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

Breast Cancer Research

Volumn 11, Issue 3, 2009, Pages

  Markopoulos, Christos ^a   Dafni, Urania ^b   Misitzis, John ^a   Zobolas, Vasilios ^a   Tzoracoleftherakis, Evagelos ^a   Koukouras, Dimitrios ^a   Xepapadakis, Grigorios ^a   Papadiamantis, John ^a   Venizelos, Basileios ^a   Antonopoulou, Zoh ^a   Gogas, Helen ^a  

^a Hellenic Society of Breast Surgeons   (Greece)

^b UNIVERSITY OF ATHENS   (Greece)

Author keywords

[No Author keywords available]

Indexed keywords

CHOLESTEROL; EXEMESTANE; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; LOW DENSITY LIPOPROTEIN CHOLESTEROL; TAMOXIFEN; TRIACYLGLYCEROL; ANDROSTANE DERIVATIVE; AROMATASE INHIBITOR; ENZYME INHIBITOR; LIPID; STEROID;

ADULT; AGED; ARTICLE; BREAST CANCER; CANCER ADJUVANT THERAPY; CANCER HORMONE THERAPY; CANCER PATIENT; CANCER RADIOTHERAPY; CHOLESTEROL BLOOD LEVEL; CLINICAL OBSERVATION; DRUG EFFECT; FEMALE; FOLLOW UP; HUMAN; MAJOR CLINICAL STUDY; MULTIMODALITY CANCER THERAPY; OPEN STUDY; PARALLEL DESIGN; PHASE 3 CLINICAL TRIAL; POSTMENOPAUSE; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; TREATMENT DURATION; TRIACYLGLYCEROL BLOOD LEVEL; ADJUVANT CHEMOTHERAPY; BREAST TUMOR; CHEMISTRY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; METABOLISM; METHODOLOGY; MIDDLE AGED;

ADULT; AGED; ANDROSTADIENES; AROMATASE INHIBITORS; BREAST NEOPLASMS; CHEMOTHERAPY, ADJUVANT; CHOLESTEROL; ENZYME INHIBITORS; FEMALE; HUMANS; LIPIDS; MIDDLE AGED; POSTMENOPAUSE; STEROIDS; TAMOXIFEN;

EID: 74049164267     PISSN: 14655411     EISSN: 1465542X     Source Type: Journal    
DOI: 10.1186/bcr2320     Document Type: Article

References (46)

1. Gail MH, Costantino JP, Bryant J, Croyle R, Freedman L, Helzlsouer K, Vogel V. Weighing the risks and benefits of tamoxifen treatment for preventing breast cancer. J Natl Cancer Inst 1999, 91:1829-1846. 10547390, 10547390, 10.1093/jnci/91.21.1829.
2. Robertson JF, Osborne CK, Howell A, Jones SE, Mauriac L, Ellis M, Kleeberg UR, Come SE, Vergote I, Gertler S, Buzdar A, Webster A, Morris C. Fulvestrant versus anastrozole for the treatment of advanced breast carcinoma in postmenopausal women: a prospective combined analysis of two multicenter trials. Cancer 2003, 98:229-238. 12872340, 12872340, 10.1002/cncr.11468.
3. Chia S, Gradishar W, Mauriac L, Bines J, Amant F, Federico M, Fein L, Romieu G, Buzdar A, Robertson JF, Brufsky A, Possinger K, Rennie P, Sapunar F, Lowe E, Piccart M. Double-blind, randomized placebo controlled trial of fulvestrant compared with exemestane after prior nonsteroidal aromatase inhibitor therapy in postmenopausal women with hormone receptor-positive advanced breast cancer: results from EFECT. J Clin Oncol 2008, 26:1664-1670. 18316794, 10.1200/JCO.2007.13.5822.
4. Ingle JN, Suman VJ. Aromatase inhibitors for therapy of advanced breast cancer. J Steroid Biochem Mol Biol 2005, 95:3-119. 16054355, 10.1016/j.jsbmb.2005.04.014.
5. Gibson LJ, Dawson CK, Lawrence DH, Bliss JM. Aromatase inhibitors for treatment of advanced breast cancer in postmenopausal women. Cochrane Database Syst Rev 2007, CD003370.
6. The ATAC (Arimidex, Tamoxifen Alone or in Combination) Trialists' Group Anastrozole alone or in combination with tamoxifen versus tamoxifen alone for adjuvant treatment of postmenopausal women with early-stage breast cancer: results of the ATAC (Arimidex, Tamoxifen Alone or in Combination) trial: efficacy and safety update analyses. Cancer 2003, 98:1802-1810. 14584060, 10.1002/cncr.11745, The ATAC (Arimidex, Tamoxifen Alone or in Combination) Trialists' Group.
7. Thürlimann B, Keshaviah A, Coates AS, Mouridsen H, Mauriac L, Forbes JF, Paridaens R, Castiglione-Gertsch M, Gelber RD, Rabaglio M, Smith I, Wardley A, Price KN, Goldhirsch A. Breast International Group (BIG) 1-98 Collaborative Group A comparison of letrozole and tamoxifen in postmenopausal women with early breast cancer. N Engl J Med 2005, 353:2747-2757. 16382061, 10.1056/NEJMoa052258, Breast International Group (BIG) 1-98 Collaborative Group.
8. Coombes RC, Hall E, Gibson LJ, Paridaens R, Jassem J, Delozier T, Jones SE, Alvarez I, Bertelli G, Ortmann O, Coates AS, Bajetta E, Dodwell D, Coleman RE, Fallowfield LJ, Mickiewicz E, Andersen J, Lønning PE, Cocconi G, Stewart A, Stuart N, Snowdon CF, Carpentieri M, Massimini G, Bliss JM, Velde C. A randomized trial of exemestane after two to three years of tamoxifen therapy in postmenopausal women with primary breast cancer. N Engl J Med 2004, 350:1081-1092. 15014181, 10.1056/NEJMoa040331.
9. Goss PE, Ingle JN, Martino S, Robert NJ, Muss HB, Piccart MJ, Castiglione M, Tu D, Shepherd LE, Pritchard KI, Livingston RB, Davidson NE, Norton L, Perez EA, Abrams JS, Cameron DA, Palmer MJ, Pater JL. Randomized trial of letrozole following tamoxifen as extended adjuvant therapy in receptor-positive breast cancer: updated findings from NCIC CTG MA.17. J Natl Cancer Inst 2005, 97:1262-1271.
10. Winer EP, Hudis C, Burstein HJ, Wolff AC, Pritchard KI, Ingle JN, Chlebowski RT, Gelber R, Edge SB, Gralow J, Cobleigh MA, Mamounas EP, Goldstein LJ, Whelan TJ, Powles TJ, Bryant J, Perkins C, Perotti J, Braun S, Langer AS, Browman GP, Somerfield MR. American Society of Clinical Oncology technology assessment on the use of aromatase inhibitors as adjuvant therapy for postmenopausal women with hormone receptor-positive breast cancer: status report, 2004. J Clin Oncol 2005, 23:619-629. 15545664, 10.1200/JCO.2005.09.121.
11. Goldhirsch A, Wood WC, Gelber RD, Coates AS, Thürlimann B, Senn HJ. Progress and promise: highlights of the international expert consensus on the primary therapy of early breast cancer 2007. Ann Oncol 2007, 18:1133-1144. 17675394, 10.1093/annonc/mdm271.
12. NCCN Clinical Practice Guidelines in Oncology™. NCCN., http://www.nccn.org
13. Early Breast Cancer Trialists' Collaborative Group (EBCTCG) Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet 2005, 365:1687-1717. 15894097, 10.1016/S0140-6736(05)66544-0, Early Breast Cancer Trialists' Collaborative Group (EBCTCG).
14. Fisher B, Dignam J, Bryant J, Wolmark N. Five versus more than five years of tamoxifen for lymph node-negative breast cancer: updated findings from the National Surgical Adjuvant Breast and Bowel Project B-14 randomized trial. J Natl Cancer Inst 2001, 93:684-690. 11333290, 10.1093/jnci/93.9.684.
15. Jakesz R, Samonigg H, Greil R, Gnant M, Schmid M, Kwasny W, . on behalf of the ABCSG Extended adjuvant treatment with anastrozole: results from the Austrian Breast and Colorectal Cancer Study Group Trial 6a (ABCSG-6a). J Clin Oncol 2005, 23:10S. (#526, abstract), on behalf of the ABCSG.
16. Mamounas E, Jeong J-H, Wickerham L, Smith R, Geyer C, Ganz P. Benefit from exemestane (EXE) as extended adjuvant therapy after 5 years of tamoxifen (TAM): intent-to-treat analysis of NSABP B-33. Breast Cancer Res Treat 2006, 100(suppl 1):S22. (#49, abstract).
17. Jacobs D, Blackburn H, Higgins M, Reed D, Iso H, McMillan G, Neaton J, Nelson J, Potter J, Rifkind B. Report of the Conference on Low Blood Cholesterol: mortality associations. Circulation 1992, 86:1046-1060.
18. Kritchevsky SB. Dietary lipids and the low blood cholesterol-cancer association. Am J Epidemiol 1992, 135:509-520.
19. National Center for Chronic Disease Prevention and Health Promotion. 2004, http://www.cdc.gov/nccdphp/
20. Kannel WB. Metabolic risk factors for coronary heart disease in women: perspective from the Framingham Study. Am Heart J 1987, 114:413-419. 3604900, 10.1016/0002-8703(87)90511-4.
21. Bass KM, Newschaffer CJ, KIag MJ, Bush TL. Plasma lipoprotein levels as predictors of cardiovascular death in women. Arch Intern Med 1993, 153:2209-2216. 8215724, 8215724, 10.1001/archinte.153.19.2209.
22. Korhonen T, Savolainen MJ, Ikäheimo M, Linnaluoto MK, Kervinen K, Kesäniemi VA. Association of lipoprotein cholesterol and triglycerides with the severity of coronary artery disease in men and women. Atherosclerosis 1996, 127:213-220. 9125311, 10.1016/S0021-9150(96)05958-8.
23. Levi F, Randimbison L, Te VC, La Vecchia C. Long-term mortality of women with a diagnosis of breast cancer. Oncology 2002, 63:266-269. 12381906, 10.1159/000065475.
24. Goss PE. Risks versus benefits in the clinical application of aromatase inhibitors. Endocr Relat Cancer 1999, 6:325-332. 10731126, 10731126, 10.1677/erc.0.0060325.
25. Grady D, Rubin SM, Petitti DB, Fox CS, Black D, Ettinger B, Ernster VL, Cummings SR. Hormone therapy to prevent disease and prolong life in postmenopausal women. Ann Intern Med 1992, 117:1016-1037.
26. Daly E, Roche M, Barlow D, Gray A, McPherson K, Vessey M. HRT: an analysis of benefits, risks, and costs. Br Med Bull 1992, 48:368-400. 1450876, 1450876.
27. Love RR, Wiebe DA, Feyzi JM, Newcomb PA, Chappell RJ. Effects of tamoxifen on cardiovascular risk factors in postmenopausal women after 5 years of treatment. J Natl Cancer Inst 1994, 86:1534-1539. 7932809, 10.1093/jnci/86.20.1534.
28. Elisaf M, Bairaktari E, Nicolaides C, Kakaidi B, Tzallas CS, Katsaraki A, Pavlidis NA. The beneficial effect of tamoxifen on serum lipoprotein-A levels: an additional anti-atherogenic property. Anticancer Res 1996, 16:2725-2728.
29. Markopoulos C, Chrissochou M, Antonopoulou Z, Xepapadakis G, Papadiamantis J, Tzoracoleftherakis E, Gogas H. Duration of tamoxifen effect on lipidemic profile of postmenopausal breast cancer patients following deprivation of treatment. Oncology 2006, 70:301-305. 17047401, 10.1159/000096251.
30. Evans TR, Di Salle E, Ornati G, Lassus M, Benedetti MS, Pianezzola E, Coombes RC. Phase I and endocrine study of exemestane (FCE24304), a new aromatase inhibitor, in postmenopausal women. Cancer Res 1992, 52:5933-5939.
31. Giudici D, Ornati G, Briatico G, Buzzeti F, Lambardi P, di Salle E. 6-Methylenandrosta-1,4-diene-3,17-dione (FCE24304): a new irreversible aromatase inhibitor. J Steroid Biochem 1988, 30:391-394. 3386266, 10.1016/0022-4731(88)90129-X.
32. Coombes RC, Kilburn LS, Snowdon CF, Paridaens R, Coleman RE, Jones SE, Jassem J, Velde CJ, Delozier T, Alvarez I, Del Mastro L, Ortmann O, Diedrich K, Coates AS, Bajetta E, Holmberg SB, Dodwell D, Mickiewicz E, Andersen J, Lønning PE, Cocconi G, Forbes J, Castiglione M, Stuart N, Stewart A, Fallowfield LJ, Bertelli G, Hall E, Bogle RG, Carpentieri M, et al. Survival and safety of exemestane versus tamoxifen after 2-3 years' tamoxifen treatment (Intergroup Exemestane Study): a randomised controlled trial. Lancet 2007, 369:559-570. Erratum in: Lancet 2007, 369:906, 17307102, 17307102, 10.1016/S0140-6736(07)60200-1.
33. Markopoulos C, Chrissochou M, Michailidou A, Tzoracoleftherakis E, Xepapadakis G, Papadiamantis J, Misitzis J, Zobolas V, Bafaloukos D, Gogas H. Effect of exemestane on the lipidemic profile of post-menopausal operable breast cancer patients following 5-7 years of adjuvant tamoxifen: preliminary results of the ATENA substudy. Anticancer Drugs 2005, 16:879-883. 16096437, 10.1097/01.cad.0000173478.12981.e1.
34. Laird NM, Ware JH. Random effect models for longitudinal data. Biometrics 1982, 38:963-974. 7168798, 10.2307/2529876.
35. Zilembo N, Noberasco C, Bajetta E, Martinetti A, Mariani L, Orefice S, Buzzoni R, Di Bartolomeo M, Di Leo A, Laffranchi A. Endocrinological and clinical evaluation of exemestane, a new steroidal aromatase inhibitor. Br J Cancer 1995, 72:1007-1012.
36. Di Salle E, Ornati G, Giudici D, Lassus M, Evans TR, Coombes RC. Exemestane (FCE24304), a new steroidal aromatase inhibitor. J Steroid Biochem Mol Biol 1992, 43:137-143. 1525055, 10.1016/0960-0760(92)90198-R.
37. Food and Drug Administration Center for Drug Evaluation and Research application number NDA 20753 (Exemestane) Medical Review. 1999, Rockville, MD: FDA, Food and Drug Administration.
38. LaRosa JC. Triglycerides and coronary risk in women and the elderly. Arch Intern Med 1997, 157:961-968. 9140266, 10.1001/archinte.157.9.961.
39. Engan T, Krane J, Johannessen DC, Lønning PE, Kvinnsland S. Plasma changes in breast cancer patients during endocrine therapy: lipid measurements and nuclear magnetic imaging (NMR) spectroscopy. Breast Cancer Res Treat 1995, 36:287-297. 8573711, 10.1007/BF00713400.
40. Atalay G, Dirix L, Biganzoli L, Beex L, Nooij M, Cameron D, Lohrisch C, Cufer T, Lobelle JP, Mattiaci MR, Piccart M, Paridaens R. The effect of exemestane on serum lipid profile in postmenopausal women with metastatic breast cancer: a companion study to EORTC Trial 10951: "randomized phase II study in first line hormonal treatment for metastatic breast cancer with exemestane or tamoxifen in postmenopausal patients". Ann Oncol 2004, 15:211-217. 14760111, 10.1093/annonc/mdh064.
41. Francini G, Petrioli R, Montagnani A, Cadirni A, Campagna S, Francini E, Gonnelli S. Exemestane after tamoxifen as adjuvant hormonal therapy in postmenopausal women with breast cancer: effects on body composition and lipids. Br J Cancer 2006, 95:153-158. 16835585, 10.1038/sj.bjc.6603258.
42. Lønning PE, Geisler J, Krag LE, Erikstein B, Bremnes Y, Hagen AI, Schlichting E, Lien EA, Ofjord ES, Paolini J, Polli A, Massimini G. Effects of exemestane administered for 2 years versus placebo on bone mineral density, bone biomarkers, and plasma lipids in patients with surgically resected early breast cancer. J Clin Oncol 2005, 23:5126-5137. 15983390, 10.1200/JCO.2005.07.097.
43. Markopoulos C, Polychronis A, Zobolas V, Xepapadakis G, Papadiamantis J, Koukouras D, Lappas H, Gogas H. The effect of exemestane on the lipidemic profile of postmenopausal early breast cancer patients: preliminary results of the TEAM Greek sub-study. Breast Cancer Res Treat 2005, 93:61-66. 16184460, 10.1007/s10549-005-3783-0.
44. Markopoulos C, Polychronis A, Dafni U, Koukouras D, Zobolas V, Tzorakoleftherakis E, Xepapadakis G, Gogas H. Lipid changes in breast cancer patients on exemestane treatment: final results of the TEAM Greek substudy. Ann Oncol 2009, 20:49-55. 18678766, 10.1093/annonc/mdn545.
45. Wasan KM, Goss PE, Pritchard PH, Shepherd L, Palmer MJ, Liu S, Tu D, Ingle JN, Heath M, Deangelis D, Perez EA. The influence of letrozole on serum lipid concentrations in postmenopausal women with primary breast cancer who have completed 5 years of adjuvant tamoxifen (NCIC CTG MA.17L). Ann Oncol 2005, 16:707-715. 15817595, 10.1093/annonc/mdi158.
46. McCloskey E, Eastell R, Lakner G, Miyamoto A, Clack G. Initial results from the LEAP study: the first direct comparison of safety parameters between aromatase inhibitors in healthy postmenopausal women. Breast Cancer Res Treat 2005, 94(suppl 1):S101. Abstract 2052.