A story in the Chicago Tribune today reports on a new National Cancer Institute (NCI) study planning to enroll over 10,000 women with breast cancer, in order to better understand when the use of chemotherapy is warranted in preventing their tumors from returning after surgery. The study, called TAILORx (Trial Assigning IndividuaLized Options for Treatment Rx) is design to determine whether an individual gene, thought to be associated with the risk of relapse for women with early-stage breast cancer, can be used to aid doctors in choosing treatments with the greatest likelihood of success. The study is sponsored by the National Cancer Institute (NCI), and coordinated by the Eastern Cooperative Oncology Group (ECOG)...

Trial Assigning IndividuaLized Options for Treatment (Rx), or TAILORx, was launched today to examine whether genes that are frequently associated with risk of recurrence for women with early-stage breast cancer can be used to assign patients to the most appropriate and effective treatment. TAILORx is sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), and is coordinated by the Eastern Cooperative Oncology Group (ECOG).

The trial shows the great potential of utilizing genetic testing kits to determine the best treatment outcomes for individual patients (i.e. personalized medicine). For both patient and doctor, the decision to start chemotherapy is a difficult one to make, primarily because its side effects can be so harsh. If the results are promising, this study may make those decisions just a little more informative.

In some instances, enhancing treatment outcomes without the long and costly process of conducting these types of trials can be achieved through the use of sophisticated modeling tools, which use data from adverse event reports, patient registries and pharmacovigilance data. That happens to be one of the solutions offered by Little Falls, N.J.-based Sentrx, a Drug Safety Solutions Provider.  CenterWatch’s Senior Editor Sara Gambrill interviewed Uwe Trinks, Chief Information Officer at Sentrx for CW Weekly. Trinks had this to say regarding this type of approach:

“What will happen much more in future clinical trials is intensive genomics analysis combined with the profiling of the adverse reactions of people to find indications for exclusion of certain sub-populations to avoid further adverse events. There are newer, electronic ways to do that that will replace the large clinical trials that we have. We will monitor the drug extensively as it goes on the market to elucidate which subpopulations will have a problem with the drug. The question, ‘Why did this drug kill 60 people?’ is the wrong question. The right question to ask is, ‘What makes that subpopulation of people so different that they had a severe side effect while the drug was well tolerated by 99% of all patients?’”

Read the complete interview profiling Sentrx in the May 22nd issue of CW Weekly.