Baseline and Early Predictors of Good Patient Candidates for Second-Line after Sorafenib Treatment in Unresectable Hepatocellular Carcinoma
Abstract
:1. Introduction
2. Methods
2.1. Patients
2.2. Sorafenib Treatment
2.3. Data Collection
2.4. Definition of Criteria of a Good Candidate for Second-Line Treatment
2.5. Statistical Analysis
3. Results
3.1. Baseline Data
3.2. Prognosis According to Baseline Liver Function
3.3. Frequency of Patients Fulfilling Criteria as a Good Candidate for Second-Line Treatment
3.4. Predictors for Fulfilling the RESORCE Study Inclusion Criteria at the Time of Sorafenib Discontinuation
3.5. Predictors for Fulfilling the RESORCE Study’s Inclusion Criteria plus Child–Pugh Score 5 at the Time of Sorafenib Discontinuation
3.6. Predictors for Fulfilling the RESORCE Study Inclusion Criteria Plus ALBI Grade 1 at the Time of Sorafenib Discontinuation
3.7. Predictive Value of These Criteria
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Acknowledgments
Conflicts of Interest
References
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Variables | n = 190 |
---|---|
Age: years, mean ± SD | 72 ± 9 |
Male: n (%) | 149 (78%) |
Maximum size of HCC nodule in the liver: mm, median (range in IQR) | 38 (20–74) |
Number of HCC nodules: 1/2–3/4 or more, n (%) | 28 (15%)/32 (17%)/130 (68%) |
Tumor burden (maximum size + number of HCC nodules): mean ± SD | 12 ± 6 |
BCLC stage: B/C, n (%) | 86 (45%)/104 (55%) |
Presence of MVI: n (%) | 45 (24%) |
Presence of metastasis: n (%) | 76 (40%) |
Albumin: g/dL, mean ± SD | 3.6 ± 0.4 |
Total bilirubin: g/dL, mean ± SD | 0.9 ± 0.5 |
Prothrombin time: %, mean ± SD | 98 ± 16 |
Child–Pugh score: 5/6, n (%) | 102/88 (54%/46%) |
ALBI predictor, mean ± SD | −2.30 ± 0.42 |
ALBI grade: 1/2, n (%) | 50/140 (26%/74%) |
AFP: ng/mL, median (range in IQR) | 181(13–3080) |
AFP L3 index: % (range in IQR) | 18 (5.8–49) |
PIVKA-II: mAU/mL, median (range in IQR) | 319 (49–2308) |
Factors | Univariate | Multivariate Model 1: ALBI | Multivariate Model 2: Alb | |||||||
---|---|---|---|---|---|---|---|---|---|---|
OR | p Value | Cut-Off Value | OR | 95% CI | p Value | Cut-Off Value | OR | 95% CI | p Value | |
Baseline factors | ||||||||||
Age | 0.67 | 0.37 | ||||||||
Male | 0.63 | 0.27 | ||||||||
Tumor burden | 1.0 | 0.91 | ||||||||
MVI | 0.63 | 0.26 | ||||||||
Metastasis | 0.91 | 0.74 | ||||||||
BCLC stage C | 0.67 | 0.19 | ||||||||
Albumin (g/dL) | 2.5 | 0.01 | - | >3.7 g/dL | 2.7 | 1.4–5.2 | 0.004 | |||
T.Bil (g/dL) | 0.54 | 0.19 | ||||||||
Prothrombin time (%) | 0.99 | 0.24 | ||||||||
ALBI predictor | 3.1 | 0.005 | <−2.33 | 2.5 | 1.3–5.2 | 0.01 | - | |||
AFP (ng/mL) | 0.71 | 0.34 | ||||||||
PIVKA-II (mAU/mL) | 1.0 | 0.54 | ||||||||
Factors at week 4 | ||||||||||
ΔAlb at week4 (g/dL) | 3.8 | <0.001 | - | <−0.2 g/dL | 2.6 | 1.3–5.2 | 0.005 | |||
ΔT.Bil at week4 (mg/dL) | 0.56 | 0.35 | ||||||||
ΔALBI at week4 | 0.29 | 0.015 | <0.255 | 4.9 | 2.1–11 | 0.0001 | - |
Factors | Univariate | Multivariate Model 1: ALBI | Multivariate Model 2: Alb | |||||||
---|---|---|---|---|---|---|---|---|---|---|
OR | p Value | Cut-Off Value | OR | 95% CI | p Value | Cut-Off Value | OR | 95% CI | p Value | |
Baseline factors | ||||||||||
Age | 1.0 | 0.20 | ||||||||
Male | 2.1 | 0.26 | ||||||||
Tumor burden | 0.96 | 0.23 | ||||||||
MVI | 0.26 | 0.07 | ||||||||
Metastasis | 0.92 | 0.86 | ||||||||
BCLC stage C | 0.55 | 0.17 | ||||||||
Albumin (g/dL) | 2.8 | 0.04 | - | >3.7 g/dL | 2.9 | 1.2–7.2 | 0.02 | |||
T.Bil (g/dL) | 0.13 | 0.01 | ||||||||
Prothrombin time (%) | 1.0 | 0.44 | ||||||||
ALBI predictor | 0.21 | 0.005 | <−2.33 | 5.4 | 1.9–16 | 0.002 | - | |||
AFP (ng/mL) | 1.0 | 0.63 | ||||||||
PIVKA-II (mAU/mL) | 1.0 | 0.23 | ||||||||
Factors at week 4 | ||||||||||
ΔAlb at week4 (g/dL) | 21 | <0.001 | - | <−0.1 g/dL | 4.1 | 1.6–11 | 0.003 | |||
ΔT.Bil at week4 (mg/dL) | 0.92 | 0.82 | ||||||||
ΔALBI at week4 | 0.13 | 0.005 | <0.19 | 5.9 | 1.9–19 | 0.003 | - |
Factors | Univariate | Multivariate Model 1: ALBI | Multivariate Model 2: Alb | |||||||
---|---|---|---|---|---|---|---|---|---|---|
OR | p Value | Cut-Off Value | OR | 95% CI | p Value | Cut-Off Value | OR | 95% CI | p Value | |
Baseline factors | ||||||||||
Age | 0.99 | 0.18 | ||||||||
Male | 1.3 | 0.78 | ||||||||
Tumor burden | 0.87 | 0.01 | <11 | 13 | 1.5–118 | 0.02 | <11 | 12 | 1.5–12 | 0.0002 |
MVI | 0.81 | 0.77 | ||||||||
metastasis | 0.36 | 0.11 | ||||||||
BCLC stage C | 0.43 | 0.90 | ||||||||
Albumin (g/dL) | 9.8 | 0.002 | - | >3.8 g/dL | 8.7 | 2.0–39 | 0.004 | |||
T.Bil (g/dL) | 0.42 | 0.34 | ||||||||
Prothrombin time (%) | 1.0 | 0.53 | ||||||||
ALBI predictor | 0.07 | 0.002 | <−2.55 | 14 | 2.4–76 | 0.003 | - | |||
AFP (ng/mL) | 1.0 | 0.79 | ||||||||
PIVKA-II (mAU/mL) | 1.0 | 0.43 | ||||||||
Factors at week 4 | ||||||||||
ΔAlb at week4 (g/dL) | 21 | <0.001 | - | <−0.1 g/dL | 5.4 | 1.2–24 | 0.03 | |||
ΔT.Bil at week4 (mg/dL) | 0.62 | 0.27 | ||||||||
ΔALBI at week4 | 0.08 | 0.01 | <0.085 | 20 | 2.2–177 | 0.008 | - |
Factors | RESORCE Study’s Criteria | RESORCE Study’s Criteria + Child–Pugh Score5 | RESORCE Study’s Criteria +ALBI Grade1 |
---|---|---|---|
Baseline albumin (g/dL) | 3.7 | 3.7 | 3.8 |
Baseline ALBI predictor | −2.33 | −2.33 | −2.55 |
ΔAlb at week 4 (g/dL) | −0.2 | −0.1 | −0.1 |
ΔALBI at week 4 | 0.255 | 0.19 | 0.085 |
Tumor burden | NS | NS | 11 |
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Share and Cite
Takada, H.; Kurosaki, M.; Tsuchiya, K.; Komiyama, Y.; Itakura, J.; Takahashi, Y.; Nakanishi, H.; Yasui, Y.; Tamaki, N.; Maeyashiki, C.; et al. Baseline and Early Predictors of Good Patient Candidates for Second-Line after Sorafenib Treatment in Unresectable Hepatocellular Carcinoma. Cancers 2019, 11, 1256. https://doi.org/10.3390/cancers11091256
Takada H, Kurosaki M, Tsuchiya K, Komiyama Y, Itakura J, Takahashi Y, Nakanishi H, Yasui Y, Tamaki N, Maeyashiki C, et al. Baseline and Early Predictors of Good Patient Candidates for Second-Line after Sorafenib Treatment in Unresectable Hepatocellular Carcinoma. Cancers. 2019; 11(9):1256. https://doi.org/10.3390/cancers11091256
Chicago/Turabian StyleTakada, Hitomi, Masayuki Kurosaki, Kaoru Tsuchiya, Yasuyuki Komiyama, Jun Itakura, Yuka Takahashi, Hiroyuki Nakanishi, Yutaka Yasui, Nobuharu Tamaki, Chiaki Maeyashiki, and et al. 2019. "Baseline and Early Predictors of Good Patient Candidates for Second-Line after Sorafenib Treatment in Unresectable Hepatocellular Carcinoma" Cancers 11, no. 9: 1256. https://doi.org/10.3390/cancers11091256