title: Treatment of advanced hormone-sensitive breast cancer in postmenopausal women with exemestane alone or in combination with celecoxib.
abstract: OBJECTIVE
  Preclinical data showed that the combination of exemestane and celecoxib has synergistic effects. Therefore, a study was undertaken to explore the efficacy and tolerability of this combination in postmenopausal patients with advanced, hormone-sensitive breast cancer.
  
  
  METHODS
  A randomized phase II study was conducted in postmenopausal patients with hormone-sensitive breast cancer and measurable disease who had progressive disease after treatment with tamoxifen. Patients were randomly assigned to either exemestane 25 mg daily or the combination of exemestane 25 mg daily with celecoxib 400 mg twice daily. Response Evaluation Criteria in Solid Tumors Group criteria were used to determine antitumor efficacy. Primary end point was the rate of clinical benefit. Secondary end points were tolerability, objective response rate, time to progression (TTP), and duration of clinical benefit. A pharmacodynamic and a pharmacokinetic study were conducted in parallel.
  
  
  RESULTS
  One hundred eleven patients (exemestane, n = 55; combination, n = 56) were enrolled in 2002. The demographic characteristics and prognostic factors were similar in both arms. In the assessable population, 24 of 51 patients in the combination arm and 24 of 49 patients in the exemestane arm achieved clinical benefit. TTP was similar in both groups. Duration of clinical benefit was longer in the combination group (median, 96.6 v 49.1 weeks). The addition of celecoxib did not change the tolerability profile of exemestane alone.
  
  
  CONCLUSIONS
  Similar rates of clinical benefit were achieved in both groups.
authors.affiliation: Medical Oncology Unit, Oncologisch Centrum Sint-Augustinus, Oosterveldlaan 24, 2610 Wilrijk, Belgium. luc.dirix@gvagroup.be
authors.forename: Luc Yves
authors.initials: LY
authors.lastname: Dirix
authors.forename: Jorge
authors.initials: J
authors.lastname: Ignacio
authors.forename: Shona
authors.initials: S
authors.lastname: Nag
authors.forename: Poonamally
authors.initials: P
authors.lastname: Bapsy
authors.forename: Henry
authors.initials: H
authors.lastname: Gomez
authors.forename: Digumarti
authors.initials: D
authors.lastname: Raghunadharao
authors.forename: Robert
authors.initials: R
authors.lastname: Paridaens
authors.forename: Stephen
authors.initials: S
authors.lastname: Jones
authors.forename: Silvia
authors.initials: S
authors.lastname: Falcon
authors.forename: Marina
authors.initials: M
authors.lastname: Carpentieri
authors.forename: Antonello
authors.initials: A
authors.lastname: Abbattista
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Lobelle
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000730:Androstadienes / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D019540:Area Under Curve; D001943:Breast Neoplasms / Q000188:drug therapy*; D000068579:Celecoxib; D018450:Disease Progression; D005260:Female; D006801:Humans; D008875:Middle Aged; D009376:Neoplasms, Hormone-Dependent / Q000188:drug therapy*; D017698:Postmenopause; D011720:Pyrazoles / Q000008:administration & dosage; D013449:Sulfonamides / Q000008:administration & dosage; D014018:Tissue Distribution; D016896:Treatment Outcome
chemical_list: D000730:Androstadienes; D011720:Pyrazoles; D013449:Sulfonamides; D000068579:Celecoxib; C056516:exemestane