Interventional Oncology: Liver Directed Therapy...•Ocular Melanoma (?) •Cholangiocarcinoma (?) •RCC (?) 11 Basics •Inoperable primary vs secondary hepatic tumors •Induces

Interventional Oncology Liver Directed TherapyAugust 24 2018

Ryan M Davis MD

Assistant Professor of Clinical Radiology

Vascular and Interventional Radiology

University of Missouri - Columbia

2

Disclosures

None

3

Liver Directed Therapy

- Thermal Ablation- Primary or metastatic lesions lt3cm

- Chemoembolization- Intermediate stage primary or metastatic disease- Bridge to transplant

- Y90 Radioembolization- Multifocal primary or metastatic disease- Bridge to transplant or resection

4

Effect of Heat on Soft Tissue

bull In thermal tumor ablation therapy energy is applied to heat and kills focal malignancies (coagulation necrosis)

bull Energy must be delivered throughout the lesion

5

gt105⁰C

60-100 ⁰C

46-52 ⁰C

Boiling vaporization and charring

(carbonization)

Near instantaneous protein coagulation leading

to coagulation necrosis

Irreversible cellular damage

Goldberg SN et al AJR Am J Roentgenol 2000 174(2)323-31

MICROWAVE SYSTEMS OVERVIEW

HOW MICROWAVE SYSTEMS WORK

bull Antenna(s) placed intonear targetbull Use CTUS guidance

bull Electromagnetic field (915 MHz or 245 GHz) rapidly oscillates water molecules generating heat

bull Electromagnetic field heatingThe electromagnetic field can penetrate all biologic tissues including dehydratedcharred tissue created during ablation

10

6

ENERGY CAN BE APPLIED CONTINUOUSLY DESPITE CHANGES IN TISSUE

EFFECTIVE IN ALL SOFT TISSUE TYPES

IMPROVED PERIVASCULAR PERFORMANCE VS RF = LESS HEAT SINK EFFECT


7

8

9

13mo Post MWA

10

TACE

bull Intermediate stage HCCbull Unresectable

bull Neuroendocrine Mets

bull mCRC (irinotecan)

bull Ocular Melanoma ()

bull Cholangiocarcinoma ()

bull RCC ()

11

Basics

bull Inoperable primary vs secondary hepatic tumorsbull Induces local ischemia and prolonged chemo exposure

to tumor

bull BCLC stage B (Extended for bridging to transplant or Stage C if local portal invasion)

bull Conventional TACE versus DEB-TACE

bull Efficacy for HCC confirmed with 2 randomized trials and several metaanalysis

bull Role for mCRC (irinotecan) reduced recently downgraded in NCCN guidelines to 3

12

Chemoembolization

bull Lancet 2002 May 18359(9319)1734-9

bull Arterial embolization or chemoembolization versus symptomatic treatment in patients with unresectablehepatocellular carcinoma a randomized controlled trial

bull Llovet JM1 Real MI Montantildea X Planas R CollS Aponte J Ayuso C Sala M Muchart J Solagrave R RodeacutesJ Bruix J Barcelona Liver Cancer Group

bull Survival benefit at 1 and 2 years of 82 and 63 for chemoembolization and 63 and 27 for control

13

14

4mo Post TACE

15

Yttrium-90 Radioembolization

bull Hepatic mCRC

bull Non-resectable HCC

bull Cholangiocarcinoma

bull Breast CA mets

bull Neuroendocrine Tumor

16

About Yttrium 90 microspheres

bull Yttrium 90 is a pure beta emitter with a half life of 268 days or 642 hours

bull 94 of the radiation is decayed in 11 days

17

Rationale for SIRT

bull Preferential blood supply to tumorbull Parenchyma is 30 arterial and 70

portal supplybull Metastases are nearly 100 arterial

bull Preferential vasculaturebull Microvasculature of hepatic tumor is

3-200x more dense than surrounding normal parenchyma

bull CRC cells are radiosensitivebull Radiation works synergistically with

radiation-sensitizing chemotherapy drugs

bull Targeted to the tumorbull Allows treatment of multiple and

large tumors not amenable to external beam radiation therapy or ablation

18

Benefits of SIRT

bull Provide a localized radiation therapy delivering a dose of internal radiation up to 40x higher than conventional external beam therapy

bull Healthy liver tissue remain relatively unaffected2

bull 90 of patients experience ltGrade 3 adverse events

bull Outpatient Procedure

bull Typically involves two treatments over 6 weeks

bull Most patients return home 4-6 hours after the treatment

19

Products

bull Y-90 Glass Microspheres (TheraSpheres)bull 1999 granted Humanitarian Device Exemption for

use in unresectable HCC

bull Requires only safety not effectiveness data

bull Y-90 Resin Microspheres (Sir-Spheres)bull 2002 FDA grants Pre Market Approval for mCRC

bull Sufficient evidence that device is safe and effective for intended use

20

SIR-Spheres Y-90 resin microspheres

Product Characteristics

bull Microsphere Material Biocompatible Polymer

bull Isotope Yttrium-90 permanently bound to the microsphere

bull Diameter ~325 microm

bull Specific Gravity 108 mgmL

bull Number of Particles per Vial 40-80 million

21

22

mCRC Liver Metastases and Mortality

bull Liver is the most common site of distant metastatic disease1-12

- 50 develop hepatic mets

- 10-25 considered resectable

bull Liver failure due to hepatic metastases is the most common cause of death among patients with mCRC13

bull Chemotherapy induced parenchymal damage also significantly contributes to liver failure1-12

Protecting healthy parenchyma while effectively treating liver metastases is a key goal when treating

patients with liver dominant metastases

23

1 McMillan DC McArdle CS Surg Oncol 200716(1)3-5 2 Sharma RA et al J Clin Oncol 200725(9)1099-1106 3 Van den Eynde M Hendlisz A Rev Recent Clin Trials 20094(1)56-62 4 National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology Colon Cancer Version 32015 httpwwwnccnorgprofessionalsphysician_glspdfcolonpdf 5 Ye LC et al J Clin Oncol 201331(16)1931-1938 6 Burke D Allen-Marsh TG Postgrad Med J 1996 72 464-469 7 Penna C Nordlinger B Surg Clin N Am 2002 82 1075-1090 8 Brown AE et al Surg Clin N Am 2010 90 839-852 9 Fowler KJ et al Ann Surg Oncol 2013 201185-1193 10 Mahnken AH et al Radiology 2013266(2)407-430 11 Helling TS Martin M Ann SurgOncol 201421501-506 12 Shimura T et al J Gastrointest Cancer 2011 4268-72 13 Cho M Gong J amp Fakih M The state of regional therapy in the management of metastatic colorectal cancer to the liver Expert Rev Anticancer Ther 13 Jan 2016

About Y90 Sir-sphere microspheres

24

- Patients with inoperable colorectal liver metastases who are not surgical candidates - Liver-only or liver-dominant disease- Percent liver involvement lt70 - ECOG 0ndash2 - Life expectancy gt3 months- Bilirubin lt20-25 mgdL- Lung Shunt lt20

Goals of Liver Directed Therapy include

- Protecting liver parenchyma- Maximizing survival- Prolonging progression-free intervals- Down staging tumors to resection- Decreasing tumor burden- Maintaining Quality of Life- Palliating tumor-related symptoms

Patient Selection

mCRC Survival Chemo

25

Survival Benefit FU + SIRT

26

SIRFLOX

bull Randomized controlled trial radioembolization as an adjuvant to first-line chemotherapy for metastatic CRC was examined

bull Chemotherapy-naive patients with liver-dominant colorectal liver metastases (530 patients) were randomized to a group receiving FOLFOX with or without bevacizumab and a group receiving FOLFOX with or without bevacizumab and radioembolization

bull There was an 8-mo increase in liver-progressionndashfree survival in the radioembolization arm (21 vs 13 mo)

bull However there was no difference in overall progression-free survival

27

SIRFLOX Study Design

28

Prospective open-label multicenter international RCT

Primary endpoint Progression-Free Survival

Eligible Patients

bull Nonresectable liver-

only or liver-dominant

mCRC

bull No prior chemo for

advanced disease

bull WHO Performance

Status 0ndash1

Stratified by

bull Presence of extra-

hepatic metastases

bull Degree of liver

involvement

bull Intended use of

bevacizumab

bull Institution

Randomized

11

N=530

mFOLFOX6 (+ bevacizumab)


SIR-Spheres Y-90 resin

microspheres

n=263 enrolled

n=267 enrolled

Bevacizumab allowed at investigatorrsquos

discretion per institutional practice

ANZ Australia New Zealand EME Europe amp Middle East mFOLFOX6 (modified FOLFOX6) leucovorin fluorouracil oxaliplatin mCRC metastatic colorectal cancer RCT randomized controlled trial US United States WHO World Health Organization

van Hazel GA et al J Clin Oncol 2016 34 1723ndash1731

ANZ 280 (53)

EME 191 (36) US 59 (11)


29

Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

205months


microspheres significantly

extend PFS in the liver

with a 31 reduction in risk

of progression in the liver

+ 79 months

HR 069(95 CI 055ndash090)

P=002126months

FOLFOX

(+ Bev)

(n=263)

Progression-Free Survival in the Liver

Bevacizumab allowed at investigatorrsquos discretion per institutional practicevan Hazel GA et al J Clin Oncol 2016 34 1723ndash1731

Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=159)

211months + 87 months

HR 064(95 CI 048ndash086)

P=003124months

FOLFOX

(+ Bev)

(n=159)

PFS in the LiverLiver-Only and Liver + Extra-hepatic Metastases

FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=108)

167months

+ 41 months

HR 077(95 CI 054ndash109)

P=147126months

FOLFOX

(+ Bev)

(n=104)

Liver-Only Metastases Liver + Extrahepatic Metastases



Pe

rce

nt

()

8

6

4

2

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

60

19

FOLFOX

(+ Bev)

(n=263)

3 x CR rateP=020

Complete Response Rate

Pe

rce

nt

()

80

60

40

20

0

Objective Response Rate

FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

787

688

FOLFOX

(+ Bev)

(n=263)

+ 99 ORRP=042


Significantly Increase CR Rate and ORR in the Liver

SIRFLOX OS

33

Right Sided Colon Ca

34

Treatment Data on SIR-Spheresreg Y-90 Resin Microspheres for Patients with Liver Metastases from Right-Sided Primary Colon Cancer

A post-hoc analysis of data from the 739-patient SIRFLOX and FOXFIRE Global studies indicates that adding SIRT with liver-directed SIR-Spheresreg Y-90 resin microspheres to standard first-line mFOLFOX6 chemotherapy for liver-only or liver-dominant metastatic colorectal cancer (mCRC) in patients with right-sided primary (RSP) tumours led to a statistically significant and clinically meaningful 49-month median overall survival benefit (Hazard Ratio [HR] 064 [95 CI 046-089] p=0007) This translates into a 36 reduction in the risk of death at any given time compared to patients who received chemotherapy alone[1]

Salvage Therapy for CRC Metastatic Disease

35


36

NCCN Guidelines Recommend SIR-Spheres Y90 Resin

Microspheres for Treatment of mCRC 2a Designation

37

Expert panel reaches uniform consensus that yttrium-90 microspheres is an appropriate option for patients with colorectal liver metastases ndash Interventional Oncology

httpwwwinterventionaloncology360comcontentnccn-guidelines-

recommend-sir-spheres-y90-resin-microspheres-treatment-metastatic-

colorectal

NCCN Categories of Evidence and ConsensusCategory 1 Based upon high-level evidence there is a uniform NCCN consensus that the intervention is appropriateCategory 2a Based upon lower-level evidence there is a uniform NCCN consensus that intervention is appropriateCategory 2b Based upon lower-level evidence there is a NCCN consensus that the intervention is appropriateCategory 3 Based upon lower level of evidence there is major NCCN disagreement that the intervention is appropriate

RESECT Study

38

RESECT Study

39

- Surgeonsrsquo blinded assessment of pre- and post-treatment CT scans of patients with previously unresectable colorectal cancer liver metastases treated in the SIRFLOX study present at 12th Annual European-African HPB meeting

- While resectability increased from baseline to follow-up in both the chemotherapy only arm and the chemotherapy + SIRT arm of the SIRFLOX study the increase was significantly more pronounced in patients receiving the combination treatment

- 381 of these were resectable on the basis of their liver CT scan at follow-up compared to 289 of the patients receiving chemotherapy only (plt00001)

bull Retrospective study 2017 ASO

bull 100 Patients who had SIRT with resin microspheres from 16 centers

bull 71 had resection 29 Liver transplant

bull Grade 3 + adverse complications and any grade liver failure in 24 resection group and 7 transplant group

bull 63 occurred in extended resection group (gt5 segments)

bull 125-23 grade 3 complications in non-SIRT patients

bull 4 Deaths gt 6 segments resected multiple comorbidities

bull Study concludes mortality rates complication rates and LF rates

Is it Safe

40

SIR-Spheres Y-90 resin microspheres Vs TACEDEB

41

Mechanisms of Actionbull TACEDEB Designed to

impede blood flow potentially resulting in PES

bull SIR-Spheres Y-90 resin microspheres Designed to travel deep into the tumor bed and deliver beta radiation directly to the tumor and not impede blood flow

Advantages over TACE in HCC

bull TACE well established by two 2002 studies for inoperable intermediate stage HCC

bull Exceeds TACE in TTP of disease

bull Better toxicity profile

bull Better post treatment quality of life

bull Effective with more advanced disease

bull May use in patients is PVT bull Relative contraindication in TACEbull Similar survival to sorafenib (13 vs 11mo) but up to half TARE

patients downstaged for transplant

bull May have survival benefit (39mo vs 31 mo in BCLC B and C patients)

bull Retrospective

42

Procedure

43

Procedure

44

Dose Calculation

45

Treatment

46

7 Months Post Treatment

References

bull Goldberg SN Gazelle GS Mueller PR Thermal ablation therapy for focal malignancy a unified approach to underlying principlestechniques and diagnostic imaging guidance AJR Am J Roentgenol 2000 Feb174(2)323-31

bull Kallini et al Transarterial Radioembolization with Yttrium-90 for the Treatment of Hepatocellular Carcinoma Adv Ther 2016 httplinkspringercomarticle1010072Fs12325-016-0324-7

bull Kritzinger et al Hepatic embolotherapy in interventional oncology Technology techniques and applications Clin Radiology 2012 httpwwwsciencedirectcomsciencearticlepiiS0009926012003704

bull Lencioni et al Chemoembolization of Hepatocellular Carcinoma Semin Intervent Radiol 2013 httpwwwncbinlmnihgovpmcarticlesPMC3700789pdfsir30003pdf

bull Llovet JM et al Arterial embolization or chemoembolization versus symptomatic treatment in patients with unresectablehepatocellular carcinoma a randomized controlled trial Lancet 2002 May18 359(9319) 1734-9

bull Pardo F et al The Post-Sir-Spheres Study Retrospective Analysis of Safety Following Resection or Transplant in Patients Previously Treated with SIRT with Y90 Resin Microspheres Annals of Surgical Oncology 2017 Sep 24 (9) 2465-2473

bull Salem R et al Radioembolization with 90Yttrium Microspheres a state-of-the-art bbachytherapy treatment for primary and secondary liver malignancies part 1 technical and methodologic considerations J Vasc Interv Radiol 17(8)1251-78 2006

bull Salem R et al Radioembolization with 90yttrium microspheres a state-of-the-art brachytherapy treatment for primary and secondary liver malignancies Part 2 special topics J Vasc Interv Radiol 17(9)1425-39 2006

bull van Hazel GA et al SIRFLOX Randomized phase III trial comparing first-line mFOLFOX6 (plus or minus bevacizumab) versus mFOLFOX6 (plus or minus bevacizumab) plus selective internal radiation therapy in patients with metastatic colorectal cancer J Clin Oncol 34(15)1723-31 2016

bull Wells et al Liver Ablation Best Practice Radiol Clin N Am 2015 httpwwwsciencedirectcomsciencearticlepiiS0033838915001050

47

Thank you

48

Ryan M Davis MD

Assistant Professor of Clinical Radiology

Vascular and Interventional Radiology

University of Missouri - Columbia

2

Disclosures

None

3





4




5

gt105⁰C

60-100 ⁰C

46-52 ⁰C


(carbonization)










10

6





7

8

9

13mo Post MWA

10

TACE






bull RCC ()

11

Basics


to tumor





12

Chemoembolization

bull Lancet 2002 May 18359(9319)1734-9




13

14

4mo Post TACE

15


bull Hepatic mCRC



bull Breast CA mets


16




17

Rationale for SIRT









18

Benefits of SIRT







19

Products






20








21

22









23



24




Patient Selection

mCRC Survival Chemo

25


26

SIRFLOX





27


28



Eligible Patients



mCRC


advanced disease


Status 0ndash1

Stratified by


hepatic metastases


involvement


bevacizumab

bull Institution

Randomized

11

N=530




microspheres

n=263 enrolled

n=267 enrolled





ANZ 280 (53)

EME 191 (36) US 59 (11)


29

Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

205months






+ 79 months

HR 069(95 CI 055ndash090)

P=002126months

FOLFOX

(+ Bev)

(n=263)



Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=159)


HR 064(95 CI 048ndash086)

P=003124months

FOLFOX

(+ Bev)

(n=159)


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=108)

167months

+ 41 months

HR 077(95 CI 054ndash109)

P=147126months

FOLFOX

(+ Bev)

(n=104)




Pe

rce

nt

()

8

6

4

2

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

60

19

FOLFOX

(+ Bev)

(n=263)

3 x CR rateP=020


Pe

rce

nt

()

80

60

40

20

0


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

787

688

FOLFOX

(+ Bev)

(n=263)

+ 99 ORRP=042



SIRFLOX OS

33


34




35


36



37




colorectal


RESECT Study

38

RESECT Study

39












Is it Safe

40


41













bull Retrospective

42

Procedure

43

Procedure

44

Dose Calculation

45

Treatment

46


References











47

Thank you

48

Disclosures

None

3





4




5

gt105⁰C

60-100 ⁰C

46-52 ⁰C


(carbonization)










10

6





7

8

9

13mo Post MWA

10

TACE






bull RCC ()

11

Basics


to tumor





12

Chemoembolization

bull Lancet 2002 May 18359(9319)1734-9




13

14

4mo Post TACE

15


bull Hepatic mCRC



bull Breast CA mets


16




17

Rationale for SIRT









18

Benefits of SIRT







19

Products






20








21

22









23



24




Patient Selection

mCRC Survival Chemo

25


26

SIRFLOX





27


28



Eligible Patients



mCRC


advanced disease


Status 0ndash1

Stratified by


hepatic metastases


involvement


bevacizumab

bull Institution

Randomized

11

N=530




microspheres

n=263 enrolled

n=267 enrolled





ANZ 280 (53)

EME 191 (36) US 59 (11)


29

Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

205months






+ 79 months

HR 069(95 CI 055ndash090)

P=002126months

FOLFOX

(+ Bev)

(n=263)



Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=159)


HR 064(95 CI 048ndash086)

P=003124months

FOLFOX

(+ Bev)

(n=159)


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=108)

167months

+ 41 months

HR 077(95 CI 054ndash109)

P=147126months

FOLFOX

(+ Bev)

(n=104)




Pe

rce

nt

()

8

6

4

2

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

60

19

FOLFOX

(+ Bev)

(n=263)

3 x CR rateP=020


Pe

rce

nt

()

80

60

40

20

0


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

787

688

FOLFOX

(+ Bev)

(n=263)

+ 99 ORRP=042



SIRFLOX OS

33


34




35


36



37




colorectal


RESECT Study

38

RESECT Study

39












Is it Safe

40


41













bull Retrospective

42

Procedure

43

Procedure

44

Dose Calculation

45

Treatment

46


References











47

Thank you

48





4




5

gt105⁰C

60-100 ⁰C

46-52 ⁰C


(carbonization)










10

6





7

8

9

13mo Post MWA

10

TACE






bull RCC ()

11

Basics


to tumor





12

Chemoembolization

bull Lancet 2002 May 18359(9319)1734-9




13

14

4mo Post TACE

15


bull Hepatic mCRC



bull Breast CA mets


16




17

Rationale for SIRT









18

Benefits of SIRT







19

Products






20








21

22









23



24




Patient Selection

mCRC Survival Chemo

25


26

SIRFLOX





27


28



Eligible Patients



mCRC


advanced disease


Status 0ndash1

Stratified by


hepatic metastases


involvement


bevacizumab

bull Institution

Randomized

11

N=530




microspheres

n=263 enrolled

n=267 enrolled





ANZ 280 (53)

EME 191 (36) US 59 (11)


29

Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

205months






+ 79 months

HR 069(95 CI 055ndash090)

P=002126months

FOLFOX

(+ Bev)

(n=263)



Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=159)


HR 064(95 CI 048ndash086)

P=003124months

FOLFOX

(+ Bev)

(n=159)


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=108)

167months

+ 41 months

HR 077(95 CI 054ndash109)

P=147126months

FOLFOX

(+ Bev)

(n=104)




Pe

rce

nt

()

8

6

4

2

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

60

19

FOLFOX

(+ Bev)

(n=263)

3 x CR rateP=020


Pe

rce

nt

()

80

60

40

20

0


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

787

688

FOLFOX

(+ Bev)

(n=263)

+ 99 ORRP=042



SIRFLOX OS

33


34




35


36



37




colorectal


RESECT Study

38

RESECT Study

39












Is it Safe

40


41













bull Retrospective

42

Procedure

43

Procedure

44

Dose Calculation

45

Treatment

46


References











47

Thank you

48




5

gt105⁰C

60-100 ⁰C

46-52 ⁰C


(carbonization)










10

6





7

8

9

13mo Post MWA

10

TACE






bull RCC ()

11

Basics


to tumor





12

Chemoembolization

bull Lancet 2002 May 18359(9319)1734-9




13

14

4mo Post TACE

15


bull Hepatic mCRC



bull Breast CA mets


16




17

Rationale for SIRT









18

Benefits of SIRT







19

Products






20








21

22









23



24




Patient Selection

mCRC Survival Chemo

25


26

SIRFLOX





27


28



Eligible Patients



mCRC


advanced disease


Status 0ndash1

Stratified by


hepatic metastases


involvement


bevacizumab

bull Institution

Randomized

11

N=530




microspheres

n=263 enrolled

n=267 enrolled





ANZ 280 (53)

EME 191 (36) US 59 (11)


29

Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

205months






+ 79 months

HR 069(95 CI 055ndash090)

P=002126months

FOLFOX

(+ Bev)

(n=263)



Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=159)


HR 064(95 CI 048ndash086)

P=003124months

FOLFOX

(+ Bev)

(n=159)


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=108)

167months

+ 41 months

HR 077(95 CI 054ndash109)

P=147126months

FOLFOX

(+ Bev)

(n=104)




Pe

rce

nt

()

8

6

4

2

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

60

19

FOLFOX

(+ Bev)

(n=263)

3 x CR rateP=020


Pe

rce

nt

()

80

60

40

20

0


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

787

688

FOLFOX

(+ Bev)

(n=263)

+ 99 ORRP=042



SIRFLOX OS

33


34




35


36



37




colorectal


RESECT Study

38

RESECT Study

39












Is it Safe

40


41













bull Retrospective

42

Procedure

43

Procedure

44

Dose Calculation

45

Treatment

46


References











47

Thank you

48






10

6





7

8

9

13mo Post MWA

10

TACE






bull RCC ()

11

Basics


to tumor





12

Chemoembolization

bull Lancet 2002 May 18359(9319)1734-9




13

14

4mo Post TACE

15


bull Hepatic mCRC



bull Breast CA mets


16




17

Rationale for SIRT









18

Benefits of SIRT







19

Products






20








21

22









23



24




Patient Selection

mCRC Survival Chemo

25


26

SIRFLOX





27


28



Eligible Patients



mCRC


advanced disease


Status 0ndash1

Stratified by


hepatic metastases


involvement


bevacizumab

bull Institution

Randomized

11

N=530




microspheres

n=263 enrolled

n=267 enrolled





ANZ 280 (53)

EME 191 (36) US 59 (11)


29

Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

205months






+ 79 months

HR 069(95 CI 055ndash090)

P=002126months

FOLFOX

(+ Bev)

(n=263)



Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=159)


HR 064(95 CI 048ndash086)

P=003124months

FOLFOX

(+ Bev)

(n=159)


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=108)

167months

+ 41 months

HR 077(95 CI 054ndash109)

P=147126months

FOLFOX

(+ Bev)

(n=104)




Pe

rce

nt

()

8

6

4

2

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

60

19

FOLFOX

(+ Bev)

(n=263)

3 x CR rateP=020


Pe

rce

nt

()

80

60

40

20

0


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

787

688

FOLFOX

(+ Bev)

(n=263)

+ 99 ORRP=042



SIRFLOX OS

33


34




35


36



37




colorectal


RESECT Study

38

RESECT Study

39












Is it Safe

40


41













bull Retrospective

42

Procedure

43

Procedure

44

Dose Calculation

45

Treatment

46


References











47

Thank you

48





7

8

9

13mo Post MWA

10

TACE






bull RCC ()

11

Basics


to tumor





12

Chemoembolization

bull Lancet 2002 May 18359(9319)1734-9




13

14

4mo Post TACE

15


bull Hepatic mCRC



bull Breast CA mets


16




17

Rationale for SIRT









18

Benefits of SIRT







19

Products






20








21

22









23



24




Patient Selection

mCRC Survival Chemo

25


26

SIRFLOX





27


28



Eligible Patients



mCRC


advanced disease


Status 0ndash1

Stratified by


hepatic metastases


involvement


bevacizumab

bull Institution

Randomized

11

N=530




microspheres

n=263 enrolled

n=267 enrolled





ANZ 280 (53)

EME 191 (36) US 59 (11)


29

Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

205months






+ 79 months

HR 069(95 CI 055ndash090)

P=002126months

FOLFOX

(+ Bev)

(n=263)



Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=159)


HR 064(95 CI 048ndash086)

P=003124months

FOLFOX

(+ Bev)

(n=159)


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=108)

167months

+ 41 months

HR 077(95 CI 054ndash109)

P=147126months

FOLFOX

(+ Bev)

(n=104)




Pe

rce

nt

()

8

6

4

2

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

60

19

FOLFOX

(+ Bev)

(n=263)

3 x CR rateP=020


Pe

rce

nt

()

80

60

40

20

0


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

787

688

FOLFOX

(+ Bev)

(n=263)

+ 99 ORRP=042



SIRFLOX OS

33


34




35


36



37




colorectal


RESECT Study

38

RESECT Study

39












Is it Safe

40


41













bull Retrospective

42

Procedure

43

Procedure

44

Dose Calculation

45

Treatment

46


References











47

Thank you

48

8

9

13mo Post MWA

10

TACE






bull RCC ()

11

Basics


to tumor





12

Chemoembolization

bull Lancet 2002 May 18359(9319)1734-9




13

14

4mo Post TACE

15


bull Hepatic mCRC



bull Breast CA mets


16




17

Rationale for SIRT









18

Benefits of SIRT







19

Products






20








21

22









23



24




Patient Selection

mCRC Survival Chemo

25


26

SIRFLOX





27


28



Eligible Patients



mCRC


advanced disease


Status 0ndash1

Stratified by


hepatic metastases


involvement


bevacizumab

bull Institution

Randomized

11

N=530




microspheres

n=263 enrolled

n=267 enrolled





ANZ 280 (53)

EME 191 (36) US 59 (11)


29

Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

205months






+ 79 months

HR 069(95 CI 055ndash090)

P=002126months

FOLFOX

(+ Bev)

(n=263)



Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=159)


HR 064(95 CI 048ndash086)

P=003124months

FOLFOX

(+ Bev)

(n=159)


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=108)

167months

+ 41 months

HR 077(95 CI 054ndash109)

P=147126months

FOLFOX

(+ Bev)

(n=104)




Pe

rce

nt

()

8

6

4

2

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

60

19

FOLFOX

(+ Bev)

(n=263)

3 x CR rateP=020


Pe

rce

nt

()

80

60

40

20

0


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

787

688

FOLFOX

(+ Bev)

(n=263)

+ 99 ORRP=042



SIRFLOX OS

33


34




35


36



37




colorectal


RESECT Study

38

RESECT Study

39












Is it Safe

40


41













bull Retrospective

42

Procedure

43

Procedure

44

Dose Calculation

45

Treatment

46


References











47

Thank you

48

9

13mo Post MWA

10

TACE






bull RCC ()

11

Basics


to tumor





12

Chemoembolization

bull Lancet 2002 May 18359(9319)1734-9




13

14

4mo Post TACE

15


bull Hepatic mCRC



bull Breast CA mets


16




17

Rationale for SIRT









18

Benefits of SIRT







19

Products






20








21

22









23



24




Patient Selection

mCRC Survival Chemo

25


26

SIRFLOX





27


28



Eligible Patients



mCRC


advanced disease


Status 0ndash1

Stratified by


hepatic metastases


involvement


bevacizumab

bull Institution

Randomized

11

N=530




microspheres

n=263 enrolled

n=267 enrolled





ANZ 280 (53)

EME 191 (36) US 59 (11)


29

Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

205months






+ 79 months

HR 069(95 CI 055ndash090)

P=002126months

FOLFOX

(+ Bev)

(n=263)



Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=159)


HR 064(95 CI 048ndash086)

P=003124months

FOLFOX

(+ Bev)

(n=159)


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=108)

167months

+ 41 months

HR 077(95 CI 054ndash109)

P=147126months

FOLFOX

(+ Bev)

(n=104)




Pe

rce

nt

()

8

6

4

2

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

60

19

FOLFOX

(+ Bev)

(n=263)

3 x CR rateP=020


Pe

rce

nt

()

80

60

40

20

0


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

787

688

FOLFOX

(+ Bev)

(n=263)

+ 99 ORRP=042



SIRFLOX OS

33


34




35


36



37




colorectal


RESECT Study

38

RESECT Study

39












Is it Safe

40


41













bull Retrospective

42

Procedure

43

Procedure

44

Dose Calculation

45

Treatment

46


References











47

Thank you

48

13mo Post MWA

10

TACE






bull RCC ()

11

Basics


to tumor





12

Chemoembolization

bull Lancet 2002 May 18359(9319)1734-9




13

14

4mo Post TACE

15


bull Hepatic mCRC



bull Breast CA mets


16




17

Rationale for SIRT









18

Benefits of SIRT







19

Products






20








21

22









23



24




Patient Selection

mCRC Survival Chemo

25


26

SIRFLOX





27


28



Eligible Patients



mCRC


advanced disease


Status 0ndash1

Stratified by


hepatic metastases


involvement


bevacizumab

bull Institution

Randomized

11

N=530




microspheres

n=263 enrolled

n=267 enrolled





ANZ 280 (53)

EME 191 (36) US 59 (11)


29

Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

205months






+ 79 months

HR 069(95 CI 055ndash090)

P=002126months

FOLFOX

(+ Bev)

(n=263)



Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=159)


HR 064(95 CI 048ndash086)

P=003124months

FOLFOX

(+ Bev)

(n=159)


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=108)

167months

+ 41 months

HR 077(95 CI 054ndash109)

P=147126months

FOLFOX

(+ Bev)

(n=104)




Pe

rce

nt

()

8

6

4

2

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

60

19

FOLFOX

(+ Bev)

(n=263)

3 x CR rateP=020


Pe

rce

nt

()

80

60

40

20

0


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

787

688

FOLFOX

(+ Bev)

(n=263)

+ 99 ORRP=042



SIRFLOX OS

33


34




35


36



37




colorectal


RESECT Study

38

RESECT Study

39












Is it Safe

40


41













bull Retrospective

42

Procedure

43

Procedure

44

Dose Calculation

45

Treatment

46


References











47

Thank you

48

TACE






bull RCC ()

11

Basics


to tumor





12

Chemoembolization

bull Lancet 2002 May 18359(9319)1734-9




13

14

4mo Post TACE

15


bull Hepatic mCRC



bull Breast CA mets


16




17

Rationale for SIRT









18

Benefits of SIRT







19

Products






20








21

22









23



24




Patient Selection

mCRC Survival Chemo

25


26

SIRFLOX





27


28



Eligible Patients



mCRC


advanced disease


Status 0ndash1

Stratified by


hepatic metastases


involvement


bevacizumab

bull Institution

Randomized

11

N=530




microspheres

n=263 enrolled

n=267 enrolled





ANZ 280 (53)

EME 191 (36) US 59 (11)


29

Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

205months






+ 79 months

HR 069(95 CI 055ndash090)

P=002126months

FOLFOX

(+ Bev)

(n=263)



Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=159)


HR 064(95 CI 048ndash086)

P=003124months

FOLFOX

(+ Bev)

(n=159)


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=108)

167months

+ 41 months

HR 077(95 CI 054ndash109)

P=147126months

FOLFOX

(+ Bev)

(n=104)




Pe

rce

nt

()

8

6

4

2

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

60

19

FOLFOX

(+ Bev)

(n=263)

3 x CR rateP=020


Pe

rce

nt

()

80

60

40

20

0


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

787

688

FOLFOX

(+ Bev)

(n=263)

+ 99 ORRP=042



SIRFLOX OS

33


34




35


36



37




colorectal


RESECT Study

38

RESECT Study

39












Is it Safe

40


41













bull Retrospective

42

Procedure

43

Procedure

44

Dose Calculation

45

Treatment

46


References











47

Thank you

48

Basics


to tumor





12

Chemoembolization

bull Lancet 2002 May 18359(9319)1734-9




13

14

4mo Post TACE

15


bull Hepatic mCRC



bull Breast CA mets


16




17

Rationale for SIRT









18

Benefits of SIRT







19

Products






20








21

22









23



24




Patient Selection

mCRC Survival Chemo

25


26

SIRFLOX





27


28



Eligible Patients



mCRC


advanced disease


Status 0ndash1

Stratified by


hepatic metastases


involvement


bevacizumab

bull Institution

Randomized

11

N=530




microspheres

n=263 enrolled

n=267 enrolled





ANZ 280 (53)

EME 191 (36) US 59 (11)


29

Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

205months






+ 79 months

HR 069(95 CI 055ndash090)

P=002126months

FOLFOX

(+ Bev)

(n=263)



Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=159)


HR 064(95 CI 048ndash086)

P=003124months

FOLFOX

(+ Bev)

(n=159)


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=108)

167months

+ 41 months

HR 077(95 CI 054ndash109)

P=147126months

FOLFOX

(+ Bev)

(n=104)




Pe

rce

nt

()

8

6

4

2

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

60

19

FOLFOX

(+ Bev)

(n=263)

3 x CR rateP=020


Pe

rce

nt

()

80

60

40

20

0


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

787

688

FOLFOX

(+ Bev)

(n=263)

+ 99 ORRP=042



SIRFLOX OS

33


34




35


36



37




colorectal


RESECT Study

38

RESECT Study

39












Is it Safe

40


41













bull Retrospective

42

Procedure

43

Procedure

44

Dose Calculation

45

Treatment

46


References











47

Thank you

48

Chemoembolization

bull Lancet 2002 May 18359(9319)1734-9




13

14

4mo Post TACE

15


bull Hepatic mCRC



bull Breast CA mets


16




17

Rationale for SIRT









18

Benefits of SIRT







19

Products






20








21

22









23



24




Patient Selection

mCRC Survival Chemo

25


26

SIRFLOX





27


28



Eligible Patients



mCRC


advanced disease


Status 0ndash1

Stratified by


hepatic metastases


involvement


bevacizumab

bull Institution

Randomized

11

N=530




microspheres

n=263 enrolled

n=267 enrolled





ANZ 280 (53)

EME 191 (36) US 59 (11)


29

Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

205months






+ 79 months

HR 069(95 CI 055ndash090)

P=002126months

FOLFOX

(+ Bev)

(n=263)



Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=159)


HR 064(95 CI 048ndash086)

P=003124months

FOLFOX

(+ Bev)

(n=159)


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=108)

167months

+ 41 months

HR 077(95 CI 054ndash109)

P=147126months

FOLFOX

(+ Bev)

(n=104)




Pe

rce

nt

()

8

6

4

2

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

60

19

FOLFOX

(+ Bev)

(n=263)

3 x CR rateP=020


Pe

rce

nt

()

80

60

40

20

0


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

787

688

FOLFOX

(+ Bev)

(n=263)

+ 99 ORRP=042



SIRFLOX OS

33


34




35


36



37




colorectal


RESECT Study

38

RESECT Study

39












Is it Safe

40


41













bull Retrospective

42

Procedure

43

Procedure

44

Dose Calculation

45

Treatment

46


References











47

Thank you

48

14

4mo Post TACE

15


bull Hepatic mCRC



bull Breast CA mets


16




17

Rationale for SIRT









18

Benefits of SIRT







19

Products






20








21

22









23



24




Patient Selection

mCRC Survival Chemo

25


26

SIRFLOX





27


28



Eligible Patients



mCRC


advanced disease


Status 0ndash1

Stratified by


hepatic metastases


involvement


bevacizumab

bull Institution

Randomized

11

N=530




microspheres

n=263 enrolled

n=267 enrolled





ANZ 280 (53)

EME 191 (36) US 59 (11)


29

Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

205months






+ 79 months

HR 069(95 CI 055ndash090)

P=002126months

FOLFOX

(+ Bev)

(n=263)



Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=159)


HR 064(95 CI 048ndash086)

P=003124months

FOLFOX

(+ Bev)

(n=159)


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=108)

167months

+ 41 months

HR 077(95 CI 054ndash109)

P=147126months

FOLFOX

(+ Bev)

(n=104)




Pe

rce

nt

()

8

6

4

2

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

60

19

FOLFOX

(+ Bev)

(n=263)

3 x CR rateP=020


Pe

rce

nt

()

80

60

40

20

0


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

787

688

FOLFOX

(+ Bev)

(n=263)

+ 99 ORRP=042



SIRFLOX OS

33


34




35


36



37




colorectal


RESECT Study

38

RESECT Study

39












Is it Safe

40


41













bull Retrospective

42

Procedure

43

Procedure

44

Dose Calculation

45

Treatment

46


References











47

Thank you

48

4mo Post TACE

15


bull Hepatic mCRC



bull Breast CA mets


16




17

Rationale for SIRT









18

Benefits of SIRT







19

Products






20








21

22









23



24




Patient Selection

mCRC Survival Chemo

25


26

SIRFLOX





27


28



Eligible Patients



mCRC


advanced disease


Status 0ndash1

Stratified by


hepatic metastases


involvement


bevacizumab

bull Institution

Randomized

11

N=530




microspheres

n=263 enrolled

n=267 enrolled





ANZ 280 (53)

EME 191 (36) US 59 (11)


29

Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

205months






+ 79 months

HR 069(95 CI 055ndash090)

P=002126months

FOLFOX

(+ Bev)

(n=263)



Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=159)


HR 064(95 CI 048ndash086)

P=003124months

FOLFOX

(+ Bev)

(n=159)


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=108)

167months

+ 41 months

HR 077(95 CI 054ndash109)

P=147126months

FOLFOX

(+ Bev)

(n=104)




Pe

rce

nt

()

8

6

4

2

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

60

19

FOLFOX

(+ Bev)

(n=263)

3 x CR rateP=020


Pe

rce

nt

()

80

60

40

20

0


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

787

688

FOLFOX

(+ Bev)

(n=263)

+ 99 ORRP=042



SIRFLOX OS

33


34




35


36



37




colorectal


RESECT Study

38

RESECT Study

39












Is it Safe

40


41













bull Retrospective

42

Procedure

43

Procedure

44

Dose Calculation

45

Treatment

46


References











47

Thank you

48


bull Hepatic mCRC



bull Breast CA mets


16




17

Rationale for SIRT









18

Benefits of SIRT







19

Products






20








21

22









23



24




Patient Selection

mCRC Survival Chemo

25


26

SIRFLOX





27


28



Eligible Patients



mCRC


advanced disease


Status 0ndash1

Stratified by


hepatic metastases


involvement


bevacizumab

bull Institution

Randomized

11

N=530




microspheres

n=263 enrolled

n=267 enrolled





ANZ 280 (53)

EME 191 (36) US 59 (11)


29

Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

205months






+ 79 months

HR 069(95 CI 055ndash090)

P=002126months

FOLFOX

(+ Bev)

(n=263)



Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=159)


HR 064(95 CI 048ndash086)

P=003124months

FOLFOX

(+ Bev)

(n=159)


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=108)

167months

+ 41 months

HR 077(95 CI 054ndash109)

P=147126months

FOLFOX

(+ Bev)

(n=104)




Pe

rce

nt

()

8

6

4

2

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

60

19

FOLFOX

(+ Bev)

(n=263)

3 x CR rateP=020


Pe

rce

nt

()

80

60

40

20

0


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

787

688

FOLFOX

(+ Bev)

(n=263)

+ 99 ORRP=042



SIRFLOX OS

33


34




35


36



37




colorectal


RESECT Study

38

RESECT Study

39












Is it Safe

40


41













bull Retrospective

42

Procedure

43

Procedure

44

Dose Calculation

45

Treatment

46


References











47

Thank you

48




17

Rationale for SIRT









18

Benefits of SIRT







19

Products






20








21

22









23



24




Patient Selection

mCRC Survival Chemo

25


26

SIRFLOX





27


28



Eligible Patients



mCRC


advanced disease


Status 0ndash1

Stratified by


hepatic metastases


involvement


bevacizumab

bull Institution

Randomized

11

N=530




microspheres

n=263 enrolled

n=267 enrolled





ANZ 280 (53)

EME 191 (36) US 59 (11)


29

Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

205months






+ 79 months

HR 069(95 CI 055ndash090)

P=002126months

FOLFOX

(+ Bev)

(n=263)



Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=159)


HR 064(95 CI 048ndash086)

P=003124months

FOLFOX

(+ Bev)

(n=159)


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=108)

167months

+ 41 months

HR 077(95 CI 054ndash109)

P=147126months

FOLFOX

(+ Bev)

(n=104)




Pe

rce

nt

()

8

6

4

2

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

60

19

FOLFOX

(+ Bev)

(n=263)

3 x CR rateP=020


Pe

rce

nt

()

80

60

40

20

0


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

787

688

FOLFOX

(+ Bev)

(n=263)

+ 99 ORRP=042



SIRFLOX OS

33


34




35


36



37




colorectal


RESECT Study

38

RESECT Study

39












Is it Safe

40


41













bull Retrospective

42

Procedure

43

Procedure

44

Dose Calculation

45

Treatment

46


References











47

Thank you

48

Rationale for SIRT









18

Benefits of SIRT







19

Products






20








21

22









23



24




Patient Selection

mCRC Survival Chemo

25


26

SIRFLOX





27


28



Eligible Patients



mCRC


advanced disease


Status 0ndash1

Stratified by


hepatic metastases


involvement


bevacizumab

bull Institution

Randomized

11

N=530




microspheres

n=263 enrolled

n=267 enrolled





ANZ 280 (53)

EME 191 (36) US 59 (11)


29

Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

205months






+ 79 months

HR 069(95 CI 055ndash090)

P=002126months

FOLFOX

(+ Bev)

(n=263)



Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=159)


HR 064(95 CI 048ndash086)

P=003124months

FOLFOX

(+ Bev)

(n=159)


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=108)

167months

+ 41 months

HR 077(95 CI 054ndash109)

P=147126months

FOLFOX

(+ Bev)

(n=104)




Pe

rce

nt

()

8

6

4

2

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

60

19

FOLFOX

(+ Bev)

(n=263)

3 x CR rateP=020


Pe

rce

nt

()

80

60

40

20

0


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

787

688

FOLFOX

(+ Bev)

(n=263)

+ 99 ORRP=042



SIRFLOX OS

33


34




35


36



37




colorectal


RESECT Study

38

RESECT Study

39












Is it Safe

40


41













bull Retrospective

42

Procedure

43

Procedure

44

Dose Calculation

45

Treatment

46


References











47

Thank you

48

Benefits of SIRT







19

Products






20








21

22









23



24




Patient Selection

mCRC Survival Chemo

25


26

SIRFLOX





27


28



Eligible Patients



mCRC


advanced disease


Status 0ndash1

Stratified by


hepatic metastases


involvement


bevacizumab

bull Institution

Randomized

11

N=530




microspheres

n=263 enrolled

n=267 enrolled





ANZ 280 (53)

EME 191 (36) US 59 (11)


29

Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

205months






+ 79 months

HR 069(95 CI 055ndash090)

P=002126months

FOLFOX

(+ Bev)

(n=263)



Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=159)


HR 064(95 CI 048ndash086)

P=003124months

FOLFOX

(+ Bev)

(n=159)


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=108)

167months

+ 41 months

HR 077(95 CI 054ndash109)

P=147126months

FOLFOX

(+ Bev)

(n=104)




Pe

rce

nt

()

8

6

4

2

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

60

19

FOLFOX

(+ Bev)

(n=263)

3 x CR rateP=020


Pe

rce

nt

()

80

60

40

20

0


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

787

688

FOLFOX

(+ Bev)

(n=263)

+ 99 ORRP=042



SIRFLOX OS

33


34




35


36



37




colorectal


RESECT Study

38

RESECT Study

39












Is it Safe

40


41













bull Retrospective

42

Procedure

43

Procedure

44

Dose Calculation

45

Treatment

46


References











47

Thank you

48

Products






20








21

22









23



24




Patient Selection

mCRC Survival Chemo

25


26

SIRFLOX





27


28



Eligible Patients



mCRC


advanced disease


Status 0ndash1

Stratified by


hepatic metastases


involvement


bevacizumab

bull Institution

Randomized

11

N=530




microspheres

n=263 enrolled

n=267 enrolled





ANZ 280 (53)

EME 191 (36) US 59 (11)


29

Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

205months






+ 79 months

HR 069(95 CI 055ndash090)

P=002126months

FOLFOX

(+ Bev)

(n=263)



Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=159)


HR 064(95 CI 048ndash086)

P=003124months

FOLFOX

(+ Bev)

(n=159)


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=108)

167months

+ 41 months

HR 077(95 CI 054ndash109)

P=147126months

FOLFOX

(+ Bev)

(n=104)




Pe

rce

nt

()

8

6

4

2

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

60

19

FOLFOX

(+ Bev)

(n=263)

3 x CR rateP=020


Pe

rce

nt

()

80

60

40

20

0


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

787

688

FOLFOX

(+ Bev)

(n=263)

+ 99 ORRP=042



SIRFLOX OS

33


34




35


36



37




colorectal


RESECT Study

38

RESECT Study

39












Is it Safe

40


41













bull Retrospective

42

Procedure

43

Procedure

44

Dose Calculation

45

Treatment

46


References











47

Thank you

48








21

22









23



24




Patient Selection

mCRC Survival Chemo

25


26

SIRFLOX





27


28



Eligible Patients



mCRC


advanced disease


Status 0ndash1

Stratified by


hepatic metastases


involvement


bevacizumab

bull Institution

Randomized

11

N=530




microspheres

n=263 enrolled

n=267 enrolled





ANZ 280 (53)

EME 191 (36) US 59 (11)


29

Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

205months






+ 79 months

HR 069(95 CI 055ndash090)

P=002126months

FOLFOX

(+ Bev)

(n=263)



Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=159)


HR 064(95 CI 048ndash086)

P=003124months

FOLFOX

(+ Bev)

(n=159)


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=108)

167months

+ 41 months

HR 077(95 CI 054ndash109)

P=147126months

FOLFOX

(+ Bev)

(n=104)




Pe

rce

nt

()

8

6

4

2

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

60

19

FOLFOX

(+ Bev)

(n=263)

3 x CR rateP=020


Pe

rce

nt

()

80

60

40

20

0


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

787

688

FOLFOX

(+ Bev)

(n=263)

+ 99 ORRP=042



SIRFLOX OS

33


34




35


36



37




colorectal


RESECT Study

38

RESECT Study

39












Is it Safe

40


41













bull Retrospective

42

Procedure

43

Procedure

44

Dose Calculation

45

Treatment

46


References











47

Thank you

48

22









23



24




Patient Selection

mCRC Survival Chemo

25


26

SIRFLOX





27


28



Eligible Patients



mCRC


advanced disease


Status 0ndash1

Stratified by


hepatic metastases


involvement


bevacizumab

bull Institution

Randomized

11

N=530




microspheres

n=263 enrolled

n=267 enrolled





ANZ 280 (53)

EME 191 (36) US 59 (11)


29

Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

205months






+ 79 months

HR 069(95 CI 055ndash090)

P=002126months

FOLFOX

(+ Bev)

(n=263)



Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=159)


HR 064(95 CI 048ndash086)

P=003124months

FOLFOX

(+ Bev)

(n=159)


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=108)

167months

+ 41 months

HR 077(95 CI 054ndash109)

P=147126months

FOLFOX

(+ Bev)

(n=104)




Pe

rce

nt

()

8

6

4

2

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

60

19

FOLFOX

(+ Bev)

(n=263)

3 x CR rateP=020


Pe

rce

nt

()

80

60

40

20

0


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

787

688

FOLFOX

(+ Bev)

(n=263)

+ 99 ORRP=042



SIRFLOX OS

33


34




35


36



37




colorectal


RESECT Study

38

RESECT Study

39












Is it Safe

40


41













bull Retrospective

42

Procedure

43

Procedure

44

Dose Calculation

45

Treatment

46


References











47

Thank you

48









23



24




Patient Selection

mCRC Survival Chemo

25


26

SIRFLOX





27


28



Eligible Patients



mCRC


advanced disease


Status 0ndash1

Stratified by


hepatic metastases


involvement


bevacizumab

bull Institution

Randomized

11

N=530




microspheres

n=263 enrolled

n=267 enrolled





ANZ 280 (53)

EME 191 (36) US 59 (11)


29

Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

205months






+ 79 months

HR 069(95 CI 055ndash090)

P=002126months

FOLFOX

(+ Bev)

(n=263)



Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=159)


HR 064(95 CI 048ndash086)

P=003124months

FOLFOX

(+ Bev)

(n=159)


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=108)

167months

+ 41 months

HR 077(95 CI 054ndash109)

P=147126months

FOLFOX

(+ Bev)

(n=104)




Pe

rce

nt

()

8

6

4

2

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

60

19

FOLFOX

(+ Bev)

(n=263)

3 x CR rateP=020


Pe

rce

nt

()

80

60

40

20

0


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

787

688

FOLFOX

(+ Bev)

(n=263)

+ 99 ORRP=042



SIRFLOX OS

33


34




35


36



37




colorectal


RESECT Study

38

RESECT Study

39












Is it Safe

40


41













bull Retrospective

42

Procedure

43

Procedure

44

Dose Calculation

45

Treatment

46


References











47

Thank you

48


24




Patient Selection

mCRC Survival Chemo

25


26

SIRFLOX





27


28



Eligible Patients



mCRC


advanced disease


Status 0ndash1

Stratified by


hepatic metastases


involvement


bevacizumab

bull Institution

Randomized

11

N=530




microspheres

n=263 enrolled

n=267 enrolled





ANZ 280 (53)

EME 191 (36) US 59 (11)


29

Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

205months






+ 79 months

HR 069(95 CI 055ndash090)

P=002126months

FOLFOX

(+ Bev)

(n=263)



Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=159)


HR 064(95 CI 048ndash086)

P=003124months

FOLFOX

(+ Bev)

(n=159)


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=108)

167months

+ 41 months

HR 077(95 CI 054ndash109)

P=147126months

FOLFOX

(+ Bev)

(n=104)




Pe

rce

nt

()

8

6

4

2

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

60

19

FOLFOX

(+ Bev)

(n=263)

3 x CR rateP=020


Pe

rce

nt

()

80

60

40

20

0


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

787

688

FOLFOX

(+ Bev)

(n=263)

+ 99 ORRP=042



SIRFLOX OS

33


34




35


36



37




colorectal


RESECT Study

38

RESECT Study

39












Is it Safe

40


41













bull Retrospective

42

Procedure

43

Procedure

44

Dose Calculation

45

Treatment

46


References











47

Thank you

48

mCRC Survival Chemo

25


26

SIRFLOX





27


28



Eligible Patients



mCRC


advanced disease


Status 0ndash1

Stratified by


hepatic metastases


involvement


bevacizumab

bull Institution

Randomized

11

N=530




microspheres

n=263 enrolled

n=267 enrolled





ANZ 280 (53)

EME 191 (36) US 59 (11)


29

Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

205months






+ 79 months

HR 069(95 CI 055ndash090)

P=002126months

FOLFOX

(+ Bev)

(n=263)



Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=159)


HR 064(95 CI 048ndash086)

P=003124months

FOLFOX

(+ Bev)

(n=159)


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=108)

167months

+ 41 months

HR 077(95 CI 054ndash109)

P=147126months

FOLFOX

(+ Bev)

(n=104)




Pe

rce

nt

()

8

6

4

2

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

60

19

FOLFOX

(+ Bev)

(n=263)

3 x CR rateP=020


Pe

rce

nt

()

80

60

40

20

0


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

787

688

FOLFOX

(+ Bev)

(n=263)

+ 99 ORRP=042



SIRFLOX OS

33


34




35


36



37




colorectal


RESECT Study

38

RESECT Study

39












Is it Safe

40


41













bull Retrospective

42

Procedure

43

Procedure

44

Dose Calculation

45

Treatment

46


References











47

Thank you

48


26

SIRFLOX





27


28



Eligible Patients



mCRC


advanced disease


Status 0ndash1

Stratified by


hepatic metastases


involvement


bevacizumab

bull Institution

Randomized

11

N=530




microspheres

n=263 enrolled

n=267 enrolled





ANZ 280 (53)

EME 191 (36) US 59 (11)


29

Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

205months






+ 79 months

HR 069(95 CI 055ndash090)

P=002126months

FOLFOX

(+ Bev)

(n=263)



Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=159)


HR 064(95 CI 048ndash086)

P=003124months

FOLFOX

(+ Bev)

(n=159)


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=108)

167months

+ 41 months

HR 077(95 CI 054ndash109)

P=147126months

FOLFOX

(+ Bev)

(n=104)




Pe

rce

nt

()

8

6

4

2

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

60

19

FOLFOX

(+ Bev)

(n=263)

3 x CR rateP=020


Pe

rce

nt

()

80

60

40

20

0


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

787

688

FOLFOX

(+ Bev)

(n=263)

+ 99 ORRP=042



SIRFLOX OS

33


34




35


36



37




colorectal


RESECT Study

38

RESECT Study

39












Is it Safe

40


41













bull Retrospective

42

Procedure

43

Procedure

44

Dose Calculation

45

Treatment

46


References











47

Thank you

48

SIRFLOX





27


28



Eligible Patients



mCRC


advanced disease


Status 0ndash1

Stratified by


hepatic metastases


involvement


bevacizumab

bull Institution

Randomized

11

N=530




microspheres

n=263 enrolled

n=267 enrolled





ANZ 280 (53)

EME 191 (36) US 59 (11)


29

Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

205months






+ 79 months

HR 069(95 CI 055ndash090)

P=002126months

FOLFOX

(+ Bev)

(n=263)



Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=159)


HR 064(95 CI 048ndash086)

P=003124months

FOLFOX

(+ Bev)

(n=159)


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=108)

167months

+ 41 months

HR 077(95 CI 054ndash109)

P=147126months

FOLFOX

(+ Bev)

(n=104)




Pe

rce

nt

()

8

6

4

2

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

60

19

FOLFOX

(+ Bev)

(n=263)

3 x CR rateP=020


Pe

rce

nt

()

80

60

40

20

0


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

787

688

FOLFOX

(+ Bev)

(n=263)

+ 99 ORRP=042



SIRFLOX OS

33


34




35


36



37




colorectal


RESECT Study

38

RESECT Study

39












Is it Safe

40


41













bull Retrospective

42

Procedure

43

Procedure

44

Dose Calculation

45

Treatment

46


References











47

Thank you

48


28



Eligible Patients



mCRC


advanced disease


Status 0ndash1

Stratified by


hepatic metastases


involvement


bevacizumab

bull Institution

Randomized

11

N=530




microspheres

n=263 enrolled

n=267 enrolled





ANZ 280 (53)

EME 191 (36) US 59 (11)


29

Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

205months






+ 79 months

HR 069(95 CI 055ndash090)

P=002126months

FOLFOX

(+ Bev)

(n=263)



Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=159)


HR 064(95 CI 048ndash086)

P=003124months

FOLFOX

(+ Bev)

(n=159)


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=108)

167months

+ 41 months

HR 077(95 CI 054ndash109)

P=147126months

FOLFOX

(+ Bev)

(n=104)




Pe

rce

nt

()

8

6

4

2

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

60

19

FOLFOX

(+ Bev)

(n=263)

3 x CR rateP=020


Pe

rce

nt

()

80

60

40

20

0


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

787

688

FOLFOX

(+ Bev)

(n=263)

+ 99 ORRP=042



SIRFLOX OS

33


34




35


36



37




colorectal


RESECT Study

38

RESECT Study

39












Is it Safe

40


41













bull Retrospective

42

Procedure

43

Procedure

44

Dose Calculation

45

Treatment

46


References











47

Thank you

48


29

Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

205months






+ 79 months

HR 069(95 CI 055ndash090)

P=002126months

FOLFOX

(+ Bev)

(n=263)



Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=159)


HR 064(95 CI 048ndash086)

P=003124months

FOLFOX

(+ Bev)

(n=159)


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=108)

167months

+ 41 months

HR 077(95 CI 054ndash109)

P=147126months

FOLFOX

(+ Bev)

(n=104)




Pe

rce

nt

()

8

6

4

2

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

60

19

FOLFOX

(+ Bev)

(n=263)

3 x CR rateP=020


Pe

rce

nt

()

80

60

40

20

0


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

787

688

FOLFOX

(+ Bev)

(n=263)

+ 99 ORRP=042



SIRFLOX OS

33


34




35


36



37




colorectal


RESECT Study

38

RESECT Study

39












Is it Safe

40


41













bull Retrospective

42

Procedure

43

Procedure

44

Dose Calculation

45

Treatment

46


References











47

Thank you

48

Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

205months






+ 79 months

HR 069(95 CI 055ndash090)

P=002126months

FOLFOX

(+ Bev)

(n=263)



Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=159)


HR 064(95 CI 048ndash086)

P=003124months

FOLFOX

(+ Bev)

(n=159)


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=108)

167months

+ 41 months

HR 077(95 CI 054ndash109)

P=147126months

FOLFOX

(+ Bev)

(n=104)




Pe

rce

nt

()

8

6

4

2

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

60

19

FOLFOX

(+ Bev)

(n=263)

3 x CR rateP=020


Pe

rce

nt

()

80

60

40

20

0


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

787

688

FOLFOX

(+ Bev)

(n=263)

+ 99 ORRP=042



SIRFLOX OS

33


34




35


36



37




colorectal


RESECT Study

38

RESECT Study

39












Is it Safe

40


41













bull Retrospective

42

Procedure

43

Procedure

44

Dose Calculation

45

Treatment

46


References











47

Thank you

48

Me

dia

n P

FS

in

th

e L

ive

r (m

on

ths

)

24

18

12

6

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=159)


HR 064(95 CI 048ndash086)

P=003124months

FOLFOX

(+ Bev)

(n=159)


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=108)

167months

+ 41 months

HR 077(95 CI 054ndash109)

P=147126months

FOLFOX

(+ Bev)

(n=104)




Pe

rce

nt

()

8

6

4

2

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

60

19

FOLFOX

(+ Bev)

(n=263)

3 x CR rateP=020


Pe

rce

nt

()

80

60

40

20

0


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

787

688

FOLFOX

(+ Bev)

(n=263)

+ 99 ORRP=042



SIRFLOX OS

33


34




35


36



37




colorectal


RESECT Study

38

RESECT Study

39












Is it Safe

40


41













bull Retrospective

42

Procedure

43

Procedure

44

Dose Calculation

45

Treatment

46


References











47

Thank you

48


Pe

rce

nt

()

8

6

4

2

0FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

60

19

FOLFOX

(+ Bev)

(n=263)

3 x CR rateP=020


Pe

rce

nt

()

80

60

40

20

0


FOLFOX (+ Bev)

+ SIR-Spheres

microspheres

(n=267)

787

688

FOLFOX

(+ Bev)

(n=263)

+ 99 ORRP=042



SIRFLOX OS

33


34




35


36



37




colorectal


RESECT Study

38

RESECT Study

39












Is it Safe

40


41













bull Retrospective

42

Procedure

43

Procedure

44

Dose Calculation

45

Treatment

46


References











47

Thank you

48

SIRFLOX OS

33


34




35


36



37




colorectal


RESECT Study

38

RESECT Study

39












Is it Safe

40


41













bull Retrospective

42

Procedure

43

Procedure

44

Dose Calculation

45

Treatment

46


References











47

Thank you

48


34




35


36



37




colorectal


RESECT Study

38

RESECT Study

39












Is it Safe

40


41













bull Retrospective

42

Procedure

43

Procedure

44

Dose Calculation

45

Treatment

46


References











47

Thank you

48


35


36



37




colorectal


RESECT Study

38

RESECT Study

39












Is it Safe

40


41













bull Retrospective

42

Procedure

43

Procedure

44

Dose Calculation

45

Treatment

46


References











47

Thank you

48


36



37




colorectal


RESECT Study

38

RESECT Study

39












Is it Safe

40


41













bull Retrospective

42

Procedure

43

Procedure

44

Dose Calculation

45

Treatment

46


References











47

Thank you

48



37




colorectal


RESECT Study

38

RESECT Study

39












Is it Safe

40


41













bull Retrospective

42

Procedure

43

Procedure

44

Dose Calculation

45

Treatment

46


References











47

Thank you

48

RESECT Study

38

RESECT Study

39












Is it Safe

40


41













bull Retrospective

42

Procedure

43

Procedure

44

Dose Calculation

45

Treatment

46


References











47

Thank you

48

RESECT Study

39












Is it Safe

40


41













bull Retrospective

42

Procedure

43

Procedure

44

Dose Calculation

45

Treatment

46


References











47

Thank you

48









Is it Safe

40


41













bull Retrospective

42

Procedure

43

Procedure

44

Dose Calculation

45

Treatment

46


References











47

Thank you

48


41













bull Retrospective

42

Procedure

43

Procedure

44

Dose Calculation

45

Treatment

46


References











47

Thank you

48










bull Retrospective

42

Procedure

43

Procedure

44

Dose Calculation

45

Treatment

46


References











47

Thank you

48

Procedure

43

Procedure

44

Dose Calculation

45

Treatment

46


References











47

Thank you

48

Procedure

44

Dose Calculation

45

Treatment

46


References











47

Thank you

48

Dose Calculation

45

Treatment

46


References











47

Thank you

48

Treatment

46


References











47

Thank you

48

References











47

Thank you

48

Thank you

48

Documents

Interventional Oncology: Liver Directed Therapy...•Ocular Melanoma (?) •Cholangiocarcinoma (?) •RCC (?) 11 Basics •Inoperable primary vs secondary hepatic tumors •Induces