title: Impact of chemotherapy followed by aromatase inhibitors on bone health of women with ER-positive early breast cancer in real world clinical settings in Greece: Results of the POCHARBI trial conducted by the Hellenic Society of Breast Surgeons.
abstract: BACKGROUND
  The aim of this observational study was to assess the combined impact of chemotherapy (CT) and aromatase inhibitors (AI) therapy on bone mineral density (BMD) in postmenopausal women with estrogen receptor (ER)-positive early breast cancer.
  
  
  METHODS
  Patients were treated with a third generation AI, either as adjuvant therapy (HT cohort, n = 166) or as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort, n = 124), and were followed up for a 12-month period. BMD was evaluated at lumbar spine (LS) and total hip (HP) before CT, before AI therapy and after 12 months of AI therapy. The primary study objective was changes in LS BMD between pre CT treatment and post 12 months AI therapy in the CT cohort.
  
  
  RESULTS
  There were no statistically significant changes in LS BMD, either within CT or HT cohort. In the CT cohort, the mean LS BMD change was -0.72% (95% CI: -2.97%, +1.53%, p = 0.5526) between CT start and month 12 of AI therapy, while it was -0.19% (95% CI: -2.12%, +1.74%, p = 0.8309) and -0.59% (95% CI: -3.18%, +2.00%, p = 0.4759) between CT start and AI start and AI start and month 12 of AI therapy respectively. The mean change in LS BMD in the HT cohort (i.e. after 12 months of AI treatment) was +1.51% (95% CI: -0.96%, +3.98%, p = 0.7420).
  
  
  CONCLUSIONS
  The results of this study indicate that, under routine clinical practice, most postmenopausal patients who receive CT before AI therapy do not experience debilitating BMD consequences during the first year of AI treatment.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier NCT01298362.
authors.affiliation: Hellenic Society of Breast Surgeons, 6 Eslin Str, PC. 11523 Athens, Greece. Electronic address: cmarkop@hol.gr.
authors.forename: C
authors.initials: C
authors.lastname: Markopoulos
authors.affiliation: Hellenic Society of Breast Surgeons, 6 Eslin Str, PC. 11523 Athens, Greece.
authors.forename: D
authors.initials: D
authors.lastname: Koukouras
authors.affiliation: Hellenic Society of Breast Surgeons, 6 Eslin Str, PC. 11523 Athens, Greece.
authors.forename: V
authors.initials: V
authors.lastname: Venizelos
authors.affiliation: Hellenic Society of Breast Surgeons, 6 Eslin Str, PC. 11523 Athens, Greece.
authors.forename: I
authors.initials: I
authors.lastname: Karyda
authors.affiliation: Hellenic Society of Breast Surgeons, 6 Eslin Str, PC. 11523 Athens, Greece.
authors.forename: G
authors.initials: G
authors.lastname: Xepapadakis
authors.affiliation: Hellenic Society of Breast Surgeons, 6 Eslin Str, PC. 11523 Athens, Greece.
authors.forename: J
authors.initials: J
authors.lastname: Misitzis
authors.affiliation: Hellenic Society of Breast Surgeons, 6 Eslin Str, PC. 11523 Athens, Greece.
authors.forename: K
authors.initials: K
authors.lastname: Kalogerakos
authors.affiliation: Hellenic Society of Breast Surgeons, 6 Eslin Str, PC. 11523 Athens, Greece.
authors.forename: F
authors.initials: F
authors.lastname: Poulakaki
authors.affiliation: Hellenic Society of Breast Surgeons, 6 Eslin Str, PC. 11523 Athens, Greece.
authors.forename: J
authors.initials: J
authors.lastname: Natsiopoulos
authors.affiliation: Hellenic Society of Breast Surgeons, 6 Eslin Str, PC. 11523 Athens, Greece.
authors.forename: V
authors.initials: V
authors.lastname: Zobolas
authors.affiliation: Hellenic Society of Breast Surgeons, 6 Eslin Str, PC. 11523 Athens, Greece.
authors.forename: C
authors.initials: C
authors.lastname: Savidou
authors.affiliation: Hellenic Society of Breast Surgeons, 6 Eslin Str, PC. 11523 Athens, Greece.
authors.forename: Z
authors.initials: Z
authors.lastname: Antonopoulou
authors.affiliation: Hellenic Society of Breast Surgeons, 6 Eslin Str, PC. 11523 Athens, Greece.
authors.forename: E
authors.initials: E
authors.lastname: Tzoracoleftherakis
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D047072:Aromatase Inhibitors / Q000494:pharmacology*; D015519:Bone Density / Q000187:drug effects*; D050071:Bone Density Conservation Agents / Q000494:pharmacology*; D001943:Breast Neoplasms / Q000737:chemistry / Q000188:drug therapy*; D017024:Chemotherapy, Adjuvant; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006115:Greece; D006801:Humans; D008159:Lumbar Vertebrae / Q000187:drug effects; D008875:Middle Aged; D010384:Pelvic Bones / Q000187:drug effects; D017698:Postmenopause; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000032:analysis; D016896:Treatment Outcome
chemical_list: D047072:Aromatase Inhibitors; D050071:Bone Density Conservation Agents; D018719:Erb-b2 Receptor Tyrosine Kinases; C508053:ERBB2 protein, human
keywords: Aromatase inhibitors; Bone health; Breast cancer; Chemotherapy; Osteoporosis