One of the largest trials ever planned US cancer prevention was killed after a lukewarm review. The National Cancer Institute (NCI) informed the leaders of the trial yesterday that the study, which would have tested two drugs to prevent breast cancer at a cost of more than $ 100 million over 10 years at least, is canceled because of scientific concerns.
proposed by the National Breast Surgical Adjuvant Bowel Project (NSABP) in Pittsburgh, Pennsylvania on STELLAR (study to evaluate letrozole and Raloxifene) trial would have tested the drug letrozole against an old drug in 12,800 postmenopausal women at high risk for breast cancer. Both drugs prevent cancer by blunt estrogen effects, but blocks the synthesis of letrozole estrogen, while the blocks of old drugs estrogen to stimulate tumor growth. A comparison head-to-head drug would test whether letrozole works better and causes milder side effects than the drug more.
Although the trial was approved by several committees NCI, NCI director John Niederhuber last January blocked because of the scientific issues and budgetary problems of the NCI ( science NOW March 13). At a closed meeting to discuss the study in March, researchers and patient groups have raised several issues, including whether the long-term side effects such as an increased risk of osteoporosis and heart attacks ( estrogen protects against two terms), prevent the use of letrozole in clinical practice. Last week, a subcommittee of the NCI National Cancer Advisory Board said it could not "provide a strong approval" for funding the trial. (See the June 22 print issue Science for details.)
NCI has now acted on that advice. in a letter sent to NSABP and the University of Pittsburgh officials yesterday, NCI officials explained that "many scientific concerns ... are sufficiently formidable that the NCI will not commit to the funding of this particular trial. " The letter mentions the side effects and the need for better biomarkers that could help identify high-risk women who could benefit most from participating in such a trial.
D. Lawrence Wickerham, NSABP associate chairman, said Science that the decision was "a disappointment. Obviously, we believe that this trial is scientifically important and has the potential to . provide an option for a large number of women "He added:" Unfortunately, we were not able to convince [the NCI director] that prevention is a priority. "
Related Sites
- Information STELLAR
- Information on a previous test of letrozole
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