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PRESS RELEASE - EMBARGO UNTIL 10 MARCH 2005
Breakthrough in medical research: New chemotherapy gives
hope to brain tumour patients. A clear improvement in survival
demonstrated for glioblastoma
Two papers published in tandem in the
New England Journal of Medicine
A large international study conducted by the European Organisation for Research and Treatment
of Cancer (EORTC) in collaboration with the National Cancer Institute of Canada(NCIC) Clinical
Trials Group demonstrated that the addition of a novel chemotherapy agent, Temozolomide
(brand name: Temodal®) to radiation therapy increases survival in patients suffering from
glioblastoma, a very aggressive form of a brain tumour. Further, molecular analyses of the tumour
allowed for the identification of those patients most likely to benefit from this type of treatment.
The findings are leading to a new standard of care for patients with this fast growing and
devastating cancer. The results of this landmark trial are published in two companion papers in
this weeks’ edition of the New England Journal of Medicine (publication date: 10 March 2005).
Primary tumours originating in the brain account for less than 5% of all cancer diagnoses.
However, brain cancer frequently affects previously healthy younger men and women in the
middle of their most active life. Glioblastoma is the most common type of primary malignant brain
tumour in adults with a yearly incidence of 5-7 persons per 100.000. Thus in the European Union
approx. 20’000 new patients are diagnosed every year. Glioblastoma is a rapidly growing
malignant brain tumour and usually has a fatal outcome.
Prior to the discovery of this new therapy, the average life expectancy of patients with
glioblastoma was about 1 year. The results of this study demonstrate a clear improvement of
survival. At 2 years only 10% of patients treated with radiotherapy alone were alive, compared to
26% of patients receiving the combination of both radiotherapy and temozolomide chemotherapy.
If patients were to be selected according to their molecular profile - the investigators analysed the
functionality of a gene responsible for DNA repair, the so called MGMT gene - the improvement is
even more dramatic, as almost half of those patients whose tumours carry an inactivated MGMT
gene are alive after 2 years. Importantly, the study also showed that this new combined therapy
did not impact negatively on the patients’ quality of life. Health-related quality of life has become
an increasingly important endpoint in cancer studies.
In this trial, almost 600 patients were randomised within less than one and a half years. This rapid
accrual and final success would not have been possible without well-established structures for
academic clinical research, like the EORTC and NCIC Clinical Trials Group. Recently
implemented new regulations in Europe with an increased administrative burden, complex liability
and insurance issues as well as exploding costs have become a threat for future successful
conduct of clinical trials. This example illustrates that progress in cancer treatment requires wellfunctioning international collaborative networks and integrated laboratory-based science.
Registered Office: EORTC, avenue E. Mounier 83 B.11 – 1200 Brussels - Belgium
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The EORTC also assembled a laboratory research team that succeeded in identifying a molecular
change in the tumour that predicts benefit from this new therapy. Future brain tumour trials by the
EORTC will continue to integrate clinical and basic research to further refine the molecular basis
of brain cancer, find new therapeutic targets, and develop and test new treatments.
The lead investigators comment:
“This is the first trial to demonstrate that we can truly impact this devastating disease with
chemotherapy. This is only a first step toward cure of brain cancer patients and should now fuel
interest, continued international collaboration and research to further improve the outcome of
these patients”, says the lead author and trial initiator Roger Stupp, MD for the University Hospital
Multidisciplinary Oncology Centre in Lausanne, Switzerland.
“Without the close collaboration between the hospital based research laboratory and the leading
clinicians, this interdisciplinary success would never have been possible. I hope this example will
stimulate a closer collaboration between basic and clinical research in the future”, remarks Monika
Hegi, PhD signing author for the translation research work and leader of the laboratory of Tumor
Biology and Genetics of the University Hospital Lausanne Neurosurgery department and project
leader at the National Center of Competence in Research (NCCR Molecular Oncology).
"In 25 years of academic cancer medicine, it is the first time that I have witnessed such a
progress in any of the deadliest forms of human cancers. The study has also been an exceptional
model of multidisciplinary as well as international cooperation, with such an outstanding input of
so many participants" said co-investigator and radiation therapy protocol leader, René-Olivier
Mirimanoff MD, at the Radiation Oncology Department of the University Hospital in Lausanne,
Switzerland.
“Until now, there have been few treatment options for glioblastoma patients,” says Dr. Gregory
Cairncross, a pioneer in neuro-oncology research and one of the study’s primary investigators
and head of the Department of Clinical Neurosciences at the University of Calgary in Alberta,
Canada. “The results of this trial will dramatically improve treatment and outcome for many of
these patients and will open the door to further trials to expand this treatment combination. The
key to the new therapy’s effectiveness is that temozolomide causes very few side effects and is
well tolerated by patients. This means patients can take the drug every day during their radiation
treatment instead of once every eight weeks – the common dosage for other chemotherapy
drugs”
“This landmark study represents the most important advance in the management of glioblastoma
since radiotherapy was shown to be of benefit over 35 years ago”, comments Dr. Warren Mason,
a lead investigators in Canada and head of the neuro-oncology unit at the Princess Margaret
Hospital in Toronto, Ontario/Canada. “This study also identified MGMT the first clinically relevant
molecular marker for glioblastoma which not only serves as a prognostic factor for survival, but
also as a predictor for response to chemotherapy. This observation paves the way for using the
unique tumor genetic signature as a guide for individualizing therapy and optimizing outcome.”
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Contacts for further information, see next page:
Registered Office: EORTC, avenue E. Mounier 83 B.11 – 1200 Brussels - Belgium
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For media information:
Mathilde Fenoulhet
EORTC Cancer Communications Office
Brussels, Belgium
Phone: +32 2 774 16 51
Fax: +32 2 772 62 33
Email: [email protected]
Carmen Kinniburgh
Canadian Cancer Society
Phone: 416-934-5684
[email protected]
Tommy Lyssy
KLK Healthcare
Basel, Switzerland
Phone +41-61-338-92 00
Fax. +41 61 338 92 10
Mobile:+41 79 320 90 02
Email: [email protected]
Karen Thomas
University of Calgary Faculty of Medicine
Phone: 403-220-2431
[email protected] or
[email protected]
Roger Stupp, MD
Multidisciplinary Oncology Center
University Hospital (CHUV)
46, Rue du Bugnon
1011 Lausanne / Switzerland
Monika E. Hegi, PhD
Laboratory of Tumor Biology and Genetics
University Hospital (CHUV)
46, Rue du Bugnon
1011 Lausanne / Switzerland
Phone:+41-21-314-0156
Fax. +41-21-314-0737
Mobile:+41-79-330-6688
email: [email protected]
Phone: +41-21-314-2582
fax.
+41-21-314-4138
email: [email protected]
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About the EORTC:
Created in 1962, the European Organisation for Research and Treatment of Cancer (EORTC) is a
private not for profit international cancer research organisation under the Belgian Law.
EORTC has the mission to develop, conduct, coordinate and stimulate laboratory and clinical
research in Europe to improve the management of cancer and related problems by increasing
survival but also patients’ quality of life. The ultimate goal of the EORTC is to improve the
standard of cancer treatment in Europe, through the development of new drugs and other
innovative approaches, and to test more effective therapeutic strategies, using drugs which are
already commercially available, or surgery or radiotherapy. EORTC has the aim to facilitate the
passage of experimental discoveries into state-of-the-art treatment by keeping to a minimum the
time lapse between the discovery of new anti-cancer agents and the implementation of their
therapeutic benefit for patients with cancer.
EORTC promotes multidisciplinary cancer research in Europe and is linked to other leading
biomedical research organisations around the world. EORTC research takes place in over 300
hospitals, universities and cancer centers in 32 countries and the unique network of investigators
of EORTC comprises more than 2000 clinicians collaborating on a voluntary basis in over 20
multidisciplinary groups.
For any further information related to the research activities of the EORTC, please consult the
website www.eortc.be
Registered Office: EORTC, avenue E. Mounier 83 B.11 – 1200 Brussels - Belgium
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