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Page 4 of 11 Tsutsui et al. Hepatoma Res 2018;4:13 I http://dx.doi.org/10.20517/2394-5079.2018.20

classification, histologic grade, and the degree of liver cirrhosis were collected. The therapeutic effect was
[24]
classified into 4 categories based on the Japanese breast cancer society criteria .

Follow-up
Laboratory variables such as serum AFP, serum DCP, serum albumin, serum total bilirubin, serum AST,
serum ALT, prothrombin time, and C-reactive protein levels and platelet counts were measured for both
groups on postoperative days 1, 3, 7, and 30.

After discharge from our hospital, all patients were followed up in the outpatient clinic. Ultrasonography,
4-phase CT, or dynamic contrast-enhanced MRI was performed every 2 to 3 months, and serologic tests
such as AFP and DCP measurements were performed at that time. In cases of recurrence, the patients were
treated accordingly.

Survival was defined as the time from surgery to death, and disease-free survival (DFS) was defined as the
time from surgery to either recurrence or death. Patients who were alive and free of recurrence at the end of
[22]
follow-up were censored for DFS .
Statistical analysis
Continuous data were presented as the mean ± standard deviation or median and range and were compared
2
using the t-test or Mann-Whitney’s U test, respectively. Categorical data were compared using Pearson’s χ
test or Fisher’s exact test, as appropriate.

The Kaplan-Meier method was used to calculate the survival curves, and the log-rank test was used to
assess the prognostic predictors of DFS. Variables with P < 0.10 in univariate analysis were included in the
multivariate analysis.

Differences were considered significant when the 2-sided P-value was < 0.05. Descriptive statistical analyses
were performed using the IBM statistical package for the social sciences, version 20.0 (SPSS, IBM Co.,
Armonk, NY, USA).

RESULTS
The baseline characteristics of the patients are shown in Table 1. No significant differences were observed
between the 2 groups.

Outcomes and complications associated with neoadjuvant HAIC
In the treatment group, all catheterization procedures were performed without critical complications. The
median procedure time for implantation of the system was 80 min (range 43-180 min). The system was
successfully implanted and used for treatment in all patients. The median catheter dwell time was 10 days
(range 9-13 days). The median time to surgery after catheter removal was 21 days (range 12-34 days). Major
complications associated with a temporary indwelling catheter system, such as hematoma, bleeding, hepatic
arterial occlusion, dislocation of the catheter, and thrombosis, did not occur. Infection was suspected
in 1 patient (7.7%), and fever and flares in the left brachial artery appeared 8 days after the procedure in
this patient. The patient’s symptoms improved soon after catheter removal, which was 9 days after the
chemotherapy [Table 2]. One patient (7.7%) experienced CTCAE grade 2 gastritis. The most common side
effects were nausea and loss of appetite; however, these symptoms were mostly CTCAE grade 1/2, and they
resolved after chemotherapy was completed.

The mean plasma AFP and DCP levels tended to decrease following neoadjuvant HAIC (415.3 ± 1086 ng/mL
and 451.4 ± 892.4 mg/mL, respectively, prior to HAIC vs. 158.8 ± 404.7 ng/mL and 118.0 ± 237.9 mg/mL,
respectively, after HAIC; P = 0.468 and P = 0.243, respectively), but the differences were not significant. No