Rituximab maintenance therapy dramatically improves survival for patients with lymphoma

Feb 14 2006

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.

http://www.eortc.be