PY
Incidence rate per 100 PY (95% CI)
Patients evaluated ()*
**
%†
PY
Incidence rate per 100 PY (95% CI)
ALT or SGPT (U/L)
>3× ULN
536
30
5.6
435
6.9 (2.7–14.3)
344
18
5.2
282
6.4 (3.4–9.3)
>5× ULN
11
2.1
454
2.4 (0.4–7.9)
10
2.9
287
3.5 (1.3–5.6)
>10× ULN
1
0.2
461
0.2 (0.0–4.1)
1
0.3
295
0.3 (0–1.9)
>20× ULN
1
0.2
461
0.2 (0.0–4.1)
1
0.3
295
0.3 (0–1.9)
AST or SGOT (U/L)
>3× ULN
536
14
2.6
453
3.1 (0.7–8.9)
353
13
3.7
296
4.4 (2.0–6.8)
>5× ULN
4
0.7
459
0.9 (0.1–5.3)
6
1.7
300
2.0 (0.4–3.6)
>10× ULN
1
0.2
461
0.2 (0.0–4.1)
2
0.6
300
0.7 (0.1–2.4)
>20× ULN
1
0.2
461
0.2 (0.0–4.1)
1
0.3
301
0.3 (0–1.9)
ALP (U/L)
>2× ULN
536
19
3.5
458
4.1 (1.9–10.5)
331
13
3.9
296
4.4 (2.0–6.8)
>3× ULN
9
1.7
460
2.0 (0.2–7.1)
7
2.1
300
2.3 (0.6–4.1)
>5× ULN
1
0.2
461
0.2 (0.0–4.1)
3
0.9
301
1.0 (0.2–2.9)
Serum bilirubin, total (mg/dL)
>1.5× ULN
537
43
8.0
442
9.7 (4.6–18.0)
399
23
5.8
342
6.7 (4.0–9.5)
>2× ULN
16
3.0
460
3.5 (0.8–9.5)
15
3.8
346
4.3 (2.1–6.5)
>5× ULN
4
0.7
461
0.9 (0.1–5.3)
7
1.8
349
2.0 (0.5–3.5)
>10× ULN
1
0.2
461
0.2 (0.0–4.1)
3
0.8
349
0.9 (0.2–2.5)
LFT combinations of Hy's Law
535
3
0.6
461
0.6 (0.0–4.9)
285
1
0.3
276
0.4 (0–2.0)
evaluated: number of eligible patients with at least one follow-up measure of the corresponding LFT. with elevation: number of patients with LFT elevation. with elevation/ evaluated. Hy’s Law = ALT or AST > 3× ULN, ALP < 2× ULN, and bilirubin > 2× ULN. TKI: tyrosine kinase inhibitor; ULN: upper limit of normal; ALP: alkaline phosphatase; ALT: alanine aminotransferase; PY: person-years; SGPT: serum glutamic pyruvic transaminase; SGOT: serum glutamate-oxaloacetate transaminase.
