Idarubicin vs doxorubicin in transarterial chemoembolization of intermediate stage hepatocellular carcinoma

Table 1 Patient baseline characteristics: Clinical and biological characteristics, portal hypertension evidence, and anthropometric analyses, n (%)

Characteristics	Doxorubicin, n = 60	Idarubicin, n = 30
Clinical and biological data
Sex, male/female	54 (90.0)/6 (10.0)	28 (93.3)/2 (6.7)
Age in yr, mean ± SD	62.9 ± 9.0	61.9 ± 9.8
WHO performance status 0/1	51 (85.0)/9 (15.0)	25 (83.3)/5 (16.6)
BMI, median (IQR)	27.6 (24.7-32.1)	25.2 (22.9-27.2)
< 20	2 (3.3)	2 (6.9)
20-24.9	15 (25.0)	12 (41.4)
≥ 25	43 (71.7)	15 (51.7)
Tumor characteristics
Tumor number, median (IQR)	2 (1-3)	2 (2-3.75)
1 nodule	17 (28.3)	7 (23.3)
2-3 nodules	31 (51.7)	15 (50.0)
> 3 nodules	12 (20.0)	8 (26.7)
2 largest nodules sum in mm, median (IQR)	49.5 (32.8-62.0)	40.5 (30.5-58.8)
Partial portal vein thrombosis	8 (13)	3 (10)
Underlying cirrhosis
Yes/no	56 (93.3)/4 (6.7)	26 (86.7)/4 (13.3)
Child-Pugh class A/B	52 (86.7)/8 (13.3)	21 (70.0)/9 (30.0)
MELD, median (IQR)	9.22 (8.13-10.57)	8.19 (7.34-9.86)
Etiology
Alcohol	18 (30.0)	6 (20.0)
HBV/HCV infection	11 (18.3)	4 (13.3)
Metabolic	7 (11.7)	1 (3.3)
Alcohol + HBV/HCV	3 (5.0)	8 (26.7)
Alcohol + Metabolic	16 (26.7)	5 (16.7)
Hemochromatosis	3 (5.0)	2 (6.7)
Biological parameters
Platelet count in G/L, median (IQR)	112.5 (82.8-171.5)	106.5 (86.3-135.3)
Albumin in g/dL, median (IQR)	3.7 (3.4-3.9)	3.5 (3.1-3.9)
Total bilirubin in mg/dL, median (IQR)	0.94 (0.58-1.18)	0.73 (0.48-1.04)
AST in IU/L, median (IQR)	46 (33-65)	55 (34-68)
ALT in IU/L, median (IQR)	44 (34-70)	40 (29-60
GGT in IU/L, median (IQR)	152 (92-261)	185 (141-332)
ALP in IU/L, median (IQR)	105 (88-133)	115 (88-139)
PT as %, median (IQR)	79.5 (67.0-85.8)	79.5 (63.3-89.3)
AFP in ng/mL, median (IQR)	12.7 (4.6-109.3)	16.0 (5.2-35.0)
Drug administration method
Conventional TACE/beads	48 (80)/12 (20.0)	24 (80)/6 (20.0)
Drug dose in mg, median (IQR)	50 (50-50)	10 (10-10)
TACE territory: Global/lobar/segmental	34 (56.7)/20 (33.3)/6 (10.0)	15 (50)/14(46.7)/1(3.3)
Portal hypertension evidence
Ascites on preoperative scan: No/yes	49 (76.6)/15 (23.4)	21 (65.6)/11 (34.4)
Splenomegaly on preoperative scan: No/yes	27 (45.0)/33 (55.0)	7 (23.3)/23 (76.7)
Esophageal varices
None	28 (46.7)	17 (56.7)
Grade 1/2/3	14 (23.3)/17 (28.3)/1 (1.7)	2 (6.7)/9 (30.0)/2 (6.7)
Low platelet count as < 100 000/mm3: No/yes	37 (61.6)/23 (38.3)	18 (60.0)/12 (40.0)

AFP: Alpha-fetoprotein; ALP: Alkaline phosphatase; ALT: Alanine aminotransferase; AST: Aspartate aminotransferase; BCLC: Barcelona Clinic Liver Cancer; BMI: Body max index; GGT: Gamma-glutamyltranspeptidase; HBV: Hepatitis B virus; HCV: Hepatitis C virus; PT: Prothrombin time; IQR: Interquartile range; WHO: World Health Organization; TACE: Transarterial chemoembolization; MELD: Model for end-stage liver disease; SD: Standard deviation.

Table 2 Early adverse events according to treatment group occurring within the month after transarterial chemoembolization, n (%)

Adverse events	Doxorubicin, n = 60		Idarubicin, n = 30
	Any grade	Grade 3-4	Any grade	Grade 3-4
Any adverse event	58 (97)	21 (35)	29 (97)	13 (43)
Treatment-related death	1 (2)	1 (2)	0	0
Post embolization syndrome	27 (45)	NA	19 (63)	NA
Fatigue	27 (45)	7 (11)	19 (63)	3 (10)
Pain	9 (15)	7 (12)	5 (17)	4 (13)
Gastrointestinal disorders
Biliary complications	5 (8)	4 (7)	1 (3)	0
Liver failure	6 (10)	4 (7)	4 (13)	2 (7)
Paralytic ileus	1 (2)	0	0	0
Portal thrombosis	0	0	1 (2)	1 (2)
Liver biological parameters
Elevated AST	55 (92)	20 (33)	26 (87)	13 (43)
Elevated ALT	51 (85)	14 (23)	24 (80)	7 (23)
Elevated GGT	21 (35)	0	12 (40)	0
Elevated ALP	16 (27)	0	5 (17)	0
Hyperbilirubinemia	34 (57)	0	22 (73)	0
Decreased prothrombin time	28 (48)	0	9 (32)	0
Neurological disorders
Stroke	1 (2)	0	0	0
Respiratory disorders
Lung failure	1 (2)	0	1 (3)	1 (3)
Lung infection	0	0	2 (7)	2 (7)
Urinary tract disorders
Acute kidney failure	1 (2)	0	0	0
Acute urine retention	3 (5)	0	1 (3)	0
Urinary tract infection	1 (2)	1 (2)	0	0

Biological adverse events are expressed based on their comparison with normal values or with patient’s baseline value in case of abnormal baseline as recommended by Common Terminology Criteria for Adverse Events Version 5.0. ALP: Alkaline phosphatase; ALT: Alanine aminotransferase; AST: Aspartate aminotransferase; GGT: Gamma-glutamyltranspeptidase; NA: Not applicable.