Quality of life of postmenopausal women in the Arimidex, Tamoxifen, Alone or in Combination (ATAC) Adjuvant Breast Cancer Trial.
OBJECTIVE
To determine the quality of life (QoL) of women participating in the Arimidex, Tamoxifen, Alone or in Combination (ATAC) Adjuvant Breast Cancer Trial during the first 2 years of treatment.


METHODS
A total of 1,021 women were enrolled onto the QoL subprotocol. All had completed primary treatment (surgery +/- radiotherapy +/- chemotherapy) and were to receive 5 years of adjuvant treatment with anastrozole (n = 335), tamoxifen (n = 347), or a combination (n = 339) of both. Patients completed the Functional Assessment of Cancer Therapy-Breast (FACT-B) plus endocrine subscale (ES) at baseline and 3, 6, 12, 18, and 24 months, or until disease recurrence. The primary end point was the FACT-B Trial Outcome Index (TOI). The secondary end point was the ES total score. Analyses of individual endocrine symptoms were also explored.


RESULTS
Questionnaire completion approximated 85% of assessments available for analysis. Overall QoL for all groups improved from baseline during the 2-year period. There were no significant differences in TOI or ES scores across treatment groups. Endocrine symptoms increased between baseline and 3 months for all groups and stabilized thereafter. There were some small differences in side effect profiles. Compared with patients receiving tamoxifen only, patients receiving anastrozole only reported significantly fewer cold sweats and vaginal discharge, yet more vaginal dryness, painful intercourse, and loss of sexual interest.


CONCLUSIONS
Two years of treatment with anastrozole, tamoxifen, or the combination had a similar overall QoL impact, showing gradual improvement over time. Endocrine-related symptoms for all three arms worsened initially and recovered partially during 2 years. The different symptoms experienced may assist in decision making about treatment and supportive care needs.
Fallowfield
Lesley
L
Cancer Research UK Psychosocial Oncology Group, Brighton & Sussex Medical School, University of Sussex, Brighton BN1 9QG, UK. Lesley@sussex.ac.uk
Cella
David
D
Cuzick
Jack
J
Francis
Stephen
S
Locker
Gershon
G
Howell
Anthony
A
D000077384:Anastrozole; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D047072:Aromatase Inhibitors / Q000008:administration & dosage; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000523:psychology*; D017024:Chemotherapy, Adjuvant; D005260:Female; D006801:Humans; D008875:Middle Aged; D009570:Nitriles / Q000008:administration & dosage; D016017:Odds Ratio; D017698:Postmenopause; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016019:Survival Analysis; D013629:Tamoxifen / Q000008:administration & dosage; D016896:Treatment Outcome; D014230:Triazoles / Q000008:administration & dosage
D018931:Antineoplastic Agents, Hormonal; D047072:Aromatase Inhibitors; D009570:Nitriles; D014230:Triazoles; D013629:Tamoxifen; D000077384:Anastrozole