title: Deterioration of quality of life of high-risk breast cancer patients treated with high-dose chemotherapy: the PEGASE 01 Quality of Life Study.
abstract: OBJECTIVE
  The aim of this study was to compare the quality of life (QOL) of high-risk breast cancer patients included in a randomized clinical trial (PEGASE 01) comparing conventional chemotherapy versus adding an additional high-dose chemotherapy (HDC) cycle with blood stem cell support.
  
  
  METHODS
  A total of 314 patients were included in the clinical trial. QOL evaluations were available for 199 patients. QOL was assessed over a 1-year follow-up period, using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30. The results were analyzed using a linear mixed-effects model.
  
  
  RESULTS
  Toxicity of HDC has a strong negative impact on patients' QOL during the treatment phase. This negative impact tended to last longer in the HDC group, as for most of the QLQ-C30 scales, the QOL scores of HDC patients tend to improve at a slower rate than that of patients receiving standard chemotherapy. In particular, physical functioning remains deteriorated 1 year after inclusion for HDC patients comparatively to conventional chemotherapy patients (85.99 vs. 76.65, P = 0.021), and the pain score was still higher in the HDC group at that time (28.32 vs. 15.97, P = 0.004).
  
  
  CONCLUSIONS
  HDC has a negative impact on QOL even after treatment phase. In the absence of an overall survival benefit of using HDC for high-risk breast cancer patients, QOL studies with a longer follow-up play an important role in informing the complex trade-off implied by HDC between higher toxicity, reduced risk of relapse, and QOL decrease after the active phase of treatment.
authors.affiliation: Inserm, Unit Research 912, Marseilles, France. marino@marseille.inserm.fr
authors.forename: Patricia
authors.initials: P
authors.lastname: Marino
authors.forename: Henri
authors.initials: H
authors.lastname: Roché
authors.forename: Pierre
authors.initials: P
authors.lastname: Biron
authors.forename: Maud
authors.initials: M
authors.lastname: Janvier
authors.forename: Dominique
authors.initials: D
authors.lastname: Spaeth
authors.forename: Michel
authors.initials: M
authors.lastname: Fabbro
authors.forename: Claude
authors.initials: C
authors.lastname: Linassier
authors.forename: Thierry
authors.initials: T
authors.lastname: Delozier
authors.forename: Anne-Laure
authors.initials: AL
authors.lastname: Martin
authors.forename: Gaelle
authors.initials: G
authors.lastname: Santin
authors.forename: Jean-Paul
authors.initials: JP
authors.lastname: Moatti
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000523:psychology*; D018450:Disease Progression; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D016014:Linear Models; D008875:Middle Aged; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016896:Treatment Outcome