TITLE: Yttrium-90 Microspheres for Cancer Patients with ... · effectiveness of Yttrium-90 microsphere radioembolization for patients with liver metastases from colorectal cancer

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TITLE: Yttrium-90 Microspheres for Cancer Patients with Primary or Secondary Liver

Tumors: Clinical and Cost-Effectiveness DATE: 13 June 2011 RESEARCH QUESTIONS 1. What is the clinical effectiveness of Yttrium-90 microsphere radioembolization for cancer

patients with primary or secondary liver tumors? 2. What is the cost-effectiveness of Yttrium-90 microspheres radioembolization for cancer

patients with primary or secondary liver tumors? KEY MESSAGE Evidence suggests that Yttrium-90 microsphere radioembolization is a safe and efficient therapy for patients with primary or secondary liver tumors; no literature was identified regarding the cost-effectiveness of Yttrium-90 microsphere radioembolization for cancer patients with primary or secondary liver tumors. METHODS A limited literature search was conducted on key resources including PubMed, The Cochrane Library (2011, Issue 5), University of York Centre for Reviews and Dissemination (CRD) databases, Canadian and abbreviated list of major international health technology agencies, as well as a focused Internet search. No filters were applied to limit the retrieval by study type. Where possible, retrieval was limited to the human population. The search was also limited to English language documents published between September 1, 2007 and May 30, 2011. Internet links were provided, where available. The summary of findings was prepared from the abstracts of the relevant information. Please note that data contained in abstracts may not always be an accurate reflection of the data contained within the full article.

Yttrium-90 Microspheres for Cancer Patients with Primary and Secondary Liver Tumors 2

RESULTS Rapid Response reports are organized so that the higher quality evidence is presented first. Therefore, health technology assessment reports, systematic reviews, and meta-analyses are presented first. These are followed by randomized controlled trials, non-randomized studies, and economic evaluations. Two systematic reviews, one randomized controlled trial, and thirty-four non-randomized studies were identified regarding the clinical effectiveness of Yttrium-90 microsphere radioembolization for cancer patients with primary or secondary liver tumors. No literature was identified regarding the cost-effectiveness of Yttrium-90 microsphere radioembolization for cancer patients with primary or secondary liver tumors. Additional references of potential interest can be found in the appendix. This report is an update from a previous CADTH report76 that focused on the clinical and cost effectiveness of Yttrium-90 microsphere radioembolization for patients with liver metastases from colorectal cancer. OVERALL SUMMARY OF FINDINGS A systematic review1 found Yttrium-90 (Y-90) microspheres to be safe and well-tolerated in patients with unresectable hepatocellular carcinoma, having a median survival range of 7 to 21.6 months. A meta-analysis2 found that Y-90 microspheres elicit high response rates especially if used in conjunction with chemotherapy in patients with colorectal liver metastases. Similarly, a randomized controlled trial3 compared the effectiveness of Y-90 microsphere radioembolization when used in addition to the chemotherapy agent, fluorouracil, in chemotherapy-refractory colorectal liver metastases. Y-90 radioembolization plus fluorouracil was well tolerated and significantly improved time to liver progression (TTLP) and median time to tumor progression (TTP) compared with fluorouracil alone. Thirty-four non-randomized studies4-38 were identified regarding the clinical effectiveness of Y-90 microsphere radioembolization for primary and secondary liver tumors and are summarized in Table 1.

Table 1: Y-90 microsphere radioembolization for primary and secondary liver tumors Authors Study design, sample

population and size

Intervention and comparators

Outcomes

Hepatocellular carcinoma (HCC)

Salem et al.4 Retrospective

comparative analysis

9-year period N=145

Y-90 radioembolization (n=123)

Chemoembolization

(n=122)

- Y-90 higher response rate than chemoembolization (49% vs 36%, p=0.104)

- Y-90 longer TTP than chemoembolization (13.3 months vs 8.4 months, p=0.046)

- Similar median overall survival* (20.5 months vs 17.4 months, p=0.323)

- Y-90 less toxicity than chemoembolization

Sangro et al.5 Retrospective analysis,

8 centers Y-90 radioembolization

administered as - Median overall survival: 12.8 months



population and size


Outcomes

Sept 2003-Dec 2009 N=325

whole-liver or right-lobe infusions

(95% CI 10.9-15.7) - Survival varied significantly by disease

stage (ECOG, hepatic function, tumor burden, presence of extrahepatic disease)

Carr et al.6 Retrospective

comparative analysis, 2-cohort experience

N=932


Chemoembolization

(n=691) No treatment (n=142)

- Y-90 slightly longer median overall survival than chemoembolization (11.5 months vs 8.5 months) but may be due to milder disease in Y-90 group

Hilgard et al.7 Prospective study

Patients with advanced

HCC and liver cirrhosis

N=108

Y-90 radioembolization administered as a lobar infusion

- Response (% of patients): complete (3%), partial (37%), stable disease (53%), primary progression (6%)

- TTP: 10 months

- Median overall survival: 16.4 months

Tsai et al.8 Retrospective analysis

Patients with HCC and

portal vein thrombosis

N=22

Y-90 radioembolization - Response (% of patients): partial (8%), stable disease (50%), primary progression (42%)

- Median overall survival: 7 months

Inarrairaegui et al.

9

Retrospective analysis Patients with HCC and

portal vein thrombosis

N=25

Y-90 radioembolization administered as a segmental, lobar, or whole-liver infusion

- Controlled disease achieved in 66.7% of patients at 2 months; in 50% of patients at 6 months

- Median overall survival: 10 months (95% CI 6.6-13.3)

- No significant changes in liver-related toxicities


10

Retrospective analysis N=72

Y-90 radioembolization - Decreased in target tumor size observed in most patients

- Y-90 did not prevent development of new lesions


- Survival dependent on aggressiveness of disease

Kooby et al.11

Retrospective comparative analysis, single center

1996-2006 N=71


Chemoembolization

(n=44)

- No significant difference in disease progression at 3 months

- Similar median overall survival (6 months for both treatments, p=0.7)

- Similar toxicity in patients

Salem et al.12

Prospective, longitudinal cohort study, single center

N=291

Y-90 radioembolization - TTP: 7.9 months (95% CI 6-10.3) - Median overall survival differed between

patients: Child-Pugh A vs Child-Pugh B (17.2 months vs

7.7 months, p=0.002) Child-Pugh B + deep vein thrombosis (5.6

months, 95% CI 4.5-6.7)

D’Avola et al.

13

Retrospective comparative analysis

Y-90 radioembolization as a first-line treatment (n=35)

- Y-90 significantly higher median overall survival than conventional treatment (16 months vs 8 months, p<0.05)



population and size


Outcomes

N=78

Potential candidates for Y-

90 radioembolization that received conventional care (n=43)

Lewandowski et al.

14

Prospective comparative study

N=86

Y-90 transarterial radioembolization (n=43)

Transarterial

chemoembolization (n=43)

- Y-90 had a greater partial response rate than chemoembolization (61% vs 37%)

- Y-90 had a higher median overall survival than chemoembolization (35.7 months vs 18.7 months, p=0.18)

Intrahepatic cholangiocarcinoma (ICC)

Hoffman et al.

15

Retrospective analysis N=33

Y-90 radioembolization - Response after three months (n): partial (12), stable disease (17), primary progression (5)

- TTP: 9.8 months - Median overall survival: 22 months

- Survival dependent on performance status and tumor burden

Ibrahim et al.

16

Open label, cohort study

N=24

Y-90 radioembolization to hepatic segments or lobes


- Survival varied significantly by ECOG performance status and the presence and absence of portal vein thrombosis

Colorectal liver metastases (mCRC)

Nace et al.17

Retrospective analysis Patients who have

failed first and second lines of systemic chemotherapy

N=51

Y-90 radioembolization - Median overall survival: 10.2 months (95% CI 7.5-13.0)

- Survival dependent on the presence of extrahepatic disease

Chua et al.18

Prospective study, single center

N=140

Y-90 radioembolization combined with systemic chemotherapy, single treatment (n=133) or repeat treatments (n=7)

- Response following treatment (% of patients): complete (1%), partial (31%), stable disease (31%), primary progression (37%)


- Predictors for survival included primary tumor site, presence of extrahepatic disease, and a favourable treatment response

Cosimelli et al.

19

Prospective phase II clinical trial, multi-center

Patients who have

failed previous systemic chemotherapy regimens

N=50

Y-90 radioembolization

- Response following treatment using RECIST criteria (% of patients): complete (2%), partial (22%), stable disease (24%), primary progression (44%), non-evaluable (8%)

- Median overall survival: 12.6 months (95% CI 7.0-18.3)

Mulcahy et Prospective study Y-90 radioembolization - Median overall survival: 14.5 months



population and size


Outcomes

al.20

N=72

- Survival dependent on tumor replacement and the presence of extrahepatic disease

Cianni et al.21


Feb 2005-Jan 2008 Patients with no

response to chemotherapy

N=41

Y-90 radioembolization - Response following treatment using RECIST criteria (n): complete (2), partial (17), stable disease (14), primary progression (8)

- Median overall survival calculated by Kaplan-Meier analysis: 354 days

Jakobs et al.22

Retrospective analysis Patients with no

response to chemotherapy

N=36

Y-90 radioembolization - Response at 2.9 months (n): partial (7), stable disease (25), primary progression (4)


Neuroendocrine tumor liver metastases (NETLMs)

Cao et al.23

Retrospective analysis of prospectively collected database, two centers

2003-2008 N=58

Y-90 radioembolization - Response to treatment (n): complete (6), partial (14), stable disease (14), primary progression (17)

- Median overall survival: 36 months (range 1-61)

- Survival dependent on extent of tumor involvement, response to treatment, extrahepatic disease, and tumor grade

Kalinowski et al.

24


N=9

Y-90 radioembolization - Response at 3 months (n): partial (6), stable disease (3)


King et al.25

Prospective study Dec 2003-Dec 2005 N=34

Y-90 radioembolization administered concomitantly with a systemic infusion of 5-fluorouracil

- Response to treatment (n): complete (6), partial (11)

- Median overall survival: 29.4 ± 3.4 months

Murthy et al.26

Prospective study Patients without other

reasonable therapeutic options

N=8

Y-90 radioembolization administered in a lobar fashion

- Response to treatment (n): partial (1), stable disease (4), primary progression (3)

- Median overall survival: 14 months (range 3-15)

Rhee et al.27

Open label phase II study, multi-center

N=42

Y-90 radioembolization administered in a lobar fashion using glass or resin

- Partial or stable response at 6 months using RECIST criteria (%): glass (92%); resin (94%)

- Median overall survival: glass (22 months); resin (28 months)

Other liver metastases

Cao et al.28

Retrospective analysis of prospectively collected database,

Y-90 radioembolization with follow-up abdominal computed tomography scan

- Response after treatment (n): partial (2), stable disease (1)

- One patient with partial response survived 15 months after Y-90 therapy



population and size


Outcomes

single center 2006-2009 Patients with pancreatic

carcinomas liver metastases

N=7

(n=5)

Kennedy et al.

29

Retrospective analysis, 5 centers

Patients with ocular

melanoma liver metastases

N=11

Y-90 radioembolization - Response seen in all patients at 3 months posttreatment

- One patient had a complete response after treatment

- Minimal toxicity

Jakobs et al.30

Retrospective analysis Patients with breast

cancer liver metastases refractory to other treatments

N=30, follow-up data for 23 patients

Y-90 radioembolization, single-session, whole liver treatment

- Response at 4.2 months (%): partial (61), stable disease (35), primary progression (4)

- Median overall survival: 11.7 months - Survival dependent on response to

treatment and presence of extrahepatic disease

Chemorefractory liver metastases

Evans et al.31

Retrospective analysis 3 years Patients with

chemotherapy-refractory liver metastases:

Group 1 - mCRC Group 2 - other liver

metastases N=208

Y-90 radioembolization - Median overall survival Entire cohort: 8.3 months Group 1: 7.9 months Group 2: 8.7 months

Cianni et al.32


3 years Patients with

chemorefractory liver metastases

N=110

Y-90 radioembolization - Response to treatment (n): complete/partial (45), stable disease (42), primary progression (23)

- Median overall survival calculated by Kaplan-Meier analysis: 323 days

Johnson et al.

33

Retrospective analysis, community hospital setting

Heavily pre-treated

patients with liver metastases

N=37

Y-90 radioembolization - TTLP: 4 months

- Median overall survival: 9.4 months - Colorectal, breast, and carcinoid

metastases responded better than other types

Sato et al.34

Prospective study Y-90 radioembolization - 42.8% response rate according to WHO



population and size


Outcomes

Patients with

chemorefractory liver metastases

N=137

criteria: 2.1% complete, 40.7 partial - Median overall survival calculated by

Kaplan-Meier analysis mCRC: 457 days NETLMs: 776 days Other: 207 days

Stuart et al.35

Retrospective analysis Patients with cancers

that failed first- and second-line therapy

N=30

Y-90 radioembolization (resin)

- 47% had a partial response or stable disease according to RECIST criteria

- Median overall survival calculated by Kaplan-Meier analysis

mCRC: 357 days Breast: not reached Other: 638 days

Other patient groups

Gaba et al.36

Prospective study Patients with liver

tumors and biliary obstruction

N=12

Y-90 radioembolization treatment to obstructed liver lobe or segment

- Complete resolution of biliary obstruction after 1 month in one mCRC patient

- No biliary complications during overall median follow-up time of 22.9 months


37

Retrospective analysis, single center

Sept 2003-Feb 2010 Elderly (≥70 years,

n=73) and younger patients (≤70 years, n=182) with primary or metastatic liver tumors

N=255

Y-90 radioembolization - Median overall survival similar in both elderly and younger groups (p=0.4)

Elderly: 13 months (95% CI 10.4-15.5) Younger: 12 months (95% CI 4.2-15.7)

- Median overall survival in mCRC patients:

Elderly: 10 months (95% CI 5.2-14.7) Younger: 13 months (95% CI 7.0-18.9)

- Median overall survival in other patients: Elderly: 9 months (95% CI 3.5-14.4) Younger: 4 months (95% CI 2.7-5.2)

*Median overall survival is measured from time of treatment CI=confidence interval; mCRC=colorectal liver metastases; ECOG= Eastern Cooperative Oncology Group;

NETLMs=neuroendocrine tumor liver metastases; RECIST= Response Evaluation Criteria in Solid Tumors; TTP=time to progression; TTLP=time to liver progression; Y-90=Yttrium-90

Y-90 microsphere radioembolization appears to be a safe and efficient therapy for patients with unresectable primary or secondary liver tumors. It is not certain whether it is more effective than chemoembolization therapy when considering the median overall survival of patients.4,6,11 Y-90 microsphere radioembolization may be combined with systemic chemotherapy to produce promising results.18,25 More commonly, it is used as a last line of therapy in patients with liver tumors that were refractory to other treatments and its place as a first or second-line treatment for primary or secondary liver tumors has yet to be determined.


REFERENCES SUMMARIZED Health technology assessments No literature identified. Systematic reviews and meta-analyses 1. Lau WY, Lai EC, Leung TW. Current role of selective internal irradiation with yttrium-90

microspheres in the management of hepatocellular carcinoma: a systematic review. Int J Radiat Oncol Biol Phys. 2010 Sep 30. PubMed: PM20888138

2. Vente MA, Wondergem M, van der Tweel I, van den Bosch MA, Zonnenberg BA, Lam MG, et al. Yttrium-90 microsphere radioembolization for the treatment of liver malignancies: a structured meta-analysis. Eur Radiol. 2009 Apr;19(4):951-9. PubMed: PM18989675

Randomized controlled trials 3. Hendlisz A, Van den Eynde M, Peeters M, Maleux G, Lambert B, Vannoote J, et al. Phase

III trial comparing protracted intravenous fluorouracil infusion alone or with yttrium-90 resin microspheres radioembolization for liver-limited metastatic colorectal cancer refractory to standard chemotherapy. J Clin Oncol. 2010 Aug 10;28(23):3687-94. PubMed: PM20567019

Non-randomized studies Primary liver tumors

Hepatocellular carcinomas

4. Salem R, Lewandowski RJ, Kulik L, Wang E, Riaz A, Ryu RK, et al. Radioembolization results in longer time-to-progression and reduced toxicity compared with chemoembolization in patients with hepatocellular carcinoma. Gastroenterology. 2011 Feb;140(2):497-507. PubMed: PM21044630

5. Sangro B, Carpanese L, Cianni R, Golfieri R, Gasparini D, Ezziddin S, et al. Survival after (90) Y resin microsphere radioembolization of hepatocellular carcinoma across BCLC stages: A European evaluation. Hepatology. 2011 May 26. PubMed: PM21618574

6. Carr BI, Kondragunta V, Buch SC, Branch RA. Therapeutic equivalence in survival for hepatic arterial chemoembolization and yttrium 90 microsphere treatments in unresectable hepatocellular carcinoma: a two-cohort study. Cancer. 2010 Mar 1 [cited 2011 Jun 8];116(5):1305-14. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2829376 PubMed: PM20066715

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=retrieve&db=pubmed&list_uids=20888138&dopt=abstract





http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2829376



7. Hilgard P, Hamami M, Fouly AE, Scherag A, Müller S, Ertle J, et al. Radioembolization with yttrium-90 glass microspheres in hepatocellular carcinoma: European experience on safety and long-term survival. Hepatology. 2010 Nov;52(5):1741-9. PubMed: PM21038413

8. Tsai AL, Burke CT, Kennedy AS, Moore DT, Mauro MA, Dixon RD, et al. Use of yttrium-90 microspheres in patients with advanced hepatocellular carcinoma and portal vein thrombosis. J Vasc Interv Radiol. 2010 Sep [cited 2011 Jun 8];21(9):1377-84. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2945527 PubMed: PM20691606

9. Iñarrairaegui M, Thurston KG, Bilbao JI, D'Avola D, Rodriguez M, Arbizu J, et al. Radioembolization with use of yttrium-90 resin microspheres in patients with hepatocellular carcinoma and portal vein thrombosis. J Vasc Interv Radiol. 2010 Aug;21(8):1205-12. PubMed: PM20598574

10. Iñarrairaegui M, Martinez-Cuesta A, Rodríguez M, Bilbao JI, Arbizu J, Benito A, et al. Analysis of prognostic factors after yttrium-90 radioembolization of advanced hepatocellular carcinoma. Int J Radiat Oncol Biol Phys. 2010 Aug 1;77(5):1441-8. PubMed: PM20056355

11. Kooby DA, Egnatashvili V, Srinivasan S, Chamsuddin A, Delman KA, Kauh J, et al. Comparison of yttrium-90 radioembolization and transcatheter arterial chemoembolization for the treatment of unresectable hepatocellular carcinoma. J Vasc Interv Radiol. 2010 Feb;21(2):224-30. PubMed: PM20022765

12. Salem R, Lewandowski RJ, Mulcahy MF, Riaz A, Ryu RK, Ibrahim S, et al. Radioembolization for hepatocellular carcinoma using Yttrium-90 microspheres: a comprehensive report of long-term outcomes. Gastroenterology. 2010 Jan;138(1):52-64. PubMed: PM19766639

13. D'Avola D, Lñarrairaegui M, Bilbao JI, Martinez-Cuesta A, Alegre F, Herrero JI, et al. A retrospective comparative analysis of the effect of Y90-radioembolization on the survival of patients with unresectable hepatocellular carcinoma. Hepatogastroenterology. 2009 Nov;56(96):1683-8. PubMed: PM20214218

14. Lewandowski RJ, Kulik LM, Riaz A, Senthilnathan S, Mulcahy MF, Ryu RK, et al. A comparative analysis of transarterial downstaging for hepatocellular carcinoma: chemoembolization versus radioembolization. Am J Transplant. 2009 Aug;9(8):1920-8. PubMed: PM19552767

Intrahepatic cholangiocarcinomas 15. Hoffmann RT, Paprottka PM, Schön A, Bamberg F, Haug A, Dürr EM, et al. Transarterial

Hepatic Yttrium-90 Radioembolization in Patients with Unresectable Intrahepatic Cholangiocarcinoma: Factors Associated with Prolonged Survival. Cardiovasc Intervent











Radiol. 2011 Mar 24. PubMed: PM21431970

16. Ibrahim SM, Mulcahy MF, Lewandowski RJ, Sato KT, Ryu RK, Masterson EJ, et al. Treatment of unresectable cholangiocarcinoma using yttrium-90 microspheres: results from a pilot study. Cancer. 2008 Oct 15;113(8):2119-28. PubMed: PM18759346

Secondary liver tumors Colorectal liver metastases 17. Nace GW, Steel JL, Amesur N, Zajko A, Nastasi BE, Joyce J, et al. Yttrium-90

radioembolization for colorectal cancer liver metastases: a single institution experience. Int J Surg Oncol [Internet]. 2011 [cited 2011 Jun 8];1-9. Available from: http://www.hindawi.com/journals/ijso/2011/571261/

18. Chua TC, Bester L, Saxena A, Morris DL. Radioembolization and systemic chemotherapy

improves response and survival for unresectable colorectal liver metastases. J Cancer Res Clin Oncol. 2011 May;137(5):865-73. PubMed: PM20859640

19. Cosimelli M, Golfieri R, Cagol PP, Carpanese L, Sciuto R, Maini CL, et al. Multi-centre phase II clinical trial of yttrium-90 resin microspheres alone in unresectable, chemotherapy refractory colorectal liver metastases. Br J Cancer. 2010 Jul 27 [cited 2011 Jun 8];103(3):324-31. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2920024 PubMed: PM20628388

20. Mulcahy MF, Lewandowski RJ, Ibrahim SM, Sato KT, Ryu RK, Atassi B, et al. Radioembolization of colorectal hepatic metastases using yttrium-90 microspheres. Cancer. 2009 May 1;115(9):1849-58. PubMed: PM19267416

21. Cianni R, Urigo C, Notarianni E, Saltarelli A, Salvatori R, Pasqualini V, et al. Selective internal radiation therapy with SIR-spheres for the treatment of unresectable colorectal hepatic metastases. Cardiovasc Intervent Radiol. 2009 Nov;32(6):1179-86. PubMed: PM19680720

22. Jakobs TF, Hoffmann RT, Dehm K, Trumm C, Stemmler HJ, Tatsch K, et al. Hepatic yttrium-90 radioembolization of chemotherapy-refractory colorectal cancer liver metastases. J Vasc Interv Radiol. 2008 Aug;19(8):1187-95. PubMed: PM18656012

Neuroendocrine tumor liver metastases 23. Cao CQ, Yan TD, Bester L, Liauw W, Morris DL. Radioembolization with yttrium

microspheres for neuroendocrine tumour liver metastases. Br J Surg. 2010 Apr;97(4):537-43. PubMed: PM20205229



http://www.hindawi.com/journals/ijso/2011/571261/









24. Kalinowski M, Dressler M, König A, El-Sheik M, Rinke A, Höffken H, et al. Selective internal radiotherapy with Yttrium-90 microspheres for hepatic metastatic neuroendocrine tumors: a prospective single center study. Digestion. 2009;79(3):137-42. PubMed: PM19307736

25. King J, Quinn R, Glenn DM, Janssen J, Tong D, Liaw W, et al. Radioembolization with selective internal radiation microspheres for neuroendocrine liver metastases. Cancer. 2008 Sep 1;113(5):921-9. PubMed: PM18618495

26. Murthy R, Kamat P, Nunez R, Madoff DC, Gupta S, Salem R, et al. Yttrium-90 microsphere radioembolotherapy of hepatic metastatic neuroendocrine carcinomas after hepatic arterial embolization. J Vasc Interv Radiol. 2008 Jan;19(1):145-51. PubMed: PM18192482

27. Rhee TK, Lewandowski RJ, Liu DM, Mulcahy MF, Takahashi G, Hansen PD, et al. 90Y Radioembolization for metastatic neuroendocrine liver tumors: preliminary results from a multi-institutional experience. Ann Surg. 2008 Jun;247(6):1029-35. PubMed: PM18520231

Other liver metastases 28. Cao C, Yan TD, Morris DL, Bester L. Radioembolization with yttrium-90 microspheres for

pancreatic cancer liver metastases: results from a pilot study. Tumori. 2010 Nov;96(6):955-8. PubMed: PM21388058

29. Kennedy AS, Nutting C, Jakobs T, Cianni R, Notarianni E, Ofer A, et al. A first report of radioembolization for hepatic metastases from ocular melanoma. Cancer Invest. 2009 Jul;27(6):682-90. PubMed: PM19219675

30. Jakobs TF, Hoffmann RT, Fischer T, Stemmler HJ, Tatsch K, La FC, et al. Radioembolization in patients with hepatic metastases from breast cancer. J Vasc Interv Radiol. 2008 May;19(5):683-90. PubMed: PM18440456

Chemorefractory liver metastases 31. Evans KA, Richardson MG, Pavlakis N, Morris DL, Liauw W, Bester L. Survival outcomes

of a salvage patient population after radioembolization of hepatic metastases with yttrium-90 microspheres. J Vasc Interv Radiol. 2010 Oct;21(10):1521-6. PubMed: PM20813542

32. Cianni R, Urigo C, Notarianni E, Saltarelli A, D'Agostini A, Iozzino M, et al. Radioembolisation using yttrium 90 (Y-90) in patients affected by unresectable hepatic metastases. Radiol Med. 2010 Jun;115(4):619-33. PubMed: PM20091135











33. Johnson DW, Mori KH, O'Laughlin SR, Deshmukh AV, Sinopoli MT, Augspurger ME, et al. Safety and efficacy of yttrium-90 labeled microsphere radiation treatment for hepatic metastases. Northeast Florida Med [Internet]. 2009 [cited 2011 Jun 8];60(1):37-41. Available from: http://www.dcmsonline.org/jax-medicine/2009journals/ColorectalCancer/RadiationTreatmentHepaticMetastases.pdf

34. Sato KT, Lewandowski RJ, Mulcahy MF, Atassi B, Ryu RK, Gates VL, et al. Unresectable

chemorefractory liver metastases: radioembolization with 90Y microspheres--safety, efficacy, and survival. Radiology. 2008 May;247(2):507-15. PubMed: PM18349311

35. Stuart JE, Tan B, Myerson RJ, Garcia-Ramirez J, Goddu SM, Pilgram TK, et al. Salvage radioembolization of liver-dominant metastases with a resin-based microsphere: initial outcomes. J Vasc Interv Radiol. 2008 Oct;19(10):1427-33. PubMed: PM18755600

Other patient groups 36. Gaba RC, Riaz A, Lewandowski RJ, Ibrahim SM, Ryu RK, Sato KT, et al. Safety of

yttrium-90 microsphere radioembolization in patients with biliary obstruction. J Vasc Interv Radiol. 2010 Aug;21(8):1213-8. PubMed: PM20598575

37. Iñarrairaegui M, Bilbao JI, Rodríguez M, Benito A, Sangro B. Liver radioembolization using 90 y resin microspheres in elderly patients: tolerance and outcome. Hosp Pract (Minneap). 2010 Aug;38(5):103-9. PubMed: PM20890058

Economic evaluations No literature identified.

PREPARED BY: Canadian Agency for Drugs and Technologies in Health Tel: 1-866-898-8439 www.cadth.ca

http://www.dcmsonline.org/jax-medicine/2009journals/ColorectalCancer/RadiationTreatmentHepaticMetastases.pdf

http://www.dcmsonline.org/jax-medicine/2009journals/ColorectalCancer/RadiationTreatmentHepaticMetastases.pdf





http://www.cadth.ca/


APPENDIX – FURTHER INFORMATION: Review articles 38. Ali SM. Radioembolization for hepatocellular carcinoma using TheraSphere®. Saudi J

Gastroenterol. 2011 May;17(3):215-7. PubMed: PM21546728

39. Kennedy A, Coldwell D, Sangro B, Wasan H, Salem R. Integrating radioembolization into the treatment paradigm for metastatic neuroendocrine tumors in the liver. Am J Clin Oncol. 2011 Jan 26. PubMed: PM21278561

40. Ahmadzadehfar H, Biersack HJ, Ezziddin S. Radioembolization of liver tumors with yttrium-90 microspheres. Semin Nucl Med. 2010 Mar;40(2):105-21. PubMed: PM20113679

41. Coldwell D, Sangro B, Salem R, Wasan H, Kennedy A. Radioembolization in the treatment of unresectable liver tumors: experience across a range of primary cancers. Am J Clin Oncol. 2010 Nov 30. PubMed: PM21127414

42. Deleporte A, Flamen P, Hendlisz A. State of the art: radiolabeled microspheres treatment for liver malignancies. Expert Opin Pharmacother. 2010 Mar;11(4):579-86. PubMed: PM20163269

43. Kennedy AS, Salem R. Radioembolization (yttrium-90 microspheres) for primary and metastatic hepatic malignancies. Cancer J. 2010 Mar;16(2):163-75. PubMed: PM20404614

44. Sangro B, Salem R, Kennedy A, Coldwell D, Wasan H. Radioembolization for hepatocellular carcinoma: a review of the evidence and treatment recommendations. Am J Clin Oncol. 2010 Jul 8. PubMed: PM20622645

45. Kennedy A, Coldwell D, Sangro B, Wasan H, Salem R. Integrating radioembolization (90Y microspheres) into current treatment options for liver tumors: introduction to the international working group report. Am J Clin Oncol. 2010 Oct 8. PubMed: PM20938320

46. Van de Wiele C. Radioembolization of hepatocellular carcinoma. Curr Drug Discov Technol. 2010 Dec 1;7(4):247-52. PubMed: PM21034410

47. Bult W, Vente MA, Zonnenberg BA, van het Schip AD, Nijsen JF. Microsphere radioembolization of liver malignancies: current developments. Q J Nucl Med Mol Imaging. 2009 Jun;53(3):325-35. PubMed: PM19521312












48. Nicolay NH, Berry DP, Sharma RA, Medscape. Liver metastases from colorectal cancer: radioembolization with systemic therapy. Nat Rev Clin Oncol. 2009 Dec;6(12):687-97. PubMed: PM19884901

49. Riaz A, Lewandowski RJ, Kulik LM, Mulcahy MF, Sato KT, Ryu RK, et al. Complications following radioembolization with yttrium-90 microspheres: a comprehensive literature review. J Vasc Interv Radiol. 2009 Sep;20(9):1121-30. PubMed: PM19640737

50. Sangro B, Bilbao JI, Iñarrairaegui M, Rodriguez M, Garrastachu P, Martinez-Cuesta A. Treatment of hepatocellular carcinoma by radioembolization using 90Y microspheres. Dig Dis. 2009;27(2):164-9. PubMed: PM19546555

51. Atassi B, Bangash AK, Bahrani A, Pizzi G, Lewandowski RJ, Ryu RK, et al. Multimodality imaging following 90Y radioembolization: a comprehensive review and pictorial essay. Radiographics. 2008 Jan;28(1):81-99. PubMed: PM18203932

Additional references Institution experiences 52. Chiesa C, Maccauro M, Romito R, Spreafico C, Pellizzari S, Negri A, et al. Need,

feasibility and convenience of dosimetric treatment planning in liver selective internal radiation therapy with 90Y microspheres: the experience of the National Tumor Institute of Milan. Q J Nucl Med Mol Imaging. 2011 Apr;55(2):168-97. PubMed: PM21386789

53. Holt A, Wagman LD, Senthil M, McKenzie S, Marx H, Chen YJ, et al. Transarterial radioembolization with Yttrium-90 for regional management of hepatocellular cancer: the early results of a nontransplant center. Am Surg. 2010 Oct;76(10):1079-83. PubMed: PM21105614

54. Peynircioğlu B, Cil B, Bozkurt F, Aydemir E, Uğur O, Balkanci F. Radioembolization for the treatment of unresectable liver cancer: initial experience at a single center. Diagn Interv Radiol. 2010 Mar;16(1):70-8. PubMed: PM20180183

55. Garin E, Rolland Y, Boucher E, Ardisson V, Laffont S, Boudjema K, et al. First experience of hepatic radioembolization using microspheres labelled with yttrium-90 (TheraSphere): practical aspects concerning its implementation. Eur J Nucl Med Mol Imaging. 2010 Mar;37(3):453-61. PubMed: PM19820932

Case reports

56. Khalaf H, Alsuhaibani H, Al-Sugair A, Al-Mana H, Al-Mutawa A, Al-Kadhi Y, et al. Use of yttrium-90 microsphere radioembolization of hepatocellular carcinoma as downstaging










and bridge before liver transplantation: a case report. Transplant Proc. 2010 Apr;42(3):994-8. PubMed: PM20430224

57. Gulec SA, Pennington K, Hall M, Fong Y. Preoperative Y-90 microsphere selective internal radiation treatment for tumor downsizing and future liver remnant recruitment: a novel approach to improving the safety of major hepatic resections. World J Surg Oncol. 2009 [cited 2011 Jun 8];7:6. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2655298 PubMed: PM19133156

58. Fenske TS, Benjamin H, Kroft SH, Hohenwalter EJ, Rilling WS. Treatment of diffuse large B-cell lymphoma of the liver with yttrium-90 microsphere embolization. Nat Clin Pract Oncol. 2008 Nov;5(11):677-81. PubMed: PM18797436

59. Sotiropoulos GC, Hilgard P, Antoch G, Nowak KM, Ertl J, Fouzas I, et al. Liver transplantation for hepatocellular carcinoma after yttrium therapy: a case report. Transplant Proc. 2008 Dec;40(10):3804-5. PubMed: PM19100496

Ongoing clinical trials Primary liver tumors 60. ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US); 2000 Feb

29 -. Identifier NCT00956930, Radiofrequency ablation, chemoembolization, and/or radioembolization in treating patients with liver cancer that cannot be removed by surgery; 2011 May 12 [cited 2011 Jun 8]. Available from: http://clinicaltrials.gov/ct2/show/NCT00956930?term=Yttrium&rank=81

61. ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US); 2000 Feb

29 -. Identifier NCT00589030, Yttrium Y 90 radiolabeled glass beads in treating patients with liver cancer that cannot be removed by surgery; 2011 May 11 [cited 2011 Jun 8]. Available from: http://clinicaltrials.gov/ct2/show/NCT00589030


29 -. Identifier NCT00469963, Internal radiation therapy in treating patients with primary liver cancer that cannot be removed by surgery; 2011 Apr 20 [cited 2011 Jun 8]. Available from: http://clinicaltrials.gov/ct2/show/NCT00469963?term=Yttrium&rank=97


29 -. Identifier NCT00846131, Y-90 alone or with sorafenib for pre-transplant hepatocellular carcinoma; 2011 Apr 15 [cited 2011 Jun 8]. Available from: http://clinicaltrials.gov/ct2/show/NCT00846131?term=Yttrium&rank=82


29 -. Identifier NCT00530010, Radiolabeled glass beads in treating patients with liver cancer that cannot be removed by surgery; 2011 Apr 7 [cited 2011 Jun 8]. Available from: http://clinicaltrials.gov/ct2/show/NCT00530010?term=Yttrium&rank=90






http://clinicaltrials.gov/ct2/show/NCT00956930?term=Yttrium&rank=81

http://clinicaltrials.gov/ct2/show/NCT00589030





65. ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US); 2000 Feb 29 -. Identifier NCT00532740, Radiolabeled glass beads in treating patients with metastatic liver cancer that cannot be removed by surgery; 2011 Apr 6 [cited 2011 Jun 8]. Available from: http://clinicaltrials.gov/ct2/show/NCT00532740?term=Yttrium&rank=93


29 -. Identifier NCT01290523, Yttrium-90 radioembolization with glass microspheres (TheraSphere) for patients with hepatocellular carcinoma; 2011 Feb 3 [cited 2011 Jun 8]. Available from: http://clinicaltrials.gov/ct2/show/NCT01290523?term=Yttrium&rank=2


29 -. Identifier NCT00877136, A treatment of unresectable hepatocellular carcinoma with TheraSphere®; 2011 Jan 28 [cited 2011 Jun 8]. Available from: http://clinicaltrials.gov/ct2/show/NCT00877136?term=Yttrium&rank=142


29 -. Identifier NCT01135056, Study to compare selective internal radiation therapy (SIRT) versus sorafenib in locally advanced hepatocellular carcinoma (HCC); 2010 Oct 18 [cited 2011 Jun 8]. Available from: http://clinicaltrials.gov/ct2/show/NCT01135056?term=Yttrium&rank=79

Secondary liver tumors 69. ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US); 2000 Feb

29 -. Identifier NCT01098422, A study of Yttrium-90 radioactive resin microspheres to treat colorectal adenocarcinoma metastatic to the liver; 2011 May 31 [cited 2011 Jun 8]. Available from: http://clinicaltrials.gov/ct2/show/NCT01098422?term=Yttrium&rank=9


29 -. Identifier NCT00466856, Internal radiation therapy in treating patients with liver metastases from neuroendocrine tumors; 2011 Apr 20 [cited 2011 Jun 8]. Available from: http://clinicaltrials.gov/ct2/show/NCT00466856?term=Yttrium&rank=96


29 -. Identifier NCT00858429, Yttrium Y 90 glass microspheres and capecitabine in treating patients with liver cholangiocarcinoma or liver metastases; 2011 Apr 15 [cited 2011 Jun 8]. Available from: http://clinicaltrials.gov/ct2/show/NCT00858429?term=Yttrium&rank=5


29 -. Identifier NCT01290536, Yttrium-90 radioembolization using glass microspheres (TheraSphere) for patients with liver metastases; 2011 Feb 3 [cited 2011 Jun 8]. Available from: http://clinicaltrials.gov/ct2/show/NCT01290536?term=Yttrium&rank=7


29 -. Identifier NCT01177007, Intra-arterial Y-90 TheraSpheres for hepatic metastases from solid tumors; 2010 Oct 1 [cited 2011 Jun 8]. Available from: http://clinicaltrials.gov/ct2/show/NCT01177007









http://clinicaltrials.gov/ct2/show/NCT01177007


74. ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US); 2000 Feb 29 -. Identifier NCT00511862, TheraSphere for the treatment of liver metastases; 2009 Sep 14 [cited 2011 Jun 8]. Available from: http://clinicaltrials.gov/ct2/show/NCT00511862?term=Yttrium&rank=60

Other 75. Lau WY, Kennedy AS, Kim YH, Lai HK, Lee RC, Leung TW, et al. Patient selection and

activity planning guide for selective internal radiotherapy with yttrium-90 resin microspheres. Int J Radiat Oncol Biol Phys. 2010 Oct 13. PubMed: PM20950954

76. Cimon K, Nkansah E. Clinical and cost effectiveness of yttrium-90 microspheres for liver metastases from colorectal cancer [Internet]. Ottawa: Canadian Agency for Drugs and Technologies in Health; 2007 Sep 21. [cited 2011 Jun 8]. Available from: http://www.cadth.ca/media/pdf/htis/Yttrium-90%20Microspheres%20for%20Liver%20Metastases%20from%20Colorectal%20Cancer.pdf



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TITLE: Yttrium-90 Microspheres for Cancer Patients with ... · effectiveness of Yttrium-90 microsphere radioembolization for patients with liver metastases from colorectal cancer