title: Promising results with exemestane in the first-line treatment of metastatic breast cancer: a randomized phase II EORTC trial with a tamoxifen control.
abstract: 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.
authors.affiliation: Universitair Ziekenhuis Gasthuisberg, Leuven, Belgium. Robert.Paridaens@uz.kuleuven.ac.be
authors.forename: R
authors.initials: R
authors.lastname: Paridaens
authors.forename: L
authors.initials: L
authors.lastname: Dirix
authors.forename: L
authors.initials: L
authors.lastname: Beex
authors.forename: M
authors.initials: M
authors.lastname: Nooij
authors.forename: T
authors.initials: T
authors.lastname: Cufer
authors.forename: C
authors.initials: C
authors.lastname: Lohrisch
authors.forename: L
authors.initials: L
authors.lastname: Biganzoli
authors.forename: I
authors.initials: I
authors.lastname: Van Hoorebeeck
authors.forename: L
authors.initials: L
authors.lastname: Duchateau
authors.forename: J P
authors.initials: JP
authors.lastname: Lobelle
authors.forename: M
authors.initials: M
authors.lastname: Piccart
mesh_terms: D000284:Administration, Oral; D000730:Androstadienes / Q000009:adverse effects / Q000627:therapeutic use*; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use; D047072:Aromatase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D018450:Disease Progression; D005260:Female; D006801:Humans; D009362:Neoplasm Metastasis; D013629:Tamoxifen / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000730:Androstadienes; D018931:Antineoplastic Agents, Hormonal; D047072:Aromatase Inhibitors; D013629:Tamoxifen; C056516:exemestane