Navigation Links
Phase III Randomised Controlled Trial Confirms Clinical Efficacy and Safety of Radioembolisation Using 90Y-resin Microspheres for Patients With Inoperable Colorectal Cancer Liver Metastases That Have Failed Chemotherapy

Phase III Randomised Controlled Trial Confirms Clinical Efficacy and Safety of Radioembolisation Using... -- BRUSSELS, August 19, 2010 /PRNewswire/ --

Advanced Search Search

  1. Send a release
  2. Member sign in
  3. Become a member
  4. For journalists
  5. Global sites
PR Newswire: news distribution, targeting and monitoring
  1. Products & Services
  2. Knowledge Center
  3. Browse News Releases
  4. Contact PR Newswire
Publishing & Information Services, Biotechnology, Health Care & Hospitals, Medical Pharmaceuticals, Clinical Trials & Medical Discoveries Click to view news release full screen  

Phase III Randomised Controlled Trial Confirms Clinical Efficacy and Safety of Radioembolisation Using 90Y-resin Microspheres for Patients With Inoperable Colorectal Cancer Liver Metastases That Have Failed Chemotherapy


BRUSSELS, August 19, 2010 /PRNewswire/ -- Using the innovative technique of radioembolisation to treat patients with inoperable colorectal cancer liver metastases who have failed all standard-of-care chemotherapy options can more than double the time until their disease progresses, according to the final results of a Phase III randomised controlled trial published in the prestigious Journal of Clinical Oncology.(1)

The prospective, randomised trial compared a protracted infusion of 5-fluorouracil (5FU) chemotherapy to the same chemotherapy in combination with radioembolisation, also known as selective internal radiation therapy (SIRT), using 90Y-resin microspheres (SIR-Spheres; Sirtex Medical, Sydney, Australia). The trial was designed to assess the efficacy and safety of this combination in patients with liver metastases from colorectal cancer and was conducted at three Belgian university hospitals.(2)

The trial recruited 46 patients who had failed all other standard-of-care treatments. The time to the progression of liver metastases - the primary endpoint of the study - increased significantly from a median of 2.1 months in patients receiving 5FU alone to 5.5 months in patients receiving radioembolisation plus 5FU. The risk of progression was 62% lower in patients receiving radioembolisation plus 5FU (hazard ratio 0.38; p=0.003). The time to progression of disease anywhere in the body was also significantly longer, from a median of 2.1 months in the 5FU control arm to 4.5 months in patients in the radioembolisation/5FU arm (hazard ratio 0.51; p=0.03). Control of liver metastases was also significantly increased in patients receiving radioembolisation plus 5FU, from 35% to 85% (p=0.001). More patients in the 5FU-only control arm experienced severe side effects than those receiving radioembolisation plus 5FU (26% versus 5%; p=0.10).

The ability to show a difference in the overall survival of patients was blunted by the ethical design of the study, since patients receiving 5FU alone were reassessed once their cancer progressed, and, if possible, were treated with radioembolisation alone. Ten patients in the control arm later received radioembolisation and 6 received further chemotherapy, as did 9 patients in the radioembolisation plus 5FU group. Median overall survival was 7.3 months in the patients receiving 5FU alone, compared to 10.0 months in patients receiving radioembolisation plus 5FU, a difference that was not statistically significant.

"The combination of radioembolisation using 90Y-resin microspheres and 5FU chemotherapy was well tolerated and significantly improves the outcomes for patients compared with 5FU alone," said Dr Alain Hendlisz, chief of the gastroenterology unit at Institut Jules Bordet in Brussels, Belgium, and lead investigator of the trial. "The results of this randomised controlled trial provide Level 1 evidence that radioembolisation with 90Y-resin microspheres is a valid therapeutic option for patients with colorectal cancer liver metastases that have failed chemotherapy."

Large international randomised controlled trials are currently evaluating the effectiveness of radioembolisation using 90Y-resin microspheres with first-line chemotherapy in the treatment of patients with colorectal cancer liver metastases compared to chemotherapy alone in order to assess whether the combination should be used as an early intervention for liver tumours.

References and notes

1. Hendlisz A, Van den Eynde M, Peeters M 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. Journal of Clinical Oncology 2010; 28: 3687-3694.

2. The clinical trial was conducted at the following hospitals: - Institut Jules Bordet, Brussels, Belgium - Universitair Ziekenhuis Gent, Gent, Belgium - University Hospital Gasthuisberg, Leuven, Belgium

Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. Xenon Pharmaceuticals Initiates a Phase 2 Clinical Trial in Post Herpetic Neuralgia (PHN) for Topical XEN402.
2. YM BioSciences announces conclusion of Phase I dose-escalation and expansion of ongoing CYT387 Phase I/II clinical study
3. Aeterna Zentaris Announces NIH Grant for a Phase 1/2 Study in Advanced Prostate Cancer with AEZS-108
4. New England Journal of Medicine Publishes Data from Pivotal Phase 3 PROVENGE IMPACT Study
5. Angiotech Pharmaceuticals and partner Athersys announce positive results from phase I study of MultiStem(R) in heart attack patients
6. Aegera Therapeutics Reports Survival Data from the Phase 1 Portion of its Phase 1-2 Study of AEG35156 in Combination with Sorafenib in Patients with Advanced Hepatocellular Carcinoma
7. Fulton Project Advances to Phase 2 of Loan Guarantee Process
8. OncoGenex Pharmaceuticals Announces Initiation of a Phase 3 Trial in Men with Metastatic Prostate Cancer
9. ChemoCentryx Reports Positive Phase I Study Results for CCX354 at the Annual European Congress of Rheumatology (EULAR)
10. PRA International Opens Phase I Unit in Budapest
11. Pieris Initiates Phase I Clinical Trial for Lead Anticalin Compound
Post Your Comments:
(Date:11/24/2015)... , Nov. 24, 2015 /CNW/ - iCo Therapeutics ("iCo" ... reported financial results for the quarter ended September ... in Canadian dollars and presented under International Financial ... States ," said Andrew Rae , ... regarding iCo-008 are not only value enriching for ...
(Date:11/24/2015)... ... November 24, 2015 , ... International Society ... one of the premier annual events for pharmaceutical manufacturing: 2015 Annual Meeting. The ... where ISPE hosted the largest number of attendees in more than a decade. ...
(Date:11/24/2015)... N.C. , Nov. 24, 2015  Clintrax Global, Inc., a ... North Carolina , today announced that the company has set ... represented a 391% quarter on quarter growth posted for Q3 of ... and Mexico , with the establishment ... in December 2015. --> United Kingdom ...
(Date:11/24/2015)... ... 24, 2015 , ... This fall, global software solutions leader SAP and AdVenture ... develop and pitch their BIG ideas to improve health and wellness in their schools. ... to win the title of SAP's Teen Innovator, an all-expenses paid trip to Super ...
Breaking Biology Technology:
(Date:10/29/2015)... 29, 2015 Today, LifeBEAM , ... with 2XU, a global leader in technical performance ... hat with advanced bio-sensing technology. The hat will ... monitor key biometrics to improve overall training performance. ... two companies will bring together the most advanced technology, ...
(Date:10/26/2015)... India , October 26, 2015 ... --> adds ... 2015 to 2021 as well as ... 2015-2019 research reports to its collection ... . --> ...
(Date:10/23/2015)... , October 23, 2015 ... announce a mobile plug and play integration of physiological ... tasks SensoMotoric Instruments (SMI) present a ... solutions for eye tracking and physiological data registration. It ... SMI Eye Tracking Glasses 2w and physiological signals ...
Breaking Biology News(10 mins):