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2001 DEC 13 - (NewsRx.com & NewsRx.net) -- The largest preoperative aromatase inhibitor trial demonstrates that the breast cancer drug Femara (letrozole) is a more effective therapy for postmenopausal women with hormone receptor positive tumors than tamoxifen, the traditional gold standard treatment.
The data reveal that doctors can offer patients, who are not suitable for breast conserving surgery, an effective, tolerable, licensed therapy proven to shrink tumors. Breast conserving surgery after treatment with Femara may be a viable option in these patients, where previously a mastectomy would have been carried out.
Trialist, Professor Oleg Eremin, consultant breast surgeon at Lincoln Hospital, commented, "These data document for the first time that a hormonal agent, Femara, has been shown to be significantly superior to the current standard, tamoxifen, in the preoperative treatment of hormone receptor positive breast cancer. The most important finding was a higher incidence of reduction in tumor volume with Femara, making breast conserving surgery possible in more cases than it was for patients receiving tamoxifen."
The data were published in the November 15, 2001, issue of the journal Annals of Oncology.
In the phase III, randomized, controlled trial, Femara or tamoxifen were administered for four months prior to surgery to reduce tumor size. In 324 postmenopausal women with hormone-sensitive (ER[superscript]+ and/or PgR[superscript]+), large localized or locally advanced breast cancers not amenable to breast-conserving surgery, the number of clinical responses was significantly higher for Femara than for tamoxifen (55% vs. 36%, p
In addition, after adjustment for tumor size, nodal involvement and age, the odds of undergoing breast-conserving surgery were increased by more than 70% for Femara compared with the odds for tamoxifen (p=0.03). Both Femara and tamoxifen were equally well tolerated.
Femara is the only drug of its class to hold a licence within the United Kingdom to treat breast tumors on a preoperative basis in hormone receptor positive patients and the only aromatase inhibitor proven to be superior to tamoxifen as ...