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 One gene closer to regenerative therapy for muscular disorders
01.06.2017 | Cincinnati Children's Hospital Medical Center

nachricht The gut microbiota plays a key role in treatment with classic diabetes medication
01.06.2017 | University of Gothenburg

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: Can we see monkeys from space? Emerging technologies to map biodiversity

An international team of scientists has proposed a new multi-disciplinary approach in which an array of new technologies will allow us to map biodiversity and the risks that wildlife is facing at the scale of whole landscapes. The findings are published in Nature Ecology and Evolution. This international research is led by the Kunming Institute of Zoology from China, University of East Anglia, University of Leicester and the Leibniz Institute for Zoo and Wildlife Research.

Using a combination of satellite and ground data, the team proposes that it is now possible to map biodiversity with an accuracy that has not been previously...

Im Focus: Climate satellite: Tracking methane with robust laser technology

Heatwaves in the Arctic, longer periods of vegetation in Europe, severe floods in West Africa – starting in 2021, scientists want to explore the emissions of the greenhouse gas methane with the German-French satellite MERLIN. This is made possible by a new robust laser system of the Fraunhofer Institute for Laser Technology ILT in Aachen, which achieves unprecedented measurement accuracy.

Methane is primarily the result of the decomposition of organic matter. The gas has a 25 times greater warming potential than carbon dioxide, but is not as...

Im Focus: How protons move through a fuel cell

Hydrogen is regarded as the energy source of the future: It is produced with solar power and can be used to generate heat and electricity in fuel cells. Empa researchers have now succeeded in decoding the movement of hydrogen ions in crystals – a key step towards more efficient energy conversion in the hydrogen industry of tomorrow.

As charge carriers, electrons and ions play the leading role in electrochemical energy storage devices and converters such as batteries and fuel cells. Proton...

Im Focus: A unique data centre for cosmological simulations

Scientists from the Excellence Cluster Universe at the Ludwig-Maximilians-Universität Munich have establised "Cosmowebportal", a unique data centre for cosmological simulations located at the Leibniz Supercomputing Centre (LRZ) of the Bavarian Academy of Sciences. The complete results of a series of large hydrodynamical cosmological simulations are available, with data volumes typically exceeding several hundred terabytes. Scientists worldwide can interactively explore these complex simulations via a web interface and directly access the results.

With current telescopes, scientists can observe our Universe’s galaxies and galaxy clusters and their distribution along an invisible cosmic web. From the...

Im Focus: Scientists develop molecular thermometer for contactless measurement using infrared light

Temperature measurements possible even on the smallest scale / Molecular ruby for use in material sciences, biology, and medicine

Chemists at Johannes Gutenberg University Mainz (JGU) in cooperation with researchers of the German Federal Institute for Materials Research and Testing (BAM)...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

Plants are networkers

19.06.2017 | Event News

Digital Survival Training for Executives

13.06.2017 | Event News

Global Learning Council Summit 2017

13.06.2017 | Event News

 
Latest News

Quantum thermometer or optical refrigerator?

23.06.2017 | Physics and Astronomy

A 100-year-old physics problem has been solved at EPFL

23.06.2017 | Physics and Astronomy

Equipping form with function

23.06.2017 | Information Technology

VideoLinks
B2B-VideoLinks
More VideoLinks >>>