© 2003 by Oxford University Press
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© 2003 Oxford University Press
NEWS |
Critics Question Price of Success in Halted Clinical Trial of Aromatase Inhibitor Letrozole
| The first 150 words of the full text of this article appear below. |
In October, results from a clinical trial showed that the aromatase inhibitor letrozole (Femara) reduced breast cancer recurrence after 5 years of tamoxifen therapy in postmenopausal women. The results were hailed as a boon for the breast cancer community; results from the trial, which was halted early, suggest that breast cancer survivors now have another option to continue to keep breast cancer at bay.
But some experts, including leading breast cancer patient advocates and some investigators, are saying that unblinding the study leaves patients in a quandary because too many questions have been left unanswered. They argue that clinical trial design that has disease-free survival—instead of overall survival—as an end point should be reconsidered.
In August, when an independent data and safety monitoring committee took the first interim look at outcomes in the 5,187-patient trial, they found results so unexpectedly strong that they concluded that the study must be unblinded
Too Many Questions
Defending Beneficial Findings