International Journal of Cancer and Oncology Int J Cancer Oncol

International Journal
of Cancer and Oncology
Int J Cancer Oncol | Volume 4: Issue 1
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Introduction
Globally, Hepatocellular Carcinoma (HCC) is the fifth
most common cancer of all malignancies and the third most
common cause of cancer-related mortality in the world. In both
developing and developed countries, the incidence of HCC has
significantly increased over the recent decades
1,2. In Egypt, liv-
er is the commonest site of cancer in males (18.7%) and the third
most common site in females (4.6%)
3. Development of HCC
generally occurs due to different underlying risk factors e.g.
Copyrights: © 2017 Abdelmaksoud, B.A. This is an Open access article distributed under the terms of Creative
Commons Attribution 4.0 International License.
1
Bader A. Abdelmaksoud*, Mostafa M. Toam, Alaa A. Fayed
*Corresponding author: Bader A. Abdelmaksoud, Department of clinical oncology and nuclear medicine, Faculty of Medicine,
Zagazig university, Zagazig, Egypt, E-mail: [email protected]
Department of clinical oncology and nuclear medicine, Faculty of Medicine, Zagazig university, Zagazig, Egypt
Research Article Open Access
Safety and Efficacy of Low-Dose Doxorubicin and Fluorouracil
(5FU) with Best Supportive Care Compared To Best Supportive
Care Alone for Patients with Advanced Hepatocellular Carcinoma
Abstract
Aim:To evaluate the safety and efficacy of low-dose doxorubicin and 5FU with best
supportive care compared to best supportive care alone for patients with advanced
hepatocellular carcinoma.
Patients and methods: Atotal of 60 patients (49 male and 11 females) with advanced
hepatocellular carcinoma were enrolled. All patients were randomly divided into two
groups. Treatment group: patients receive one day cycle of intravenous doxorubicin
20 mg/m
2 and 5FU 500 mg along with best supportive care, the cycle repeated every
two weeks continuously until disease progression, unacceptable toxicity or patient
refusal. Control group (best supportive care only): Patients received supportive treat-
ment in the form of liver support, tonics, and other symptomatic treatment until death
or patient refusal.
Results: After a median follow- up of one year, all patients died except three patients
still alive. There were 5 patients (16.7%) in treatment group (group A) achieved Par-
tial Response(PR) compared to No Response (NR) in all patients (100%) of control
group (group B )(P -value 0.052). the median Progression Free Survival (PFS) was 5
months in group A and 3.5 months in group B, ( P- value 0.018), also, in group A the
median Overall Survival (OS) was 8 months compared to 6 months in group B, with
one year (OS) rates 9.4% and 3.7% in group A and B respectively (P-value 0.125).
there were minimal treatment-related toxicities, and all patients completed treatment
without interruption.
Conclusion: Low dose doxorubicin with 5FU are well tolerated and shows modest
anti- tumor efficacy in patients with advanced hepatocellular carcinoma.

Keywords: Hepatocellular carcinoma; Low dose doxorubicin; 5FU
Received Date: October 31, 2016
Accepted Date: January 06, 2017
Published Date: January 13, 2017
Citation: Abdelmaksoud, B.A., et al.
Safety and Efficacy of Low-Dose Doxoru-
bicin and Fluorouracil (5FU) with Best Sup-
portive Care Compared To Best Supportive
Care Alone for Patients with Advanced He-
patocellular Carcinoma. (2017) Int J Cancer
Oncol 4(1): 1- 8.
DOI: 10.15436/2377-0902.17.1194
Abdelmaksoud, B.A., et al.
cirrhosis, hepatitis C and B viruses, hemochromatosis, Wilson’s
disease, biliary cirrhosis, and other abnormal liver conditions4
. After diagnosis of HCC, surgery such as surgical resection or
transplantation is considered a potentially curative method for
HCC treatment, but it is only applicable to small proportion of
patients, for patients with localized unresectable HCC, localized
therapy, such as percutaneous thermo-ablation or transarterial
chemoembolization, has been reported to be useful for treating
such patients, but in most cases, the disease recurs or progresses
to an advanced stage for which local treatments are in effective

2
or not applicable, therefore, these groups of patients are in need
for systemic therapy5,6. For patients presenting with locally ad-
vanced or metastatic HCC, there is no approved systemic treat-
ment except sorafenib
7. The role of systemic chemotherapy for
advanced or metastatic HCC has not been established despite
numerous chemotherapeutic agents have been investigated
8.
Results of prospective phase II/III clinical trials to investigate
the efficacy of doxorubicin in advanced HCC showed that doxo-
rubicin can be effective in about 20% of cases when used as
single agent but without Overall Survival (OS) advantages
9-12.
Fluorouracil (5-FU) was also commonly used and had
undergone extensive evaluation in hepatocellular carcinoma
with response rates around10% in many phase II clinical stud-
ies
13-15. Regarding to combination chemotherapy, until now no
combination has been proven to have higher activity compared
to single agents
16. Based on the results of randomized trials and
retrospective studies that tested the role of doxorubicin and 5FU
in treatment of advanced HCC, we conducted this study to eval –
uate the safety and efficacy of low-dose doxorubicin when com-
bined with 5FU along with supportive measures compared with
best standard of care for cases had advanced HCC not suitable
for curative local therapies.
Patients and Methods
Patients eligibility
Patients had hepatocellular carcinoma confirmed by bi-
opsy, typical radiological criteria applicable in HCC and/or level
of alpha fetoprotein above 200 ng/ml were enrolled. Regarding
staging, Patients had either distant metastases or non metastat –
ic locally advanced disease not suitable for other therapeutic
modalities involved in management of HCC e.g chemoembo –
lization and sorafenib due to any cause. Other inclusion criteria
were age ; 18 years, ECOG performance status ? 2, adequat liv-
er reserve Child-Pugh score of A, bilirubin 2.0 mg/dL or less,
transaminases level 4 times or lower than upper limit of normal
(ULN), adequate renal and bone marrow function specifically
serum creatinine level 2.0 mg/dL or less, platelets ? 100,000 /
mm
3, neutrophil count ? 1000/mm3, hemoglobin ? 10g/dL. The
main exlusion criteria include Child-Pugh class B or C, chronic
active hepatitis B not treated, and/or patients suitable for cura-
tive local treatments measures ( liver transplantation, resection,
percutaneous ablative therapy), poor cardiac reserve(EF ; 60%)
and other malignancies in the body elsewhere. Written informed
consent was taken.
Treatment schedule
For patients met the above inclusion criteria, they were
randomly divided into two groups. Experimental group: patients
receive intravenous doxorubicin 20 mg/m
2 and 5FU 500 mg, one
day cycle. The cycle repeated every two weeks continuously un-
til disease progression, unacceptable toxicity or patient refus-
al. In between chemotherapy cycles, patients were maintained
on supportive treatment also. Control group (best supportive
care only): Patients received supportive treatment in the form
of liver supports, tonics, and other symptomatic treatment until
death or patient refusal. Before starting treatment, patients were
subjected to full medical history and physical examination, per-
formance status assessment, evidence of recent weight loss and
other comorbidities as cardiac diseases. Other studies included a full
and differential blood count, kidney and liver function tests,
Alpha Feto Protien (AFP), pelvi- abdomial CT scan,and chest
X- ray.
Treatment evaluation and follow- up
The patients were monitored during treatment every
week by physical examination for determination of patient’s
compliance to treatment and possible side effects. A complete
blood picture, kidney, and liver functions were considered pri-
or to every cycle. Patients received four cycles (8 weeks) were
well thought-out for evaluation of response by triphasic CT and
AFP continuously during treatment. Response assessment was
done according to revised RECIST guideline as follow: Com-
plete Response (CR) was defined as complete disappearance of
all radiological and clinical evidence of tumor. Partial Response
(PR) was defined as 30% decrease in the sum of diameters of
target lesions. Progressive Disease (PD) was considered if there
was appearance of new lesions, there was an increase in the size
of the tumor size by ? 25% compared to pretreatment size or if
there were deterioration in the patient clinical conditions due to
disease progression. Stable Disease (SD) was considered if the
patient not met criteria of CR, PR or PD mentioned above and
remained for at least 2 cycles of treatment. The toxicity profile
was based on the NCI commontoxicity criteria.
Endpoints
The primary endpoints of this study were overall sur-
vival and safety profile. Secondary endpoints were response and
Progression Free Survival (PFS) rates.

Statistical analysis
Continuous variables were expressed as the mean ± SD
& median (range), and the categorical variables were expressed
as number (percentage). Comparison between the two groups
of normally distributed variables was done using independent
samples Student’s t-tests, while Mann Whitney U test was used
for non-normally distributed variables. Overall Survival (OS)
was calculated as the time from randomization to death or the
most recent follow-up contact (censored) but Progression Free
Survival (PFS)/Time to Tumor Progression (TTP) was cal-
culated as the time from randomization to tumor progression.
Stratification of OS and PFS was done according to all basic
characteristics and response to treatment. These time-to-event
distributions were estimated using the method of Kaplan-Meier
plot, and compared using two-sided exact log-rank test. All tests
were- two sided. A p-value of ; 0.05 was considered significant.
Results
Basic characteristics
A total of 60 patients with advanced HCC were en-
rolled, 30 patients in each group. In the two groups, the demo-
graphic basic characteristics were well balanced as possible.
The clinicodemographic parameters and treatment outcome are
shown in (Table 1). Regarding the age, the median age was 51.5,
range (39 to 62 years) in group A and 53.5, ranging from 41 to 65
years in group B. The study includes 49 males, 25 in group A and
24 in group B, and 11 females, 5 in group A and 6 in group B.
Regarding ECOG PS, group A includes, 9 patients (30%) had PS
of 1 and 21 patients(70%) had PS of 2, while group B includes, 7
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Safety and Efficacy of Low-Dose Doxorubicin and Fluorouracil (5FU)
2

patients (23.3%) had PS of 1 and 23 patients (66.7%) had PS of
2. Of patients in group A, 14 (46.7%) had no previous treatment,
6 (20%) treated with PEI, 3(10%) underwent RFA, 5(16.7 %)
underwent TACE, and 2 (6.7%) had combination of RFA and
TACE, while in group B, 16 (53.3%) had no previous treatment,
4 (13.3%) treated with Percutaneous Ethanol Injection(PEI), 4
(13.3%) underwent Radio Frequency Ablation (RFA), 4 (13.3%)
Int J Cancer Oncol | Volume 4: Issue 13Abdelmaksoud, B.A., et al.
Safety and Efficacy of Low-Dose Doxorubicin and Fluorouracil (5FU)
under went Transarterial Chemoembolization(TACE), and 2
(6,7%) had combination of RFA and TACE. All patients in this
study were Child – Pugh class A, but some patients were either
of score 5 or 6 in both groups, in group A, there were 20 patients
(66.6%) with score 5 and 10 (33.3.3%) score 6, while in group
B, there were 11(36.7%) with score 5 and 19(63.3%) score 6.
Table 1: Basic Characteristics and Treatment Outcome in both Experimental Group (Group A) and Control Group (Group B) .
CharacteristicsGroup A (N = 30)
Group B (N = 30)
p-value
No. (%) No.(%)
Age (years)
Mean ± SD 51.66± 6.60 52.96± 7.08
0.465*
Median (Range) 51.50(39-62) 53.50(41-65)
? 40 years 2(6.7%) 0(0%)
0.242 ‡
41 – 59 years
24(80%) 23(76.7%)
? 60 years 4(13.3%) 7(23.3%)
Sex
Male 25(83.3%) 24(80%)
0.739‡
Female 5(16.7%) 6(20%)
ECOG PS
ECOG 1 9(30%) 7(23.3%)
0.559‡
ECOG 2 21(70%) 23(76.7%)
Previous treatment
No 14(46.7%) 16(53.3%)
0.940‡
PEI
6(20%) 4(13.3%)
R FA 3(10%) 4(13.3%)
TACE 5(16.7%) 4(13.3%)
RFA+TACE 2(6.7%) 2(6.7%)
Child score
Score 5 20(66.7%) 11(36.7%)
0.020‡
Score 6 10(33.3%) 19(63.3%)
Response
NR 25(83.3%) 30(100%)
0.052‡
OAR 5(16.7%) 0(0%)
PD 9(30%) 19(63.3%)
0.009‡
SD
16(53.3%) 11(36.7%)
PR 5(16.7%) 0(0%)
PFS
Median PFS 5 months3.5 months
0.018§
6 mon PFS 10%3.3%
OS
Median OS 8 months6 months
0.125§
6 mon OS
73.3%40%
12 mon OS 9.4%3.7%
* Independent samples Student’s t-test,
‡Chi-square test, § Chi-square test for trend.
P < 0.05 is significant.
Treatment outcome
After median follow- up of 12 months range (6 – 18), all patients died except, three patients still alive, two in group A and

4
one in group B. Regarding to tumor response in the two groups,
there were five patients (16.7%) in group A achieved overall re-
sponse (OAR) in the form of partial response(PR) compared to
no response (NR) in all patients (100%) of group B (P-value <
0.052), also, there were nine patients(30 %) in group A showed
progressive disease (PD) compared to 19 patients (63.3%) in
group B, and 16 patients (53.3%) with stable disease in group
A compared to 11 patients (36.7%) in group B (P- value 0.009). In
this study, the median progression free survival (PFS) was 5
months in group A and 3.5 months in group B, with 6 months
PFS rate of 10% and 3.3% in group A and B respectively (
P- value 0.018), also, in group A the median overall survival
(OS) was 8 months compared to 6 months in group B, with one
year (OS) rate of 9.4% and 3.7% in group A and B respectively
(P-value0.125), (figure 1).
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Safety and Efficacy of Low-Dose Doxorubicin and Fluorouracil (5FU)
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Figure 1: Kaplan-Meier plot: (A) Progression Free Survival (PFS); (B) Overall survival (OS).
Table 2: Effect of Basic Characteristics on Response to Treatment in 30 Patients with HCC (Group A).
Charac-
teristicsResponse
p-
value Response
p-
value
All
(N = 30) NR
(N = 25) OAR
(N = 5) PD (N = 9)
SD (N = 16) PR (N = 5)
No. (%) No.(%) No.(%) No.(%) No.(%)No.(%)
Age (years)
Mean ±
SD 51.66
± 6.60 51.96± 6.37 50.20± 8.31
0.595*53.44
± 7.24 51.12± 5.90 50.20± 8.31
0.621*
Median
(Range) 51.50
(39-62) 52(40-62) 51(39-59) 54(40-62) 51.50(41-62) 51(39-59)
? 40
years 2
(6.7%) 1(50%) 1(50%)
0.301‡ 1
(50%) 0(0%) 1(50%)
0.104‡
41-59
years 24
(80%) 20(83.3%) 4(16.7%) 5(20.8%) 15(62.5%) 4(16.7%)
? 60
years 4
(13.3%) 4(100%) 0(0%) 3(75%) 1(25%) 0(0%)
Sex
Male 25(83.3%) 21(84%) 4(16%)
1.000‡ 8
(32%) 13(52%) 4(16%)
0.865‡
Female 5(16.7%) 4(80%) 1(20%) 1(20%) 3(60%) 1(20%)
ECOG PS
ECOG 1 9(30%) 6(66.7%) 3(33.3%)
0.143‡ 2
(22.2%) 4(44.4%) 3(33.3%)
0.274
ECOG 2 21(70%) 19(90.5%) 2(9.5%) 7(33.3%) 12(57.1%) 2(9.5%)
Previous treatment
No 14(46.7%) 10(71.4%) 4(28.6%)
0.489‡ 2
(14.3%) 8(57.1%) 4(28.6%)
0.633
PEI
6(20%) 5(83.3%) 1(16.7%) 2(33.3%) 3(50%) 1(16.7%)
R FA 3(10%) 3(100%) 0(0%) 1(33.3%) 2(66.7%) 0(0%)

Int J Cancer Oncol | Volume 4: Issue 15Abdelmaksoud, B.A., et al.
Safety and Efficacy of Low-Dose Doxorubicin and Fluorouracil (5FU)
TACE5(16.7%) 5(100%) 0(0%) 3(60%) 2(40%) 0(0%)
RFA+-
TACE 2
(6.7%) 2(100%) 0(0%) 1(50%) 1(50%) 0(0%)
Child score
Score 5 20(66.7%) 16(80%) 4(20%)
0.640‡ 4
(20%) 12(60%) 4(20%)
0.235
Score 6 10(33.3%) 9(90%) 1(10%) 5(50%) 4(40%) 1(10%)
* Independent samples Student’s t-test for two groups ; One way ANOVA test for more than 2 groups;
‡Chi-square test;
p ; 0.05 is significant.

In this study, the effect of patient basic characteristics on response to treatment and subsequently the effect of both on pro-
gression free survival and overall survival were statistically analyzed into group A to determine the impact of variable prognostic
factors on treatment outcome (Tables 2,3,4). From this subset analysis; previous treatments, Child score, and treatment response
were the prognostic factors that have a significant impact on PFS but not on OS, while other factors as age, sex, and PS showed no
significant impact on both PFS or OS.
Table 3: Effect of Basic Characteristics and Response to Treatment on Progression Free Survival in 30 Patients with HCC (Group A).
Characteristics Progression Free Survival (PFS)
p-value
All (N = 30)
Median TTP
(months) 3 month PFS
(%) 6 month PFS
(%)
No. (%)
All patients 30(100%) 5 months 80%10%
Age (years)
? 40 years 2(6.7%) 5 months 100%50%
0.369†
41-59 years
24(80%) 5 months 79.2%8.3%
? 60 years 4(13.3%) 4 months 75%0%
Sex
Male 25(83.3%) 5 months 76%12%
0.417†
Female 5(16.7%) 6 months 100%0%
ECOG PS
ECOG 1 9(30%) 5 months 88.9%22.2%
0.567†
ECOG 2 21(70%) 5 months 76.1%4.7%
Previous treatment
No 14(46.7%) 6 months 92.9%7.1%
0.009†
PEI
6(20%) 5 months 100%33.3%
R FA 3(10%) 5 months 100%0%
TACE 5(16.7%) 5 months 60%0%
RFA+TACE 2(6.7%) 2 months 0%0%
Child score
Score 5 20(66.7%) 5 months 100%15%
; 0.001†
Score 6 10(33.3%) 3 months 40%0%
Response
NR 25(83.3%) 5 months 84%28%
0.021†
OAR 5(16.7%) 6 months 100%80%
PD 9(30%) 4 months 55.6%0%
0.006†
SD
16(53.3%) 5 months 87.5%37.5%
PR 5(16.7%) 6 months 100%80%

NR denote not reached,
† Log rank test,
p ; 0.05 is significant.

6
Safety and Efficacy of Low-Dose Doxorubicin and Fluorouracil (5FU)
Int J Cancer Oncol | Volume 4: Issue 1
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Table 4: Effect of Basic Characteristics and Response to Treatment on Overall Survival in 30 patients with HCC (Group A).
CharacteristicsSurvival
p-valueOverall Survival (OS)
p-value
All (N = 30)
Alive (N = 2) Died (N = 28) Median OS
(months)3 month
OS (%)6 month
OS (%)
No. (%) No.(%) No.(%)
All patients 30(100%) 2(6.7%) 28(93.3%) 8 months93.3%73.3%
Age (years)
Mean ± SD 51.66± 6.60 50.50± 7.77 51.75± 6.67
0.803•
Median (Range) 51.50(39-62) 50.50(45-56) 51.50(39-62)
? 40 years 2(6.7%) 0(0%) 2(100%)
0.765‡ 10 months
100%100%
0.504†
41-59 years
24(80%) 2(8.3%) 22(91.7%) 8 months91.7%75%
? 60 years 4(13.3%) 0(0%) 4(100%) 6 months100%50%
Sex
Male 25(83.3%) 1(4%) 24(96%)
0.310‡ 8 months
92%68%
0.547†
Female 5(16.7%) 1(20%) 4(80%) 9 months100%100%
ECOG PS
ECOG 1 9(30%) 0(0%) 9(100%)
1.000‡ 8 months
100%66.7%
0.910†
ECOG 2 21(70%) 2(9.5%) 19(90.5%) 9 months90.5%76.1%
Previous treatment
No 14(46.7%) 2(14.3%) 12(85.7%)
0.654‡ 9 months
100%85.8%
; 0.001†
PEI
6(20%) 0(0%) 6(100%) 8 months100%83.3%
R FA 3(10%) 0(0%) 3(100%) 7 months100%66.7%
TACE 5(16.7%) 0(0%) 5(100%) 9 months100%60%
RFA+TACE 2(6.7%) 0(0%) 2(100%) 3 months0%0%
Child score
Score 5 20(66.7%) 2(10%) 18(90%)
0.540‡ 9 months
100%80%
0.003†
Score 6 10(33.3%) 0(0%) 10(100%) 5 months90%40%
Response
NR 25(83.3%) 2(8%) 23(92%)
1.000‡ 8 months
100%76%
0.062†
OAR 5(16.7%) 0(0%) 5(100%) 11 months100%100%
PD 9(30%) 1(11.1%) 8(88.9%)
0.723‡ 6 months
88.9%44.4%
0.090†
SD
16(53.3%) 1(6.3%) 15(93.8%) 8 months93.7%81.3%
PR 5(16.7%) 0(0%) 5(100%) 11 months100%100%

• Mann Whitney U test; ‡Chi-square test;
† Log rank test;
p ; 0.05 is significant.
Treatment toxcity
Regarding haematological toxicities, there were no
grade III ; IV toxicities. There was only grade I ; II anaemiain
(20%) which do not need cycle interruption. Other non-haema –
tological toxicities include grade II ; III anorexia, vomiting and
diarrhea (25%), grade I ; II stomatitis (10%), grade I ; II al-
opecia (5%), grade I elevated liver enzymes (30%), grade II ;
III fatigue (10%). There was no any treatment –related mortality
observed in this study.
Discussion
Until now, there is no approved systemic treatment ap-
plicable for patients with advanced HCC except sorafenib. Al-
though, sorafenib is the only systemic treatment demonstrating
significant statistically but modest overall survival advantages
in phase III randomized, placebo-controlled trial, it still has its
limitations
17. In addition to smaller absolute survival benefits
in patients with macrovascular invasion and/or extrahepatic spread,
drug availability and its costs are the major challenges
for its use especially, in developing countries as Egypt. So, the
role of sorafenib in advanced HCC should be conformed, and
additional trials of other possible systemic chemotherapeutic
agents are also needed, especially after the promising results of
some other chemotherapeutic regimens
18-20. The role of system-
ic chemotherapy in the treatment of advanced HCC was eval-
uated and reviewed in many studies
17,21. In this study, safety
and efficacy of low dose of doxorubicin and 5 FU along with
supportive treatment were evaluated compared to best standard
of supportive care alone in patients with advanced HCC, the
overall response was 16.7 % (PR) with disease control of 70%
(16.7% PR, 53,3% SD and 0% CR) in treatment arm compared
with 0 % OARin control arm, this results differ from the results
achieved by previous studies e.g. Yeo et al
11 who studied doxo-
rubicin versus (PIAF) combination chemotherapy in patients
with HCC carcinoma, where the OAR was 20.9% in the treat –
ment arm, and Qin et al
22 who studied the efficacy and survival

Safety and Efficacy of Low-Dose Doxorubicin and Fluorouracil (5FU)
Int J Cancer Oncol | Volume 4: Issue 17Abdelmaksoud, B.A., et al.
benefits of FOFOX4 compared to doxorubicin in patients had
advanced HCC, where the RR was 8.15% in FOLFOX4 arm,
this difference may be due to small number of the patients in
our study, all patients were Child class A and most patients had
received primary treatment for localized disease before enroll-
ment in this study, but in another study conducted in Egypt by
Farrag A
18 evaluating the role of metronomic dose of capecit –
abine in patients with advanced HCC, the RR was 16% and dis-
ease control was 69%, nearly the same results obtained in our
study, however, our protocol less expensive and more compliant
with the patients. Generally, regarding RR, the results obtained
in this study are comparable to or slightly better than the results
obtained in other studies evaluating old and newer chemothera –
peutic agents in the treatment of advanced HCC. There were two
small randomized controlled trials studied chemotherapy ver-
sus best supportive care, one tested the efficacy of single agent
doxorubicin and another tested enteric- coated tegafur/ uracil,
where median survival was 2.7 and 12.1 months in two studies
versus 1.9 and 6.2 in best supportive care respectively
10,23. No-
latrexede, a thymidylate synthetase inhibitor was evaluated in
phase III randomized controlled trial compared to doxorubicin
to determine overall survival benefits in patients with advanced
hepatocellular carcinoma: RR was 1.4% and 4.0% favoring
doxorubicin
12. Also, other agents e.g. gemcitabine, taxanes,
capecitabine, and cisplatin were studied in the treatment of ad-
vanced HCC, its results were comparable or slightly inferior to
our results
24-29. Regarding overall survival (OS) and progression
free survival (PFS), in our study, the median OS was 8 months
in treatment arm compared to 6 months in control arm while
PFS was 5 months with 6 months PFS rate 10% and 3.5 months
with 6 months PFS rate 3.3% in treatment arm and control arm
respectively. These results were comparable with other obtained
in previous studies mentioned above. Compared with the results
obtained in SHARP trial
7 evaluating the role of sorafenib in ad-
vanced HCC compared to placebo, in which the median OS was
10.7 months compared to 7.9 months in sorafenib and placebo
groups respectively, and time to symptomatic tumor progression
was 4.1 versus 4.9 favoring placebo, as shown, the results in our
study differ from that of SHARP study, this difference may be
due to small number in our study and different inclusion criteria
in both trials. The toxicity profile of this regimen was very low
regarding hamatological and non- haematological toxicities, so,
the drugs were tolerated and convenient with the patients.
Conclusion
Aadvanced HCC remains a challenging disease with
bad prognosis, the median survival in most studies ranging from
6 to 9 months with response rates 10 – 15 % to chemotherapeutic
agents. Because of expense and some unresolved issues regard-
ing sorafenib optimal use in Egyptian patients where prevalence
of HCC involves a large sector of these populations, a substantial
needs for more effective treatment options still present. Based
on the results of this study compared with other obtained in pre-
vious trials regarding overall survival, progression free survival,
response rates, and safety profile, this protocol may confer some
benefits for patients with advanced HCC and may provide an-
other profitable treatment option.
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Safety and Efficacy of Low-Dose Doxorubicin and Fluorouracil (5FU)
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