title: Activity of exemestane in metastatic breast cancer after failure of nonsteroidal aromatase inhibitors: a phase II trial.
abstract: OBJECTIVE
  To evaluate the antitumor activity and toxicity of a new steroidal aromatase inactivator, exemestane, in postmenopausal women with metastatic breast cancer who had progressive disease (PD) after treatment with a nonsteroidal aromatase inhibitor.
  
  
  METHODS
  In this phase II trial, eligible patients were treated with exemestane 25 mg daily (n = 241) followed, at the time PD was determined, by exemestane 100 mg daily (n = 58).
  
  
  RESULTS
  On the basis of the intent-to-treat analysis by independent review, exemestane 25 mg produced objective responses in 6.6% of patients (95% confidence interval [CI], 3.8% to 10.6%) and overall success (complete response + partial response + no change for 24 weeks or longer) in 24.3% (95% CI, 19.0% to 30.2%). The median durations of objective response and overall success were 58.4 weeks (95% CI, 49.7 to 71.1 weeks) and 37.0 weeks (95% CI, 35.0 to 39.4 weeks), respectively. Increasing the dose of exemestane to 100 mg upon the development of PD produced one partial response (1.7%; 95% CI, 0.0% to 9.2%). Both dosages were well tolerated and were discontinued because of adverse events in only 1.7% of patients.
  
  
  CONCLUSIONS
  Exemestane 25 mg once daily seems to be an attractive alternative to chemotherapy for the treatment of patients with metastatic breast cancer after multiple hormonal therapies have failed.
authors.affiliation: Department of Oncology, Haukeland University Hospital, Bergen, Norway. plon@haukeland.no
authors.forename: P E
authors.initials: PE
authors.lastname: Lønning
authors.forename: E
authors.initials: E
authors.lastname: Bajetta
authors.forename: R
authors.initials: R
authors.lastname: Murray
authors.forename: M
authors.initials: M
authors.lastname: Tubiana-Hulin
authors.forename: P D
authors.initials: PD
authors.lastname: Eisenberg
authors.forename: E
authors.initials: E
authors.lastname: Mickiewicz
authors.forename: L
authors.initials: L
authors.lastname: Celio
authors.forename: P
authors.initials: P
authors.lastname: Pitt
authors.forename: M
authors.initials: M
authors.lastname: Mita
authors.forename: N K
authors.initials: NK
authors.lastname: Aaronson
authors.forename: C
authors.initials: C
authors.lastname: Fowst
authors.forename: A
authors.initials: A
authors.lastname: Arkhipov
authors.forename: E
authors.initials: E
authors.lastname: di Salle
authors.forename: A
authors.initials: A
authors.lastname: Polli
authors.forename: G
authors.initials: G
authors.lastname: Massimini
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000730:Androstadienes / Q000008:administration & dosage / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy / Q000556:secondary*; D016009:Chi-Square Distribution; D005260:Female; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D010166:Palliative Care; D017698:Postmenopause; D018709:Statistics, Nonparametric; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000730:Androstadienes; D000970:Antineoplastic Agents; D018931:Antineoplastic Agents, Hormonal; C056516:exemestane