Expected outcomes and patients’ selection before chemoembolization—“Six-and-Twelve or Pre-TACE-Predict” scores may help clinicians: Real-life French cohorts results

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World Journal of Clinical Cases

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Retrospective Cohort Study

World J Clin Cases. Jun 26, 2021; 9(18): 4559-4572
Published online Jun 26, 2021. doi: 10.12998/wjcc.v9.i18.4559

Table 1 Summary of points-based scores

Prognostic systems	Constituents		Risk stratification
Pre-TACE-predict	Pre-TACE score was calculated according to the following equation = 0.313 × tumor number (0 = single, 1 = multifocal) + 1.252 × log10 tumor size (cm) + 0.230 × baseline log10 AFP (ng/mL) + [-0.0176 × baseline albumin (g/L)] + 0.458 × baseline log10 bilirubin (mcmol/L) + 0.437 × VI (0 = no, 1 = yes) + 0.149 × HBV (0 = no, 1 = yes) + 0.333 × alcoholic (0 = no, 1 = yes) + 0.211 × other etiology if not HCV/HBV/alcoholic (0 = no, 1 = yes)		C-1: ≤ 0.94, C-2: > 0.94 to ≤ 1.47, C-3: > 1.47 to ≤ 2.10, C-4: > 2.10
Post-TACE-predict	Post-TACE score was calculated according to the following equation 0.207 × tumor number (0 = single, 1 = multifocal) + 1.129 × log10 tumor size (cm) + 0.147 × baseline log10 AFP (ng/mL) + 0.750 × baseline log10 bilirubin (mcmol/L) + 0.447 × VI (0 = no, 1 = yes) + 0.469 × PR (0 = no, 1 = yes) + 1.143 × SD (0 = no, 1 = yes) + 1.354 × PD (0 = no, 1 = yes)		C-1: ≤ 1.82, C-2 > 1.82 to ≤ 2.49, C-3: > 2.49 to ≤ 3.37, C-4: > 3.37
6 and 12	6 and 12 score = tumor size in cm + tumor number		≤ 6/6-12/> 12
NIACE	Tumor nodules ≥ 3, Infiltrative vs Nodular HCC, AFP ≥ 200 ng/mL, Child-Pugh grade A/B, PS ≥ 1	1 point, 1.5 / 0 point(s), 1.5 points, 0/1.5 points, 1.5 points	≤ 1/1.5-3/> 3
ALBI	The ALBI score was calculated according to the following equation = 0.66 × log10 bilirubin - 0.085 × albumin (bilirubin level in mcmol/L and albumin level in g/L)		Grade 1: ≤ -2.60, Grade 2: > -2.60 to ≤ -1.39, Grade 3: > -1.39

TACE: Transarterial chemoembolization; AFP: Alpha-fetoprotein; VI: Vascular invasion; HCV: Hepatitis C virus; HBV: Hepatitis B virus; PR: Partial response; SD: Stable disease; PD: Progressive disease; PS: Performance status; C: Category; 6 and 12: Six-and-Twelve.

Table 2 Baseline characteristics of hepatocellular carcinoma patients undergoing transarterial chemoembolization treatment

Demographic variables	Marseille/Nancy cohort, n = 324	Nice cohort, n = 137
Age, median (Q1-Q3), yr	68 (62-74)	67 (57-75)
Gender n (%)
Male/Female	276 (85)/48 (15)	126 (92%)/11 (8)
Liver disease n (%)
HCV/HBV/Alcoholism/MS/other	129 (40)/14 (4)/122 (38)/42 (13)/17 (5)	55 (40)/8 (6)/44 (32)/11 (8)/19 (14)
ECOG (PS-0/1) n (%)	324 (100)	69 (50)/68 (50)
Cirrhosis n (%)	311 (96)	118 (86)
Tumor variables
Tumor size, mm, median (Q1-Q3)	35 (25-50)	46 (25-70)
Nodule (s): n (%) 1/2/3/4/≥ 5	95 (29)/72 (22)/80 (25)/38 (12)/39 (12)	20 (15)/22 (16)/63 (46)/32 (23)/0
Vascular invasion	0	24 (18%)
Laboratory variables
AFP, ng/mL, median (Q1-Q3)	16.3 (6.0-120.3)	18 (1-600)
PT (%), median (Q1-Q3)	76 (64-88)	90 (79-100)
Albumin (g/L), median (Q1-Q3)	35 (28-38)	37 (33-41)
Total bilirubin (mcmol/L), median (Q1-Q3)	19.0 (13.7-28.7)	11 (8-19)
Platelet count, 10⁹/L, Median (IQR)	106 (82-153)	-
Child-Pugh grade n (%) A/B7	249 (77)/75 (23)	126 (92)/11 (8)
ALBI grade 1/ 2/3 n (%)	64 (20)/230 (71)/30 (9)	52 (38)/79 (58/6 (4)
BCLC stage A/B/C n (%)	145 (45)/179 (55)/0	0/58 (42)/79 (58)
“6 and 12” score allocation n (%)
≤ 6/6-12/> 12	154 (48)/163 (50)/7 (2)	51 (37)/73 (53)/13 (10)
NIACE score allocation n (%)
≤ 1/1.5-3/> 3	168 (52/134 (41)/22 (7)	41 (30)/72 (52)/24 (18)
¹Pre-TACE allocation n (%)
C-1/C-2/C-3/C-4	47 (15)/144 (44/109 (34)/23 (7)	32 (23)/35 (26)/47 (34)/23 (17)
TACE session, mean (SD)	2.7 ± 1.8	4.0 ± 2.3
Radiological response (after first TACE)
CR/PR/SD²/PD n (%)	176 (54)/67 (21)/15 (5)/66 (20)	34 (25)/88 (64)/6 (4)/9 (7)

¹Available data for 323 patients for score calculation. HCC: Hepatocellular carcinoma; TACE: Transarterial chemoembolization; HCV: Hepatitis C virus; HBV: Hepatitis B virus; MS: Metabolic syndrome; ECOG (PS): Eastern Cooperative Oncology Group (performance status); AFP: Alpha-fetoprotein; PT: Prothrombin Time; ALBI: Albumin-Bilirubin; BCLC: Barcelona Clinic Liver Cancer; “6 and 12”: “Six-and-Twelve”; NIACE: Number of tumor(s), Infiltrative hepatocellular carcinoma, Alpha-fetoprotein, Child-Pugh class, Eastern Cooperative Oncology Group Performance Status; C: Category; SD: Standard deviation; CR: Complete response; PR: Partial response; SD²: Stable disease; PD: Progressive disease.

Table 3 Kaplan-Meier survival analysis according to scores and other systems in cohort 1 (n = 324)

Scoring/Staging systems	OS (95%CI), mo	P value (log-rank)	Sidak¹	Hazard ratio (95%CI)	P value
²Pre-TACE-predict		< 0.0001
Category 1 (n = 47)	38 (30-68)		Ref	Ref
Category 2 (n = 144)	32 (28-36)		0.9707	1.45 (0.96-2.19)	0.0769
Category 3 (n = 109)	18 (16-21)		< 0.0001	2.99 (1.97-4.54)	< 0.0001
Category 4 (n = 23)	11 (8-15)		< 0.0001	4.87 (2.81-8.47)	< 0.0001
²Post-TACE-Predict		< 0.0001
Category 1 (n = 74)	44 (35-66)		Ref	Ref
Category 2 (n = 125)	32 (25-35)		0.0725	1.94 (1.35-2.78)	0.0003
Category 3 (n = 80)	19 (16-24)		< 0.0001	4.33 (2.92-6.41)	< 0.0001
Category 4 (n = 44)	12 (8-13)		< 0.0001	14.0 (8.89-22.15)	< 0.0001
“6 and 12” score		< 0.0001
Sum ≤ 6 (n = 154)	31 (27-35)		Ref	Ref
Sum 6-12 (n = 163)	20 (17-24)		0.0009	1.55 (1.21-1.99)	0.0005
Sum > 12 (n = 7)	15 (5-19)		< 0.0001	3.80 (1.76-8.21)	0.0007
BCLC staging		< 0.0001
A (n = 145)	35 (29-38)		-	Ref
B (n = 179)	19 (17-23)		-	1.88 (1.47-2.41)	< 0.0001
NIACE score		< 0.0001
≤ 1 (n = 168)	35 (28-36)		Ref	Ref
1.5-3 (n = 134)	20 (16-23)		< 0.0001	1.92 (1.49-2.48)	< 0.0001
> 3 (n = 22)	11 (5-16)		< 0.0001	6.23 (3.87-10.02)	< 0.0001
Child-Pugh class		0.0003
A (n = 249)	27 (25-31)		-	Ref
B (n = 75)	21 (15-24)		-	1.66 (1.26-2.19)	0.0003
ALBI grade		0.0029
Grade 1 (n = 64)	35 (25-43)		Ref	Ref
Grade 2 (n = 230)	26 (22-28)		0.1228	1.50 (1.06-2.11)	0.0216
Grade 3 (n = 30)	16 (12-24)		0.0016	2.30 (1.41-3.75)	0.0009

¹Sidak test for multiple comparisons.

²Available data for 323 patients for score calculation. OS: Overall survival; CI: Confidence interval; “6 and 12”: “Six-and-Twelve”; Ref: Reference; BCLC: Barcelona Clinic Liver Cancer; NIACE: Number of tumor(s), Infiltrative hepatocellular carcinoma, Alpha-fetoprotein, Child-Pugh class, Eastern Cooperative Oncology Group Performance Status; ALBI: Albumin-Bilirubin.

Table 4 Comparison of predictive accuracy for overall survival between pre-/post transarterial chemoembolization-predict and staging/scoring systems in cohort 1 (n = 324)

Scoring/Stage systems	1-yr AUROC	P (vs Ref)	2-yr AUROC	P (vs Ref)	3-yr AUROC	P (vs Ref)	C-index	P (vs Ref)
Pre-TACE-predict	0.67(0.60-0.75)	Ref	0.60(0.56-0.64)	Ref	0.57(0.53-0.60)	Ref	0.59(0.56-0.61)	Ref
“6 and 12” score	0.65(0.56-0.74)	0.6040	0.64(0.58-0.70)	0.1425	0.63(0.57-0.70)	0.0347	0.66(0.58-0.73)	0.0806
BCLC staging	0.60(0.52-0.67)	0.0549	0.64(0.58-0.69)	0.1705	0.61(0.55-0.67)	0.1537	0.61(0.54-0.68)	0.4459
NIACE score	0.77(0.69-0.84)	0.0254	0.69(0.63-0.75)	0.0010	0.69(0.63-0.75)	< 0.0001	0.70(0.64-0.77)	0.0004
Child-Pugh class	0.56(0.49-0.63)	0.0399	0.55(0.51-0.60)	0.1574	0.54(0.49-0.59)	0.4784	0.59(0.55-0.64)	0.8075
ALBI grade	0.63(0.57-0.69)	0.3997	0.56(0.51-0.61)	0.1972	0.55(0.49-0.61)	0.7351	0.62(0.55-0.68)	0.3909
Post-TACE-predict	0.81(0.76-0.87)	Ref	0.73(0.68-0.78)	Ref	0.73(0.67-0.78)	Ref	0.74(0.68-0.80)	Ref
“6 and 12” score	0.65(0.56-0.74)	< 0.0001	0.64(0.58-0.70)	0.0011	0.63(0.57-0.70)	0.0029	0.66(0.58-0.73)	0.0145
BCLC staging	0.60(0.52-0.67)	< 0.0001	0.64(0.58-0.69)	0.0005	0.61(0.55-0.67)	< 0.0001	0.61(0.54-0.68)	0.0002
NIACE score	0.77(0.69-0.84)	0.1673	0.69(0.63-0.75)	0.1263	0.69(0.63-0.75)	0.1927	0.70(0.64-0.77)	0.2562
Child-Pugh class	0.56(0.49-0.63)	< 0.0001	0.55(0.51-0.60)	< 0.0001	0.54(0.49-0.59)	< 0.0001	0.59(0.55-0.64)	< 0.0001
ALBI grade	0.63(0.57-0.69)	< 0.0001	0.56(0.51-0.61)	< 0.0001	0.55(0.49-0.61)	< 0.0001	0.62(0.55-0.68)	0.0051

“6 and 12”: “Six-and-Twelve”; AUROC: Area under receiver operating characteristic curve; C-index: Concordance index; Ref: Reference; BCLC: Barcelona Clinic Liver Cancer; NS: Non-significant; NIACE: Number of tumor(s), Infiltrative hepatocellular carcinoma, Alpha-fetoprotein, Child-Pugh class, Eastern Cooperative Oncology Group Performance Status; ALBI: Albumin-Bilirubin.

Table 5 Kaplan-Meier survival analysis according to scores and other systems in cohort 2 (n = 137)

Scoring/Staging systems	OS (95%CI), mo	P value (log-rank)	Sidak¹	Hazard ratio (95%CI)	P value
Pre-TACE-Predict		0.0032
Category 1 (n = 32)	26 (21-44)		Ref	Ref
Category 2 (n = 35)	30 (17-50)		0.8786	0.83 (0.46-1.52)	0.5463
Category 3 (n = 47)	16 (11-20)		0.2611	1.56 (0.92-2.65)	2.6614
Category 4 (n = 23)	12 (5-15)		0.0418	2.27 (1.24-4.14)	0.0079
Post-TACE-Predict		0.0022
Category 1 (n = 36)	36 (23-44)		Ref	Ref
Category 2 (n = 38)	21 (12-30)		0.4851	1.47 (0.83-2.61)	0.1843
Category 3 (n = 48)	16 (12-24)		0.0699	1.89 (1.10-3.23)	0.0203
Category 4 (n = 15)	9 (5-15)		0.0022	3.68 (1.79-7.55)	0.0004
“6 and 12” score		0.8633
Sum ≤ 6 (n = 51)	26 (16-36)		Ref	Ref
Sum 6-12 (n = 73)	18 (15-23)		0.8328	1.12 (0.74-1.70)	0.5913
Sum > 12 (n = 13)	24 (3-48)		0.8867	1.09 (0.54-2.18)	0.8159
BCLC staging		0.0234
B (n = 58)	29 (18-39)		-	Ref
C (n = 79)	16 (13-21)		-	1.58 (1.06-2.36)	0.0253
NIACE score		< 0.0001
≤ 1 (n = 41)	29 (21-43)		Ref	Ref
1.5-3 (n = 72)	22 (16-30)		0.5463	1.38 (0.86-2.19)	0.1782
> 3 (n = 24)	9 (5-12)		< 0.0001	3.69 (2.09-6.51)	< 0.0001
Child-Pugh class		< 0.0001
A (n = 126)	23 (18-29)		-	Ref
B (n = 11)	9 (6-11)		-	4.74 (2.34-9.59)	< 0.0001
ALBI grade		< 0.0001
Grade 1 (n = 51)	32 (25-44)		Ref	Ref
Grade 2 (n = 77)	17 (12-21)		0.0074	1.93 (1.26-2.97)	0.0026
Grade 3 (n = 9)	9 (1-16)		< 0.0001	6.82 (3.14-14.83)	< 0.0001

¹Sidak test for multiple comparisons. OS: Overall survival; CI: Confidence interval; “6 and 12”: “Six-and-Twelve”; Ref: Reference; BCLC: Barcelona Clinic Liver Cancer; NIACE: Number of tumor(s), Infiltrative hepatocellular carcinoma, Alpha-fetoprotein, Child-Pugh class, Eastern Cooperative Oncology Group Performance Status; ALBI: Albumin-Bilirubin.

Citation: Adhoute X, Larrey E, Anty R, Chevallier P, Penaranda G, Tran A, Bronowicki JP, Raoul JL, Castellani P, Perrier H, Bayle O, Monnet O, Pol B, Bourliere M. Expected outcomes and patients’ selection before chemoembolization—“Six-and-Twelve or Pre-TACE-Predict” scores may help clinicians: Real-life French cohorts results. World J Clin Cases 2021; 9(18): 4559-4572
URL: https://www.wjgnet.com/2307-8960/full/v9/i18/4559.htm
DOI: https://dx.doi.org/10.12998/wjcc.v9.i18.4559