Comparison of menopausal symptoms during the first year of adjuvant therapy with either exemestane or tamoxifen in early breast cancer: report of a Tamoxifen Exemestane Adjuvant Multicenter trial substudy.
OBJECTIVE
Hormonal breast cancer treatment increases menopausal symptoms in women. This study investigated differences between the symptoms associated with either adjuvant tamoxifen or exemestane.


METHODS
Ten common symptoms were assessed by self-report questionnaire administered to 1,614 consecutive patients at baseline and every 3 months during the first year of a double-blind, randomized trial of postmenopausal women with early hormone receptor-positive breast cancer. Symptoms were categorized as none, mild, moderate, or severe. A hot flash score was calculated at each time point. Symptoms were analyzed by repeated-measures analysis of variance. Each time period was tested repeatedly against the baseline; an overall P value was assigned for each reported symptom.


RESULTS
Compliance was excellent, with 7,286 questionnaires analyzed. Baseline symptom prevalence ranged from 2% (vaginal bleeding) to 60% to 70% (bone/muscle aches and low energy). There were no significant differences in vaginal bleeding, mood alteration, or low energy. Patients receiving tamoxifen had significantly more vaginal discharge (P < .0001). Exemestane patients reported more bone/muscle aches (P < .0001), vaginal dryness (P = .0004), and difficulty sleeping (P = .03). In both groups, the hot flash score peaked at 3 months and decreased thereafter. At 12 months, patients receiving tamoxifen had a significantly higher mean hot flash score (P = .03), with daily hot flashes increasing from baseline by 33% compared with a 7% increase from baseline with exemestane.


CONCLUSIONS
At 12 months, exemestane was associated with fewer hot flashes and less vaginal discharge than tamoxifen, but with more vaginal dryness, bone/muscle aches, and difficulty sleeping. Symptoms were common in both groups.
Jones
Stephen E
SE
US Oncology Research Inc, Houston, TX, USA. Steve.Jones@usoncology.com
Cantrell
James
J
Vukelja
Svetislava
S
Pippen
John
J
O'Shaughnessy
Joyce
J
Blum
Joanne L
JL
Brooks
Robert
R
Hartung
Nicole L
NL
Negron
Angel G
AG
Richards
Donald A
DA
Rivera
Ragene
R
Holmes
Frankie Ann
FA
Chittoor
Sreeni
S
Whittaker
Thomas L
TL
Bordelon
James H
JH
Ketchel
Steven J
SJ
Davis
Jennifer C
JC
Ilegbodu
Des
D
Kochis
Jean
J
Asmar
Lina
L
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000730:Androstadienes / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D017024:Chemotherapy, Adjuvant; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D019584:Hot Flashes; D006801:Humans; D008593:Menopause; D008875:Middle Aged; D011788:Quality of Life; D011795:Surveys and Questionnaires; D013629:Tamoxifen / Q000008:administration & dosage; D013997:Time Factors; D016896:Treatment Outcome
D000730:Androstadienes; D013629:Tamoxifen; C056516:exemestane