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Interventional Oncology

Current Concepts in Transarterial Chemoembolization

November 11, 2013

Deepak Sudheendra, M.D. Assistant Professor of Clinical Radiology & Surgery Division of Interventional Radiology Hospital of the University of Pennsylvania

No Financial Disclosures

HCC Epidemiology

HCC is the most common primary liver malignancy

Worldwide incidence > 600,000 cases per year

• Liver cancer is the most rapidly increasing cancer in the U.S.

– 19,160 new cases and 16,780 deaths in 2007

More common in men than women (4:1)

For resection, rate of recurrence can be as high as 50% at 2 years

• Only 12% are eligible for resection or for transplant

• 80%-90% of HCC cases occur in cirrhotic livers

International Agency for Cancer Research. Globocan 2002. Available at: http://www -dep.iarc.fr. Accessed February 19, 2008; Parkin DM et al. Int J Cancer. 2001;94;153-156; American Cancer Society. Cancer Facts & Figures 2007. Atlanta, GA; American Cancer Society, 2007. McGlynn KA et al. Int J Cancer. 2001;94:290-296; McGlynn KA et al. Cancer Epidemiol Biomarkers Prev. 2006;15:1198-1203; Jemal A et al. CA Cancer J Clin. 2006;56:106-130; El-Serag HB. Gastroenterology. 2004;127:S27-S34.

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Management of Hepatocellular Carcinoma Requires a Multidisciplinary Approach

Radiation Oncology

Pathology

Oncology

IR/DR

Hepatobiliary Surgery

Hepatology

Why Can We Embolize the Liver?

Unique blood supply

Portal Vein supplies 75%, Hepatic Artery 25%

Doesn’t infarct with hepatic arterial embolization

Primary and Metastatic tumors – hepatic arterial supply

Advances in IR technology

Overall Survival with TACE

1yr 2yr 3yr

Control1 32% 11% 3%

TACE1 57% 31% 26%

Bland2,3 75% 50% 33%

TACE2,3 82% 63% 50%

1Lo et al. Randomized controlled trial of transarterial lipiodol chemoembolization for unresectable HCC. Hepatology 2002; 35(5):1164-71

2Llovet et al. Arterial embolisation or chemoembolisation vs symptomatic treatment in patient with unresectable HCC: A randomised controlled

trial. Lancet 2002: 359(9319):1734-9 3Llovet et al. The Barclona approach: diagnosis, staging, and treatment of HCC. Liver Transpl 2004; 10:115-120

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Indications Treatment for palliation of unresectable HCC

and cholangiocarcinoma

Palliative treatment of metastatic disease from: Colorectal cancer

Neuroendocrine tumors

Sarcomas

Breast cancer

Melanoma

Other liver dominant mets

Adjunctive therapy to liver resection

Bridge to liver transplantation

Guidelines

National Comprehensive Cancer Network (NCCN)

Unresectable HCC

+ Transplant candidate TACE/DEB/Y90 as bridge

− Transplant candidate TACE/DEB/Y90/Nexavar

Guidelines

American Association for the Study of Liver Diseases (AASLD)

TACE is recommended as first line non-curative therapy for non-surgical patients with large/ multifocal HCC who do not have vascular invasion or extrahepatic spread (level I).

Y90 has been shown to induce extensive tumor necrosis with acceptable safety profile. However, there no studies demonstrating an impact on survival and hence, its value in the clinical setting has not been established and cannot be recommended as standard therapy for advanced HCC outside clinical trials (level II).

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Absolute Contraindications 1. Tumor resectability

2. Significant infection

3. Extensive liver disease compromising hepatopetal collateral flow

1. Total bilirubin > 2 mg/dl

2. Borderline liver function

3. Portal vein thrombosis

4. Uncorrectable coagulopathy

5. Poor general health

6. Significant AV shunts through tumor

7. Hepatic encephalopathy

Relative Contraindications

Complications of TACE

Post-embolization syndrome (pain, fever, nausea, fatigue) MOST COMMON!!!

Liver abscess

Gallbladder infarction

Vascular injury

Sepsis

Liver failure

Hepatorenal syndrome

Pulmonary oil embolization

Stroke

Pre-op Orders

IVF

Chemotherapy cocktail (Cisplatin 100 mg, Doxorubicin 50 mg, Mitomycin 10 mg)

Ancef 1 mg IV + Flagyl 500 mg IV

Dexamethasone 10 mg IV

Zofran 16 mg IV

Benadryl 50 mg IV

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Post-op Orders

Aggressive IVF ~ 3 L

Ancef 1 mg IV Q 8 hrs

Flagyl 500 mg IV Q12 hrs

Dexamethasone 8 mg IV Q8 hrs until discharge

Zofran 8 mg IV Q 8 hrs prn

Tylenol

Pain meds (Dilaudid 0.4 mg IV Q 2 hrs then once tolerating PO Dilaudid 4 mg PO Q 4 hrs)

Advance diet

Remove foley (if indicated)

Antibiotic Regimen for Patients with Hepaticojejunostomy

Starting 2 days before procedure

Levaquin 250 mg – 2 tablets QD prior to TACE followed by 1 tablet daily for 2 weeks

Flagyl 500 mg – 1 tablet BID for 2 weeks

Starting 1 day before procedure

Neomycin 500 mg – 2 tabs PO at 1pm, 2pm, & 11pm

Erythromycin 500 mg – 2 tabs PO at 1pm, 2pm, & 11pm

Post-embolization Management

Continue vigorous hydration -- NS 150cc/hr for total 3 liters

Continue abx/antiemetics IV

Pain meds prn or PCA

Compazine/Phenergan/Zofran prn

Advance diet as tolerated

Foley out in AM if urine output adequate & patient ambulatory

Discharge when oral intake adequate & pain controlled with oral meds

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Follow-up TACE/DEB

Repeat laboratory studies at 3 weeks

Next chemoembolization 4 weeks, if indicated

Can be delayed for protracted PES, social reasons, etc.

When all Rx complete, labs at 3 weeks, re-image and office visit at 4 weeks.

Follow responders q3 mo x 1 yr, q4 mo x 1 yr, then q 6m

Retreat responders for intrahepatic recurrence. Consider systemic Rx for all mets.

Take Home Points

Image-guided therapies can extend the curative potential of hepatic resection with acceptable morbidity.

Extended control of unresectable disease can be achieved through complementary local, regional and systemic therapies.

The successful IO procedure is based on good preoperative and postoperative planning

Educate patients on PES and what to expect after procedure

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Developing a

Chemoembolization Practice

Michael C. Soulen, MD FSIR FCIRSE

Professor of Radiology and Surgery

Director, InterventionalOncology

Abramson Cancer Center

University of Pennsylvania

Consultant: Guerbet, BTG, Bayer, Merit

Research: BTG

Royalites: Cambridge Univ Press

What’s So Great About

Interventional Oncology? • Is it the scientific wonder of molecularly-targeted

imaging and therapeutics?

• Is it the technological marvel of 3D image processing,

registration, and guidance systems?

• Is it the satisfaction of providing minimally-invasive

locoregional treatment, sparing cancer patients the

hideous morbidity of surgery and radiation?

What’s So Great About

Interventional Oncology? It’s the money

1991: IO practice starts at Penn

No clinic space, no clinic time, no nurse

1995: IO practice is #1 referral source for IR

• 1999 Two of the top 10 referring physicians are IR

• 2001 Four of the top 10 referring physicians are IR

• 140 new patients seen in IR clinic per quarter

• Average downstream Medicare professional reimbursement per IO referral $10,000

Tuite C, Solomon J, SIR 2004

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Chemoembolization Economics

downstream revenue

Chest Port

IVC Filter

HACE

Interventional Oncology Practice

Development

• Become an oncologist

• Be familiar with the science

• Develop a program

• Offer a complete range of treatments

• Be part of the team

• Do a great job

Clinic: the Hub of

Interventional Oncology Medical Oncology Surgical Oncology Transplant Surgery Urology Thoracic Surgery

IO Clinic

Formal Evaluation

Therapy and Follow Up

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Interventional Oncology at HUP

• 10 Physicians

• 3 admins

• 1 clinic receptionist

• 2 pre-cert clerks

• 2 Physician Assistants

• 2 Nurse Practitioners

• 3 clinic rooms

• 2 attg in clinic daily

• Mulit-D Tumor Clinic

A Global Community Where IO Meets

•

•

A Global Community Where IO Meets

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CHEMOEMBOLIZATION • No standards:

- Patient selection

- Number and type of embolics

- Number and type of drugs

- Volume of liver treated

- Frequency and end-point of treatment

- Measurement of response

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Copy right © 2010 by the American Roentgen Ray Society

Takayasu, K. et al. Am. J. Roentgenol. 2010;194:830-837

Survival: Oil +/- Particles Lipiodol chemoembolization (solid line) vs. Lipiodol without

embolization (dotted line) matched by propensity score

HR 0.70 [0.63-0.76]

p=0.0001

Copy right © 2011 by the American Roentgen Ray Society

Takayasu, K. et al. Am. J. Roentgenol. 2000;175:699-704

Lipiodol is an

imaging

biomarker for

tumor

response...

+ Dox in resected HCC @ 1-2 mo

...and Survival!

Figure 4. Courbe de survie selon la fixation lipiodolée.

Survival curve according to lipiodol tumor uptake.

• El Khaddari S, Gastroenterol Clin Biol. 2002;26:728-34.

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Oil Retention vs. Survival

Kim, AP&T 2012;35:1343

Hydrophilic vs. Lipophilic Drugs

Water-in-Oil Emulsion • Specific gravity of contrast adjusted to match

Lipiodol Ultra-Fluide

• 8.5ml contrast + 1.5ml sterile water

• Mix at oil:chemo ratio of 1-2:1

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Risk Factors for Chemoembolization:

Liver Reserve and Disease Burden

• MD Anderson criteria:

- LDH >425

- AST >100

- TB >2

- 50% liver replacement

• Child’s C cirrhosis

• Extrahepatic disease (not liver dominant)

• End stage cancer

- Okuda Stage III

- BCLC-D

Risk Factors for Chemoembolization:

Portal Blood Flow

RadioGraphics May 2002 vol. 22 no. 3 527-541

Risk Factors for Chemoembolization:

Portal Blood Flow

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Risk Factors for Chemoembolization:

Bile Duct Obstruction

RadioGraphics November 2010 vol. 30 no. 7

1935-1953

Risk Factors for Chemoembolization:

Bile Duct Stent or Surgery

Pre-treatment Evaluation

• CT/MRI of liver

• Metastatic workup

• CBC, creat, LFTs, coags, tumor markers

• Initial office consultation

- H&P, data review, discussion of

procedure, post-embolization

syndrome, benefits and risks,

brochure, consent

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Pre-Treatment Imaging • Where is/are the tumor(s)? Segmental location

– Dominant disease burden; disease-free segments

• Classical or variant arterial anatomy?

• Status of hepatic and portal veins and bile ducts

• Ascites; extrahepatic disease

• Lobar or segment volumes for resection (FLR) or Y-90

Procedure

• SMA and celiac angiography

• Identify variant anatomy

• Identify non-target branches to gut

• Identify cystic artery

• Confirm portal flow to liver

• Be sure you know where the tumor is

• Selectively catheterize target lobe or

segment

• F

• Feeder detected only by CBCT 13%

• Additional feeders detected only by CBCT 6.5%

• MIPS of arterial anatomy altered plan 26%

• Additional HCC nodules detected by CBCT 21%

• Insufficient Lipiodol uptake requiring additional dose detected 44%

• Better Lipiodolization on f/u MDCT (p=0.04)

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BUILDING AN

INTERVENTIONAL ONCOLOGY PRACTICE

SCOTT K. PRICE, MD

PRESIDENT, DIAGNOSTIC AND INTERVENTIONAL

ONCOLOGY ASSOCIATES, P.C.

DISCLOSURE

• NONE

DIAGNOSTIC AND INTERVENTIONAL ONCOLOGY ASSOCIATES, P.C.

COVER 2 HOSPITAL

2 IR DOCS AND 2 IR PA

SEE 400 PATIENT CONSULTS/YEAR

PERFORM 500 COMPLEX IO PROCERDURES/YEAR

Y90, CHEMOEMBO, ABLATIONS, IRE

PERFORM 1500 OTHER IO PROCEDURES/YEAR

PICC, PORTS, PARA, THORA, BX, PAIN, BILIARY

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GETTING STARTED

• BUY IN FROM YOUR DIAGNOSTIC RADIOLOGY PARTNERS

• REFERRAL BASE

• ONCOLOGISTS, SURGEONS, GI, RAD ONCO, PRIMARY CARE,

SELF

• EASY TO REACH AND VISIBLE

• OFFICE NUMBER, CELL, TEXT, EMAIL

• TUMOR BOARD, GRAND ROUNDS, SPECIALTY CONFERENCES, FLOOR

ROUNDS, MED STAFF MEETINGS, COMMITTEES

• VISIT REFFERAL OFFICES, OPEN HOUSES, HOLIDAYS

• GET TO KNOW OFFICE SUPPORT STAFF

• IF YOU ADD A PARTNER, GET THEM INVOLVED

• WEBSITE

GETTING STARTED

• PLACE TO SEE CONSULTS AND FOLLOW UPS

• WAITING AREA, CONSULT ROOM WITH PACS, LOTS OF

CHAIRS, BROCHURES, DRAW PICTURES, SHOW

PREVIOUS CASES

• DEFINE SERVICES OFFERED

• BX, CHEMBO, Y90, ABLATION, PORTS, PARA, THORA,

PAIN, VERTEBROPLASTY

• TYPE UP LIST, UPDATE LIST AND DOCS WHEN YOU GET

NEW TECHNOLOGY

• ADMIT PATIENTS OR CONSULT HOSPITALIST

MAINTAINING IO SERVICE

• WORKFLOW

• CONSULTS, PROCEDURES, FLOOR ROUNDS, OR,

CONFERENCES

• FLEXIBLE

• SUPPORT STAFF

• RECEPTIONIST, PA

• COMMUNICATION IS KEY

• LETTER AND PHONE CALL

• EMAIL

• TEXT

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MAINTAINING AN IO SERVICE

• PATIENT SATISFACTION

• TALK TO PATIENT’S FAMILY

• RETURN PT AND FAMILY PHONE CALLS

• PA CAN HELP

• FOLLOW UP VISITS

• FOLLOW UP ON ALL PATIENTS, OFFER TO REVIEW

FILMS WITH THEM IN THE FUTURE

MAINTAINING AN IO SERVICE

• REFERRING DOC SATISFACTION

• COLLABORATIVE EFFORT

• KEEP REFERRING DOC INVOLVED

• SYSTEMIC CHEMO, SUGGESTIONS FOR F/U, GET THE

PATIENT BACK TO THEM

• COORDINATE F/U APPOINTMENTS AND IMAGING WITH ONCO

• REFER NEW PATIENTS TO THEM

• PT SELECTION AND OUTCOMES

QUESTIONS

• CONTACT INFO

• SCOTTPRICEMD@GMAIL.COM

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November 11, 2013

Drug Eluting Microspheres

J.F. Geschwind, MD

Professor of Radiology, Surgery and Oncology

Director, Vascular and Interventional Radiology

Johns Hopkins University School of Medicine

Baltimore, Maryland

DISCLOSURES

Grant support:

NCI RO1, DOD, RSNA, SIR, Genentech, Bayer Healthcare, Nordion,

BTG, Philips Health Care, Guerbet, Abdulmalik Research Fund, Alice

Pratt Liver Cancer Fund

Consultant:

Philips Health Care, Bayer Healthcare, Nordion, BTG, Guerbet, Koo

Foundation, PreScience Labs

Founder and Chairman of the board: PreScience Labs

Patent:

Use of 3-BrPA as an anti-cancer agent

Why Drug-eluting Technology? Clear Rationale: 1. Maximize drug delivery 2. Consistent (scientifically reproducible) 3. Long lasting effect/slow release (sustained) 4. Tumor effect vs. systemic side effects

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What are we talking about?

Not all drug-eluting microspheres are created equal! - DC/LC Bead vs. Hepaspheres - DEBDOX - M1

Data: >70 manuscripts on DC/LC Beads 2 manuscripts on Hepaspheres

Will focus on established Therapy ie DEB-TACE with DEBDOX (LC/DC beads with dox.)

What are the facts? 1. Technical Recommendations 2. Toxicity profile 3. Efficacy: Single arm studies and comparison vs. cTACE (level 2 evidence)

6

Where are we with DEB-TACE?

What have we learned from GIDEON?

Worldwide trends in locoregional therapy for

hepatocellular carcinoma (HCC):

Second interim analysis (1500 patients) of the GIDEON

(Global Investigation of therapeutic DEcisions in HCC

and Of its treatment with sorafeNib) study

Global investigators worldwide (multidisciplinary):

Jorge Marrero

Alan Venook

Riccardo Lencioni

Jeff Geschwind

Sheng-Long Ye

Masatoshi Kudo

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7

Prior and

Concomitant TACE Treatment

%a

Total

(N=722)

Europe

(n=186)

USA

(n=116)

Latin America

(n=9)

Asia-Pacific

(n=289)

Japan

(n=122)

Number of treatments 1 2 3-5 ≥6

40 21 27 12

47 23 25 5

59 27 13 1

78 11 11 0

36 20 27 17

19 15 43 23

TACE drugsb,c

Doxorubicin Cisplatin Epirubicin Mitomycin

48 30 24 15

69 6

18 6

84 41 1

30

100 0 0 0

35 45 15 14

8

23 82 15

TACE agentsd,e

Conventional (Lipiodol) Drug-eluting beads

76

16

62

34

43

37

89

22

93 2

90 1

aPercentages based on patients who received prior TACE; bDenotes lead drug, combinations may have been used; cTACE drug was not specified for 36 patients and was specified as unknown for 32 patients; dTACE agent was not specified for 38 patients and was specified as unknown for 23 patients; eGelatin sponge (n=187) and microsphere (n=9) not shown

8

1.

Technical

Recommendations

Technical Recommendations

1. Small size microspheres (100-300µm)

2. Must use microcatheter (same as Y90)

3. Must place catheter selectively

4. Use cone beam CT for tumor targeting

5. Visibility of beads critical: mix with contrast 4:1

6. Inject slowly (1 ml/min)

7. Avoid complete stasis

8. Repeat treatment 2-4 weeks if needed

Lencioni R, de Baere T, Burrel M, Caridi JG, Lammer J, Malagari K, Martin RC, O'Grady E, Real MI, Vogl TJ,

Watkinson A, Geschwind JF. Transcatheter Treatment of Hepatocellular Carcinoma with Doxorubicin-loaded DC

Bead (DEBDOX): Technical Recommendations. Cardiovasc Intervent Radiol. 2012 Oct;35(5):980-5.

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10

2.

Pharmacokinetics/

Toxicities

Chemoembolization of Hepatocellular Carcinoma with Drug Eluting Beads: Efficacy and Doxorubicin Pharmacokinetics

•27 patients with Child-Pugh A

•Response rate assessed by CT at

6 months

•Response rate: 75%

•1- and 2-year survival: 92% and

89% (median follow-up of

28 months)

Varela M, et al. J Hepatology 2007

12

p=0.012*

Incid

en

ce o

f d

oxo

rub

icin

-re

late

d A

Es (

%)

35

30

25

20

15

10

5

0 DC Bead cTACE

Alopecia

Marrow suppression

Mucositis

Skin discoloration

DC Bead® cTACE

PRECISION V trial: DC Bead Associated with

Significantly Lower Incidence of AEs than cTACE

AE = adverse event Lammer J, et al. Cardiovasc Intervent Radiol 2010;44:41–52

*p=0.0001 for analysis with assumption of independence of events

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13

2.

Efficacy/

Tumor Response

Chemoembolization of Hepatocellular Carcinoma with Drug Eluting Beads: Efficacy and Doxorubicin Pharmacokinetics

•27 patients with Child-Pugh A

•Response rate assessed by CT at

6 months

•Response rate: 75%

•1- and 2-year survival: 92% and

89% (median follow-up of

28 months)

Varela M, et al. J Hepatology 2007

Levels of Evidence for Cancer Treatment Studies (PDQ®) Study design 1. Randomized controlled trial, meta-analysis -Double-blinded: 1i

-Non-blinded: 1ii

2. Non-randomized controlled trials

3. Case series -Population-based: 3i

-Non–population-based, consecutive: 3ii

-Non–population-based, non-consecutive: 3iii

Endpoint A. Survival

B. Cause-specific mortality

C. Quality of life

D. Indirect surrogates

-Disease-free survival: Di

-Progression-free survival: Dii

-Tumor response: Diii

http://www.cancer.gov/cancertopics/pdq/levels-evidence-adult-treatment

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DEB-TACE

Investigator

Level of Evidence

# Patients BCLC Child-Pugh-Class

CR/PR Survival

Reyes (2009) 2DIII 22 A - 6 B - 2 C - 12

A (75%) B (5%)

CR: (5%) PR: (35%) (RECIST)

MOS: 26 mo

Nawawi (2009) 3III 19 A - 4 B - 15

A (64%) B(36%)

CR: (21%) PR: (37%) SD: (21%) PD: (21%)

MOS: 17 mo (mean Follow-up)

Wiggermann (2011)

3III 22 N/A A (100%) CR: (14%) PR: (9%) SD: (68%) PD: (9%)

MOS: 21 mo

Recchia (2012) 2DIII 35 N/A A (12) B (23)

CR/PR: (63%) (EASL)

18.4 mo

Burrel (2012) 2A 104 N/A A (95%) B (5%)

N/A MOS: 47.7mo (after censor)

Malagari (2012)

2A 173 A – 38 B – 135

A (102) B (71)

R/NR after 3rd E.: 72.5 %/27.5% for CP A and 69%/31 for CP B

5Yr: 47.6 % for CP A ,< 5 cm 23.5% for CP A < 5 cm

Lammer (2012) PRECISION V

1IID DEB-TACE: N=93 (108 for cTACE)

A – 24 B – 69

A (77) B (16)

CR: 27% PR: 25.% SD: 16% PD: 32%

N/A

• Study Design:

– Prospective single-arm, single center phase II study to evaluate safety and efficacy of DEB-TACE

• Enrolled Patients:

– 22 Patients with unresectable HCC (75% Child’s A, 65%BCLC C, 95% ECOG 0-1)

– Excluded: Previous HCC therapy other than resection

• Treatment Protocol: – 100-300 µm LC Beads loaded with 100 mg Doxorubicin

– Superselective Injections

18

Kaplan-Meier Survival Curves

Time Months

40 30 20 10 0

100

80

60

40

20

0

Surv

ival

Pro

babili

ty %

OS

PFS

Reyes D et al. Cancer J. 2009

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Comparative study between doxorubicin-eluting beads and conventional transarterial chemoembolization for treatment of HCC

Purpose: To evaluate the efficacy and safety of drug-eluting bead

(DC Bead) TACE in comparison with conventional TACE (cTACE)

Methods: Case control study

HCC patients: TACE with DC bead (n=60) vs. cTACE (n=69)

Primary end points: Treatment response + treatment-related adverse

events

Secondary end point: TTP

Song MJ et al. Comparative study between doxorubicin-eluting beads and conventional transarterial

chemoembolization for treatment of hepatocellular carcinoma. J Hepatol. 2012 Dec; 57(6): 1244-50.

Treatment response: DC bead TACE >> cTACE (p<0.001)

TTP: DC bead TACE >> cTACE group (11.7 vs. 7.6months, p=0.018)

Intermediate-stage HCC (BCLC B): DC bead TACE >> cTACE (treatment response

+ TTP; p<0.001 and 0.038, respectively)

No statistically significant difference in liver toxicity (p>0.05)

Comparative study between doxorubicin-eluting beads and conventional transarterial chemoembolization for treatment of HCC

Tumor response (mRECIST) DCR =95% overall

TTP: Significant differences

Overall survival rates: Again significant differences

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Univariate and

multivariate analysis:

Factors that influenced

tumor progression

Univariate and

multivariate analysis:

Factors that influenced

survival rate

Adverse effects and toxicities

according to the treatment group

Survival of patients with hepatocellular carcinoma treated by transarterial chemoembolisation (TACE) using Drug Eluting Beads. Implications for clinical practice and trial design

Purpose: To evaluate the survival of HCC patients treated with DEB-TACE following a strict selection (preserved liver function, absence of symptoms, extrahepatic spread or vascular invasion)

Methods: All HCC patients treated with DEB-TACE from February 2004 to June 2010 (n=104)

Patient Characteristics: 62% HCV+, 95% Child-Pugh A, 41 BCLC A and 63 BCLC B

Results:

Median survival cohort = 48.6 months

BCLC A = 54.2 and BCLC B 47.7 months

Conclusions: “Survival expectancy applying current selection criteria and technique is better than that previously reported”

Burrel M, Reig M, Forner A, Barrufet M, De Lope CR, Llovet J, Bruix J. J Hepatol. 2012 Jun;56(6):1330-5.

Treatment of HCC

DEB-TACE:

DEB-TACE consistent and repeatable (not possible with conventional

TACE)

Implementation of a fairly standardized technical approach (small

beads, addition of contrast during delivery, slow delivery,

microcatheter use and cone beam CT for improved targeting)

Objective response rate (ORR) and disease control rate (DCR) better

for DEB-TACE than cTACE

Case-control study Response Rate: DEB-TACE > conventional TACE

1)Lencioni R. Chemoembolization for hepatocellular carcinoma. Semin Oncol. 2012

2) Pawlik T., et al. Phase II trial of sorafenib and DEB-TACE for HCC. JCO. 2011

3) Lencioni R., et al. CVIR 2011

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Odds ratio:

- Arterial Phase:

0.95 (0.91, 0.99); p= .023

- Venous Phase:

0.96 (0.93, 0.99), p= .035

Prospective study

n=27 patients

47 HCC

27

Conclusions

DEB-TACE: Proven Rationale

Extension of cTACE

Excellent PK profile

Minimal toxicities

Efficacy: Tumor response 75-85% EASL

Survival: >30 months well controlled

populations (strict BCLC B)

Future: Small/imageable spheres

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JHU-NIH Project: Imageable Beads (70-150 microns) Micro CT Images in Rabbit Model Liver Cancer

MDCT post-Tx CBCT post-Tx

JHU-NIH Project: Imageable Beads (70-150 microns) Micro CT Images in Rabbit Model Liver Cancer

Thank you!

11/11/2013

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Lencioni R. Personal communication.

Hong K, et al. Clin Cancer Res. 2006;12:2563-7. Available at: www.biocompatibles.com. Last accessed September 2010.

Non-selective

treatment of the

entire liver

parenchyma

Selective

treatment

(segmental

approaches with

microcatheters)

“Homemade”

drug-in-oil

emulsions and

embolic agents

“conventional”

TACE

Drug-eluting

bead

(calibrated embolic

microsphere)

TACE: Evolving Technique Toward Improving the Treatment of HCC

FROM

TO TO

FROM