Promising Results with Exemestane in the First-Line Treatment of Metastatic Breast Cancer: A Randomized Phase II EORTC Trial with a Tamoxifen Control

Because tamoxifen (TAM), a nonsteroidal antiestrogen, is routinely used in the adjuvant setting, other hormone therapies are needed as alternatives for first-line treatment of metastatic breast cancer (MBC). Currently, exemestane (EXE) and other antiaromatase agents are indicated for use in patients...

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Published in:Clinical breast cancer 2000-09, Vol.1, p.S19-S21
Main Authors: Paridaens, Robert, Dirix, Luc, Beex, Louk, Nooij, Marianne, Cufer, Tania, Lohrisch, Caroline, Biganzoli, Laura, Van Hoorebeeck, Irène, Duchateau, Luc, Lobelle, Jean-Pierre, Piccart, Martine
Format: Article
Language:English
Subjects:
Administration, Oral
Androstadienes - adverse effects
Androstadienes - therapeutic use
Antiestrogen
Antineoplastic Agents, Hormonal - therapeutic use
Aromatase inactivator
Aromatase Inhibitors - adverse effects
Aromatase Inhibitors - therapeutic use
Breast cancer
Breast Neoplasms - drug therapy
Breast Neoplasms - pathology
Disease Progression
Female
Humans
Neoplasm Metastasis
Tamoxifen - therapeutic use
Treatment Outcome
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Summary:Because tamoxifen (TAM), a nonsteroidal antiestrogen, is routinely used in the adjuvant setting, other hormone therapies are needed as alternatives for first-line treatment of metastatic breast cancer (MBC). Currently, exemestane (EXE) and other antiaromatase agents are indicated for use in patients who experience failure of TAM. In this multicenter, randomized, open-label, TAM-controlled (20 mg/day), phase II trial, we examined the activity and tolerability of EXE 25 mg/day for the first-line treatment of MBC in postmenopausal women. Exemestane was well tolerated and demonstrated substantial first-line antitumor activity based on intent-to-treat analysis of peer-reviewed responses. In the EXE arm, values for complete, partial, and objective response, clinical benefit, and time to tumor progression (TTP) exceeded those reported for TAM although no statistical comparison was made. Based on these encouraging results, a phase III trial will compare EXE and TAM.
ISSN:1526-8209
1938-0666
DOI:10.3816/CBC.2000.s.004