title: Breast cancer patients on endocrine therapy reveal more symptoms when self-reporting than in pivotal trials: an outcome research study.
abstract: OBJECTIVE
  The purpose of this investigation was firstly to assess the overall frequency of subjectively experienced symptoms self-reported by patients receiving endocrine therapy and secondly to compare these symptoms with side effects assessed by clinicians in pivotal trials.
  
  
  METHODS
  Unselected patients with early and advanced breast cancer receiving endocrine therapy were approached consecutively during a routine outpatient visit. They received a questionnaire called Checklist for Patients with Endocrine Therapy (C-PET), a validated self-assessment tool to determine prespecified symptoms associated with endocrine therapy. Data on toxicity were also obtained from previously published trials.
  
  
  RESULTS
  405 patients were approached and 373 agreed to participate in this study. Some symptoms were significantly more often recorded by the women in the adjuvant setting completing the C-PET than by physicians' reports in pivotal trials: hot flushes/sweats (C-PET 70%, ATAC 40% and BIG1-98 38%), low energy (C-PET 45%, ATAC 15% and BIG1-98 9%), fluid retention (C-PET 22% and BIG1-98 7%) and vaginal dryness (C-PET 30% and BIG1-98 3%). Similar differences were observed in the metastatic and adjuvant setting.
  
  
  CONCLUSIONS
  A simple tool like the C-PET questionnaire is able to reflect the treatment burden of endocrine therapies and may be helpful to improve communication between patients and care providers. Some symptoms were significantly more often reported by the women in the C-PET than by physicians in pivotal trials.
authors.affiliation: Senology Center of Eastern Switzerland, St. Gallen, Switzerland. thomas.ruhstaller@kssg.ch
authors.forename: Thomas
authors.initials: T
authors.lastname: Ruhstaller
authors.forename: Roger
authors.initials: R
authors.lastname: von Moos
authors.forename: Kaspar
authors.initials: K
authors.lastname: Rufibach
authors.forename: Karin
authors.initials: K
authors.lastname: Ribi
authors.forename: Agnes
authors.initials: A
authors.lastname: Glaus
authors.forename: Bruno
authors.initials: B
authors.lastname: Spaeti
authors.forename: Dieter
authors.initials: D
authors.lastname: Koeberle
authors.forename: Urs
authors.initials: U
authors.lastname: Mueller
authors.forename: Markus
authors.initials: M
authors.lastname: Hoefliger
authors.forename: Dagmar
authors.initials: D
authors.lastname: Hess
authors.forename: Christel
authors.initials: C
authors.lastname: Boehme
authors.forename: Beat
authors.initials: B
authors.lastname: Thuerlimann
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018931:Antineoplastic Agents, Hormonal / Q000009:adverse effects* / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D002986:Clinical Trials as Topic; D005260:Female; D006801:Humans; D008495:Medical Oncology / Q000379:methods; D008875:Middle Aged; D009362:Neoplasm Metastasis; D049268:Positron-Emission Tomography; D011446:Prospective Studies; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D018931:Antineoplastic Agents, Hormonal