Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Exemestane beats tamoxifen in first phase III head to head trial in advanced breast cancer

18.03.2004


The first results from the world’s only phase III trial to compare tamoxifen with the newer hormone treatment exemestane in advanced breast cancer shows that exemestane is safe, superior and lengthens progression-free survival.



The median progression-free survival for patients taking exemestane was 10.9 months compared with 6.7 months for those taking tamoxifen. Complete and partial response rates were also higher in the exemestane arm with 7.4% responding completely and 36.8% partially, compared to 2.6% of tamoxifen patients completely responding and 26.6% partially responding.

Dr Robert Paridaens will tell delegates at the 4th European Breast Cancer Conference today (Thursday 18 March) that the drug would be a good choice for first line treatment in hormone responsive metastatic breast cancer and that its safety profile meant it was also an attractive proposition for use as an adjuvant drug or to prevent breast cancer in high risk women. In Europe, it is currently licensed for use only in metastatic breast cancer that has recurred after, or during, tamoxifen treatment.


The majority of breast cancers in postmenopausal women rely on female hormones to grow. Exemestane is a steroidal aromatase inhibitor (SAI); it permanently inactivates aromatase, the enzyme that converts androgens into oestrogens in postmenopausal women. So, the effect of the drug is to deprive breast cancer cells of oestrogen.

Dr Paridaens, a medical oncologist at the University Hospital Gasthuisberg in Leuven, Belgium, said the trial was initiated as a phase II with the possibility of extending to phase III if results were promising. Phase III has involved 382 patients from 81 centres in 25 countries. It was an ’open label’ study i.e. both doctors and patient knew which drug was being administered after patients were randomised to the tamoxifen or exemestane arm. The primary objective was to identify whether exemestane would produce an increase of three months progression-free survival over tamoxifen. It also aimed to establish the safety of the drug.

Said Dr Paridaens: "The main endpoint of treatment in advanced disease is control of symptoms – in other words, progression free survival with the fewest possible side effects as qualify of life in incurable disease is essential. Aromatase inhibitors do induce hot flushes and menopausal symptoms like tamoxifen does and they may elicit more muscular and joint aches. But they produce less thromboembolic (clotting) events than tamoxifen and unlike tamoxifen they avoid a risk of endometrial cancer."

One interesting finding in the study, according to Dr Paridaens, was that there was no adverse effect on patients’ lipid profiles, contrary to what has been seen in studies of non-steroidal aromatase inhibitors (NSAIs). "We don’t know yet whether that will translate in the long term into greater cardiovascular safety or not, or whether it would be an indication for use in women with dyslipidemia (abnormal lipid measurements). That remains to be demonstrated in clinical studies."

He said there were many questions still to be answered in future trials – for example, can steroidal and non-steroidal aromatase inhibitors (AIs) safely be combined with chemotherapy; what effect does exemestane have on the bones, and can resistance to treatment be delayed by use of other drugs such as HER pathway blockers? Numerous trials were underway looking at AIs as adjuvant treatment. It was possible that sequential treatments with anti-oestrogens and AIs will turn out to be the best solution, but if so, in which sequence and for how long would also have to be determined. "A door that has been opened shows numerous other doors to be explored," he said.

He concluded: "Accrual to our trial was slow because the inclusion criteria were strict and there were other trials running at the same time, so I am really grateful for the patients and for the centres that participated and made it possible for us to get a clear answer on our primary objective of progression-free survival."


Note: The study was sponsored by Pfizer (formerly Pharmacia at start of the trial), who supplied Exemestane and covered the costs of study monitoring, data management at participating centres and data processing at the EORTC data centre.

Margaret Willson | EurekAlert!
Further information:
http://www.fecs.be/

More articles from Health and Medicine:

nachricht Second cause of hidden hearing loss identified
20.02.2017 | Michigan Medicine - University of Michigan

nachricht Prospect for more effective treatment of nerve pain
20.02.2017 | Universität Zürich

All articles from Health and Medicine >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Breakthrough with a chain of gold atoms

In the field of nanoscience, an international team of physicists with participants from Konstanz has achieved a breakthrough in understanding heat transport

In the field of nanoscience, an international team of physicists with participants from Konstanz has achieved a breakthrough in understanding heat transport

Im Focus: DNA repair: a new letter in the cell alphabet

Results reveal how discoveries may be hidden in scientific “blind spots”

Cells need to repair damaged DNA in our genes to prevent the development of cancer and other diseases. Our cells therefore activate and send “repair-proteins”...

Im Focus: Dresdner scientists print tomorrow’s world

The Fraunhofer IWS Dresden and Technische Universität Dresden inaugurated their jointly operated Center for Additive Manufacturing Dresden (AMCD) with a festive ceremony on February 7, 2017. Scientists from various disciplines perform research on materials, additive manufacturing processes and innovative technologies, which build up components in a layer by layer process. This technology opens up new horizons for component design and combinations of functions. For example during fabrication, electrical conductors and sensors are already able to be additively manufactured into components. They provide information about stress conditions of a product during operation.

The 3D-printing technology, or additive manufacturing as it is often called, has long made the step out of scientific research laboratories into industrial...

Im Focus: Mimicking nature's cellular architectures via 3-D printing

Research offers new level of control over the structure of 3-D printed materials

Nature does amazing things with limited design materials. Grass, for example, can support its own weight, resist strong wind loads, and recover after being...

Im Focus: Three Magnetic States for Each Hole

Nanometer-scale magnetic perforated grids could create new possibilities for computing. Together with international colleagues, scientists from the Helmholtz Zentrum Dresden-Rossendorf (HZDR) have shown how a cobalt grid can be reliably programmed at room temperature. In addition they discovered that for every hole ("antidot") three magnetic states can be configured. The results have been published in the journal "Scientific Reports".

Physicist Dr. Rantej Bali from the HZDR, together with scientists from Singapore and Australia, designed a special grid structure in a thin layer of cobalt in...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

Booth and panel discussion – The Lindau Nobel Laureate Meetings at the AAAS 2017 Annual Meeting

13.02.2017 | Event News

Complex Loading versus Hidden Reserves

10.02.2017 | Event News

International Conference on Crystal Growth in Freiburg

09.02.2017 | Event News

 
Latest News

Switched-on DNA

20.02.2017 | Materials Sciences

Second cause of hidden hearing loss identified

20.02.2017 | Health and Medicine

Prospect for more effective treatment of nerve pain

20.02.2017 | Health and Medicine

VideoLinks
B2B-VideoLinks
More VideoLinks >>>