title: Phase II trial of anastrozole plus goserelin in the treatment of hormone receptor-positive, metastatic carcinoma of the breast in premenopausal women.
abstract: OBJECTIVE
  To explore the antitumor activity of the aromatase inhibitor, anastrozole, in the treatment of premenopausal women with hormone receptor-positive, metastatic breast cancer who have been rendered functionally postmenopausal with the use of the luteinizing hormone-releasing hormone agonist, goserelin.
  
  
  METHODS
  Premenopausal women with estrogen and/or progesterone receptor-positive, metastatic or recurrent breast cancer were enrolled in this prospective, single-arm, multicenter phase II trial. Patients were treated with goserelin 3.6 mg subcutaneous monthly and began anastrozole 1-mg daily 21 days after the first injection of goserelin. Patients continued on treatment until disease progression or unacceptable toxicity.
  
  
  RESULTS
  Thirty-five patients were enrolled of which 32 were evaluable for response and toxicity. Estradiol suppression was assessed, with mean estradiol levels of 18.7 pg/mL at 3 months and 14.8 pg/mL at 6 months. One participant (3.1%) experienced a complete response, 11 (34.4%) experienced partial response, and 11 (34.4%) experienced stable disease for 6 months or longer for a clinical benefit rate of 71.9%. Median time to progression was 8.3 months (range, 2.1 to 63+) and median survival was not been reached (range, 11.1 to 63+). The most common adverse events were fatigue (50%), arthralgias (53%), and hot flashes (59%). There were no grade 4 to 5 toxicities.
  
  
  CONCLUSIONS
  The combination of goserelin plus anastrozole has substantial antitumor activity in the treatment of premenopausal women with hormone receptor-positive metastatic breast cancer.
authors.affiliation: Stanford Cancer Center, Stanford University, Stanford, CA 94305, USA. rcarlson@stanford.edu
authors.forename: Robert W
authors.initials: RW
authors.lastname: Carlson
authors.forename: Richard
authors.initials: R
authors.lastname: Theriault
authors.forename: Christine M
authors.initials: CM
authors.lastname: Schurman
authors.forename: Edgardo
authors.initials: E
authors.lastname: Rivera
authors.forename: Cathie T
authors.initials: CT
authors.lastname: Chung
authors.forename: See-Chun
authors.initials: SC
authors.lastname: Phan
authors.forename: Banu
authors.initials: B
authors.lastname: Arun
authors.forename: Kristine
authors.initials: K
authors.lastname: Dice
authors.forename: Vivian Y
authors.initials: VY
authors.lastname: Chiv
authors.forename: Marjorie
authors.initials: M
authors.lastname: Green
authors.forename: Vicente
authors.initials: V
authors.lastname: Valero
mesh_terms: D000328:Adult; D000077384:Anastrozole; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000473:pathology; D004958:Estradiol / Q000378:metabolism; D005260:Female; D017273:Goserelin / Q000008:administration & dosage*; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009376:Neoplasms, Hormone-Dependent / Q000188:drug therapy*; D009570:Nitriles / Q000008:administration & dosage*; D017697:Premenopause; D014230:Triazoles / Q000008:administration & dosage*
chemical_list: D009570:Nitriles; D014230:Triazoles; D017273:Goserelin; D000077384:Anastrozole; D004958:Estradiol