Lenvatinib as an Initial Treatment in Patients with Intermediate-Stage Hepatocellular Carcinoma Beyond Up-To-Seven Criteria and Child–Pugh A Liver Function: A Proof-Of-Concept Study
Abstract
:1. Introduction
2. Methods
2.1. Patients
2.2. Treatment Protocol
2.3. Propensity Score Matching
2.4. Evaluation of Treatment Response
2.5. Efficacy Analysis
2.6. Statistical Analysis
3. Results
3.1. Patient Characteristics
3.2. Change of Liver Function
3.3. Efficacy and Safety
4. Discussion
5. Conclusions
Author Contributions
Funding
Conflicts of Interest
Appendix A
Response Category | Lenvatinib n = 19 (%) | TACE n = 37 (%) | p-Value Odds Ratio (95% CI) |
---|---|---|---|
ORR | 14 (73.7%) | 14 (37.8%) | p < 0.05 |
4.47 (1.19–19.51) | |||
CBR (CR + PR + SD ≥ 24w) | 19 (100.0%) | 16 (43.2%) | |
DCR | 19 (100.0%) | 22 (59.5%) | |
CR | 1 | 4 | |
PR | 13 | 10 | |
SD | 5 | 8 | |
Durable stable disease (SD ≥ 24w) | 5 | 2 | |
PD | 0 | 13 | |
NE | 0 | 2 |
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Characteristics | Before Matching | After Matching | ||||
---|---|---|---|---|---|---|
Lenvatinib n = 37 (%) | TACE n = 139 (%) | p Value | Lenvatinib n = 30 (%) | TACE n = 60 (%) | p Value | |
Age, mean | 68.6 | 71.9 | 0.173 | 68.2 | 72.4 | 0.272 |
Gender, male | 30 (81.1%) | 106 (76.3%) | 0.661 | 24 (80.0%) | 42 (70.0%) | 0.449 |
HCV positive | 15 (40.5%) | 84 (60.4%) | 0.040 | 12 (40.0%) | 29 (48.3%) | 0.506 |
HBV positive | 8 (21.6%) | 12 (8.6%) | 0.039 | 7 (23.3%) | 10 (16.7%) | 0.430 |
Alcohol abuse | 6 (16.2%) | 27 (19.4%) | 0.814 | 3 (10.0%) | 10 (16.7%) | 0.532 |
Size of intrahepatic lesion, >30 mm | 26 (70.3%) | 81 (58.3%) | 0.255 | 20 (66.7%) | 39 (65.0%) | 1.000 |
Number of intrahepatic lesion, >5 | 17 (45.9%) | 70 (50.4%) | 0.713 | 14 (46.7%) | 35 (45.0%) | 0.371 |
EHS positive | 0 (0%) | 0 (0%) | 1.000 | 0 (0%) | 0 (0%) | 1.000 |
MVI positive | 0 (0%) | 0 (0%) | 1.000 | 0 (0%) | 0 (0%) | 1.000 |
Child–Pugh score 5A | 25 (67.6%) | 91 (65.5%) | 0.848 | 20 (66.7%) | 37 (61.7%) | 0.817 |
Child–Pugh score 6A | 12 (32.4%) | 48 (34.5%) | 0.848 | 10 (33.3%) | 23 (38.3%) | 0.817 |
Child–Pugh score ≥ 7 | 0 (0%) | 0 (0%) | 1.000 | 0 (0%) | 0 (0%) | 1.000 |
ALBI grade 1 | 22 (59.5%) | 66 (47.5%) | 0.267 | 19 (63.3%) | 37 (61.7%) | 0.880 |
Albumin, median (g/dL) | 4.0 | 3.8 | 0.092 | 4.0 | 3.9 | 0.881 |
Total bilirubin, median (mg/dL) | 0.7 | 0.7 | 0.098 | 0.7 | 0.7 | 0.293 |
Baseline AFP ≥ 200 ng/mL | 18 (48.6%) | 97 (69.8%) | 0.020 | 15 (50.0%) | 28 (46.7%) | 0.825 |
Baseline AFP, median (ng/mL) | 101 | 28 | 0.049 | 103 | 107 | 0.355 |
Response Category | Lenvatinib n = 30 (%) | TACE n = 60 (%) | p-Value Odds Ratio (95% CI) |
---|---|---|---|
ORR | 22 (73.3%) | 20 (33.3%) | p < 0.001 |
5.39 (1.90–16.67) | |||
CBR(CR + PR + SD ≥ 24w) | 29 (96.7%) | 22 (36.7%) | p < 0.001 |
48.1 (7.01–2073.85) | |||
DCR | 30 (100.0%) | 32 (53.3%) | |
CR | 2 | 4 | |
PR | 20 | 16 | |
SD | 8 | 12 | |
Durable stable disease (SD ≥ 24w) | 7 | 2 | |
PD | 0 | 26 | |
NE | 0 | 2 |
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Kudo, M.; Ueshima, K.; Chan, S.; Minami, T.; Chishina, H.; Aoki, T.; Takita, M.; Hagiwara, S.; Minami, Y.; Ida, H.; et al. Lenvatinib as an Initial Treatment in Patients with Intermediate-Stage Hepatocellular Carcinoma Beyond Up-To-Seven Criteria and Child–Pugh A Liver Function: A Proof-Of-Concept Study. Cancers 2019, 11, 1084. https://doi.org/10.3390/cancers11081084
Kudo M, Ueshima K, Chan S, Minami T, Chishina H, Aoki T, Takita M, Hagiwara S, Minami Y, Ida H, et al. Lenvatinib as an Initial Treatment in Patients with Intermediate-Stage Hepatocellular Carcinoma Beyond Up-To-Seven Criteria and Child–Pugh A Liver Function: A Proof-Of-Concept Study. Cancers. 2019; 11(8):1084. https://doi.org/10.3390/cancers11081084
Chicago/Turabian StyleKudo, Masatoshi, Kazuomi Ueshima, Stephan Chan, Tomohiro Minami, Hirokazu Chishina, Tomoko Aoki, Masahiro Takita, Satoru Hagiwara, Yasunori Minami, Hiroshi Ida, and et al. 2019. "Lenvatinib as an Initial Treatment in Patients with Intermediate-Stage Hepatocellular Carcinoma Beyond Up-To-Seven Criteria and Child–Pugh A Liver Function: A Proof-Of-Concept Study" Cancers 11, no. 8: 1084. https://doi.org/10.3390/cancers11081084