Vol.1, No.1, 1-4 (2012) Modern Chemotherapy
Can we achieve complete remission in locally
advanced unresectable Hepatocellular Carcinoma
(HCC) by using Sorafenib? Case report and review
of literature from Qatar
Kakil Ibrahim Rasul
National Center for Cancer Care and Research (NCCCR), Doha, Qatar; kakil954@yahoo.com
Received 7 May 2012; revised 20 June 2012; accepted 18 July 2012
Patients with HCC continue to have a dismal
prognosis, with 1-year and 3-year survival rates
of 36 and 17%, respectively. This is in part re-
lated to more than two-thirds of tumors being
diagnosed at advanced stages, as well as a sub-
stantial portion of patients with early HCC failing
to receive potentially curative treatments. Sys-
temic therapy for advanced unresectable HCC
limited until the discovery of sorafenib, we are
reporting a 53 year patient with unresectable HCC
achieved complete remission clinically, radiolo-
gically and biochemically with sorafenib which
is the first case report.
Keywords: Hepatocellular Ca; Sorafenib;
Patients with HCC continue to have a dismal progno-
sis, with 1-year and 3-year survival rates of 36 and 17%,
respectively [1]. Sorafenib (Nexavar Payer-Schering) is
the only systemic therapy indicated to treat HCC, in two
Phase III studies (SHARP and Asia-Pacific). Sorafenib
significantly improved OS in patients with unresectable
HCC (uHCC) [2,3]. There is no report of complete re-
mission in all the studies used sorafenib in unresectable
The efficacy of sorafenib has been recently investi-
gated in a phase III trial, reported in abstract form at the
2007 American Society of Clinical Oncology meeting.
LLovet and colleagues randomized 602 patients with
Child Class A cirrhosis and hepatocellular carcinoma to
sorafenib versus placebo group [4]. The overall results
were encouraging. Treatment with sorafenib significantly
improved survival (hazard ratio for all cause mortality:
0.69, P = 0.0006). Treatment was also associated with an
increased time to disease progression (5.5 mo vs 2.8 mo)
and disease control rate (43% versus 32%). But there is
no complete remission in these studies. Overall toxicity
did not differ between treatment and placebo arm (52%
versus 54%). Based on this trial, sorafenib has become
the most promising chemotherapeutic agent in the treat-
ment of hepatocellular carcinoma in patients with pre-
served liver function.
A 53 years male Egyptian known non insulin depen-
dent diabetes mellitus (NIDDM) on Metformin 500 mg
orally twice daily since 6 years, and HCV + ve Chronic
smoker1pack/day since 35 years On December 2010 dur-
ing follow up ultrasound examination found to have fo-
cal lesion in the liver He had mild right hypochondrial
pain which dull in nature not radiating and no associated
symptoms, his ECOG (Eastern Cooperative Oncology
Group performance status) PS is 0, Child-pugh assess-
ment of the liver scored A. laboratory tests, AFP 13,241
I.U/L, normal kidney function, complete blood picture
and PT, APPT. after nearly 4 weeks AFP level raised to
21,227 I.U/L, CT Scan showed cirrhotic liver with large
lesion (6 × 7 cm) in the right lobe of the liver with typi-
cal radiological features of HCC (arterial enhancement
and venous wash out) (Figure 1). He had first session of
Tans-arterial chemo-embolization on mid Feb 2011, CT
scan repeated after 2 weeks showed marked enlargement
of the lesion become involving nearly whole right lobe of
the liver with thrombosis of the right branch of the portal
vein (Figure 1), AFP level raised to 48,928 I.U/L, so
further local treatment was stopped and patient started on
Sorafenib 400 mg orally twice daily on 7 March 2011.
By June 2011 his AFP was back to normal and his CT
scan showed dramatic decrease in size of the tumor and
maintained normal AFP (Figure 2) till now and his last
CT scan on Jan, 2012 show nearly complete remission of
the lesion and recanalization of the left main portal vein
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K. I. Rasul / Modern Chemotherapy 1 (2012) 1-4
Figure 1. CT scan Jan 2011 showed big
lesion in the right lobe of the liver.
Figure 2. After chemoemb & before sorafennib.
Figure 3. After sorafeninb.
(Figure 3). He developed the usual side effects which are
reported from the previous studies of sorafenib, skin rash,
hand foot syndrome (Figure 4), hypertension and fatigue.
Patients with hepatocellular carcinoma (HCC) have a
poor prognosis, with a 5-year survival rate of less than
5% and a median survival rate of less than 4 months if
the disease is unresectable [5-7]. Indeed, curative treat-
ment (liver transplantation, surgical resection, percuta-
neous ablation) can only be performed in less than 25%
of patients. This is either because of contraindications to
surgery (advanced cirrhosis in particular), the presence of
locally advanced disease (multifocal lesions, invasion of
the portal vein), or, more rarely, technical reasons (lesion
difficult to access, subcapsular or diaphragmatic loca-
tion). For locally advanced unresectable HCC until re-
cently we have limited option for treatment of such cases,
systemic chemotherapy either as single agent or in com-
bination were not helpful. We introduction of sorafenib
lead to hope for such patients. In the phase 3 Sorafenib
HCC Assessment Randomized Protocol (SHARP) trial
that randomized patients with advanced HCC to sora-
fenib versus placebo patients with Child-Pugh A were
allowed to be on the study as were patients with micro-
scopic vascular disease or extrahepatic disease and an
Eastern Cooperative Oncology Group (ECOG) perfor-
mance status of 0 to 2. Patients were allowed to be ran-
domized to sorafenib or placebo and to stay in the study
until radiologic progression and also clinical progression.
This study showed an improvement in survival for the
sorafenib arm of 10.7 months versus 7.9 months with
placebo with a clinical significance and statistical signi-
ficance depicted by hazard ratio of 0.69 and a P value of
0.00058 [1]. Another study Asian pacific study Im-
provement in OS for the patients randomized to sorafenib
in the Asia-Pacific Study was consistent with the SHARP
Trial as indicated by hazard ratios for survival (HR: 0.68
and 0.69, respectively), Like the SHARP Trial, the Asia-
Pacific Study was stopped early and patients taking pla-
cebo crossed over to receive Nexavar [1,2]. We are re-
porting a case with HCV who developed HCC which was
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K. I. Rasul / Modern Chemotherapy 1 (2012) 1-4
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Figure 4. AFP level during treatment, Nov. 2011-Jan. 2012.
Figure 5. Side effects of sorafenib mouth ulcers, hand foot syndrome and skin rash.
rapidly progressing over 2 months and did not benefit
from local treatment (TACE) who responded dramatically
to sorafeinib and maintained this response near complete
remission for more than 6 months now. It 1st case of com-
plete remission, none of the previous study reported com-
plete remission with sorafenib treatment. He developed
the known side effects of sorafenib as skin rash, hyper-
tension and fatigue (Figure 5).
This is the first case of HCV associated HCC reporting
complete remission with sorafenib.
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