Page 98 - Read Online
P. 98

test was performed to test for homogeneity of      Table 1: Baseline characteristics of 38 patients included in
            variances. Homogeneous variances were indicated    the study
            as a mean plus or minus SD (mean ± SD) and the      Variable                          n = 38
                                                                Sex (male/female)
                                                                                                   35/3
            Student’s  t-test was used for statistical analysis. If   Age (years)                53.3 ± 11.1
                                                                ECOG PS
            the variances were not homogeneous, they were         0                                 32
                                                                  1
            presented as median in combination with the         BCLC stage                          6
            range. Categorical variables were compared using      B                                 18
                                                                                                    20
                                                                  C
            the Chi-square test with Yates correction or the    Arterial supply of the tumor
                                                                                                    17
            Fisher exact test where appropriate. P < 0.05 was     Good                              21
                                                                  Poor
            considered  significantly.  Hazard ratios  (HRs) and   Portal invasion
            their corresponding 95% confidence interval (CI) were   Yes                             14
                                                                                                    24
                                                                  No
            calculated using simple logistic-regression analysis.  Extrahepatic metastasis          9
                                                                  Yes
                                                                  No                                29
            Survival rates were obtained by the Kaplan-Meier    Collaborative treatment             30
                                                                  TACE
                                                                  None
            method  and were  compared using  the  log-rank     Hepatitis background                8
            test. Cox regression model was used to analyze the    Hepatitis B                       36
                                                                  Hepatitis C
            prognostic predictors for survival.  Survival time   Vascular thrombus                  2
            started from the date of treatment  with sorafenib    Presence                          12
                                                                                                    26
                                                                  Absence
            until death or the closing date. The closing date of   Tumor size                     8.1 ± 3.1
            this study was August 31, 2011.                     AFP (ng/mL)                   205.1 (2-2,483,000)
                                                                                                 15.0 ± 7.6
                                                                Total bilirubin (umol/L)
                                                                Albumin (g/L)                    39.3 ± 4.6
            RESULTS                                             Pre-albumin (mg/L)              144.0 ± 46.0
                                                                                                 48.3 ± 65.9
                                                                ALT (IU/L)
                                                                AST (IU/L)                       55.3 ± 49.3
                                                                                                 12.5 ± 1.1
            Baseline characteristics                            PT (s)                           5.43 ± 0.69
                                                                BUN (mmol/L)
            Among the 38 patients treated with sorafenib, mean   Cr (umol/L)                    69.18 ± 11.61
            age was 53.3 ± 11.1 years and 35 (92.1%) were males.   ECOG PS: Eastern Cooperative Oncology Group Performance Status; BCLC:
                                                               Barcelona Clinic Liver Cancer; TACE: transarterial chemoembolization;
            All the patients had viral hepatitis background, with   AFP: alpha-fetoprotein; ALT: alanine aminotransferase; AST: aspartate
            a hepatitis B prevalence of 94.7%.  The baseline   aminotransferase; PT: prothrombin time; BUN: blood urea nitrogen; Cr: creatinine
            characteristics of the 38 patients are shown in Table   12.7) and the  1-year  OS  was  41.0%. On  univariate
            1. Tumors in 17 patients were classified as good   analysis [Table 2], the MST and 1-year OS in patients
            arterial  supply  while  the  other  patients  belonged   with good arterial supply of tumors were 12 months
            to  poor  arterial supply according  to the  judgment   (range: 4-20 months) and 52.9%, compared with
            of the radiologist. A total of 30 patients received 1   that of 7 months (range: 1-16 months) and 23.8% in
            time additional therapy of TACE during the period of   patients  with  poor arterial  supply of  tumors  (P  =
            follow-up, of which 13 patients with a good arterial   0.002). Similarly, patients who had tumors at BCLC
            supply of the tumors and 17 with poor arterial supply.  stage B had longer MST and higher OS than those
                                                               who had tumors at BCLC stage C. However, there was
            Safety and adverse events                          no statistically significant difference between these
            Each patient experienced at least one adverse event   two stages.
            in the duration of sorafenib administration.  Hand-
            foot skin reaction and diarrhea were the most      Eight variables were selected on multivariate analysis
            common discomforts complained by the patients.     to determine the prognostic predictors for survival
            Less  common  adverse  effects  included  fatigue,   in  patients  treated  with  sorafenib  [Table  3]. Only
            alopecia, hypertension, and diabetes.  A total of 6   arterial supply of the tumors remained statistically
            patients had dose reduction due to severe adverse   predictive for OS (HR: 0.22, 95% CI, 0.07-0.67, P =
            events,  of which 3 for diarrhea and 3 for hand-   0.008).
            foot skin  reaction.  None  of the  patients  had drug
            discontinuation.                                   DISCUSSION

            Survival analysis                                  As a highly vascularized neoplasm, most HCCs exert
            At the closing date of this study, 29 (76.3%) patients   imaging characteristics of intense contrast uptake
            died and 9 patients were still alive. The median   in the arterial phase, followed by contrast washout
            survival time (MST) was 10.7 months (95%  CI, 8.7-  in the delayed venous phase at dynamic imaging by


                  Hepatoma Research | Volume 2 | April 1, 2016                                             89
   93   94   95   96   97   98   99   100   101   102   103