Can we achieve complete remission in locally advanced unresectable Hepatocellular Carcinoma (HCC) by using Sorafenib? Case report and review of literature from Qatar

doi:10.4236/mc.2012.11001

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Vol.1, No.1, 1-4 (2012) Modern Chemotherapy

http://dx.doi.org/10.4236/mc.2012.11001

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; [email protected]

Received 7 May 2012; revised 20 June 2012; accepted 18 July 2012

ABSTRACT

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;

Chemoembolization

1. INTRODUCTION

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

HCC.

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.

2. CASE PRESENTATION

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

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.

3. DISCUSSION

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

K. I. Rasul / Modern Chemotherapy 1 (2012) 1-4

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).

4. CONCLUSION

This is the first case of HCV associated HCC reporting

complete remission with sorafenib.

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