The combination of a cholesterol-lowering drug and a contraceptive drug has been shown in its first UK clinical trial to be potentially safer and more effective treatment for certain leukaemia patients than conventional chemotherapy.
Researchers from the University of Birmingham treated 20 acute myeloid leukaemia (AML) patients with the cholesterol-lowering drug Bezafibrate (BEZ) and the female contraceptive drug Medroxyprogesterone Acetate (MPA). These patients were all too frail to undergo the debilitating chemotherapy that is usually used to treat the cancer - a problem that affects over half of all patients with AML.
The study, which will be published online in the British Journal of Haematology on Wednesday 13 January, showed that patients treated with the drugs had none of the side effects of chemotherapy and that survival was improved by several months. The patients, who all had a poor prognosis and would have only been expected to live for less than two months on average without treatment, survived for an average of five months when treated with BEZ and MPA.
The scientists, who were funded by the blood cancer charity Leukaemia Research, have established that when BEZ and MPA are given together they are able to destroy AML cells because they block a key enzyme within the leukaemia cells. The enzyme is critical for the survival and growth of AML cells, but blocking its action causes the cells to self-destruct.
Dr Chris Bunce at the University of Birmingham, who has developed the therapy and led the research, said: “Normal chemotherapy can be fatal for frail patients because it attacks healthy blood cells as well as the leukaemia cells. This new treatment for AML is very exciting because it only targets the leukaemia cells. It has no significant toxicities, which means that in future trials we can use higher doses of the drugs that our laboratory based studies suggest will generate even more promising survival rates for patients.”
Dr David Grant, Scientific Director at Leukaemia Research, said: “Patients who are elderly or have relapsed after their leukaemia treatment are often not fit enough to tolerate rounds of gruelling chemotherapy and survival rates are low for this group. The very intriguing success of these two non-cancer drugs in increasing survival rates offers real hope for these AML patients.”
The patients on the trial were treated at Birmingham’s Queen Elizabeth Hospital and hospitals across the West Midlands and Glasgow. Leukaemia Research currently has £8,500,000 invested in blood cancer research in Birmingham.
ENDS
For further information, please contact
Ben Hill, Press Officer, University of Birmingham, Tel: 0121 4145134
Mob: 07789 921 163, email: b.r.hill@bham.ac.uk
Notes for Editors:
1. The study will be published on online on 13 January 2009 in the British Journal of Haematology under the title: ‘Combined Bezafibrate and Medroxyprogesterone Acetate have Efficacy without Haematological Toxicity in Elderly and Relapsed Acute Myeloid Leukaemia (AML’). Corresponding author: Dr Chris Bunce, Birmingham University.
2. 20 patients (19 AML, 1 high risk myelodysplasia) on the clinical trial were treated with BEZ and MPA for whom intensive chemotherapy was not an option. No patient exhibited haematological toxicity from the treatment. Eleven patients took BEZ and MPA alone for over four weeks. One reverted from high-risk myelodysplasia and remains transfusion independent after 201 weeks of therapy. Three AML patients gained major haematological improvements for 22-30 weeks; in one, marrow was available to document a partial AML response. Thus, this trial indicates that BEZ and MPA therapy has potential for treatment of elderly and relapsed AML.
3.Acute myeloid leukaemia (AML) is diagnosed in 2,000 people in the UK every year. It is characterised by the uncontrolled proliferation, abnormal survival and maturation arrest of malignant blood cells. The concurrent loss of normal blood cell production creates life-threatening deficits of blood cells that are managed by supportive care, involving blood and platelet transfusion. Current anti-AML therapies are based on chemotherapy, which further damages blood producing stem cells and therefore the production of healthy cells. Five-year survival rates for patients under 60 years of age remain around 30%. Survival in patients over 60, who account for three quarters of AML patients, is worse. This is largely because older patients cannot tolerate intensive chemotherapy and its associated damage to normal blood cell production. Little improvement has been made in this group in the last two decades.
4.Leukaemia Research is the only national charity devoted exclusively to improving treatments, finding cures and learning how to prevent leukaemia, Hodgkin's and other lymphomas, myeloma and the related blood disorders, diagnosed in 24,500 people in the UK every year.
Over the next five years, Leukaemia Research urgently needs to raise over £100million to commit to new research. From basic laboratory research to clinical trials with patients, Leukaemia Research is committed to saving lives by funding high quality, carefully selected research throughout the UK. Further information, including patient information booklets, is available from www.lrf.org.uk or on 020 7405 0101.
5. The University of Birmingham
The University of Birmingham is a truly vibrant, global community and an internationally-renowned institution. Its work brings people from across the world to Birmingham, including researchers and teachers and more than four thousand international students from nearly 150 different countries.
The University is home to nearly 30,000 students. With more than 7,500 postgraduate students from across the world, Birmingham is one of the most popular universities for postgraduate study in the UK.
The University has a global reputation and is ranked 66th in the world in the latest Times Higher Education–QS World University Rankings.
The University is the eighth largest employer in the Birmingham/Solihull sub-region and plays an integral role in the economic, social and cultural growth of local and regional communities; working closely with businesses and organisations, employing approximately 6,000 staff and providing 10,000 graduates annually.
The University contributes £662 million to the City of Birmingham and £779 million to the West Midlands region, with an annual income of more than £388.6 million.
