Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Rituximab maintenance therapy dramatically improves survival for patients with lymphoma

15.02.2006


EORTC 20981 trial demonstrates: Risk of death can be halved



Two years of maintenance therapy with rituximab dramatically improves the chances of survival for patients suffering from one of the most frequent forms of lymphoma, indolent non-Hodgkin’s Lymphoma (NHL). The EORTC 20981 trial reveals that rituxibam maintenance treatment prologns progression free survival by about 2,5 years, irrespective of initial treatment. Moreover, the risk of death is halved for patients who receive rituximab maintenance therapy, compared to those who receive no maintenance treatment. The outcome of the clinical trial was presented at the 47th annual meeting of the American Society of Hematology in Atlanta, USA, late last year. The final report of the trial is about to be published shortly.

Professor Marinus van Oers M.D. from the Academic Medical Center of the University of Amsterdam, lead investigator of the EORTC pivotal study together with her colleague Professor Anton Hagenbeek, said: “Our trial confirms that rituximab maintenance therapy is highly beneficial for all patients, including those who have already received rituximab as part of their initial therapy. We have not seen such an impressive improvement in progression free and overall survival for indolent NHL in the last 30 years. Maintenance therapy with rituximab may well become the new standard of care for these patients.”


“We are conscious that these results open a new era in the management of indolent NHL“, comments William M. Burns, CEO of the Pharmaceuticals Division at Roche. Based on the findings of the EORTC 20981 trial, Roche has filed with the European authorities for a label extension for rituximab (Mabthera) maintenance therapy for patients suffering from indolent lymphoma. In Western Europe alone, 20,000 people are newly diagnosed with indolent NHL every year, and around 40,000 are being treated for this disease.

”Besides being a scientific breakthrough, this exemplifies nicely the extent to which the pharmaceutical sector also depends on academic clinical research. One of the aims of EORTC is to bring about innovation in the clinical practice by exploring how drugs already on the market may be used more effectively. The patients, the scientific community and the pharmaceutical industry clearly benefit from our findings: If we hadn’t initiated the trial on this ‘academic question’ about rituximab in the first place, no label extension would have been filed”, concludes Patrick Therasse, Director of the EORTC Data Center.

“Which is why policymakers and health care providers committed to promote innovation in clinical practice in Europe should keep this interdependence in mind and promote multi-centre academic clinical research – both by providing appropriate funding and by ensuring that the legal frameworks are conducive to transnational academic clinical trials.” adds Francoise Meunier, Director General of the EORTC.

About the study

In the EORTC 20981 trial, 465 patients with relapsed and refractory indolent NHL were randomised to receive either 3-weekly cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy or rituximab plus CHOP as induction therapy. Responding patients were then again randomised to either rituximab maintenance, or observation (no further treatment).

Rituximab maintenance therapy was applied as a single infusion of 375mg/m2 every three months over a period of two years. The primary endpoints were response rates and progression-free survival for the initial treatment phase and the maintenance phase of the study, respectively. The trial was performed in 130 centres in Canada, Australia, Netherlands, UK, Norway, Slovenia, Slovakia, Belgium, Hungary, South Africa, Sweden, New Zealand, Denmark, Egypt, France, Switzerland, Italy and Poland.

Results of the induction phase

The results of the induction phase of the trial showed that patients who received rituximab and CHOP (R-CHOP) had a significantly higher rate of complete remission than patients who received CHOP chemotherapy alone (29% vs 16%, p value <0.0001). Furthermore, rituximab and CHOP chemotherapy significantly increased progression free survival compared to CHOP chemotherapy alone (median progression-free survival of 33 months vs 20 months, p value 0.0003).

Results of the maintenance phase

Overall survival (% of patients alive at 3 years)
No maintenance Maintenance p value Risk reduction1
All patients 77% 85% 0.011 48%
CHOP subgroup 71% 82% 0.073 48%
R-CHOP subgroup 81% 88% 0.059 50%
1 Treatment effect of maintenance therapy – reduction in the risk of death

Median progression-free survival

No maintenance Maintenance p value Risk reduction2
All patients 15 months 52 months <0.0001 60%
CHOP subgroup 12 months 42 months <0.0001 70%
R-CHOP subgroup 23 months 52 months 0.0043 46%
2 Treatment effect of maintenance therapy – reduction in the risk of progression of the disease, relapse or death

About Non-Hodgkin’s Lymphoma

Non-Hodgkin’s lymphoma (NHL) affects 1.5 million people worldwide. Indolent NHL, representing about 45% of NHL patients, is a slow developing but serious cancer of the lymphatic system. It is currently considered incurable. NHL is one of the fastest growing cancers and has grown in incidence by 80% since the early 1970s.

About Rituximab

Rituximab is a therapeutic antibody that binds to a particular protein - the CD20 antigen - on the surface of normal and malignant B-cells. It then recruits the body’s natural defences to attack and kill the marked B-cells. Stem cells (B-cell progenitors) in bone marrow lack the CD20 antigen, allowing healthy B-cells to regenerate after treatment and return to normal levels within several months.

Rituximab is indicated for the treatment of indolent and aggressive Non-Hodgkin’s Lymphoma. It is known as MabThera in Europe and as Rituxan in the United States, Japan and Canada.

Nicole Heine | alfa
Further information:
http://www.eortc.be/Services/doc/web_release_rituximab_14_02_2006.htm

More articles from Studies and Analyses:

nachricht Drone vs. truck deliveries: Which create less carbon pollution?
31.05.2017 | University of Washington

nachricht New study: How does Europe become a leading player for software and IT services?
03.04.2017 | Fraunhofer-Institut für System- und Innovationsforschung (ISI)

All articles from Studies and Analyses >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Can we see monkeys from space? Emerging technologies to map biodiversity

An international team of scientists has proposed a new multi-disciplinary approach in which an array of new technologies will allow us to map biodiversity and the risks that wildlife is facing at the scale of whole landscapes. The findings are published in Nature Ecology and Evolution. This international research is led by the Kunming Institute of Zoology from China, University of East Anglia, University of Leicester and the Leibniz Institute for Zoo and Wildlife Research.

Using a combination of satellite and ground data, the team proposes that it is now possible to map biodiversity with an accuracy that has not been previously...

Im Focus: Climate satellite: Tracking methane with robust laser technology

Heatwaves in the Arctic, longer periods of vegetation in Europe, severe floods in West Africa – starting in 2021, scientists want to explore the emissions of the greenhouse gas methane with the German-French satellite MERLIN. This is made possible by a new robust laser system of the Fraunhofer Institute for Laser Technology ILT in Aachen, which achieves unprecedented measurement accuracy.

Methane is primarily the result of the decomposition of organic matter. The gas has a 25 times greater warming potential than carbon dioxide, but is not as...

Im Focus: How protons move through a fuel cell

Hydrogen is regarded as the energy source of the future: It is produced with solar power and can be used to generate heat and electricity in fuel cells. Empa researchers have now succeeded in decoding the movement of hydrogen ions in crystals – a key step towards more efficient energy conversion in the hydrogen industry of tomorrow.

As charge carriers, electrons and ions play the leading role in electrochemical energy storage devices and converters such as batteries and fuel cells. Proton...

Im Focus: A unique data centre for cosmological simulations

Scientists from the Excellence Cluster Universe at the Ludwig-Maximilians-Universität Munich have establised "Cosmowebportal", a unique data centre for cosmological simulations located at the Leibniz Supercomputing Centre (LRZ) of the Bavarian Academy of Sciences. The complete results of a series of large hydrodynamical cosmological simulations are available, with data volumes typically exceeding several hundred terabytes. Scientists worldwide can interactively explore these complex simulations via a web interface and directly access the results.

With current telescopes, scientists can observe our Universe’s galaxies and galaxy clusters and their distribution along an invisible cosmic web. From the...

Im Focus: Scientists develop molecular thermometer for contactless measurement using infrared light

Temperature measurements possible even on the smallest scale / Molecular ruby for use in material sciences, biology, and medicine

Chemists at Johannes Gutenberg University Mainz (JGU) in cooperation with researchers of the German Federal Institute for Materials Research and Testing (BAM)...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

Plants are networkers

19.06.2017 | Event News

Digital Survival Training for Executives

13.06.2017 | Event News

Global Learning Council Summit 2017

13.06.2017 | Event News

 
Latest News

Touch Displays WAY-AX and WAY-DX by WayCon

27.06.2017 | Power and Electrical Engineering

Drones that drive

27.06.2017 | Information Technology

Ultra-compact phase modulators based on graphene plasmons

27.06.2017 | Physics and Astronomy

VideoLinks
B2B-VideoLinks
More VideoLinks >>>