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Old 10-28-2005, 03:07 PM   #1
Becky
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Aromosin

Exemestane approved for adjuvant treatment of estrogen-receptor–positive breast cancer

By Brian Reid

October 26, 2005

The US Food and Drug Administration (FDA) has expanded approved usage of the aromatase inhibitor exemestane (Pfizer, Inc.) for adjuvant treatment of postmenopausal women with breast cancer who have already undergone 2 to 3 years of tamoxifen therapy.[1]

Exemestane was originally approved in 1999 for the treatment of postmenopausal women with advanced breast cancer who were no longer responding to tamoxifen. The FDA’s decision to expand exemestane’s indication for use was based upon data recently published by the Intergroup Exemestane Study in the New England Journal of Medicine, showing significant improvement in disease-free survival when patients were switched from tamoxifen to exemestane compared with patients who remained on tamoxifen alone[2]

The investigators reported that 5 years of tamoxifen monotherapy after surgery “may be suboptimal” for postmenopausal patients with estrogen-receptor–positive breast cancer, and suggested that clinicians “should consider” switching patients to exemestane 2 and 3 years after the start of tamoxifen therapy.

The Intergroup study followed more than 4700 women who had already been taking tamoxifen for 2 to 3 years. One half of the patients were switched to exemestane while the remaining patients remained on tamoxifen for a total of 5 years. After a median follow-up of 30.6 months, there were 183 events (including local or metastatic recurrence, contralateral breast cancer, or death) in the exemestane group compared with 226 in the tamoxifen group (P < .001).

Exemestane is a member of the aromatase inhibitor family of drugs, which includes anastrozole and letrozole. Anastrozole has been approved for primary adjuvant therapy in breast cancer since 2002, and letrozole is approved for adjuvant therapy following 5 years of tamoxifen use. The FDA is currently considering a request to approve letrozole for use as primary adjuvant therapy.

Prior to the introduction of aromatase inhibitors, a 5-year course of tamoxifen had been considered standard therapy for adjuvant treatment of breast cancer, based upon data showing improved survival rates. The aromatase inhibitors have certainly changed that standard for different patient subsets, and will likely continue to do so as more data become available.

Reference

1. Aromasin [exemestane] package insert. New York, NY: Pfizer Inc; 2005.

2. Coombes RC, Hall E, Gibson LJ, et al., for the Intergroup Exemestane Study. A randomized trial of exemestane after two to three years of tamoxifen therapy in postmenopausal women with primary breast cancer. N Engl J Med. 2004;350:1081-1092.
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