The evolving role of letrozole in the adjuvant setting: First results from the large, phase III, randomized trial BIG 1-98

Breast

Volumn 15, Issue 1 SUPPL., 2006, Pages 21-29

  Monnier, A ^a  

^a Traumatologie du Centre Hospitalier de Belfort Montbéliard Site de Montbéliard   (France)

Author keywords

Adjuvant therapy; Aromatase inhibitors; BIG 1 98; Early breast cancer; Letrozole; Tamoxifen

Indexed keywords

AROMATASE INHIBITOR; LETROZOLE; TAMOXIFEN;

ADULT; ARTHROPATHY; ARTICLE; BREAST CANCER; CANCER ADJUVANT THERAPY; CANCER HORMONE THERAPY; CANCER SURVIVAL; CARDIOVASCULAR DISEASE; CEREBROVASCULAR DISEASE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; EARLY CANCER; ENDOMETRIUM CANCER; FEMALE; FRACTURE; HAZARD ASSESSMENT; HEART FAILURE; HUMAN; HYPERCHOLESTEROLEMIA; MAJOR CLINICAL STUDY; METASTASIS; MONOTHERAPY; PHASE 3 CLINICAL TRIAL; POSTMENOPAUSE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RISK REDUCTION; STATISTICAL ANALYSIS; THROMBOEMBOLISM; TRANSIENT ISCHEMIC ATTACK; VAGINA BLEEDING;

EID: 33144456352     PISSN: 09609776     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.breast.2006.01.004     Document Type: Article

References (29)

1. Early Breast Cancer Trialists' Collaborative Group Tamoxifen for early breast cancer: An overview of the randomised trials Lancet 351 1998 1451-1467
2. B. Fisher J.P. Costantino D.L. Wickerham C.K. Redmond et al. Tamoxifen for prevention of breast cancer: Report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study J Natl Cancer Inst 90 1998 1371-1388
3. J. Cuzick T. Powles U. Veronesi et al. Overview of the main outcomes in breast-cancer prevention trials Lancet 361 2003 296-300
4. B. Fisher J. Dignam J. Bryant N. Wolmark 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 93 2001 684-690
5. F. Janicke Are all aromatase inhibitors the same? A review of the current evidence Breast 13 Suppl. 1 2004 S10-S18
6. A.S. Bhatnagar D. Batzl A. Hausler K. Schieweck M. Lang P.F. Trunet Pharmacology of non-steroidal aromatase inhibitors J.R. Pasqualini B.S. Katzenellenbogen Hormone-dependent cancer 1996 Marcel Dekker New York 155-168
7. A.S. Bhatnagar C. Batzl A. Hausler V. Nogues The role of estrogen in the feedback regulation of follicle-stimulating hormone secretion in the female rat J Steroid Biochem Mol Biol 47 1993 161-166
8. J. Geisler B. Haynes G. Anker M. Dowsett P.E. Lonning Influence of letrozole and anastrozole on total body aromatization and plasma estrogen levels in postmenopausal breast cancer patients evaluated in a randomized, cross-over study J Clin Oncol 20 2002 751-757
9. A. Bernardi C. Zamagni F. Di Fabio E. Piana A. Martoni F. Vecchi Randomized comparative study on estrogen suppression induced by 3 different aromatase inhibitors in postmenopausal patients with advanced breast cancer Proc Am Soc Clin Oncol 21 2002 55a [Abstract 217]
10. P. Dombernowsky I. Smith G. Falkson et al. Letrozole, a new oral aromatase inhibitor for advanced breast cancer: Double-blind randomized trial showing a dose effect and improved efficacy and tolerability compared with megestrol acetate J Clin Oncol 16 1998 453-461
11. H. Mouridsen M. Gershanovich Y. Sun et al. Superior efficacy of letrozole versus tamoxifen as first-line therapy for postmenopausal women with advanced breast cancer: Results of a phase III study of the International Letrozole Breast Cancer Group J Clin Oncol 19 2001 2596-2606
12. H. Mouridsen M. Gershanovich Y. Sun et al. Phase III study of letrozole versus tamoxifen as first-line therapy of advanced breast cancer in postmenopausal women: Analysis of survival and update of efficacy from the International Letrozole Breast Cancer Group J Clin Oncol 21 2003 2101-2109
13. C. Rose O. Vtoraya A. Pluzanska et al. An open randomised trial of second-line endocrine therapy in advanced breast cancer. Comparison of the aromatase inhibitors letrozole and anastrozole Eur J Cancer 39 2003 2318-2327
14. W. Eiermann S. Paepke J. Appfelstaedt et al. Letrozole Neo-Adjuvant Breast Cancer Study Group Preoperative treatment of postmenopausal breast cancer patients with letrozole: A randomized double-blind multicenter study Ann Oncol 12 2001 1527-1532
15. P.E. Goss J.N. Ingle S. Martino et al. A randomized trial of letrozole in postmenopausal women after five years of tamoxifen therapy for early stage breast cancer N Engl J Med 349 2003 1793-1802
16. P.E. Goss J.N. Ingle S. Martino N.J. Robert H.B. Muss M.J. Piccart et al. 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 97 2005 1262-1271
17. B. Thürlimann Letrozole vs. tamoxifen as adjuvant endocrine therapy for postmenopausal women with receptor positive breast cancer, BIG 1-98: A prospective, randomized, double blind, phase III study Breast 14 Suppl. 1 2005 S3 [Abstract S4]
18. M. Baum A. Buzdar J. Cuzick et. al. 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 98 2003 1802-1810
19. The 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 353 2005 2747-2757
20. M. Baum A.U. Budzar J. Cuzick et al. ATAC Trialists' Group Anastrozole alone or in combination with tamoxifen versus tamoxifen alone for adjuvant treatment of postmenopausal women with early breast cancer: first results of the ATAC randomised trial Lancet 359 2002 2131-2139
21. R.C. Coombes E. Hall L.F. Gibson et al. A randomized trial of exemestane after two to three years of tamoxifen therapy in postmenopausal women with primary breast cancer N Engl J Med 350 2004 1081-1092
22. S.S. Franklin W. Gustin IV N.D. Wong et al. Hemodynamic patterns of age-related changes in blood pressure. The Framingham Heart Study Circulation 96 1997 308-315
23. C.C. McDonald F.E. Alexander B.W. Whyte A.P. Forrest H.J. Stewart Cardiac and vascular morbidity in women receiving adjuvant tamoxifen for breast cancer in a randomised trial. The Scottish Cancer Trials Breast Group Br Med J 311 1995 977-980
24. L.E. Rutqvist A. Mattsson Cardiac and thromboembolic morbidity among postmenopausal women with early stage breast cancer in a randomized trial of adjuvant tamoxifen. The Stockholm Breast Cancer Study Group J Natl Cancer Inst 85 1993 1398-1406
25. C. Harper-Wynne G. Ross N. Sacks et al. Effects of the aromatase inhibitor letrozole on normal breast epithelial cell proliferation and metabolic indices in postmenopausal women: A pilot study for breast cancer prevention Cancer Epidemiol Biomarkers Prev 11 2002 614-621
26. H.M. Heshmati S. Khosla S.P. Robins W.M. O'Fallon L.J. Melton III B.L. Riggs Role of low levels of endogenous estrogens in regulation of bone resorption in late postmenopausal women J Bone Miner Res 17 2002 172-178
27. A. Brufsky G. Harker T. Beck et al. Zoledronic acid (ZA) effectively inhibits cancer treatment-induced bone loss (CTIBL) in postmenopausal women (PMW) with early breast cancer (BCa) receiving adjuvant Letrozole (Let): 12 mos BMD results of the Z-FAST trial J Clin Oncol 23 Suppl. 16 2005 12S [Abstract 533]
28. N. Davidson P. Neven A. Llombart et al. Zoledronic acid in the prevention of cancer treatment induced bone loss in post menopausal women receiving letrozole as adjuvant therapy for early breast cancer Breast 14 Suppl. 1 2005 S44 [Abstract P105]
29. B.J. Thürlimann A. Keshaviah H. Mouridsen et al. BIG 1-98: Randomized double-blind phase III study to evaluate letrozole (L) vs. tamoxifen (T) as adjuvant endocrine therapy for postmenopausal women with receptor-positive breast cancer Proc Am Soc Clin Oncol 23 Suppl. 16 2005 6S [Abstract 511. Presented slides are available at: http://www.asco.org/ac/1,1003,_12-002511-00_18-0034-00_19-003771,00.asp]