by Mary DeLucco
When the National Cancer Institute (NCI) decided in June not to go ahead with the P-4 chemoprevention trial (STELLAR), BCA applauded the decision.
The STELLAR trial would have randomly assigned almost 13,000 women who do not have breast cancer but are at high risk for the disease to receive either raloxifene or letrozole (an aromatase inhibitor) for five years. In addition to its long-held concerns about attempts to prevent breast cancer with pills, BCA was opposed to this trial in particular, based on information it has obtained about the side effects of aromatase inhibitors (AI), including letrozole, in women with breast cancer (for more information, read BCA’s report, Side Effects Revealed: Women’s Experiences With Aromatase Inhibitors).
BCA cheers the cancellation in part because of BCA’s opposition to a pills-based approach to breast cancer prevention. BCA is concerned that pills to “prevent” breast cancer will always result in disease substitution. (For more information, visit our policies page.)
NCI director John Niederhuber’s reason for canceling the trial echoed BCA’s concerns. In a written statement, Niederhuber said the dangers of the drugs outweighed their benefits and said the agency was committed to finding options that “do not ask otherwise healthy people to trade cancer risk for the increased risk of other serious health conditions.”
Niederhuber’s statement made clear that the dangerous side effects of the drugs, not the expense—he has estimated the trial’s cost at upwards of $100 million—was the factor in his decision.
With this decision, the NCI put public health first, protecting many women from the potentially dangerous side effects of powerful drugs. Kudos to the NCI.