HAIC & Toray Anthron P-U Catheter
杏昌生技股份有限公司
HAIC: ●Advantages of HAIC ●Paper Discussion
Toray Anthron P-U CatheterToray Anthron P-U Catheter : : ● ●What is APUCWhat is APUC ?? ● Animal test ●Types of AnthronAnthron P-U Catheter P-U Catheter
● ●Instructions for implantation
● ●APUCAPUC 先端固定留置法先端固定留置法 ● ●RegimenRegimen
● ●PerorationPeroration
Contents
HAIC〈 Hepatic Arterial infusion
chemotherphy 〉
Advantages of HAIC
Increase the local drug concentration Good response rateProlong the survivalReduction in systemic side effectsMade it possible to perform treatment on an outpatient basis
Paper Discussion
HCC with PVTT
Liver Metastases from Colon Cancer
Liver Metastases from Gastric Cancer
Liver Metastases from Breast Cancer
HCC with PVTT
Dr. TanakaYear Researcher Pt's pattern Patient (n=) Regimen Response Rate Survival / Median SV Publish
1997 M. Tanaka(Kurume U)
ad. HCC withPVTT
9 10 mg cisplatin /250 mg 5-FU
44.40% 3 yr-40%14.9 Mons
American CancerSociety(1997)
1996~1997
M. Tanaka(Kurume U)
ad. HCC withPVTT
77 10 mg cisplatin /250 mg 5-FU
45% 1-yr, 2-yr, 3-yr /55.8% , 27.6% ,18.3%
1999 ~2000
M. Tanaka(Kurume U)
ad. HCC withPVTT
48 7 mg cisplatin /170 mg 5-FU
48% 45% , 31% , 25% /36.1 Ms & 5.4 Ms
American CancerSociety(2002)
HCC with PVTT
國泰醫院Year Researcher Pt's pattern Patient (n=) Regimen Response Rate Survival / Median SV Publish
2000/1/1~2003/5/31 (國泰醫院)ad. HCC
with PVTT18
10 mg cisplatin/ 250 mg 5-FU
33%3,6,9,12,18-
month/83%,72%,50%,28%,7%
World JGastroenterol
(2003)
Liver Metastases from Colon Cancer
Dr. Kemeny ( Memorial Sloan-Kettering Cancer Center )
●receive 6 cycles of HAI with floxuridine and dexamethasone plus intravenous fluorouracil, with or without leucovorin(Group A), or 6 wks of similar sys alone (Group B). (p=0.03)
●At 2 yrs,the risk ratio of B/A=2.34.
Researcher Patient (n=) overall survival at 2 yrsmediansurvival
Publish
HAIC +systemic
156 86% 72.2 months
systemic 82 72% 59.3 months
after resection of HepaticMetastases from Colorectal
CancerDr. Kemeny
The NewEngland
Journal ofMedicine
Pt's pattern
Liver Metastases from Colon Cancer
Arai, M.D.
Target lesion Patients Regimen Response Rate Survival
Arai (1992) Liver metastases from gastric carcinoma 40 5-FU 72% 17 months
Arai (1997) Liver metastases from colorectal carcinoma 32 5-FU 78% 25.8 months
Liver Metastases from Colon Cancer
Side effects and complications
nausea (grade 1) 22%
nausea (grade 2) 9%
dizziness 3%
GTP elevation 13%
bile lake 9%
HA occlusion 22%
Response
CR PR NC PD Response rate
4 20 7 1 75% (24/32)
50% survival
overall 22.0 months (7.5+~40.0+)
extra hepatic lesion(-) 25.0 months
extra hepatic lesion(+) 16 months
Age: 59.7< 60.8<70
Extra hepatic lesion:
Patient characteristics (n=32) Colorectal cancer
Sex: male 24 & female 8
(-) 21 (+)11
Degree of liver involvement:
<30% 11
30%~60% 16
60%< 5
Histology:
well 6
moderately 24
unknown 2
Regimen
5-FU 1000mg/m2/5hrs qw continuously
(WBC>=2000 and platelets>=50000)
Tetsuo Taguchi, M.D. Osaka University Medical School
Liver Metastases from Gastric Cancer
Tetsuo Taguchi, M.D. Osaka University Medical School
ADR 20mg/m2 or EPIR 30mg/m2 q4wbolusly
(WBC>=3000 and platelets>=100000)
MMC 2.7 mg/m2q2w bolusly
(WBC>=3000 and platelets>=100000)
Side effects and complications
myelo-suppression (>=grade 3) 35%(14/40)
narsea (>=grade 2) 10%(4/40)
HA occlusion 5%(2/40)
Response
CR PR NC PD NE Response rate
6 20 6 4 4 72% (26/36)
50% survival
overall 15 months(3+~66)
extra hepatic lesion(-) 17.0 months
extra hepatic lesion(+) 9 months
Patient characteristics (n=56) Gastric cancer
Sex: male 29 & female 11
Age: 53.7< 62.3<70.9
Extra hepatic lesion:
(-) 20 (+)20
Degree of liver involvement:
<30% 12
30%~60% 16
60%< 12
Histology:
well 6
moderately 24
unknown 2
Regimen
poorly 2
5-FU 330mg/m2qw bolusly
(WBC>=2000 and platelets>=50000)
Liver Metastases from Breast cancer
Side effects and complications
myelosuppression (>=grade 3) 41%
hepatic arterial occlusion 23%
gastroduodenal toxicity 20%
(ulcer, gastritis, subjective symptoms)
Response
CR PR NC PD NE Response rate
10 33 6 4 3 81% (43/53)
Survival
overall 12.5months (3~64+)
pleural/peritoneal carcinomatosis:
(-) 14.0months (+)9.0 months
Response:
(-) 16.0months (+)5.0 months
Patient characteristics (n=56) Breast cancer
Sex: All female
Age: 38.7<48.0<57.3
Degree of liver involvement:
<30% 13
30%~60% 25
60%< 18
Extra hepatic lesion:
(-) 9 (+)47
Prior systemic chemo/endocrine therapy:
(-) 6 (+)50
Regimen
to 42 patients
5-FU 330mg/m2 qw bolusly
ADR 20mg/m2 qw bolusly
MMC 2.7mg/m2 qw bolusly
to 42 patients
5-FU 330mg/m2 qw bolusly
EPIR 20mg/m2 q2w bolusly
Tetsuo Taguchi, M.D. Osaka University Medical School
pleural/peritoneal carcinomatosis 54%liver metastases 14%lung metastases 9%others 23%
Causes of death in 35 responders
Toray Anthron P-U Catheter
-
H eparin
H eparinH eparin
H eparin
H eparin
H eparin
H eparin
H eparin
H eparin
H eparin
- - -
- -H eparin
--
What is Anthron ?
Anthron is hydrophilic polymer which is ionically bound Heparin and originally developed by Toray.
Anthron continues to release Heparin into blood for a long term period which prevents thrombus formation.
Raw material of this catheter
●Tube : Polyurethane
●Coating on outer surface : Anthron
●Coating on inner surface : Anthron
about 8 cm from distal end.
(Catheters with entire inner surface coated is under development.)
●The surface of catheter becomes slippery after moistening, then, manipulation(操作 ) in blood vessel is smooth.
Heparin Release Curve fromAnthron P-U Catheter
0 100 200 300 400
Time (days)
Eluted Heparin Amount
( units/ cm2 min.) BzCl-Hep
Anthron
10-1
10-2
10-3
10-4
10-5
10-6
0 20 40 60
Time (hour)
Elu
ted
Hep
arin
Am
oun
t(
un
its/
cm
2 m
in.)
BzCl-Hep
Anthron
10-1
10-2
10-3
10-4
10-5
10-6
Concept & Target
★Catheter for long-term inderwelling★
★ Catheter for chemotherapy ★
Animal test
Material & Method:●Material: silicon catheter Anthron P-U Catheter●Animal: Dogs(Biegle)●Indwelling place: from femoral vein to vena cava●Indwelling term: 6 months
597
666
623 616
5E+2
6E+2
7E+2M
ale
Fem
ale
silic
one
Anth
ron
107
115
132
112
100E+4
125E+4
150E+4
Male
Fem
ale
silic
one
Anth
ron
56 57.868.6 70.6
0%
50%
100%
Ma
le
Fem
ale
silic
one
Anth
ron
5.3 4.9
7.3
4.8
0%
5%
10%
Ma
le
Fe
male
silic
on
e
Anth
ron
Analysis of blood components after indwelling Test results(1)
WBC RBC
Seg-Neutrophile α2-globlin
Frequency of pulmonary embolism(n=87)
Test results(2)
Silicone : higher risk of PE
Observation by optical microscopy
Anthron
Silicone
1%
30%
5%0%
20%
40%
60%
80%
100%
Control si l i cone Anthron
Frequency of phlebitis on indwelling place(n=87)
Test results(3)
Observation by eyes
Anthron
Silicone
Observation by optical microscopyAnthron Silicone21%
81%
18%0%
20%
40%
60%
80%
100%
Control silicone Anthron
Frequency of phlebitis where the catheter is placed
Frequency of thrombus formation on catheter surface
Test results(4)
Observation by SEM
Anthron
Silicone
0%
47%
24%
0%
20%
40%
60%
80%
100%
Control si l i cone Anthron
Anthron:lower risk of thrombus formation due to catheters indwelling
Types of Anthron P-U Catheter
Fr. size Ring O.D. (mm) Length(cm) Hardness of catheter Suitable guidewire
PU6070HCS 6 - 70 Hard 0.97(0.038)
PU5070HCS 5 - 70 Hard 0.89(0.035)
PU5070HDS 5 - 70 Hard 0.89(0.035)
PU5070SDS 5 - 70 Soft 0.89(0.035)
PU5090HCS 5 - 90 Hard 0.89(0.035)
PU5000HCS 5 - 100 Hard 0.89(0.035)
PU3370HCS 3.3 - 70 Hard 0.46(0.018)
PU6035SAR 6 3 35 Soft -
PU6070SAR 6 3 70 Soft -
PU5035SAR 5 2.7 35 Soft -
PU5070SAR 5 2.7 70 Soft -
Headhunter APU5070HDAA 5 - 70 Hard 0.89(0.035)
Cobra A PU5070HDCB 5 - 70 Hard 0.89(0.035)
Hook A PU5080HDCC 5 - 80 Hard 0.89(0.035)
RH-A PU5080HDCG 5 - 80 Hard 0.89(0.035)
Twist PU5070HDCY 5 - 70 Hard 0.89(0.035)
Regular Type
Catalogue No.
Ringed Type
Pre-Shaped
Type
Fr. size Guide wire Fr. size Guide wire
PU5070SDST 5 0.89mm (0.035") 2.7 0.46mm (0.018") 2.5cm 72.5cm Soft type
PU5090SDST 5 0.89mm (0.035") 2.7 0.46mm (0.018") 20cm 90cm Soft type
Catalogue No. Tapar length Length HardnessProximal portion Distal portion
Instructions for implantation
●Check the tumor location using an angiographic catheter. If necessary, redistribute the blood circulation
●Insert a guidewire into the angiographic catheter
●The guidewire must not be removed into the vessel. Then remove the angiographic catheter.
Instructions for implantation
●Slide in the catheter through the guidewire until it reaches the target vessel.
●Insert an indwelling catheter into the
vessel by the Seldinger technique.
●Indwell the catheter at the site to be treated, assuring the position of the end of the catheter with the radioscope. To reduce the risk of the dislocation of the catheter, coil down the catheter into the aorta.
●Cut the catheter to adjust the length
appropriately
●Prepare the ST301C or ST305C
manufactured by B. Braun Aesculap.
●Insert a lock for ST301C or ST305C
over the catheter ring, over the
proximal end of the catheter.
ST301C ST305C
●Fix the lock ring onto the portal.
●Insert the exit cannula of ST301C or
ST305C into the catheter, as in the
following illustration.
IA Catheter 的先端固定留置法
Conventional percutaneous method
CHA-coil 法
SPA-coil 法
GDA-coil法
Converntional percutaneous method
RGA and GDA were embolized and the indwelling catheter was inserted to PHA
CHA-coil 法
RGA was embolized and the indwelling catheter was inserted into PHA, then CHA was embolized by coils.
SPA-coil 法
Embolization of RGA, GDA, LGA and DPA were performed before the following catheter placement. The indwelling catheter was inserted to SPA with the catheter-tip fixed employing steel coils and NBCA-Lipiodol mixture, the side hole of which was placed on the celiac artery.
GDA-coil 法
Embolization of RGA was performed before the following catheter placement. The indwelling catheter was inserted to GDA with the catheter-tip fixed employing steel coils and NBCA-Lipiodol mixture, the side hole of which was placed on CHA.
各種留置法的比較
Regimen
For HCC
(1) High dose : 5-FU+Ifα(for one month)
一 二 三 四 五 六 日 一
Response Rate : 50%
5-FU (1600mg/body) 5-FU (1600mg/body)
IF IF IF
For HCC
(2) Low dose : 5-FU+CDDP(for one month)
一 二 三 四 五 六 日 一
Response Rate : 60%
5-FU (250mg/body)+CDDP (10mg/body)
For HCC
(3) EEP (for one month)
一 二 三 四 五 六 日 一
Etoposido 80~90mg/body
EP 50mg/body EP 50mg/body
CDDP 70mg/body CDDP 70mg/body
Response Rate : 43%
For Metastasis
WHF
一 二 三 四 五 六 日 一
5-FU 1600mg/body for 5-FU 5-FU 1600mg/body for 5-FU
One-time/week
Peroration
HAIC + Toray Anthron P-U Catheter is the best.
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