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

nachricht Reusable carbon nanotubes could be the water filter of the future, says RIT study
30.03.2017 | Rochester Institute of Technology

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: Making lightweight construction suitable for series production

More and more automobile companies are focusing on body parts made of carbon fiber reinforced plastics (CFRP). However, manufacturing and repair costs must be further reduced in order to make CFRP more economical in use. Together with the Volkswagen AG and five other partners in the project HolQueSt 3D, the Laser Zentrum Hannover e.V. (LZH) has developed laser processes for the automatic trimming, drilling and repair of three-dimensional components.

Automated manufacturing processes are the basis for ultimately establishing the series production of CFRP components. In the project HolQueSt 3D, the LZH has...

Im Focus: Wonder material? Novel nanotube structure strengthens thin films for flexible electronics

Reflecting the structure of composites found in nature and the ancient world, researchers at the University of Illinois at Urbana-Champaign have synthesized thin carbon nanotube (CNT) textiles that exhibit both high electrical conductivity and a level of toughness that is about fifty times higher than copper films, currently used in electronics.

"The structural robustness of thin metal films has significant importance for the reliable operation of smart skin and flexible electronics including...

Im Focus: Deep inside Galaxy M87

The nearby, giant radio galaxy M87 hosts a supermassive black hole (BH) and is well-known for its bright jet dominating the spectrum over ten orders of magnitude in frequency. Due to its proximity, jet prominence, and the large black hole mass, M87 is the best laboratory for investigating the formation, acceleration, and collimation of relativistic jets. A research team led by Silke Britzen from the Max Planck Institute for Radio Astronomy in Bonn, Germany, has found strong indication for turbulent processes connecting the accretion disk and the jet of that galaxy providing insights into the longstanding problem of the origin of astrophysical jets.

Supermassive black holes form some of the most enigmatic phenomena in astrophysics. Their enormous energy output is supposed to be generated by the...

Im Focus: A Quantum Low Pass for Photons

Physicists in Garching observe novel quantum effect that limits the number of emitted photons.

The probability to find a certain number of photons inside a laser pulse usually corresponds to a classical distribution of independent events, the so-called...

Im Focus: Microprocessors based on a layer of just three atoms

Microprocessors based on atomically thin materials hold the promise of the evolution of traditional processors as well as new applications in the field of flexible electronics. Now, a TU Wien research team led by Thomas Müller has made a breakthrough in this field as part of an ongoing research project.

Two-dimensional materials, or 2D materials for short, are extremely versatile, although – or often more precisely because – they are made up of just one or a...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

Fighting drug resistant tuberculosis – InfectoGnostics meets MYCO-NET² partners in Peru

28.04.2017 | Event News

Expert meeting “Health Business Connect” will connect international medical technology companies

20.04.2017 | Event News

Wenn der Computer das Gehirn austrickst

18.04.2017 | Event News

 
Latest News

Wireless power can drive tiny electronic devices in the GI tract

28.04.2017 | Medical Engineering

Ice cave in Transylvania yields window into region's past

28.04.2017 | Earth Sciences

Nose2Brain – Better Therapy for Multiple Sclerosis

28.04.2017 | Life Sciences

VideoLinks
B2B-VideoLinks
More VideoLinks >>>