1. DC Bead Terumo Workshop
GEST 2011
April Paris
DC Bead Terumo Workshop
DEBIRI on colorectal cancer liver metastases: personal experience and tips & tricks
Ivan Marri, Camillo Aliberti
Unit of Oncological Diagnostic and Interventional Radiology,
Delta Hospital AUSL Ferrara, Ferrara Italy
Slide 1

2. GEST 2011 April Paris
Intra-arterial treatment of liver malignancy with drug eluting Beads: Global Report of five years of experience (from March 2006 to March 2011)
357 patients treated
626 TACE
2 cases of major complications
(1 acute pancreatitis and 1 liver abscess)
Slide 2

3. DEBDOX DEBIRI Cholangiocarcinoma: 54pts Colorectal Cancer: 148pts
GEST 2011 April Paris
DEBDOX
DEBIRI
Cholangiocarcinoma: 54pts
Pancreatic Cancer: 8pts
Breast Cancer: 22pts
Gastric Cancer: 8pts
Carcinoid: 20pts
Sarcoma: 5pts
Willms Cancer: 2pts
Colorectal Cancer: 148pts
Uveal Melanoma: 78pts
Melanoma: 12pts

4. 1 major complication (acute pancreatitis)
GEST 2011 April Paris
Liver metastases of Colorectal Cancer: General Report (From 2006 to 2011)
148 patients treated
254 TACE
100% technical success
1 major complication (acute pancreatitis)

5. Pre-Treatment Imaging
GEST 2011 April Paris
Pre-Treatment Imaging
Obtaining a triple-phase CT or MRI of the liver is mandatory to evaluate the indication to the treatment of metastases with DC-Bead
Site and number of LM
% of liver substitution
Vascular map of the liver
Feeding vessels of the lesions
Morphologic evaluation of ileo-femoral arteries
Additional imaging examinations to rule out extrahepatic disease should be performed as appropriate.

6. Loading dose of Irinotecan
GEST 2011 April Paris
Loading dose of Irinotecan
Each vial of DC Bead (2ml of Beads) can load 100mg of Irinotecan (loading dose 50mg Irinotecan/ml of Beads)
Complete loading achieved within min: we usually load Beads the day before the TACE.

7. Choice of Dose + For small lesions or lobar treatment:
GEST 2011 April Paris
Choice of Dose
For small lesions or lobar treatment:
100mg of Irinotecan loaded in 2ml of Beads +
100mg Irinotecan

8. GEST 2011 April Paris
Choice of Dose
For larger lesion or full liver treatment: a maximum of 200mg of Irinotecan loaded in 4ml of Beads +
200mg Irinotecan
Indication to treatment with DC Bead in patients with liver replacing less than 70% .
In case of replacing more than 50% interventional and clinical expertise is required to manage patients.

9. Optimizing drug delivery: preferable use of small particles
GEST 2011 April Paris
Choice of DC Bead size
Optimizing drug delivery: preferable use of small particles
Chemosaturation
Size μm
Size μm
Deeper penetration into the tumor vascular bed permits to deliver a greater effective dose of drug

10. Choice of DC Bead size Use of 100-300μm Beads
GEST 2011 April Paris
Choice of DC Bead size Use of μm Beads
for a standard procedure
After TACE
Before TACE

11. Choice of DC Bead size Hypovascular metastases
GEST 2011 April Paris
Choice of DC Bead size
CE Marked for use ONLY with Irinotecan
Hypovascular metastases
Treatment of microsatellites lesions
Treatment of residual viable tissue after first TACE
Treatment of recurrent lesions

12. Treatment of microsatellites
GEST 2011 April Paris
Hypovascular
lesions
Before TACE
Before TACE
After TACE
Treatment of microsatellites
After TACE

13. Peri-procedural medication
GEST 2011 April Paris
Peri-procedural medication
Pain treatment:
1 vial (10mg) of Morphine/100ml of physiological solution e.v. 30min. before the procedure
1 vial of Morphine/100ml of physiological solution e.v. slow infusion during the TACE
1 vial of Morphine/100ml of physiological solution very slow infusion afther the procedure
Prophylactic treatment against nausea: 1 vial (5mg) of Tropisetron/100ml of phs.sol. e.v. before TACE and at +6 hours
Antibiotic prophylaxis and gastric protection should be administered from day 0 to day 5

14. Drug administration 5-10ml of contrast media / ml of DC Bead
GEST 2011 April Paris
Drug administration
1 Remove the overnatant fluid
2 Mix Beads with a solution of
5-10ml of contrast media / ml of DC Bead

15. The use of microcatheter is advisable:
GEST 2011 April Paris
The use of microcatheter is advisable:
Reduces the vasospasm
Permits the catheterization of difficult arteries
Permits an optimal distribution of microspheres
Very Slow infusion of Beads!

16. GEST 2011 April Paris
Drug administration
A selective (segmental or lobar) approach should be used; only in selected cases full liver treatment.
Right lobe
Lefth lobe
L+R lobe
101/ %
75/254 30%
76/254 30%

17. GEST 2011 April Paris
Lobar approach:
Place the catheter as selectively as possible in the right or left hepatic artery

18. Whole liver treatment:
GEST 2011 April Paris
Whole liver treatment:
Place the catheter as selectively as possible in tumors feeding arteries in right and left lobe
Do not infuse Beads in common trunk of hepatic artery! High risk of administration of even a few DC Beads into extra-hepatic vessels
6 months after TACE

19. DEBIRI administration
GEST 2011 April Paris
DEBIRI administration
Pay attention to identify the origin of cystic and pancreatic artery!
Pancreatic artery
Cystic artery 19

20. The aim of TACE with DC Bead is drug delivery not embolotherapy!
GEST 2011 April Paris
Embolization Endpoint
Injection should be continued until “near stasis” is observed in the artery directly feeding the tumor
The aim of TACE with DC Bead is drug delivery not embolotherapy!
AFTER TACE
BEFORE TACE
Endpoint: FULL DOSE (not stasis)
No additional embolization should be performed 20

21. GEST 2011 April Paris
Treatment response should be assessed according to modified RECIST (mRECIST)

22. DEBIRI in Colorectal L.M.: Report of 120 pts
GEST 2011 April Paris
DEBIRI in Colorectal L.M.: Report of 120 pts
Median survival time 22,4 months.
Median time to progression 8.04 months
Median duration of response 5,6 months
Aliberti et al. JVIR in press 22

23. GEST 2011 April Paris
The association with sistemic therapy increase the response to treatment
DEBIRI+Sistemic therapy
63/116
Median survival time 24,6months
Median duration of response 8,2months
Median time to progression 10,2months
Only DEBIRI
53/116
Median survival time 15,7months
Median duration of response 3,2months
Median time to progression 4,6months 23

24. DEBIRI Colorectal Liver Metastases treatment algorithm
GEST 2011 April Paris
DEBIRI Colorectal Liver Metastases treatment algorithm
DEBIRI TACE 2/4 ml of Beads Loaded with mg od Drug
4 week CT/MR or PET
Complete Response
Partial Response
Progression
Follow up and other oncological therapy
TACE
Other oncological therapy
Progression
TACE

25. Liver metastases from Uveal Melanoma
GEST 2011 April Paris
Liver metastases from Uveal Melanoma
60-70% Intrahepatic diffuse, 30-40% oligonodular
Surgery is feasible in only a minority of patients (30%) .
Systemic chemotherapy (nitrosureas, DITC, Cisplatin and Interferons) has achieved a low median survival (range 5-7 months)
Conventional TACE showed slightly better median survival (10 months)
Other therapeutic approaches (Photodynamic, RT, HIFU) are still investigational and require further supporting data.
Palliative therapies have not been shown to significantly improve survival 25

26. Liver metastases from Uveal Melanoma
GEST 2011 April Paris
Liver metastases from Uveal Melanoma
General report
(from May 2007 to March 2011):
78 Patients treated
104 TACE

27. Liver metastases from Uveal Melanoma
GEST 2011 April Paris
Liver metastases from Uveal Melanoma
Treatment Schedule
Bead size μm
Dose of drug mg (when is possible use the maximum dose)
Segmental or lobar approch if necessary is possible to treat whole liver.
Peri-procedural medication is the same of colorectal metastases

28. Results: clinical responses
GEST 2011 April Paris
Liver metastases from Uveal Melanoma
Results: clinical responses
One month after TACE we observed a significant reduction (>50%) of the lesional contrast enhancement in 93% of patients
We observed an overall Response Rate of 45/52 pts (86%) followed RECIST-modified criteria at 3 months f.u.
37 patients out 52 are alive at time of analysis, with a median time to progression of 7,5 months and median follow-up of 10 months (range 1-24 months)
40% of entire population are alive at 15 months
Fiorentini G, Aliberti C, Del Conte A, Tilli M, Rossi S, Ballardini P, Turrisi G, Benea G: Intra-arterial hepatic chemoembolization (TACE) of liver metastases from ocular melanoma with slow-release irinotecan-eluting beads. Early results of a phase II clinical study. In Vivo; 2009 Jan-Feb;23(1):131-7

29. Liver metastases from Uveal Melanoma
GEST 2011 April Paris
Before TACE
Liver metastases from Uveal Melanoma
After TACE
DSA
Before TACE
After TACE

30. Advantages of TACE with DEBIRI in Liver Metastases
GEST 2011 April Paris
Advantages of TACE with DEBIRI in Liver Metastases
Absence of systemic toxicity
Good treatment option for patients with toxicity of chemotheraphy waiting for further therapy (Chemo-Holiday)
Effective palliation in preminent hepatic metastatic disease from various tumors
Probably the best treatment in ocular melanoma patients