Real-world clinical effectiveness of sorafenib among patients with unresectable hepatocellular carcinoma at two centers in the United States

Table 1 Patient demographics

Characteristic	Overall (n = 134)	Advent Health (n = 62)	City of Hope (n = 72)
Age at diagnosis (yr)
Mean	65	64	65
Median (range)	64 (33-90)	63 (44-79)	66 (33-90)
Sex, n (%)
Male	101 (75)	50 (81)	51 (71)
Female	33 (25)	12 (19)	21 (29)
BMI, n (%)
< 18.5	4 (3)	4 (6)	-
18.5-24.9	48 (36)	20 (32)	28 (39)
25-29.9	38 (28)	14 (23)	24 (33)
≥ 30	34 (25)	21 (34)	13 (18)
Not reported	10 (8)	3 (5)	7 (10)
Race, n (%)
Asian	25 (19)	3 (5)	22 (31)
African-American	15 (11)	11 (18)	4 (6)
Native Hawaiian or other Pacific Islander	1 (1)	-	1 (1)
Caucasian	83 (62)	41 (66)	42 (58)
Not reported	10 (7)	7 (11)	3 (4)
Ethnicity, n (%)
Hispanic or Latino	34 (25)	16 (26)	18 (25)
Non-Hispanic or Non-Latino	94 (70)	45 (73)	49 (68)
Not reported	6 (5)	1 (1)	5 (7)

BMI: Body mass index.

Table 2 Patient clinical characteristics

	Overall (n = 134)	Advent Health (n = 62)1	City of Hope (n = 72)
Child-Pugh class, n (%)
A	48 (36)	26 (42)	22 (31)
B	54 (40)	25 (40)	29 (40)
C	12 (9)	7 (11)	5 (7)
Not reported	20 (15)	4 (6)	16 (22)
BCLC stage, n (%)
0	1 (1)	1 (2)	-
A	12 (9)	2 (3)	10 (14)
B	25 (19)	22 (35)	3 (4)
C	94 (70)	36 (58)	58 (81)
D	1 (1)	-	1 (1)
Not reported	1 (1)	1 (2)	0
ECOG, n (%)
0	28 (21)	10 (16)	18 (25)
1	103 (77)	49 (79)	54 (75)
Not reported	3 (2)	3 (5)	0
Etiology, n (%)
Hepatitis B	15 (11)	5 (8)	10 (14)
Hepatitis C	72 (54)	35 (56)	37 (51)
Alcohol-related liver disease	21 (16)	10 (16)	11 (15)
Nonalcoholic fatty liver disease	11 (8)	4 (6)	7 (10)
Not reported/none of the above	15 (11)	8 (13)	7 (10)

¹Due to rounding, percentages may not add to 100%.

BCLC: Barcelona Clinic Liver Cancer; ECOG: Eastern Cooperative Oncology Group.

Table 3 Clinical outcomes by subgroup

Cohort/subgroup	Best overall response, % (CR + PR)	N (PFS)	Median PFS (Q1, Q3), months	HR (95%CI)	N (OS)	Median OS (Q1, Q3), months	HR (95%CI)
Overall	7.3	121	2.9 (1.5, 5.6)		134	8.5 (3.6, 24.6)
Age group (yr)
< 651	7.7	61	3.5 (1.8, 7.1)		69	8.5 (3.6, 23.4)
65-75	9.8	42	2.3 (1, 10.3)	1.40 (0.90-2.15)	45	10.6 (4, 29.7)	0.87 (0.53-1.44)
> 75	0	18	3.8 (1.5, 7.9)	0.85 (0.48-1.52)	18	6 (3.1, 31.6)	1.09 (0.58-2.02)
Sex
Male1	7.4	91	2.8 (1.6, 5.4)		92	7.1 (3.6, 21.8)
Female	6.9	30	3.6 (1.3, 7.9)	0.84 (0.53-1.32)	31	14.2 (3.7, 30.3)	0.68 (0.41-1.15)
Race
Asian1	12.0	25	3 (1.5, 5.4)		25	10.6 (5.4, 23.4)
African-American	7.7	12	4.5 (1.9, 6.7)	0.90 (0.43-1.89)	15	13.7 (1.8, 36.2)	1.03 (0.47-2.27)
Native Hawaiian or other Pacific Islander	0	1	2.8 (2.8, 2.8)	1.37 (0.18-10.3)	1	2.8 (2.8, 2.8)	6.52 (0.82-51.7)
Caucasian	6.4	77	2.6 (1.5, 6.4)	0.89 (0.54-1.47)	82	9.3 (4, 29.7)	1.05 (0.59-1.84)
Child-Pugh Class
A1	9.1	43	3.1 (1.9, 5.4)		47	10.6 (5.2, 24.6)
B	10.2	50	2.6 (1.5, 5.6)	1.23 (0.79-1.93)	54	6.3 (2.8, 14.2)	1.36 (0.84-2.19)
C	0	11	1.4 (0.7, 2.5)	3.27 (1.57-6.79)a	12	3 (1.7, 4.2)	4.49 (1.87-10.8)a
BCLC stage
0	0	1	1 (1, 1)	NA	1	Not reached	NA
A1	9.1	10	10.8 (1, 14.8)		12	23.4 (23.4, -)
B	21.7	23	2.9 (1.5, 9.8)	1.64 (0.68-3.96)	24	9 (3.1, 22.6)	4.67 (1.08-20.1)
C	3.4	85	3 (1.6, 5.3)	1.79 (0.80-3.98)	93	7.1 (3.6, 24.6)	4.35 (1.06-17.8)
D	0	1	2.1 (2.1, 2.1)	NA	1	5.4 (5.4, 5.4)	NA
ECOG
01	12.5	25	5.1 (3, 10.5)		27	29.1 (6, 30.3)
1	6.2	94	2.4 (1.4, 5.2)	1.70 (1.03-2.83)a	102	6.3 (3.1, 14.2)	2.02 (1.13-3.60)
Hepatitis B
No1	6.5	106	3 (1.5, 6)		116	7.9 (3.6, 29.7)
Yes	13.3	14	3 (1.9, 7.3)	0.90 (0.48-1.70)	15	9 (5.4, 21.8)	1.31 (0.70-2.42)
Hepatitis C
No1	5.5	54	2.8 (1.5, 5.4)		60	7.9 (5, 21.8)
Yes	8.8	66	3 (1.5, 7.1)	0.94 (0.63-1.39)	71	9.3 (3.6, 29.1)	0.85 (0.54-1.32)
Alcohol-related liver disease
No1	7.8	102	3 (1.5, 6.4)		110	9 (3.7, 29.1)
Yes	4.8	18	2.6 (2.1, 4.1)	1.17 (0.68-2.00)	21	7.1 (3.1, 13.4)	1.46 (0.81-2.61)
Nonalcoholic fatty liver disease
No1	7.1	110	3 (1.6, 5.6)		120	7.9 (3.7, 23.4)
Yes	10.0	10	2.8 (1.4, 10.6)	0.79 (0.38-1.63)	11	10.6 (3.1, 29.7)	0.71 (0.31-1.64)

¹Reference. The subgroup within a categorical variable (e.g. age) that the other subgroup/s (within the same variable) are compared to for calculation of the Hazard Ratios reported.

^aP < 0.05. BCLC: Barcelona Clinic Liver Cancer; CI: Confidence interval; CR: Complete response; ECOG: Eastern Cooperative Oncology Group; HR: Hazard ratio; NA: Not applicable; OS: Overall survival; PFS: Progression-free survival; PR: Partial response; Q1: Quartile 1; Q3: Quartile 3.