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©The Author(s) 2021.
World J Gastroenterol. Aug 28, 2021; 27(32): 5424-5437
Published online Aug 28, 2021. doi: 10.3748/wjg.v27.i32.5424
Published online Aug 28, 2021. doi: 10.3748/wjg.v27.i32.5424
Table 1 Baseline characteristics of patients in Groups A, B, and C
Group A (n = 41) | Group B (n = 30) | Group C (n = 63) | P value | |
Age (yr) | 70 (43–89) | 67 (41–87) | 69 (48–87) | 0.233 |
Sex | ||||
Male, n (%) | 33 (80.5) | 22 (73.3) | 44 (69.8) | 0.481 |
Child-Pugh class, n (%) | 0.288 | |||
A | 33 (80.5) | 27 (90.0) | 57 (90.5) | |
B | 8 (19.5) | 3 (10.0) | 6 (9.5) | |
Etiology, n (%) | ||||
HCV | 22 (53.7) | 11 (36.7) | 44 (69.8) | 0.235 |
HBV | 9 (21.9) | 10 (33.3) | 11 (17.5) | 0.417 |
Other | 10 (24.4) | 9 (30.0) | 8 (12.7) | 0.109 |
Portal vein thrombosis | 14 (34.1) | 10 (33.3) | 11 (17.5) | 0.099 |
Extrahepatic spread, n (%) | 20 (48.8) | 19 (63.3) | 28 (44.4) | 0.230 |
AFP (ng/mL), n (%) | ||||
> 400 | 17 (41.5) | 17 (56.7) | 29 (46.0) | 0.437 |
BCLC staging, n (%) | 0.333 | |||
Stage B | 15 (36.6) | 10 (33.3) | 30 (47.6) | |
Stage C | 26 (63.4) | 20 (66.7%) | 33 (52.4) | |
ECOG performance status, n (%) | 0.955 | |||
0 | 30 (75.6) | 22 (73.3) | 46 (73.0) | |
1 | 10 (24.4) | 8 (26.7) | 17 (27.0) | |
Total bilirubin (mg/dL) | 0.99 ± 0.36 | 0.91 ± 0.37 | 0.83 ± 0.33 | 0.052 |
Albumin (g/L) | 3.61 ± 0.50 | 3.73 ± 0.54 | 3.82 ± 0.49 | 0.301 |
INR | 1.14 ± 0.11 | 1.15 ± 0.16 | 1.14 ± 0.19 | 0.481 |
Pre-sorafenib TACE procedures, n (%) | 0.531 | |||
0 | 13 (31.7) | 9 (30.0) | 20 (31.8) | |
1 | 3 (7.3) | 6 (20.0) | 13 (20.6) | |
2 | 6 (14.6) | 1 (3.3) | 4 (6.4) | |
3 | 4 (9.8) | 2 (6.7) | 8 (12.7) | |
4 | 5 (12.2) | 3 (10.0) | 12 (19.0) | |
> 5 | 10 (24.4) | 9 (30.0) | 6 (9.5) |
Table 2 Prevalence of adverse events after beginning sorafenib, according to CTCAE version 5.0, n (%)
Group A (n = 41) | Group B (n = 30) | Group C (n = 63) | ||||||||||
All grades | Grade 1 | Grade 2 | Grade 3 | All grades | Grade 1 | Grade 2 | Grade 3 | All grades | Grade 1 | Grade 2 | Grade 3 | |
Any adverse event | 37 (90.2) | 30 (73.2) | 18 (43.9) | 5 (12.2) | 30 (100) | 28 (93.3) | 24 (80.0) | 14 (46.6) | 63 (100) | 58 (92.1) | 36 (57.1) | 14 (22.2) |
Hand-foot skin reaction | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 30 (100) | 15 (50.0) | 10 (33.3) | 5 (16.7) | 63 (100) | 39 (61.9) | 19 (30.2) | 5 (7.9) |
Anemia | 17 (41.5) | 8 (19.5) | 8 (19.5) | 1 (2.4) | 20 (66.6) | 13 (43.3) | 4 (13.3) | 3 (10.0) | 23 (36.5) | 14 (22.2) | 7 (11.1) | 2 (3.2) |
Diarrhea | 15 (36.6) | 12 (29.3) | 3 (7.3) | 0 (0) | 11 (36.6) | 9 (30.0) | 1 (3.3) | 1 (3.3) | 27 (42.8) | 21 (33.3) | 2 (3.2) | 4 (6.3) |
Fatigue | 14 (34.1) | 10 (26.8) | 3 (7.3) | 0 (0) | 11 (36.6) | 7 (23.3) | 4 (13.3) | 0 (0) | 16 (25.4) | 10 (15.9) | 6 (9.5) | 0 (0) |
Anorexia | 14 (34.1) | 10 (24.4) | 3 (7.3) | 1 (2.4) | 7 (23.3) | 5 (16.7) | 1 (3.3) | 1 (3.3) | 19 (30.1) | 15 (23.8) | 4 (6.3) | 0 (0) |
Hypertension | 12 (29.3) | 10 (24.4) | 2 (4.9) | 0 (0) | 7 (23.3) | 2 (6.6) | 5 (16.7) | 0 (0) | 23 (36.5) | 16 (25.4) | 4 (6.3) | 3 (4.8) |
Thrombocytopenia | 9 (22.0) | 2 (4.9) | 4 (9.7) | 3 (7.3) | 23 (76.7) | 10 (33.3) | 8 (26.7) | 5 (16.7) | 20 (31.7) | 10 (15.9) | 5 (7.9) | 5 (7.9) |
Alopecia | 6 (14.6) | 4 (9.7) | 2 (4.9) | 0 (0) | 2 (6.6) | 2 (6.6) | 0 (0) | 0 (0) | 20 (31.7) | 19 (30.2) | 1 (1.6) | 0 (0) |
Hepatic encephalopathy | 1 (2.4) | 0 (0) | 1 (2.4) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Table 3 Dose modification related to adverse events
Group A (n = 41) | Group B (n = 30) | Group C (n = 63) | Group A vs Group B, P value | Group A vs Group C, P value | Group B vs Group C, P value | |
Dose reduction to initial dose of sorafenib | 8/41 (19.5%) | 2/30 (6.7%) | 26/63 (41.3%) | 0.700 | 0.108 | 0.005 |
Re-escalation to initial dose of sorafenib | 2/8 (25.0%) | 2/2 (100.0%) | 2/26 (7.7%) | NA | NA | NA |
Table 4 Radiological response according to the modified response evaluation criteria in solid tumors
Group A (n = 41) | Group B (n = 30) | Group C (n = 63) | |
Complete response | 0 | 1 | 1 |
Partial response | 1 | 1 | 5 |
Stable disease | 10 | 11 | 35 |
Progressive disease | 30 | 17 | 22 |
Response rate | 2.4% | 6.7% | 9.5% |
Disease control rate | 26.8% | 43.3% | 65.1% |
Table 5 Reasons for permanent sorafenib discontinuation, n (%)
Group A (n = 41) | Group B (n = 30) | Group C (n = 63) | Group A vs Group B, P value | Group A vs Group C, P value | Group B vs Group C, P value | |
Progression | 26 (63.4) | 7 (23.3) | 33 (52.4) | 0.006 | 1.000 | 0.046 |
Intolerance | 7 (17.1) | 18 (60.0) | 13 (20.6) | 0.002 | 1.000 | 0.001 |
Liver failure | 6 (14.6) | 3 (10.0) | 8 (12.7) | 1.000 | 1.000 | 1.000 |
Other | 2 (4.9) | 2 (6.7) | 9 (14.3) | 1.000 | 0.690 | 1.000 |
Table 6 Prognostic factors of overall survival by multivariable Cox regression analysis
Univariate analysis | Multivariate analysis | |||||
HR | 95%CI | P value | HR | 95%CI | P value | |
Age (within 70 yr) | 0.867 | 0.603–1.246 | 0.440 | - | - | - |
Male | 1.216 | 0.802–1.842 | 0.357 | - | - | - |
Etiology (HBV) | 1.313 | 0.809–2.133 | 0.271 | - | - | |
BCLC stage B | 0.667 | 0.459–0.969 | 0.033 | 0.601 | 0.405–0.891 | 0.011 |
Portal vein thrombosis | 1.677 | 1.092–2.575 | 0.018 | 1.133 | 0.674–1.903 | 0.638 |
Extrahepatic spread | 0.740 | 0.509–1.074 | 0.113 | 0.671 | 0.419–1.076 | 0.098 |
AFP (> 400 ng/mL) | 1.282 | 0.893–1.839 | 0.178 | 1.370 | 0.936–2.006 | 0.105 |
ECOG Performance status 1 | 0.752 | 0.488–1.158 | 0.196 | 1.042 | 0.636–1.708 | 0.869 |
Group A vs Group B | 0.703 | 0.431–1.147 | 0.159 | 0.658 | 0.398–1.088 | 0.103 |
Group A vs Group C | 0.431 | 0.281–0.663 | < 0.001 | 0.407 | 0.253–0.654 | < 0.001 |
Sorafenib administration period (second half vs first half) | 1.205 | 0.840–1.728 | 0.311 | - | - | - |
Table 7 Prognostic factors of time-to-treatment failure by multivariable Cox regression analysis
Univariate analysis | Multivariate analysis | |||||
HR | 95%CI | P value | HR | 95%CI | P value | |
Age (within 70 yr) | 1.059 | 0.747–1.501 | 0.747 | - | - | - |
Male | 0.926 | 0.625–1.372 | 0.703 | - | - | - |
Etiology (HBV) | 1.208 | 0.768–1.901 | 0.413 | - | - | - |
BCLC stage C | 1.311 | 0.921–1.866 | 0.132 | - | - | - |
Portal vein thrombosis | 1.379 | 0.925–2.056 | 0.115 | 1.011 | 0.662–1.545 | 0.958 |
Diarrhea | 0.675 | 0.473–0.965 | 0.031 | 0.654 | 0.449–0.952 | 0.027 |
Hypertension | 1.070 | 0.735–1.556 | 0.725 | - | - | - |
ECOG Performance status 1 | 0.687 | 0.446–1.058 | 0.089 | 0.725 | 0.463–1.135 | 0.159 |
Group B vs Group A | 1.670 | 1.034–2.698 | 0.036 | 1.694 | 1.044–2.748 | 0.033 |
Group C vs Group A | 0.495 | 0.328–0.747 | < 0.001 | 0.529 | 0.346–0.811 | 0.003 |
Sorafenib administration period (second half vs first half) | 0.980 | 0.694–1.384 | 0.908 | - | - | - |
Table 8 Prognostic factors of proportion of days covered by logistic regression analyses
Adjusted analyses | |||
OR | 95%CI | P value | |
Male | 0.352 | 0.141–0.877 | 0.025 |
Child-Pugh stage B | 3.830 | 1.180–12.400 | 0.025 |
Diarrhea | 0.472 | 0.198–1.120 | 0.089 |
Group B vs Group A | 0.113 | 0.036–0.356 | < 0.001 |
Group B vs Group C | 0.091 | 0.031–0.266 | < 0.001 |
- Citation: Ochi M, Kamoshida T, Araki M, Ikegami T. Prolonged survival in patients with hand-foot skin reaction secondary to cooperative sorafenib treatment. World J Gastroenterol 2021; 27(32): 5424-5437
- URL: https://www.wjgnet.com/1007-9327/full/v27/i32/5424.htm
- DOI: https://dx.doi.org/10.3748/wjg.v27.i32.5424