title: Comparison of patient reported quality of life and impact of treatment side effects experienced with a taxane-containing regimen and standard anthracycline based chemotherapy for early breast cancer: 6 year results from the UK TACT trial (CRUK/01/001).
abstract: BACKGROUND
  The TACT trial (CRUK/01/001) compared adjuvant sequential FEC-docetaxel (FEC-D) chemotherapy with standard anthracycline-based chemotherapy of similar duration in women with early breast cancer. Results at a median of 5 years suggested no improvement in disease-free survival with FEC-D. Given differing toxicity profiles of the regimens, the impact on quality of life (QL) was explored.
  
  
  METHODS
  Patients from 44 centres completed standardised QL questionnaires before chemotherapy, after cycles 4 and 8, at 9, 12, 18 and 24 months and at 6 years follow-up. Patient diaries assessed frequency, associated distress and impact on daily activity of 15 treatment related side effects.
  
  
  RESULTS
  830 patients (415 FEC-D; 415 controls) contributed assessments during 0-24 months; 362 of whom participated again at 6 years. During chemotherapy, FEC-D impaired global health/QL and depression rates and significantly more QL domains than standard regimens. Novel diary card ratings highlighted significantly more distress and interference with daily activities due to FEC-D side effects compared with standard treatment. In both groups, most QL parameters returned to baseline levels by 2 years and were unchanged at 6 years.
  
  
  CONCLUSIONS
  Within expected negative effects of chemotherapy on wide ranging QL domains FEC-D patients reported greater toxicity, disruption and distress during treatment with no improvement in disease outcome at 5 years than patients receiving standard anthracycline-based chemotherapy. Findings should inform future patients of relative costs and benefits of adjuvant chemotherapy.
authors: Clinical Trials and Statistics Unit (ICR-CTSU), The Institute of Cancer Research, London, UK. Electronic address: Emma.Hall@icr.ac.uk.
authors: E
authors: E
authors: Hall
authors: Edinburgh Cancer Research Centre, Western General Hospital, University of Edinburgh, UK.
authors: D
authors: D
authors: Cameron
authors: Clinical Trials and Statistics Unit (ICR-CTSU), The Institute of Cancer Research, London, UK.
authors: R
authors: R
authors: Waters
authors: Academic Breast Unit, Velindre Cancer Centre, Velindre NHS Trust, Cardiff, UK.
authors: P
authors: P
authors: Barrett-Lee
authors: Department of Medical Oncology, Guy's & St Thomas' Foundation Trust, London, UK.
authors: P
authors: P
authors: Ellis
authors: Cancer Clinical Trials Team, Information Services Division, Edinburgh, UK.
authors: S
authors: S
authors: Russell
authors: Clinical Trials and Statistics Unit (ICR-CTSU), The Institute of Cancer Research, London, UK.
authors: J M
authors: JM
authors: Bliss
authors: Clinical Trials and Statistics Unit (ICR-CTSU), The Institute of Cancer Research, London, UK.
authors: P
authors: P
authors: Hopwood
mesh_terms: D000328:Adult; D018943:Anthracyclines / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000601:surgery; D001952:Bridged-Ring Compounds / Q000008:administration & dosage / Q000009:adverse effects; D017024:Chemotherapy, Adjuvant; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D015251:Epirubicin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D008727:Methotrexate / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D011788:Quality of Life; D011795:Surveys and Questionnaires; D013629:Tamoxifen / Q000008:administration & dosage / Q000009:adverse effects; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D013812:Therapeutics; D006113:United Kingdom
chemical_list: D018943:Anthracyclines; D001952:Bridged-Ring Compounds; D043823:Taxoids; D013629:Tamoxifen; C080625:taxane; D015251:Epirubicin; D003520:Cyclophosphamide; D005472:Fluorouracil; D008727:Methotrexate
keywords: Breast; Chemotherapy; Early; Patient reported outcomes; Quality of life; Randomised controlled trial