Comparison an effectiveness of drug-eluting bead
(Hepasphere) transarterial chemoembolization and
conventional (Lipiodol) transarterial chemoembolization in
treatment of hepatocellular carcinoma in Srinagarind
Hospital
Paksom Rachupimol, MD
Vivian Klungboonkrong, MD
Jitraporn Wongwiwatchai, MD
Kulyada Somsap, MD
Vallop Laopaiboon, MD
Department of Radiology, Faculty of Medicine, KhonKaen
University, Khon Kaen, 40002, Thailand
ABSTRACT
Objective: To compare effectiveness of drug-eluting bead transarterial chemoembolization (dTACE)
and conventional transarterial chemoembolization (cTACE) of hepatocellular carcinoma in the
aspect of tumor response, liver injury and survival outcome of patients treated in Srinagarind
hospital.
Material and method: Retrospective included 66 from total enrolled 109 unresectable HCC
patients during Jan 2014 to May 2014 with post first TACE treatment. Statistical analysis compared
pre-operative status (cirrhosis, Child-Pugh classification, BCLC stage and ECOG score) and tumor
response by objective response (complete response and partial response) of both cTACE and
dTACE according to mRECIST criteria. Post treatment complications and tumor marker were
performed. Survival outcome was evaluation between two groups using Kaplan-Meier analysis.
Results: The total patient in this study was 66 which 54 were cTACE and 12 were dTACE. Tumor
response between cTACE and dTACE were 13% vs. 8.3% in complete response, 38.9% vs. 50% in
objective response and 20.4% vs. 8.3% in stable disease (p = 0.61). Objective response of target lesion
was 53.7% and 58.4% of cTACE and dTACE (p = 0.46). No statistical significant difference between
demographics, pre- and post-TACE liver enzymes, tumor characteristics and procedure technique
were noted. The survival outcome was 29.13 +/- 2.23 months but not significant (p = 0.73).
Conclusion: Comparison tumor response between cTACE and dTACE was not met superiority.
Post-TACE liver injury was not showed significant difference may be due to long period follow up.
No conclusion which is better in survival outcome between those groups was noted.
Keywords Conventional chemoembolization (cTACE), hepatocellular carcinoma (HCC),
Hepasphere, drug eluting bead chemoembolization (dTACE), lipiodol, mRECIST
Correspondence to:
Paksom R., Vivian K., Jitraporn W., Kulyada S., Vallop L.
123/2000 Department of Radiology, Faculty of Medicine, Khon Kaen University, Khon Kaen Thailand 40002
Tel: +6643363178
Email: [email protected], [email protected], [email protected], [email protected],
[email protected]
Introduction
Hepatocellular carcinoma is the fifth most common worldwide cancer (1). In every year, the
increment of prevalence has reported. Development of advance radiologic imaging can help in early
detection of the disease. Surgical treatment in early state of hepatocellular carcinoma had good
outcome that make the benefit to the patient. For unresectable patient, transarterial
chemoembolization (TACE) was the treatment of choice.
Conventional (Lipiodol) TACE (cTACE) is the standard method which is the one of most
popular treatment. Base on technique with emulsified combination of chemotherapy such as
Doxorubicin and lipiodol administrate via arterial feeder.
Less in systemic chemotherapy and increase overall survival rate were the most concern in
treatment but many studies reported side effects from conventional (Lipiodol) TACE significantly
among an improvement of overall survival rate.
Drug-eluting bead TACE (dTACE) is the new method which sustained releasing the
chemotherapy. In Srinagarind Hospital, we performed dTACE with (Hepasphere) to treat HCC in
palliative role. The studies showed less systemic side effect in patient than cTACE but no definite
statistical difference in treatment and survival outcome. However, there is no research supported in
Thailand.
This retrospective study compares effectiveness of those methods in treatment of
Hepatocellular carcinoma in Srinagarind Hospital.
Material and method
The protocol was confirmed to the ethical guideline of the Declaration of Helsinki and the
International Conference on Harmonization Guideline on Good Clinical Practice (ICH GCP) by
Khon Kaen investigational review board.
Patient inclusion
The retrospective study enrolled 109 patients which was performed first TACE in period of
January 2014 to May 2014.
Hepatocellular carcinoma (HCC) was diagnosed by radiologic imaging due to angiogenicity
pattern (Fig.1a,1b) (1). All of the patient have Child-Pugh status A or B and BCLC stage A or B.
Previous medical history such as hepatic infection and cirrhotic liver were performed.
Exclusion criteria
The patients with history of previous treatment resection, percutaneous ablation, known
chemotherapy treatment and previous TACE. Poor image quality and loss follow up image were
also excluded.
Embolization procedure
Selective celiac and superior mesenteric angiograms were performed using 5 Fr. Catheter
(Yashiro, Chuang and Cobra) then superselective angiogram were used both catheter and
microcatheter (2.7 Fr Progreat and Renegrade).
In cTACE, we prepared mixture of Lipiodol and chemotherapy (Doxorubicin or 5-FU) vary
in dosage depend on operator consideration. The dTACE were using drug-eluting microsphere (25
mg Hepasphere 50-100 micron) loaded with 50 mg doxorubicin solution for 2 hours. HepaSphere are
calibrated, spherical, hydrophilic microspheres made from 2 monomers (vinyl acetate and methyl
acrylate) that combine to form a copolymer (sodium acrylate alcohol copolymer). This microsphere
allowed targeted occlusion of the blood vessels with delivery of doxorubicin for therapeutic or
preoperative purposes in dTACE.
Both embolization methods were administered via right hepatic, left hepatic or common
hepatic arteries after superselection until slow flow. Post embolization images were performed.
Response assessment
According to modified Response Evaluation Criteria in Solid Tumors (mRESIST) criteria
was assessed in HCC patients by reduction of angiogenic activity lesion (sum of longest diameter
(SLD) (3). The measurement was included target lesion, non-target lesion, new lesion and overall
response assessment. Response categories were classified as complete response (CR), partial
response (PR), stable disease (SD) and progressive disease (PD) (2,3). CR was defined as the
disappearance of arterial enhancement areas. PR and PD were decrease SLD more than 30% and
increase SLD greater than 20%, respectively. SD was neither PR nor PD (2,3). Objective response (OR)
defined CR plus PR (3).
Imaging modalities we use were taken from outsource and Srinagarind hospital CT
imagings (Brillinace ICT-SP128, Phillps or Somatom Definition Flash, Seimens) and MR imagings
(3T MR scanner, Phillips Achieva and 1.5T MAGNETOM Aera, Siemens) in both scanned (JPEG)
and Digital Imaging and Communications in Medicine (DICOM) files. Srinagarind imaging
protocols of CT and MRI were included pre-contrast phase, arterial phase and portovenous phases.
Some of studies may added delayed 5-minute phase to confirm wash out pattern.
Interpretation of the tumor response using Picture archiving and communication system
(PACS)to demonstrated images and estimated by 2 radiologists which evaluated each patient and
consensus when the diagnosis was inconcludable.
Laboratory evaluation
Liver enzymes including aspartate aminotransferase (AST), alanine aminotransferase
(ALT), Alkaline phosphatase (ALP) and tutor marker (alpha-fetoprotein; AFP) were assessed in
preoperative, post-operation 1 and 2 months follow up.
Statistical analysis
All of continuous variables such as age are defined as mean, SD, minimum and maximum
used by Student t-test. Comparative other demographics information, tumor distribution and
compared method procedures were used Crosstab mode in Descriptive statistics and evaluated
association between groups by Fisher’s Exact test. Compared laboratory result of pre- and postembolization between groups were performed by analysis of covariant, univariate analysis.
Survival outcome collected from medical record and registration office. The survival
outcomes were calculated from the time when the patients were diagnosed from first radiological
images (ultrasonography, CT or MRI) until death. Kaplan-Meier analysis was used for calculation
mean and median. Data statistical significance was noted as p value < 0.05. Used 95% confidential
interval for association measurement was noted. Data calculation and analysis were made with IBM
SPSS statistic version 19.0.
Result
From 109 enrolled post first TACE patients, we excluded 43 patients indicated by previous
treatment (previous TACE, percutaneous ablation or tumor resection (n= 24)), poor quality image (n=
8), and loss of follow up images (n=11).
Patient
Total 66 patients were included to study which 54 of 66 patients were treated with cTACE
and 12 of 66 patients (18.2%) were dTACE treatment.
Patient demographic of pre-TACE are presented (Table 1). There are no statistical difference
of age and sex between cTACE group and dTACE group (p-valve 0.142 and 0.446 respectively).
Most of the patient in two groups were male (51 of 66 cases). 36% were underlying of cirrhosis.
Cause of cirrhosis had no classified in this study. Distribution of the patient with hepatitis B were 32
of 66 patients (48.5%) and hepatitis C were 33 of 66 patients (50%). All patients were noted ECOG
grade 0 from medical record, Child-Pugh A (51 cases in cTACE and 12 cases in dTACE), ChildPugh B (3 cases in cTACE) and BCLC classification A 12 of 66 cases (11 in cTACE and 1 in
dTACE), B 54 of 66 cases (43 in cTACE and 11 in dTACE). No statistical difference between these
group is presented.
Serum liver enzyme and tumor marker were shown in Table 2.
The minimum and maximum of pre-operative AFP in cTACE and dTACE were 1.13 to
400,000 IU/ml and 3.94 to 7,474 IU/ml, respectively. Mean and median were calculated and found
11,726.55 +/- 59763.33, 52.00 IU/ml in cTACE and 958.04 +/- 2455.08, 10.39 IU/ml in dTACE. So, we
used median of AFP to be reference in this study.
Pre-operative liver enzymes were received 1 day prior to treatment. Mean of serum AST
were 91.28 +/- 82.15 U/L in cTACE and 104.25 +/- 115.21 U/L in dTACE, ALT were 64.36 +/- 64.13
U/L in cTACE and 62.42 +/-58.96 U/L in dTACE, and ALP were 161.04 +/- 172.46 U/L in cTACE
and 128.80 +/- 68.72 U/L in dTACE.
Between two groups of this study, there were no statistical difference which p-value of AFP,
AST, ALT and ALP are 0.508, 0.872, 0.618 and 0.79 respectively. No different between pre-TACE
and post-TACE in each group were found.
No other complications were reported in this study.
Tumor characteristic and procedure
As showed on Table 3, all of HCC patients showed retrospective angiogenic pattern in preTACE imaging. Mean of target diameter were 62.48 +/- 40.29 mm. in cTACE and 86+/- 49.52 mm. in
dTACE. Range of tumor diameter of both methods were 13.8 to 168.2 mm. in cTACE and 19.9 to
170.4 mm. in dTACE. Number of the lesion was commonly single lesion. Most lesion distribution is
unilobar and common on the right lobe. Just 1 enrolled patient was infiltrative lesion.
Most of artery we embolized was right hepatic artery (50 of 54 in cTACE and 11 of 12 in
dTACE). Selection process we used 5.0Fr catheter, the most was Yashiro 61% in cTACE and 58.30 %
in dTACE. Other were Chuang and Cobra orderly. In superselection, we choosed both 5.0 Fr
catheter and 2.7 Fr. microcathter which Progreat was the most choice for our operator consideration
(Table 4). There is no difference in mean dosage use of doxorubicin (33.98 +/- 17.20 mg in cTACE
and 43.75 +/- 15.53 mg in dTACE, p-value = 0.075). All of the dTACE patients were treated with 25
mg of Hepasphere, 50 – 100 micron.
Evaluation of effectiveness (Table 4)
Radiological assessment by 2 radiologists consensus were performed. Imaging modalities
including upper abdomen CT or MRI in Srinagarind Hospital and outsource DICOM or scanned
(JPEG) CT or MRI.
Sixty-six included patients had assessment (54 cTACE patient and 12 dTACE patients)
according to mRECIST criteria. Tumor responsiveness as showed in Table 4 reveals 8 complete
responses (7 from cTACE and 1 from 1 dTACE) and 19 partial responses (14 from cTACE and 5
from dTACE) patients.
Twenty-seven cases of progressive disease (22 in cTACE and 5 from dTACE) were assessed
by increase SLD > 20% (3). 2 patients were found stable disease.
Post embolization evaluation showed follow up PD due to increase SLD (Fig.3) and nontarget PD (16 cases, 12 from cTACE and 4 from dTACE) by portal vein invasion (Fig.4), increase
diameter of non-target HCC to be > 1 cm. in follow up study and increase size of locoregional
lymph nodes to be more than 2 cm. During follow up found 10 patients developed new HCC lesion
that concluded overall progressive disease. However, overall response between both methods
showed no statistical difference (p-value = 0.61).
Survival outcome (Figure 5)
During studying, we found 33 of 66 patients dead which 28 of 54 patients were cTACE
patients and 5 of 12 were dTACE patients. Mean overall survival outcome was 29.127 +/- 2.23
months. Mean survival outcome of cTACE and dTACE groups were 29.13 +/- 2.4 months and
28.82+/- 5.0 months. There was no statistical significant difference between these group (p-value=
0.73).
Discussion
As we know until now, TACE is widely standard use to be the treatment option for
unresectable or intermediate HCC to improve survival outcome (4,5,6). cTACE is currently be the
standard worldwide method. Three major concern of this treatment are overall survival outcome,
tumor response, post treatment complication such as liver injury representing rising liver enzyme.
Development of dTACE such as Hepasphere was made in objection for improved the result of those
concerns. Many studies showed no significant difference between cTACE and dTACE (4,6,7).
However, there is report using Hepasphere to be the drug eluting beads (8).
Our retrospective study demonstrated no statistical difference in demographic data including
baseline pre-TACE liver enzymes and tumor diameter of both two groups of enrolled patients. After
compared between type of catheter, there is no significant. These can be concluded no definite
biological characteristics and technical factor effect our overall response resulted. Scartozzi M. et al
implied that biological characteristics such as cirrhosis or hepatitis infection and characteristic of
HCC can affect responsive treatment with TACE which is undefinable in this study (7). In our
institute, they assessed tumor response by using mRECIST criteria which better evaluated in tumor
viability via arterial enhancement (3). Usefulness of this criteria in our study in my opinion is better
compared overall target response which focus on residual target lesion enhancement.
In approximately 2 months after post first TACE the objective response (OR) rate of target
response were 53.7% in cTACE and 58.4% in dTACE which OR of dTACE similar with the previous
reported of PRECISION V study about 52% phase I/II studies with DC bead about 44-82% (4,5). But,
there are no statistical significant between these methods (p value = 0.46). OR rate of overall response
seems less than target response (38.9% in cTACE and 50% in dTACE) because increment of PD due
to reported follow up progression of non-target response or developed new lesion. However, in this
study we observed for only 2 months as compared with other study (4).
Post TACE follow up of complication in order to liver injury which presented by elevation
of liver enzymes were observed. Many studies found that dTACE was significant decrease liver
toxicity and associated with lower degree of chemotherapy-related side effect correlated with
evidence of lower peak drug concentration and plasma doxorubicin level (4,5,8,9,10). Plasma
doxorubicin level was immediately increase at 5 minutes and decrease into baseline at 7 days after
embolization (8,9). Our study noted that no significant change of serum liver enzymes level between
pre- and post-dTACE. This could be due to the follow up duration of post-treatment liver enzyme.
Katerina et al. noted that liver enzymes were probably increase only several days transiently after
drug-eluting embolization and back to normal at 1 month (8,). This could be explain of our normal
liver enzyme on follow up day.
Mean overall survival outcome of our study was 29.13 months (range 2.7 - 46.3) similar to
Scartozzi M. et al. which the median is about 32 months. As Dhanasekaran et al. said drug-eluting
bead TACE were improved survival outcome and the benefit of survival outcome by dTACE was
significantly improved compared to conventional method. However, in Scartozzi M. et al study
found out that the result was opposite (6,7). In our study, there was no statistical different in survival
outcome between both methods similar to Kloeckner R. et al (11). However, the survival outcome of
dTACE in our study was 28.82 +/- 5.0 months (range 2.7 - 46.3) which similar to the survival outcome
of Dhanasekaran et al. (610 days or 20.3 months) (6). The limitation of our study is due to inadequate
sample size and short period observation.
One of our idea to classified group by tumor sizes was designed base on Timothy M. et al.
reported significant in tumor size related with microvascular invasion and noted that tumor size
more than 5 cm was significantly associated. At this size of tumor, high grade histology result can
be predicted even if solitary or multiple tumor (12). We demonstrated correlation between target
response from dTACE treatment with tumor size (<3, 3-5, >5-10 and >10 cm). Tumor size less than 5
cm had CR and PR but the tumor size more than 5 cm found PD as shown on Fig. 6 and 7. However
the lesion that larger more than 10 cm also detected PR for 3 patients. We can explain that smaller
size may have less microvascular invasion and cause better outcome, as complete and partial
responses. However, the single tumor size larger than 10 cm may be low grade tumor type. Due to
limitation of our study, this is non-significant result. We are looking forward to collect more number
of patients.
Advantage of our study is we are the first study in Thailand that compared between standard
conventional TACE versus drug eluting bead TACE (Hepasphere). Limitation of this study, first is
retrospective study even though there was no significant between two groups. Selection bias was
noted due to nature of investigation. The second is small sample size for analyzed and difference in
population characteristic were presented which required further larger volume of population. The
other limitations are uncontrollable radiological image quality, usage dose of chemotherapy and size
of drug-eluting embolic agent which could affect the overall response.
Table 1. Demographics data of HCC patents treated with TACE
cTACE
dTACE
(n=54)
(n=12)
mean
Age
SD
p-value
mean
SD
58.10
9.06
53.67
10.88
n
%
n
%
p-value
0.142
Range
Sex
0.446
Male
43
79.60
8
66.70
Female
11
20.40
4
33.30
39
72.20
3
25.00
0.006
HBV*
24
46.30
7
58.30
0.532
HCV*
27
51.90
5
41.70
0.751
Both HBV/HCV
1
Cirrhosis
Hepatitis
infection
0
Child pugh
1.000
classification
A
51
94.40
12
100
B
3
5.60
0
0
BCLC stage
0.442
A
11
20.40
1
8.30
B
43
79.60
11
91.70
-
ECOG Status
0
54
100
12
100
1
0
0
0
0
*HBV= hepatitis B virus infection, HCV= hepatitis C virus infection
Table 2. Laboratory characteristics (pre- and post-TACE)
cTACE (n=54)
dTACE (n=12)
p-value
p-value
between 2
groups
AFP
0.508
Mean
11726.55 (+/-59763.33)
958.04 (+/-2455.08)
Pre-TACE Median
52
10.39
Post-TACE Median
18.19
10.23
Range
1.13-400000
3.94-7474
AST
0.146
0.872
Pre-TACE Mean
91.28 (+/- 82.15)
104.25 (+/- 115.2)
Post-TACE Mean
88.13 (+/- 148.03)
110.83 (+/- 82.43)
Median
61
74.5
Range
23 - 425
18 - 434
ALT
0.905
0.618
Pre-TACE Mean
64.36 (+/- 64.13)
62.42 (+/- 58.96)
Post-TACE Mean
52.52 (+/- 40.25)
62.17 (+/- 41.0)
0.459
Median
41
40
Range
18-396
17-195
ALP
0.79
Pre-TACE Mean
161.04 (+/- 172.46)
128.80 (+/- 68.72)
Post-TACE Mean
149.08 (+/- 112.04)
183.67 (+/- 102.27)
0.332
Median
111.5
113
Range
0 - 1126
54-261
Table 3. Tumor information and distribution
cTACE
dTACE
(n=54)
(n=12)
p-value
n
%
n
%
Unilobar
44
81.5
9
75
0.61
Bilobar
10
18.5
3
25
0.61
single
34
63
7
58.3
0.765
2
8
14.8
2
16.7
0.871
Multinodular
12
22.2
3
25
0.835
Tumor location
Number of tumor
Tumor diameter
53/54
12/12
0.083
(mm)
Mean
62.48
Median
50
Range
13.8
168.20
19.9
170.40
54/0
100
12/0
100
Tumor vascularity
86
40.29
49.52
92
(Yes/No)
Table 4. Tumor response according to mRECIST criteria
Overall response
Target response
NonTarget lesion
New lesion
cTACE
cTACE
cTACE
cTACE
dTACE
dTACE
CR
7 (13)
1 (8.30)
8 (14.80)
2 (16.70)
PR
14 (25.9)
5 (41.70)
21 (38.90)
5 (41.70)
SD
11 (20.40)
1 (8.30)
15 (27.8)
1 (8.30)
PD
22 (40.70)
5 (41.70)
10 (18.50)
4 (3.30)
Non-
dTACE
29 (53.70)
2 (16.70)
12 (22.20)
4 (33.30)
13 (24.1)
6 (50)
dTACE
CR/NonPD
Yes
9
1
Figure1.Upper abdominal CT (DICOM file) of 59-years old female with HCC at segment 5 in arterial and
portovenous phase of pre-TACE and post dTACE (Heparsphere). (a,b) Pre-TACE images showed
characteristic pattern of hepatocellular carcinoma; enhancement on arterial phase and portal venous phase
washout which can diagnosed without further investigation requirement (1). (c,d) Post dTACE (Heparsphere)
follow up images demonstrated disappearance of angiogenic activity of target embolization lesion. This
patient was reported complete response (CR).
Figure. 2 Pre-TACE upper abdominal scanned MRI (JPEG file) and post-TACE upper abdominal CT
(DICOM file) of 50-years old male with HCC at segment 8/5 in arterial and portovenous phase of and post
cTACE (Lipiodol). (a,b,c) Pre-TACE scanned MRI images showed well-define hyperinstensity lesion on T2
weighted and characteristic pattern of hepatocellular carcinoma; enhancement on arterial phase and portal
venous phase washout after contrast (gadovist) administration. (d,e) Post dTACE (Heparsphere) follow up
images demonstrated full filled lipiodol staining and disappearance of angiogenic activity of target
embolization lesion. This patient was reported complete response (CR).
Figure 3. Upper abdominal CT of 67-years old male with HCC at segment 5 in arterial and portovenous phase of
pre-TACE and post dTACE. (a,b) Pre-TACE scanned (JPEG) images showed characteristic pattern of hepatocellular
carcinoma. (c,d)Post cTACE (DICOM) follow up images demonstrated residual angiogenic activity of target
embolization lesion which increase SLD >20%. This patient was consensus between 2 radiologists and reported
progressive disease (PD).
Figure 4. Pre-TACE upper abdominal MRI and post-TACE upper abdominal CT (DICOM file) of 60-years old male
with HCC at segment 6/7 in arterial and portovenous phase of and post cTACE (Lipiodol). (a,b) Pre-TACE MRI
images showed poorly define mass with characteristic enhancement pattern of hepatocellular carcinoma;
enhancement on arterial phase and portal venous phase washout after contrast administration. (c,d,e,f) Post cTACE
follow up images demonstrated less lipiodol staining and no significantly change in angiogenic activity of target
embolization lesion. However, follow up axial CT images (e) showed arterioportal shunt of right portal vein (RPV)
which demonstrated abnormal early contrast filled in RPV during performed arterial phase CT. (f) Coronal
portovenous CT images presented abnormal contrast filling defect at posterior branch of RPV diagnosed tumoral
thrombus, noted progression of non-target lesion. This patient was reported progressive disease (PD).
Figure 5. Overall survival from first image
diagnosis for the HCC patients who treated
with cTACE (------) and dTACE (----). Mean
overall 29.127 +/- 2.23 months (p-value=0.73).
Figure 6. Histogram between tumor size correlated with target tumor response in dTACE
treatment (50-100 micron Hepasphere), classify tumor size into <3 cm, 3-5 cm, 5-10 cm
and > 10 cm based on Timothy et al. reported significant in tumor size related with
microvascular invasion (12).
Figure 7. Histogram between number of lesion
(only single lesion) correlated with target tumor
response in dTACE treatment (50-100 micron
Hepasphere), classify tumor size into <3 cm, 3-5
cm, 5-10 cm and > 10 cm based on Timothy et al.
noted size related with high grade tumor.
Conclusion
TACE is standard way to treat unresectable HCC and has better outcome. Eventhough many
studies found benefit survival outcome of dTACE, there were no significant difference between
cTACE and dTACE in tumor response, complication and survival outcome. Many limitations of our
retrospective study needed further larger sample size and control variable factor.
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Oi-Lin Ng, Iwao Ikai, et al. Tumor size predicts vascular invasion and histologic grade:
implications for selection of surgical treatment for hepatocellular carcinoma. Liver
Transplantation, Vol 11, No 9 (September), 2005: pp 1086-1092.
การเปรี ยบเทียบผลสัมฤทธิ์ระหว่ าง drug eluting bead transarterial chemoembolization (dTACE) กับ
conventional transarterial chemoembolization (cTACE)ในการรั กษา มะเร็ งตับชนิดปฐมภูมิใน
โรงพยาบาลศรี นครินทร์
ภักดิ์สม ราชูภิมล, วิเวียน คลังบุญครอง, จิตราภรณ์ วงศ์ วิวัฒน์ ไชย, กุลญาดา สมทรั พย์ , วัลลภ เหล่ า
ไพบูลย์
บทคัดย่ อ
วัตถุประสงค์
ศึกษาเปรี ยบเทียบผลสัมฤทธิ์ของรักษามะเร็ งตับปฐมภูมิด้วยวิธี dTACE เทียบกับ cTACE ด้ านการตอบสนองต่อการรักษา
ภาวะแทรกซ้ อน และอัตราการรอดชีวติ ว่ามีความแตกต่างกันอย่างมีนยั สาคัญหรื อไม่
วัสดุและวิธีการ
การศึกษาแบบย้ อนหลังในผู้ป่วยมะเร็ งตับชนิดปฐมภูมิ 66 คน ที่ได้ ทาการรักษาครัง้ แรกด้ วย TACE ช่วงระหว่างมกราคมถึง
พฤษภาคม 2557 โดยวิเคราะห์ทางสถิตเิ ปรี ยบเทียบข้ อมูลเบื ้องต้ นของประชากร เช่น อายุ, เพศ, ภาวะตับแข็ง, Child-Pugh,
BCLC, ECOG และเทคนิคที่ใช้ ทาการรักษา เปรี ยบเทียบการตอบสนองของก้ อนมะเร็ งโดยใช้ เกณฑ์ mRECIST จากภาพวินิจฉัย
ทางรังสี รวมถึงผลเลือดของเอนไซม์ตบั ในช่วงก่อนและหลังทาการรั กษา TACE และ เปรี ยบเทียบอัตราการอยู่รอดของผู้ป่วยทั ้ง
สองกลุ่มโดยใช้ การวิเคราะห์ Kaplan-Meier
ผลการศึกษา
จากผู้ป่วย 54 คนที่ทา cTACE เปรี ยบเทียบกับ dTACE พบว่า overall complete response, objective response และ stable
disease อยู่ที่ 13% กับ 8.3%, 38.9% กับ 50% และ 20.4% กับ 8.3% (p = 0.61)ตามลาดับ ส่วน Objective response ของ
target lesion อยู่ที่ 53.7% กับ 58.4% (p = 0.46) ซึง่ ไม่พบความแตกต่างกันของการตอบสนองต่อการการั กษา รวมถึงข้ อมูล
เบื ้องต้ นของประชากร เทคนิค ผลเลือดของเอนไซม์ ตบั ทั ้งก่อนและหลังทาการรักษา และ ค่าเฉลี่ยและค่าเบี่ยงเบนมาตรฐาน ของ
อัตราการรอดชีวิตโดยรวม อยู่ที่ 29.13 +/- 2.23 เดือน
ผลสรุ ป
การศึกษานี ้ไม่พบว่ามีความแตกต่างกันอย่างมีนัยสาคัญทางสถิตริ ะหว่างทั ้งสองกลุ่ม เนื่องด้ วยการวิจัยนี ม้ ีข้อจากัดในเรื่ องจานวน
ประชากรที่ไม่เพียงพอช่วงเวลาการศึกษาที่คอ่ นข้ างสั ้น และการควบคุมคุณภาพภาพทางรังสีวนิ ิจฉัย โดยในอนาคตน่าจะสามารถ
ควบคุมปั จจัยต่างๆเหล่านี ้ได้ มากขึ ้น