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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

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