title: Toxicity and health-related quality of life in breast cancer patients receiving adjuvant docetaxel, doxorubicin, cyclophosphamide (TAC) or 5-fluorouracil, doxorubicin and cyclophosphamide (FAC): impact of adding primary prophylactic granulocyte-colony stimulating factor to the TAC regimen.
abstract: BACKGROUND
  The aim of the study was to analyse the toxicity and health related quality of life (HRQoL) of breast cancer patients treated with FAC (5-fluorouracil, doxorubicin, cyclophosphamide) and TAC (docetaxel, doxorubicin, cyclophosphamide) with and without primary prophylactic G-CSF (PPG).
  
  
  METHODS
  This was a phase III study to compare FAC and TAC as adjuvant treatment of high-risk node-negative breast cancer patients. After the entry of the first 237 patients, the protocol was amended to include PPG in the TAC arm due to the high incidence of febrile neutropenia. A total of 1047 evaluable patients from 49 centres in Spain, two in Poland and four in Germany were included in the trial. Side-effects and the scores of the EORTC QLQ-C30 and QLQ BR-23 questionnaires were compared in the three groups (FAC, TAC pre-amendment and TAC post-amendment).
  
  
  RESULTS
  The addition of PPG to TAC significantly reduced the incidence of neutropenic fever, grade 2-4 anaemia, asthenia, anorexia, nail disorders, stomatitis, myalgia and dysgeusia. Patient QoL decreased during chemotherapy, more with TAC than FAC, but returned to baseline values afterwards. The addition of PPG to TAC significantly reduced the percentage of patients with clinically relevant Global Health Status deterioration (10 or more points over baseline value) at the end of chemotherapy (64% versus 46%, P<0.03).
  
  
  CONCLUSIONS
  The addition of PPG significantly reduces the incidence of neutropenic fever associated with TAC chemotherapy as well as that of some TAC-induced haematological and extrahaematological side-effects. The HRQoL of patients treated with TAC is worse than that of those treated with FAC but improves with the addition of PPG, particularly in the final part of chemotherapy treatment.
authors.affiliation: Hospital Universitario San Carlos, Madrid, Spain. mmartin@geicam.org
authors.forename: M
authors.initials: M
authors.lastname: Martín
authors.forename: A
authors.initials: A
authors.lastname: Lluch
authors.forename: M A
authors.initials: MA
authors.lastname: Seguí
authors.forename: A
authors.initials: A
authors.lastname: Ruiz
authors.forename: M
authors.initials: M
authors.lastname: Ramos
authors.forename: E
authors.initials: E
authors.lastname: Adrover
authors.forename: A
authors.initials: A
authors.lastname: Rodríguez-Lescure
authors.forename: R
authors.initials: R
authors.lastname: Grosse
authors.forename: L
authors.initials: L
authors.lastname: Calvo
authors.forename: C
authors.initials: C
authors.lastname: Fernandez-Chacón
authors.forename: M
authors.initials: M
authors.lastname: Roset
authors.forename: A
authors.initials: A
authors.lastname: Antón
authors.forename: D
authors.initials: D
authors.lastname: Isla
authors.forename: P Martínez
authors.initials: PM
authors.lastname: del Prado
authors.forename: L
authors.initials: L
authors.lastname: Iglesias
authors.forename: J
authors.initials: J
authors.lastname: Zaluski
authors.forename: A
authors.initials: A
authors.lastname: Arcusa
authors.forename: J M
authors.initials: JM
authors.lastname: López-Vega
authors.forename: M
authors.initials: M
authors.lastname: Muñoz
authors.forename: J R
authors.initials: JR
authors.lastname: Mel
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy*; D017024:Chemotherapy, Adjuvant; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000077143:Docetaxel; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D006402:Hematologic Diseases / Q000139:chemically induced / Q000517:prevention & control; D006801:Humans; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced / Q000517:prevention & control*; D011788:Quality of Life; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D043823:Taxoids; D016179:Granulocyte Colony-Stimulating Factor; D000077143:Docetaxel; D004317:Doxorubicin; D003520:Cyclophosphamide; D005472:Fluorouracil