Letrozole therapy alone or in sequence with tamoxifen in women with breast cancer

New England Journal of Medicine

Volumn 361, Issue 8, 2009, Pages 766-776

  Mouridsen, Henning ^a   Giobbie Hurder, Anita ^b   Goldhirsch, Aron ^e,f   Thürlimann, Beat ^g,h   Paridaens, Robert ⁱ   Smith, Ian ^j,k   Mauriac, Louis ^l   Forbes, John F ^m   Price, Karen N ^b,d   Regan, Meredith M ^b,c   Gelber, Richard D ^b,c,d   Coates, Alan S ⁿ  

^a Rigshospitalet   (Denmark)

^b DANA FARBER CANCER INSTITUTE   (United States)

^c HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

^d FRONTIER SCIENCE AND TECHNOLOGY RESEARCH FOUNDATION   (United States)

^e EUROPEAN INSTITUTE OF ONCOLOGY   (Italy)

^f ONCOLOGY INSTITUTE OF SOUTHERN SWITZERLAND   (Switzerland)

^g CANTONAL HOSPITAL ST GALLEN   (Switzerland)

^h SWISS GROUP FOR CLINICAL CANCER RESEARCH SAKK   (Switzerland)

ⁱ UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^j ROYAL MARSDEN HOSPITAL   (United Kingdom)

^k INSTITUTE OF CANCER RESEARCH   (United Kingdom)

^l INSTITUT BERGONIÉ   (France)

^m UNIVERSITY OF NEWCASTLE   (Australia)

ⁿ UNIVERSITY OF SYDNEY   (Australia)

more..

Author keywords

[No Author keywords available]

Indexed keywords

HORMONE RECEPTOR; LETROZOLE; TAMOXIFEN;

ADULT; AGED; ARTHRALGIA; ARTICLE; BREAST CANCER; CANCER CHEMOTHERAPY; CANCER RELAPSE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE FREE SURVIVAL; DOUBLE BLIND PROCEDURE; DRUG FATALITY; ENDOMETRIUM CANCER; FEMALE; FOLLOW UP; FRACTURE; HOT FLUSH; HUMAN; HYPERCHOLESTEROLEMIA; MAJOR CLINICAL STUDY; MONOTHERAPY; MYALGIA; NIGHT SWEAT; OVERALL SURVIVAL; PHASE 3 CLINICAL TRIAL; POSTMENOPAUSE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; STROKE; THROMBOEMBOLISM; TRANSIENT ISCHEMIC ATTACK; TREATMENT DURATION; VAGINA BLEEDING;

EID: 69049113989     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMoa0810818     Document Type: Article

References (29)

1. Early Breast Cancer Trialists' Collaborative Group. Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet 2005;365:1687-717.
2. 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 2005;353:2747-57.
3. Coates AS, Keshaviah A, Thürlimann B, et al. Five years of letrozole compared with tamoxifen as initial adjuvant therapy for postmenopausal women with endocrine-responsive early breast cancer: update of study BIG 1-98. J Clin Oncol 2007;25:486-92.
4. Forbes JF, Cuzick J, Buzdar A, Howell A, Tobias JS, Baum M. Effect of anastrozole and tamoxifen as adjuvant treatment for early-stage breast cancer: 100-month analysis of the ATAC trial. Lancet Oncol 2008;9:45-53.
5. Baum M, Budzar AU, Cuzick J, et al. 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 2002;359:2131-9. [Erratum, Lancet 2002;360:1520.]
6. Coombes RC, Hall E, Gibson LJ, 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 2004;350:1081-92. [Erratum, N Engl J Med 2004;351:2461.]
7. Jakesz R, Jonat W, Gnant M, et al. Switching of postmenopausal women with endocrine-responsive early breast cancer to anastrozole after 2 years' adjuvant tamoxifen: combined results of ABCSG trial 8 and ARNO 95 trial. Lancet 2005;366:455-62.
8. Kaufmann M, Jonat W, Hilfrich J, et al. Improved overall survival in postmenopausal women with early breast cancer after anastrozole initiated after treatment with tamoxifen compared with continued tamoxifen: the ARNO 95 Study. J Clin Oncol 2007;25:2664-70.
9. Boccardo F, Rubagotti A, Puntoni M, et al. Switching to anastrozole versus continued tamoxifen treatment of early breast cancer: preliminary results of the Italian Tamoxifen Anastrozole Trial. J Clin Oncol 2005;23:5138-47.
10. Boccardo F. Switching to anastrozole after tamoxifen improves survival in postmenopausal women with breast cancer. Nat Clin Pract Oncol 2008;5:76-7.
11. Coombes RC, Kilburn LS, Snowdon CF, et al. Survival and safety of exemestane versus tamoxifen after 2-3 years' tamoxifen treatment (Intergroup Exemestane Study): a randomised controlled trial. Lancet 2007;369:559-70. [Erratum, Lancet 2007;369:906.]
12. Jonat W, Gnant M, Boccardo F, et al. Effectiveness of switching from adjuvant tamoxifen to anastrozole in postmenopausal women with hormone-sensitive early-stage breast cancer: a meta-analysis. Lancet Oncol 2006;7:991-6. [Erratum, Lancet Oncol 2007;8:6.]
13. Ingle JN, Dowsett M, Cuzick J, Davies C. Aromatase inhibitors versus tamoxifen as adjuvant therapy for postmenopausal women with estrogen receptor positive breast cancer: meta-analyses of randomized trials of monotherapy and switching strategies. Cancer Res 2009;69:Suppl:12. abstract.
14. Winer EP, Hudis C, Burstein HJ, et al. 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;23:619-29.
15. Goldhirsch A, Wood WC, Gelber RD, et al. Progress and promise: highlights of the international expert consensus on the primary therapy of early breast cancer 2007. Ann Oncol 2007;18:1133-44. [Erratum, Ann Oncol 2007;18:1917.]
16. Carlson RW, Brown E, Burstein HJ, et al. NCCN Task Force report: adjuvant therapy for breast cancer. J Natl Compr Canc Netw 2006;4:Suppl 1:S1-S26.
17. Cuzick J, Sasieni P, Howell A. Should aromatase inhibitors be used as initial adjuvant treatment or sequenced after tamoxifen? Br J Cancer 2006;94:460-4.
18. Punglia RS, Kuntz KM, Winer EP, Weeks JC, Burstein HJ. Optimizing adjuvant endocrine therapy in postmenopausal women with early-stage breast cancer: a decision analysis. J Clin Oncol 2005;23:5178-87.
19. Giobbie-Hurder A, Price KN, Gelber RD. Design, conduct, and analyses of Breast International Group (BIG) 1-98: a randomized, double-blind, phase-III study comparing letrozole and tamoxifen as adjuvant endocrine therapy for postmenopausal women with receptor-positive, early breast cancer. Clin Trials 2009;6:272-87.
20. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958;53:457-81.
21. Cox DR. Regression models and life-tables. J R Stat Soc [B] 1972;34:187-220.
22. Gray RJ. A class of k-sample tests for comparing the cumulative incidence of a competing risk. Ann Stat 1988;16:1141-54.
23. Mauriac L, Keshaviah A, Debled M, et al. Predictors of early relapse in postmenopausal women with hormone receptor-positive breast cancer in the BIG 1-98 trial. Ann Oncol 2007;18:859-67.
24. Wang R, Lagakos SW, Ware JH, Hunter DJ, Drazen JM. Statistics in medicine - reporting of subgroup analyses in clinical trials. N Engl J Med 2007;357:2189-94.
25. Goss PE, Ingle JN, Martino S, 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 2003;349:1793-802.
26. Mamounas EP, Jeong JH, Wickerham DL, et al. Benefit from exemestane as extended adjuvant therapy after 5 years of adjuvant tamoxifen: intention-to-treat analysis of the National Surgical Adjuvant Breast and Bowel Project B-33 trial. J Clin Oncol 2008;26:1965-71.
27. Clinical Trials (PDQ). Phase III randomized study of continuous letrozole versus intermittent letrozole in postmenopausal women with hormone receptor-positive, node-positive, early-stage breast cancer after completion of 4 to 6 years of prior adjuvant endocrine therapy. Bethesda, MD: National Cancer Institute. (Accessed July 24, 2009, at http://www.cancer.gov/clinicaltrials/ IBCSG-35-07.)
28. Jordan VC. The 38th David A. Karnofsky lecture: the paradoxical actions of estrogen in breast cancer - survival or death? J Clin Oncol 2008;26:3073-82.
29. Sabnis GJ, Macedo LF, Goloubeva O, Schayowitz A, Brodie AM. Stopping treatment can reverse acquired resistance to letrozole. Cancer Res 2008;68:4518-24.