title: Exemestane and chemotherapy as first-line treatment of metastatic breast cancer: results of a phase II study.
abstract: BACKGROUND
  Metastatic breast cancer remains largely incurable. Strategies involving the combination of the selective estrogen receptor modulator tamoxifen and chemotherapy have been abandoned in view of unacceptable toxicity because of thromboembolic events. The aim of this study was to investigate the safety and efficacy of the third-generation steroidal aromatase inhibitor exemestane plus chemotherapy.
  
  
  METHODS
  Postmenopausal women with advanced breast cancer received 6 cycles of intravenous chemotherapy (5-fluorouracil [5-FU], epirubicin, and cyclophosphamide) and exemestane 25 mg/day that was continued after chemotherapy was completed. The primary efficacy endpoint was time to progression (TTP), and response rates were also assessed. Safety was assessed from adverse events.
  
  
  RESULTS
  Twenty-three patients (median age, 62 years) were included in this study. Twenty patients completed 6 chemotherapy cycles. Median TTP was 13.7 months. Overall response was achieved by 20 patients (73.9%), and the clinical benefit rate was 87%. During the chemotherapy plus exemestane treatments, 50 adverse events were reported in 14 of the 23 patients (60.9%). As expected, the incidence of adverse events decreased during the phase of exemestane treatment alone (19 adverse events in 10 of 20 patients [50%]). There were 2 grade 4 events reported, pulmonary embolism and pneumonia, although pneumonia was not considered to be related.
  
  
  CONCLUSIONS
  Although a small number of patients were included, the combination of exemestane and chemotherapy was well tolerated and only 1 thromboembolic event was reported. Response rates were similar to other comparable series and may encourage further studies to confirm the efficacy of chemotherapy in combination with an aromatase inhibitor.
authors: Hospital Reina Sofía, Córdoba, Spain. juandelahaba@hotmail.com
authors: Juan
authors: J
authors: de la Haba-Rodriguez
authors: Rosario González
authors: RG
authors: Mancha
authors: Gumersindo Pérez
authors: GP
authors: Manga
authors: Enrique Aranda
authors: EA
authors: Aguilar
authors: José Manuel
authors: JM
authors: Baena Cañada
authors: Pedro Sánchez
authors: PS
authors: Rovira
authors: Emilio Alba
authors: EA
authors: Conejo
mesh_terms: D000368:Aged; D000730:Androstadienes / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D047072:Aromatase Inhibitors / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality; D003520:Cyclophosphamide / Q000008:administration & dosage; D018572:Disease-Free Survival; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D017698:Postmenopause; D016896:Treatment Outcome
chemical_list: D000730:Androstadienes; D047072:Aromatase Inhibitors; D015251:Epirubicin; D003520:Cyclophosphamide; C056516:exemestane; D005472:Fluorouracil