Extended adjuvant hormonal therapy with exemestane has no detrimental effect on the lipid profile of postmenopausal breast cancer patients: final results of the ATENA lipid substudy.
BACKGROUND
Extended adjuvant endocrine therapy for breast cancer with aromatase inhibitors may potentially alter the lipid profile of postmenopausal patients and thus increase the risk of developing cardiovascular disease. In this study, a subprotocol of the ATENA (Adjuvant post-Tamoxifen Exemestane versus Nothing Applied) trial, we compared the effect of the steroidal aromatase inactivator exemestane on the lipid profile of postmenopausal patients with operable breast cancer, in the adjuvant setting, with that of observation alone after completion of 5 to 7 years of primary treatment with tamoxifen.


METHODS
In this open-label, randomized, parallel-group study, 411 postmenopausal patients with operable breast cancer, who had been treated with tamoxifen for 5 to 7 years, were randomized to either 5 additional years of exemestane (25 mg/day; n = 211) or observation only (n = 200). Assessments of total cholesterol (TC), high-density lipoprotein (HDL), low-density lipoprotein (LDL), and total serum triglycerides (TRG) were performed at baseline and then during each follow-up visit, performed at either 6 or 12 months, according to the center's clinical practice, until completing 24 months in the study.


RESULTS
TC and LDL levels increased significantly across time for both arms; TC increase was more pronounced for the observation arm, and that was sustained up to 24 months. HDL levels decreased significantly across time for the exemestane arm, whereas no significant change was detected across time for the observation arm. Triglyceride levels decreased significantly across time on both arms, with no difference detected in changes from baseline between the exemestane and the observation arms.


CONCLUSIONS
Exemestane lacks the beneficial effect of tamoxifen on lipids; however, sequential adjuvant treatment with exemestane in postmenopausal breast cancer patients after cessation of 5 to 7 years of tamoxifen does not appear to alter the lipid profile significantly compared with that of an observational arm.


BACKGROUND
ClinicalTrials.gov ID: NCT00810706.
Markopoulos
Christos
C
Hellenic Society of Breast Surgeons, Athens, Greece. cmarkop@hol.gr
Dafni
Urania
U
Misitzis
John
J
Zobolas
Vasilios
V
Tzoracoleftherakis
Evagelos
E
Koukouras
Dimitrios
D
Xepapadakis
Grigorios
G
Papadiamantis
John
J
Venizelos
Basileios
B
Antonopoulou
Zoh
Z
Gogas
Helen
H
D000328:Adult; D000368:Aged; D000730:Androstadienes / Q000627:therapeutic use*; D047072:Aromatase Inhibitors / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000628:therapy*; D017024:Chemotherapy, Adjuvant / Q000379:methods; D002784:Cholesterol / Q000378:metabolism; D004791:Enzyme Inhibitors / Q000494:pharmacology; D005260:Female; D006801:Humans; D008055:Lipids / Q000737:chemistry*; D008875:Middle Aged; D017698:Postmenopause; D013256:Steroids / Q000494:pharmacology; D013629:Tamoxifen / Q000494:pharmacology
D000730:Androstadienes; D047072:Aromatase Inhibitors; D004791:Enzyme Inhibitors; D008055:Lipids; D013256:Steroids; D013629:Tamoxifen; D002784:Cholesterol; C056516:exemestane