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so he/she was excluded from the study, we were unable to in patients with HCC of Barcelona Clinic Liver Cancer (BCLC)
contact either 8 since no contact details were available, the stage C. The combination of sorafenib with transplantation
rest of 41 patients were included in the study. They were or resection, either sequential or concomitant, cannot be
followed up for about 4 months that is January 2015 to April recommended outside clinical trials; however, sorafenib
2015. Median overall survival was 3.8 months, ranging from can be given for residual/recurrent disease after surgery/
12 to 885 days. The baseline characteristics and median transplant/TACE/RFA. [2]
overall surveillance are listed in Table 1.
Køstner et al. conducted a retrospective study with
[10]
For some patients physicians done ablative therapies like 76 patients in 2011 in Denmark found that patients in
transarterial chemoembolization (TACE) and radiofrequency performance status 0-1 had a median overall survival of
ablation (RFA) were done, the details regarding that were 6.2 months compared to 1.8 months in patients with
like as follows, for around 3 patients RFA was done, around poorer performance status. Child-Pugh A patients had
4 were undergone for TACE, for around 2 patients were median overall survival of 6.6 months versus 3.6 months
done with both TACE and RFA. For the rest of their details among patients with Child-Pugh B or C.
was not available. Usually, sorafenib was given as 400 mg
bid. In our patient population mainly 3 types of dosing In this study, we found that the efficacy was depending
regimen were used. They are 400 mg bd, 600 mg daily, and upon the survival rate which has depended on upon the
200 mg bid. They were given to the patients in the following liver functions which can be determined through liver
manner 30 (73.17%), 1 (2.44%), and 10 (24.39%) respectively. function test and haematological parameters.
Among this population due to the ADR, dose reduction was
done in 3 patients from 400 mg bid to 200 mg bd, and 2 Ji et al. conducted an open-label randomized study
[11]
was ceased and continued. Apart from this, all the patients with 189 patients with advanced HCC Child-Pugh B or
showed good compliance with the therapy. C HCC patients into 2 groups, one with sorafenib and
other with best supportive care. Median overall survival
Treatment outcome was 4 months and 3.5 months in the sorafenib group and
The overall survival in our population was estimated best supportive care group respectively. In the sorafenib
using the Kaplan-Meier method using statistical software group, the median performance status and overall
SPSS 16.0 for Windows. The overall survival was found as survival were significantly longer in patients with BCLC
114 days. The Kaplan-Meier curve for each criterion was stage B and Child-Pugh class B liver function.
illustrated in Figure 1.
In this study, Child-Pugh B has more median overall
The efficacy of the drug sorafenib was assessed by the survival when compared to Child-Pugh C, 125 days and 66
changes in laboratory values such as haematological and days respectively. The overall median survival was shown
clinical biochemistry. The haemoglobin level was found to to be similar to the above study that was 3.8 months.
be increased in 34 (82.9%) patients and no changes were
observed in 7 (17.1%) patients. The platelet count was found Llovet et al. conducted randomized double-blind
[12]
to be raised in 30 (73.2%) patients and no observed changes placebo-controlled phase 3 trial at 121 centres in 21
were found in 11 (26.8%) patients. The WBC count was found countries in Europe, North America, South America,
to be decreased in 30 (73.2%) and no observed change was and Australia in 602 patients. The study shows that the
found in 11 (26.8%) patients. While looking to clinical liver median overall survival was 10.7 months in sorafenib
parameters the bilirubin level was reduced for 19 (46.3%) group and 7.9 months in the placebo group. The median
patients and increased in 22 (53.7%) patients. That may be time to radiological progression was 5.5 months in
due to adverse reaction to the drug (hyperbilirubinemia). sorafenib group and 2.8 months in the placebo group.
The albumin level was found to be increased in 26 (63.4%)
patients and no observed changes were found in 15 (36.6%). In this study about 8 patients had good survival (558 days
The AST level was found to be decreased in 32 (78%) patients to 885 days, in which sorafenib was highly effective.
and no observed changes were found in 9 (22%) patients.
[10]
The ALP level was found to be decreased in 32 (78%) patients Køstner et al. conducted a retrospective study in 2011 in
and no observed changes were found in 9 (22%) patients. Denmark with 76 patients in that they found that fatigue
The ALT level was found to be reduced in 33 (80.5%) patients (68%) was the main ADR followed by anorexia (47%);
and no observed changes were found in 8 (19.5%) patients. diarrhoea (42%); rash (33%); nausea (32%); and hand-foot
Therefore the efficacy of the drug sorafenib has been proved syndrome (28%). Sorafenib is generally tolerable also in more
from the favourable changes in the laboratory values of the compromised patients as the number and grade of adverse
patients. ADRs found was illustrated in Table 2. events did not differ significantly between the patients with
good versus poor performance status and liver function.
DISCUSSION
In this study, main ADRs were fatigue, anorexia, diarrhoea,
In Indian population, therapy with sorafenib was indicated rash, nausea, hand-foot syndrome. Dose reduction was made
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