New Drug Shows Promise for Advanced Breast Cancer Treatment

A pre-release of a study that will be published in the Journal of Clinical Oncology on August 10 has announced that research into ixabepilone is showing promise for treating advanced unresponsive breast cancer.

The results, which will soon be made fully available, are from a Phase II study, which was carried out by researchers from Yale Cancer Centre, Washington Hospital Center, Bristol-Myers Squibb and other on ixabepilone. Bristol-Meyers Squibb produces the new drug.

Ixabepilone is an epothilone B that helps to stabilize cell structures and it also creates mitotic arrest. In the Phase II study tests were carried out to see if there were any safety concerns linked to using ixabepilone to treat women with advance breast cancer that had failed to respond to other types of chemotherapy.

Eligible subjects were treated with 6mg/m2/d of ixabepilone on the first five days of a three week cycle. To be eligible for participation in the study the woman had to have advanced breast cancer and to have not been treated with taxanes previously. The treatment was continued until toxicity levels got to high to continue of the subjects breast cancer has progressed to far for treatment. At the start of the study each patients underwent tests on their tissues and tumours. The same process was carried out after the treatments were ended.

In total 126 subjects took part in the breast cancer study. The researchers were able to study correctly 113 of these subjects of which a significant amount showed some response to the ixabepilone treatments.

According to the Bristol-Myers Squibb press release about the study the number of subjects who responded to the treatment was 11.5 percent, determined by an independent radiology facility and as high as 18.6 percent according to the projects researchers. The average time for a subject to show a response to the treatment was 6.1 weeks with the average length of the response lasting 5.7 months. The average overall survival rate was 8.6 months.

Unfortunately like most chemotherapy treatments, ixabepilone was not without side effects. Common side effects amongst the test subjects included fatigue, neuropathy, neutropenia, nausea, vomiting, hair lose and anaemia.

Currently there are three main treatments administered to those suffering from breast cancer, capecitabine, taxane and anthracycline. However, metastic breast cancer, the type of cancer treated in the study seemed to be resistant to any of these treatments. Fast spreading breast cancer is also lacking in treatments.

Bristol-Myers Squibb are currently awaiting a review by the U.S. Food and Drug Administration. The U.S Food and Drug Administration granted the pharmaceutical company's request to have their application given priority review. The company also plan to submit similar applications to the European Union and other countries around the world.

Around 178,000 woman and 2000 men in the United States alone will be diagnosed with Breast Cancer each year. It is the second leading cancer death for woman in the United States.

Sources

Bristol-Myers Squibb press release
http://prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/07-06-2007/0004620760&EDATE=

JCO prestudy results report
http://jco.ascopubs.org/cgi/content/abstract/JCO.2006.10.0784v1

Breast cancer statistics
http://www.mayoclinic.com/health/breast-cancer/DS00328