biocompatibles satellite symposium at gest 2011 review of treatment algorithms and procedural...

Biocompatibles Satellite Symposium at GEST 2011

Review of Treatment Algorithms and

Procedural Standards for DC Bead in HCC

Professor Riccardo Lencioni

Director, Diagnostic Imaging and InterventionDepartment of Hepatology and Liver Transplantation

Pisa University Hospital and School of Medicine, Pisa, Italy

Llovet JM, DiBisceglie A, Lencioni R, et al.

EASL-EORTCClinical Practice Guideline:Hepatocellular Carcinoma

Journal of Hepatology, 2011 - European Journal of Cancer, 2011

Portal pressure/bilirubin

HCC

Ablation Sorafenib

Stage 0PST 0, Child–Pugh A

Very early stage (0) 1 HCC < 2 cm

Carcinoma in situ

Early stage (A)1 HCC or 3 nodules

< 3 cm, PST 0

End stage (D)

Liver transplantation TACEResection Symptomatictreatment (20%)

Survival < 3 monthsCurative treatments (30%)

5-year survival 40–70%Palliative treatments (50%)

Median survival 11–20 months

Associated diseases

YesNo

3 nodules ≤ 3 cm

Increased

Normal

1 HCC

Stage DPST > 2, Child–Pugh C

Intermediate stage (B)Multinodular,

PST 0

Advanced stage (C) Portal invasion, N1, M1, PST 1–2

Stage A–CPST 0–2, Child–Pugh A–B

Treatment of Hepatocellular Carcinoma (HCC):The BCLC Staging System

adapted from Llovet JM, DiBisceglie A, Lencioni R, et al. (in press)

Cancer Treat Rev 2011;37:212-220

Clinical Management of Hepatocellular Carcinoma: Building Multidisciplinary Consensus

• Compared with conventional TACE, drug eluting bead has a standardized methodology, is more reproducible, and offers improved response and a significantly better safety profile.

Drug eluting bead vs conventional TACE: A randomized trial (“PRECISION V”)

Lammer J et al. Cardiovasc Intervent Radiol 2010;33:41-52

p=0.001

0

50

100

150

200

250

300

AS

T U

nit

s/L

DC Bead cTACE

0

50

100

150

200

AL

T U

nit

s/L

p<0.001

p=0.001

Drug-related adverse events Liver toxicity (AST – ALT levels)

DEBDOX: drug-related adverse events and liver toxicity are significantly reduced

Lammer J et al. Cardiovasc Intervent Radiol 2010;33:41-52

Lencioni R. Personal Communication

80

70

60

50

40

30

20

10

0

-

-

-

-

-

-

-

-

44

52

80

Mal

agar

i

77

Gro

sso

75

Var

ela

70

Po

on

60

Rey

es

85S

on

g

Drug-eluting beads

35

27

LL

ove

t

Lo

cTACE

p=0.11

Precision V

DEBDOX versus conventional Lipiodol TACE: Tumor response

Tailoring Transcatheter Treatment with DC Bead to the Individual Patient / Tumor Characteristics

DC Bead in HCC: Development of Procedural Standards and Technical Recommendations

• The panel: Thierry De Baere / Institut Gustav-Roussy, Paris, France James G. Caridi / University of Florida, USA Jean-Francois H. Geschwind / Johns Hopkins University, USA Riccardo Lencioni / University of Pisa, Italy Katerina Malagari / University of Athens, Greece Robert C. Martin / University of Louisville, USA Elizabeth O’Grady / University Hospital Aintree, UK Thomas J. Vogl / Universty of Frankfurt, Germany

• Consensus Meeting during the ECIO 2010 in Florence

• Independent reviewers: Martha Burrel and Maria Isabel Real, Liver Unit, Barcelona, Spain Johannes Lammer, University of Vienna, Austria Anthony Watkinson, Royan Devon and Exeter University Hospital, UK

Pre-Treatment Imaging

Obtaining a triple-phase CT or MRI of the liver is mandatory to integrate clinical and laboratory data to evaluate the indication to transcatheter treatment of HCC with DC Bead in each individual patient by the local multidisciplinary liver tumor board.

Additional imaging examinations to rule out extrahepatic disease should be performed as appropriate.


Peri-Procedure Medication

Pain medication should be given according to standard hospital protocol.

Antibiotic prophylaxis and gastric protection should be administered at the physician's discretion.


Loading Dose of Doxorubicin

Each vial of DC Bead (2 ml of beads) should be loaded with 50-75 mg doxorubicin (loading dose, 25-37.5 mg doxorubicin / ml of beads).



Planned Dose:

Single / Small HCC

Each treatment:

- 1 vial

- up to 75 mg doxo

Planned Dose:

Large / Multiple HCC

Each treatment:

- 2 vials

- up to 150 mg doxo

Bilobar Tumors

In bilobar tumors, both hepatic lobes should be treated in separate treatment sessions 2-4 weeks apart, in the absence of complications requiring a longer time interval between the two sessions.

Obtaining confirmation that the liver enzymes have returned to baseline before performing the second treatment session is recommended.


Very Large Tumors

In very large tumors, even if unilobar, the same approach including two sessions should be followed.

Indication to treatment with DC Bead in patients with tumor replacing more than 50% of the liver should be carefully evaluated: adequate interventional and clinical expertise is required to manage patients with such advanced disease.


Choice of DC Bead Size

Use of 100-300μm beads is recommended for a standard procedure.

However, individual patient and tumor characteristics, particularly the identification of arterio-venous shunting, should be taken into account when the safety of the treatment and the choice of DC Bead size are determined.


Choice of DC Bead Size

In the case of significant arterio-portal or hepatic venous shunting, embolization of the shunt with gelfoam pledgets is recommended before proceeding with DC Bead treatment.

Confirmation that the shunt is no longer present must be obtained before the DC Bead can be safely administered.


DC Bead Dilution

Mix loaded DC Bead with a non-ionic contrast medium.

At least 5-10 ml of non-ionic contrast should be used per 1 ml of DC Bead (i.e., 10-20 ml are required to dilute one vial of DC Bead) prior to injection).


Catheter Positioning

A superselective (i.e., segmental or subsegmental) approach should be used whenever possible by using a microcatheter.

Use of C-arm rotational angiography with a flat-panel detector system (cone-beam CT) is recommended, if available, to improve the accuracy in identifying tumor-feeding arteries and to confirm adequate targeting and saturation of the tumor(s).



Segmental / Subsegmental approach

Place the microcatheter into the segmental or subsegmental vessel feeding the tumor as distally as possible but avoiding wedging the catheter to avoid reflux along the catheter shaft. Flow within the artery must be preserved.

Lobar approach

Place the catheter as selectively as possible in the right or left hepatic artery. Pay attention to identifying the origin of the cystic artery as well as other arteries supplying flow to extra-hepatic organs. If identified, these vessels must be either embolized using coils or avoided by placing the catheter tip well beyond the origin of these vessels.

Injection of the DC Bead

The injection must be very slow: an injection rate of 1 ml of the contrast agent - DC Bead suspension per minute is recommended.

Care should be taken to avoid sedimentation of the beads in the syringe by rotating the syringes or using a 3-way stopcock to gently suspend the beads in the solution.


Embolization Endpoint

Injection should be continued until “near stasis” is observed in the artery directly feeding the tumor (i.e., the contrast the contrast column should clear within 2-5 heart beats). At that point, injection should be stopped – regardless of the amount of beads that have been actually administered – to avoid reflux of embolic material.


Embolization Endpoint

Once the embolisation endpoint has been achieved, no additional embolic material should be injected.

If the “near stasis” endpoint is not obtained after injection of the scheduled volume of beads, no additional embolization should be performed. This patient is likely to benefit from a second course after imaging follow-up.


Post-Treatment Management

Obtaining a triple-phase CT or MRI of the liver 2-4 weeks after the procedure is recommended to assess the outcome of the first treatment and to plan further action.

Treatment response should be assessed according to modified RECIST (mRECIST) for HCC. *

* Lencioni R, Llovet JM, Semin Liver Dis 2010;30:52-60


Post-Treatment Management

Residual viable tumor (partial response, stable disease, progression): further treatment with DC Bead can be scheduled after 4-8 weeks in the absence of contraindications.

Complete response: imaging follow-up should be scheduled every 2-3 months.


Treatment Discontinuation

Treatment with DC Bead should be discontinued in patients presenting with untreatable progression. *

* Lencioni R et al. ASCO 2010


Untreatable Progression (1)

Failure to achieve objective response in the targeted tumor after at least two DC Bead treatments. The emergence of new intrahepatic tumor foci remote from the treated territory, although clearly represents tumor progression according to modified RECIST for HCC, does not contraindicate further treatment with DC Bead.


Untreatable Progression (2)

Clinical or functional deterioration. Treatment should be discontinued in patients showing clinical progression to ECOG performance status > 2 or evolution to sustained hepatic decompensation (not merely after therapy).


General Statement

The Interventional Radiologists is the only qualified physician to decide how to approach the unique combination of patients and tumor characteristics that he is facing at the time of the procedure.


biocompatibles satellite symposium at gest 2011 review of treatment algorithms and procedural...

Documents

dc bead treatment

transcatheter treatment

separate treatment sessions

single small hcceach

liver enzymes

individual patient

hepatic venous shunting

tumor characteristics