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  • Disclaimer: The Rapid Response Service is an information service for those involved in planning and providing health care in Canada. Rapid responses are based on a limited literature search and are not comprehensive, systematic reviews. The intent is to provide a list of sources of the best evidence on the topic that CADTH could identify using all reasonable efforts within the time allowed. Rapid responses should be considered along with other types of information and health care considerations. The information included in this response is not intended to replace professional medical advice, nor should it be construed as a recommendation for or against the use of a particular health technology. Readers are also cautioned that a lack of good quality evidence does not necessarily mean a lack of effectiveness particularly in the case of new and emerging health technologies, for which little information can be found, but which may in future prove to be effective. While CADTH has taken care in the preparation of the report to ensure that its contents are accurate, complete and up to date, CADTH does not make any guarantee to that effect. CADTH is not liable for any loss or damages resulting from use of the information in the report. Copyright: This report contains CADTH copyright material and may contain material in which a third party owns copyright. This report may be used for the purposes of research or private study only. It may not be copied, posted on a web site, redistributed by email or stored on an electronic system without the prior written permission of CADTH or applicable copyright owner. Links: This report may contain links to other information available on the websites of third parties on the Internet. CADTH does not have control over the content of such sites. Use of third party sites is governed by the owners’ own terms and conditions.

    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

  • Yttrium-90 Microspheres for Cancer Patients with Primary and Secondary Liver Tumors 3

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

    population and size

    Intervention and comparators

    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

    Y-90 radioembolization (n=99)

    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

    Inarrairaegui et al.

    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

    - Median overall survival: 13 months (95% CI 9.6-16.3)

    - Survival dependent on aggressiveness of disease

    Kooby et al. 11

    Retrospective comparative analysis, single center

    1996-2006 N=71

    Y-90 radioembolization (n=27)

    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