In the BIG 1-98 trial, researchers enrolled 8,010 patients to receive letrozole and tamoxifen either alone or in sequence, with a total of 4,922 patients included in the monotherapy arms of the study.
Efficacy analyses comparing the treatment groups were conducted every two years following the initial report of results, because the patients had a long-term risk of recurrence. This 12-year update shows that, among all 8,010 patients, there were 2,074 relapses and 1,284 deaths, compared with 1,569 relapses and 923 deaths at the ten-year update.
"The data also show that the sequential use of letrozole and tamoxifen (two years of one agent followed by three years of the other) provided similar outcomes compared with five years of letrozole alone for patients who are not at high risk for recurrence," said Prof Gelber.
"The optimal regimen remains an open question in many areas of the world, and this large trial presents definitive results for the treatment of the largest group diagnosed with breast cancer: post-menopausal women with hormone-responsive early breast cancer."
He added: "Letrozole and tamoxifen have different side effects, and clinicians should consider the individual patient's medical history when prescribing treatment. Both agents are considered to be safe, especially in view of the substantial reduction in the risk of recurrence and the improved survival provided by these two e
|Contact: Kay Roche|
ECCO-the European CanCer Organisation