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Study Demonstrates Radioembolization Using SIR-Spheres Significantly Improves Overall Survival for Patients With Inoperable



Study Demonstrates Radioembolization Using SIR-Spheres Significantly Improves
       Overall Survival for Patients With Inoperable Colorectal Cancer

  PR Newswire

  MAGDEBURG, Germany, October 21, 2012

MAGDEBURG, Germany, October 21, 2012 /PRNewswire/ --

Survival of patients treated with SIR-Spheres more than double that of
patients who received best supportive care, benefit rivals that found with new
biological agents, authors note

The results of a matched-pair comparison of patients with metastatic
colorectal cancer predominately affecting the liver, for whom all chemotherapy
options had been exhausted, showed that the addition of radioembolization
using SIR-Spheres significantly prolonged survival compared with best
supportive care (BSC) alone. ^[ ^1 ^]

     (Logo: http://photos.prnewswire.com/prnh/20121019/568108 )

The study, published in October's edition of Cardiovascular and Interventional
Radiology , showed that median overall survival was more than doubled in
patients receiving radioembolization plus BSC versus BSC alone: 8.3 months vs.
3.5 months (hazard ratio [HR] 0.26; 95% confidence interval 0.15-0.48; P
<0.001).  A multivariate analysis confirmed that radioembolization was the
only significant predictor for prolonged survival among all the baseline
parameters investigated (HR 0.30; 95% CI 0.16-0.55; P <0.001).

"Radioembolization significantly prolonged overall survival compared with
supportive care alone in a well-matched cohort of patients with extensive,
liver-dominant chemotherapy refractory disease for whom there are limited
treatment options," said Prof. Jens Ricke, Director of Radiology and Nuclear
Medicine at the University Hospital of Magdeburg, Germany, and senior author
of the study.  "The evidence suggests that radioembolization should be
considered as a treatment option for patients with liver-only or
liver-dominant colorectal metastases who have failed or are intolerant of
chemotherapy."

                               About the Study

The study compared the overall survival of 58 patients with colorectal cancer
metastases that were either limited to or predominately affected the liver,
who were refractory to all recommended chemotherapy or had refused further
chemotherapy, and were unsuitable for other treatment options such as surgical
resection, local ablation or other forms of radiotherapy.  Twenty-nine
patients received radioembolization using SIR-Spheres ( ^90 Y-labeled resin
microspheres; Sirtex Medical Limited, Sydney, Australia) and were followed
prospectively.  These patients were matched retrospectively for prior
treatments and tumour burden with a contemporary cohort of >500 patients who
received BSC from 3 centres in Germany to identify 29 consecutive patients
with at least 2 of 4 specific matching criteria (the presence of synchronous
or metachronous metastases, tumour burden, increased alkaline phosphatase,
and/or carcinoembryonic antigen [CEA] >200 U/mL).  The primary endpoint of the
study was overall survival.

Following radioembolization, 12 patients (41.4%) had a partial response and a
further 5 (17.2%) had stable disease, giving a disease control rate of 58.6%.
 The progression-free survival was 5.5 months in the radioembolization cohort
compared to 2.1 months in those receiving BSC.  The adverse events following
radioembolization were generally mild-to-moderate in nature, predominately
transient, self-limiting and manageable.

"The results of this study are consistent with those from similar cohorts of
chemotherapy-refractory patients with colorectal liver metastases treated
using radioembolization," said Dr Ricarda Seidensticker, consultant
interventional radiologist and lead author of the study.  "This was the first
comparative study of radioembolization to use overall survival as the primary
endpoint, in an ethical design that avoided the crossover of patients to
active therapy, which usually blunts the ability of trials to show a
difference in survival.  These results also compare favourably with recent
studies using new biological agents to treat metastatic colorectal cancer.  In
one randomized controlled trial of cetuximab, for example, the median overall
survival was 6.1 months versus 4.6 months with best supportive care. In a
similar trial with panitumumab, median overall survival was 6.4 months versus
similar survival with best supportive care followed by crossover to
panitumumab at progression."  

Large international randomised controlled trials are currently evaluating the
effectiveness of radioembolization using SIR-Spheres combined with first-line
chemotherapy in the treatment of patients with colorectal cancer liver
metastases compared to chemotherapy alone in order to assess whether this
treatment should be used as an early intervention.

                           About Colorectal Cancer

In 2008, 153,000 people in the United States of Americans and 333,000 in the
European Union were diagnosed with colorectal cancer. ^[ ^2 ^]  Around half of
these patients will develop metastases that have spread from the original site
of the disease, predominately to the liver.  Up to 90% of these patients
ultimately die from liver failure due to the spread of the disease.
 Radioembolization (also called Selective Internal Radiation Therapy or SIRT)
is a novel approach to treating liver tumours using microspheres labelled with
radioactive yttrium-90 ( ^90 Y).  The microspheres are implanted by
interventional radiologists to selectively target the tumours with radiation
while sparing the remaining healthy liver tissue.

The 3 centres involved in the study (and the numbers of control patients
screened) were:

  * University Hospital of Magdeburg, Germany / Universitätsklinikum Magdeburg
    (n = 348);
  * Charité Campus, University Hospital of Berlin, Germany /
    Universitätsmedizin Berlin (n = 120);
  * Magdeburg Hospital, Germany / Klinikum Magdeburg (n = 86).

SIR-Spheres are approved for use in Australia, the European Union (CE Mark),
New Zealand, Switzerland, Turkey and several other countries for the treatment
of unresectable liver tumours.  

SIR-Spheres are also fully FDA-approved and are indicated in the U.S. for the
treatment of non-resectable metastatic liver tumours from primary colorectal
cancer in combination with intra-hepatic artery chemotherapy using
floxuridine.

References:

 1. Seidensticker R, Denecke T, Kraus P et al.  Matched-pair comparison of
    radioembolization plus best supportive care versus best supportive care
    alone for chemotherapy refractory liver-dominant colorectal metastases.
    Cardiovascular and Interventional Radiology 2012; 35 (5): 1066-1073.
 2. International Agency for Research on Cancer.  GLOBOCAN 2008: Colorectal
    Cancer Incidence and Mortality Worldwide in 2008.
    http://globocan.iarc.fr/factsheets/cancers/colorectal.asp accessed
    12/8/2011.

Contact: For Further Information: Contact: Martina Dörmann, Ipse
Communication, Berlin, Germany, +49(0)171-7719176 ; Andrea Moody, Fleishman
Hillard, Raleigh NC, USA, +1-919-457-0743
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