HAIC & Toray Anthron P-U Catheter 杏昌生技股份有限公司. HAIC ： ● Advantages of HAIC...

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


45% 1-yr, 2-yr, 3-yr /55.8% , 27.6% ,18.3%

1999 ~2000

M. Tanaka(Kurume U)

ad. HCC withPVTT


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)


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


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


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


ADR 20mg/m2 or EPIR 30mg/m2 q4wbolusly


MMC 2.7 mg/m2q2w bolusly



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


(-) 20 (+)20


<30% 12

30%~60% 16

60%< 12

Histology:

well 6

moderately 24

unknown 2

Regimen

poorly 2

5-FU 330mg/m2qw bolusly


Liver Metastases from Breast cancer


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


<30% 13

30%~60% 25

60%< 18


(-) 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


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)



5-FU (250mg/body)+CDDP (10mg/body)

For HCC

(3) EEP (for one month)


Etoposido 80~90mg/body

EP 50mg/body EP 50mg/body

CDDP 70mg/body CDDP 70mg/body


For Metastasis

WHF


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.

HAIC & Toray Anthron P-U Catheter 杏昌生技股份有限公司. HAIC ： ● Advantages of HAIC...

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