Gastroenterol Res

Gastroenterology Research, ISSN 1918-2805 print, 1918-2813 online, Open Access

Article copyright, the authors; Journal compilation copyright, Gastroenterol Res and Elmer Press Inc

Journal website http://www.gastrores.org

Original Article

Volume 12, Number 1, February 2019, pages 16-20

Sorafenib-Related Adverse Events in Predicting the Early Radiologic Responses of Hepatocellular Carcinoma

**Table 1.** The General Data of Each Group With Different Radiologic Responses With Sorafenib
	PR group (N = 8)	SD group (N = 82)	PD stage (N = 132)	P-value
^aP-values were analyzed with independent t-test; ^bPearson’s Chi-square test. AFP: alpha-fetoprotein; ALT: alanine aminotransferase; BCLC: Barcelona Clinic Liver Cancer staging system; HBV: hepatitis B; HCV: hepatitis C; HFSR: hand-foot syndrome reaction; HTN: hypertension; M: mean; N: number of patients; PD: progressive disease; PR: partial response; PVT: portal vein thrombosis; SD: stable disease or standard derivation.
Age (years)	67 ± 10.36			65.27 ± 13.44			63.8 ± 11.53			0.355^a
Gender (male)		7	87.50%		68	82.90%		114	86.40%	0.775^b
BCLC stage C		8	100%		82	100%		132	100%	1.000^b
PVT		2	25.00%		45	54.90%		79	59.80%	0.141^b
Extra-hepatic metastasis		6	75.00%		44	53.70%		68	51.50%	0.431^b
HBV		3	37.50%		37	45.10%		67	50.80%	0.599^b
HCV		6	75.00%		36	43.90%		49	37.10%	0.085^b
Bilirubin (U/L)	0.7 ± 0.35			0.83 ± 0.39			0.92 ± 0.47			0.084^a
ALT (U/L)	84.25 ± 71.39			69.03 ± 62.45			60.58 ± 54.16			0.220^a
AFP (× 10⁴ ng/mL)	3.11 ± 6.31			7.76 ± 26.45			24.52 ± 69.45			0.012^a
Sorafenib dosage (× 200 mg/day)	3.5 ± 0.93			3.48 ± 0.88			3.29 ± 0.96			0.745^a

Table 1. The General Data of Each Group With Different Radiologic Responses With Sorafenib

PR group (N = 8)

SD group (N = 82)

PD stage (N = 132)

P-value

M ± SD

^aP-values were analyzed with independent t-test; ^bPearson’s Chi-square test. AFP: alpha-fetoprotein; ALT: alanine aminotransferase; BCLC: Barcelona Clinic Liver Cancer staging system; HBV: hepatitis B; HCV: hepatitis C; HFSR: hand-foot syndrome reaction; HTN: hypertension; M: mean; N: number of patients; PD: progressive disease; PR: partial response; PVT: portal vein thrombosis; SD: stable disease or standard derivation.

Age (years)

67 ± 10.36

65.27 ± 13.44

63.8 ± 11.53

0.355^a

Gender (male)

87.50%

82.90%

114

86.40%

0.775^b

BCLC stage C

100%

132

100%

1.000^b

PVT

25.00%

54.90%

59.80%

0.141^b

Extra-hepatic metastasis

75.00%

53.70%

51.50%

0.431^b

HBV

37.50%

45.10%

50.80%

0.599^b

HCV

75.00%

43.90%

37.10%

0.085^b

Bilirubin (U/L)

0.7 ± 0.35

0.83 ± 0.39

0.92 ± 0.47

0.084^a

ALT (U/L)

84.25 ± 71.39

69.03 ± 62.45

60.58 ± 54.16

0.220^a

AFP (× 10⁴ ng/mL)

3.11 ± 6.31

7.76 ± 26.45

24.52 ± 69.45

0.012^a

Sorafenib dosage (× 200 mg/day)

3.5 ± 0.93

3.48 ± 0.88

3.29 ± 0.96

0.745^a

**Table 2.** The Ratio of Adverse Events Detected in Each Group
	PR group (N = 8)	SD group (N = 82)	PD stage (N = 132)	P-value^a	P-value^b	Overall (N = 222)
All P-values were analyzed with Pearson’s Chi-square test; ^aP-value between PR group and PD group; ^bP-valued between SD group and PD group. HFSR: hand-foot syndrome reaction; HTN: hypertension; N: number of patients; PD: progressive disease; PR: partial response; SD: stable disease.
HFSR	5	62.40%	40	48.80%	33	25.00%	0.001	0.001	33	36.90%
HTN	3	37.50%	11	13.40%	9	6.90%	0.012	0.038	2	10.40%
Diarrhea	2	25.00%	28	34.60%	21	15.90%	0.007	0.002	21	23.00%

Table 2. The Ratio of Adverse Events Detected in Each Group

PR group (N = 8)

SD group (N = 82)

PD stage (N = 132)

P-value^a

P-value^b

Overall (N = 222)

All P-values were analyzed with Pearson’s Chi-square test; ^aP-value between PR group and PD group; ^bP-valued between SD group and PD group. HFSR: hand-foot syndrome reaction; HTN: hypertension; N: number of patients; PD: progressive disease; PR: partial response; SD: stable disease.

HFSR

62.40%

48.80%

25.00%

0.001

36.90%

HTN

37.50%

13.40%

6.90%

0.012

0.038

10.40%

Diarrhea

25.00%

34.60%

15.90%

0.007

0.002

23.00%

**Table 3.** Odd Ratios and 95% Confidence Interval of Associated Adverse Events With Sorafenib Response
Radiologic findings	OR	95% CI	aOR^a	95% CI
^aaOR: adjusted OR (adjusted for age, sex, AFP and sorafenib dosage). Analyzed with Multivariate Cox’s regression. CI: confidence interval; HFSR: hand-foot syndrome reaction; HTN: hypertension; OR: odd ratio; PD: progressive disease; PR: partial response; SD: stable disease.
PR
PD	1	(reference)	1	(reference)
HFSR	2.5	(1.36 - 4.61)	5.76	(1.19 - 27.88)
Hypertension	5.5	(1.81 - 16.43)	7.68	(1.50 - 39.23)
Diarrhea	1.57	(0.45 - 5.56)	2.02	(0.36 - 11.42)
SD
PD	1	(reference)	1	(reference)
HFSR	2.86	(1.59 - 5.13)	2.6	(1.39 - 4.87)
Hypertension	2.12	(0.84 - 5.36)	2.02	(0.76 - 5.39)
Diarrhea	2.74	(1.43 - 5.26)	3.54	(1.70 - 7.40)
PR + SD
PD	1	(reference)	1	(reference)
HFSR	2	(1.39 - 2.87)	2.8	(1.52 - 5.16)
Hypertension	2.28	(1.03 - 5.04)	2.48	(0.98 - 6.29)
Diarrhea	2.1	(1.28 - 3.41)	3.42	(1.67 - 7.01)

Table 3. Odd Ratios and 95% Confidence Interval of Associated Adverse Events With Sorafenib Response

Radiologic findings

95% CI

aOR^a

95% CI

^aaOR: adjusted OR (adjusted for age, sex, AFP and sorafenib dosage). Analyzed with Multivariate Cox’s regression. CI: confidence interval; HFSR: hand-foot syndrome reaction; HTN: hypertension; OR: odd ratio; PD: progressive disease; PR: partial response; SD: stable disease.

(reference)

HFSR

2.5

(1.36 - 4.61)

5.76

(1.19 - 27.88)

Hypertension

5.5

(1.81 - 16.43)

7.68

(1.50 - 39.23)

Diarrhea

1.57

(0.45 - 5.56)

2.02

(0.36 - 11.42)

(reference)

HFSR

2.86

(1.59 - 5.13)

2.6

(1.39 - 4.87)

Hypertension

2.12

(0.84 - 5.36)

2.02

(0.76 - 5.39)

Diarrhea

2.74

(1.43 - 5.26)

3.54

(1.70 - 7.40)

PR + SD

(reference)

HFSR

(1.39 - 2.87)

2.8

(1.52 - 5.16)

Hypertension

2.28

(1.03 - 5.04)

2.48

(0.98 - 6.29)

Diarrhea

2.1

(1.28 - 3.41)

3.42

(1.67 - 7.01)