Introduction
Methods
Patients
Study design and treatment
Study assessments
Statistical considerations
Results
Patient characteristics
Characteristic | Patients (N = 46) |
---|---|
Median age, years (range) | 66.5 (37–80) |
Sex, n (%) | |
Female | 13 (28.3) |
Male | 33 (71.7) |
Region, n (%) | |
Japan | 43 (93.5) |
South Korea | 3 (6.5) |
Median weight, kg (range) | 56.7 (42.8–85.5) |
ECOG PS, n (%) | |
0 | 38 (82.6) |
1 | 8 (17.4) |
Child Pugh Class, n (%) | |
A | 45 (97.8) |
B | 1 (2.2) |
BCLC staging, n (%) | |
B | 19 (41.3) |
C | 27 (58.7) |
Portal vein invasion, n (%) | |
Yes | 5 (10.8) |
No | 41 (89.1) |
Extrahepatic metastasis, n (%) | |
Yes | 21 (45.7) |
No | 25 (54.3) |
Cause of HCC, n (%) | |
Hepatitis B | 15 (32.6) |
Hepatitis C | 27 (58.7) |
Alcohol | 2 (4.3) |
Non-alcohol-related fatty liver disease | 1 (2.2) |
Unknown | 2 (4.3) |
AFP value at baselinea
| |
<200 ng/mL | 27 (57.7) |
≥200 ng/mL | 18 (39.1) |
Prior surgery for HCC, n (%) | |
No | 27 (58.7) |
Yes | 19 (41.3) |
Prior local therapy, n (%) | |
No | 4 (8.7) |
Yes | 42 (91.3) |
RFA | 32 (69.6) |
PEI | 12 (26.1) |
TACE | 39 (84.8) |
TAE | 3 (6.5) |
Prior chemotherapy, n (%) | |
Sorafenib | 6 (13.0) |
Other systemic chemotherapy | 5 (10.9) |
Hepatic intra-arterial chemotherapy | 5 (10.9) |
Efficacy
Response category | Investigator assessment (mRECIST), n = 46 | IRRC assessment (mRECIST), n = 46 | IRRC assessment (RECIST 1.1), n = 46 |
---|---|---|---|
Best response, n (%) | |||
Complete response | 0 (0) | 0 (0) | 0 (0) |
Partial response | 17 (37) | 17 (37) | 11 (24) |
Stable disease | 21 (46) | 19 (41) | 25 (54) |
Progressive disease | 5 (11) | 6 (13) | 6 (13) |
Not evaluable | 3 (7) | 4 (9) | 4 (9) |
Objective response rate, n (%) | 17 (37) | 17 (37) | 11 (24) |
Disease control rate, n (%) | 38 (83) | 36 (78) | 36 (78) |
Safety
Adverse event | Any grade, n = 46 | Grade 3, n = 46 | Grade 4, n = 46 |
---|---|---|---|
Hypertension | 35 (76.1) | 25 (54.3) | 0 |
Palmar-plantar erythrodysesthesia syndrome | 30 (65.2) | 4 (8.7) | 0 |
Decreased appetite | 28 (60.9) | 1 (2.2) | 0 |
Proteinuria | 28 (60.9) | 9 (19.6) | 0 |
Fatigue | 25 (54.3) | 0 | 0 |
Diarrhea | 20 (43.5) | 6 (13.0) | 0 |
Constipation | 19 (41.3) | 0 | 0 |
Nausea | 17 (37.0) | 1 (2.2) | 0 |
Dysphonia | 17 (37.0) | 0 | 0 |
Thrombocytopenia | 16 (34.8) | 9 (19.6) | 1 (2.2) |
Peripheral edema | 16 (34.8) | 0 | 0 |
Decreased weight | 14 (30.4) | 2 (4.3) | 0 |
Neutropenia | 13 (28.3) | 2 (4.3) | 0 |
Nasopharyngitis | 13 (28.3) | 0 | 0 |
Rash | 13 (28.3) | 0 | 0 |
Increased blood thyroid-stimulating hormone level | 12 (26.1) | 0 | 0 |
Back pain | 11 (23.9) | 0 | 0 |
Stomatitis | 11 (23.9) | 0 | 0 |
Vomiting | 11 (23.9) | 1 (2.2) | 0 |
Pyrexia | 10 (21.7) | 0 | 0 |
Hypothyroidism | 10 (21.7) | 0 | 0 |
Insomnia | 10 (21.7) | 0 | 0 |