Assessment of letrozole and tamoxifen alone and in sequence for postmenopausal women with steroid hormone receptor-positive breast cancer: the BIG 1-98 randomised clinical trial at 8·1 years median follow-up

The Lancet Oncology - Tập 12 - Trang 1101-1108 - 2011
Meredith M Regan1,2, Patrick Neven3, Anita Giobbie-Hurder1, Aron Goldhirsch4,5, Bent Ejlertsen6, Louis Mauriac7, John F Forbes8, Ian Smith9,10, István Láng11, Andrew Wardley12, Manuela Rabaglio13, Karen N Price1,14, Richard D Gelber1,2,14, Alan S Coates15, Beat Thürlimann16,17
1International Breast Cancer Study Group (IBCSG) Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA, USA
2Harvard Medical School and Harvard School of Public Health, Boston, MA, USA
3Department of Medical Oncology, University Hospital Gasthuisberg, Catholic University of Leuven, Leuven, Belgium
4European Institute of Oncology, Milan, Italy
5Swiss Center for Breast Health, Sant'Anna Clinics, Lugano-Sorengo, Switzerland
6Danish Breast Cancer Cooperative Group (DBCG), Rigshospitalet, Copenhagen, Denmark
7Fédération Nationale des Centres de Lutte Contre le Cancer, Institut Bergonié, Bordeaux, France
8Australian New Zealand Breast Cancer Trials Group, University of Newcastle, Calvary Mater Newcastle, Newcastle, NSW, Australia
9The Royal Marsden Hospital, London , UK
10Royal Marsden NHS Trust, Surrey, UK
11National Institute of Oncology, Budapest, Hungary
12Christie Hospital NHS Trust, South Manchester University Hospital Trust, Manchester, UK
13IBCSG Coordinating Center and Inselspital, Bern, Switzerland
14Frontier Science and Technology Research Foundation, Boston, MA, USA
15International Breast Cancer Study Group and University of Sydney, Sydney, Australia
16Breast Center, Kantonsspital, St. Gallen, Switzerland
17Swiss Group for Clinical Cancer Research (SAKK), Bern, Switzerland

Tài liệu tham khảo

Burstein, 2010, American Society of Clinical Oncology Clinical Practice Guideline: Update on adjuvant endocrine therapy for women with hormone receptor-positive breast cancer, J Clin Oncol, 28, 3784, 10.1200/JCO.2009.26.3756 2005, A comparison of letrozole and tamoxifen in postmenopausal women with early breast cancer, N Engl J Med, 353, 2747, 10.1056/NEJMoa052258 Coates, 2007, 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, 25, 486, 10.1200/JCO.2006.08.8617 2009, Letrozole therapy alone or in sequence with tamoxifen in women with breast cancer, N Engl J Med, 361, 766, 10.1056/NEJMoa0810818 Colleoni, 2011, Analyses adjusting for selective crossover show improved overall survival with adjuvant letrozole compared with tamoxifen in the BIG 1-98 study, J Clin Oncol, 29, 1117, 10.1200/JCO.2010.31.6455 Saphner, 1996, Annual hazard rates of recurrence for breast cancer after primary therapy, J Clin Oncol, 14, 2738, 10.1200/JCO.1996.14.10.2738 Pritchard, 2011, Long-term follow-up of women in trials of adjuvant therapy for breast cancer: is it still important?, J Clin Oncol, 29, 1651, 10.1200/JCO.2010.34.2766 Giobbie-Hurder, 2009, 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, 6, 272, 10.1177/1740774509105380 Hudis, 2007, Proposal for standardized definitions for efficacy end points in adjuvant breast cancer trials: the STEEP system, J Clin Oncol, 25, 2127, 10.1200/JCO.2006.10.3523 Dowsett, 2010, Meta-analysis of breast cancer outcomes in adjuvant trials of aromatase inhibitors versus tamoxifen, J Clin Oncol, 28, 509, 10.1200/JCO.2009.23.1274 Regan, 2011, Interpreting Breast International Group (BIG) 1-98: a randomized, double-blind, phase III trial comparing letrozole and tamoxifen as adjuvant endocrine therapy for postmenopausal women with receptor-positive, early breast cancer, Breast Cancer Res, 13, 209, 10.1186/bcr2837 Baum, 2002, 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, 2131, 10.1016/S0140-6736(02)09088-8 Finkelstein, 2011, Correcting for discretionary treatment crossover in an analysis of survival in the Breast International Group BIG 1-98 Trial by using the inverse probability of censoring weighted method, J Clin Oncol, 29, 1093, 10.1200/JCO.2010.33.9374 Mauriac, 2007, Predictors of early relapse in postmenopausal women with hormone receptor-positive breast cancer in the BIG 1-98 trial, Ann Oncol, 18, 859, 10.1093/annonc/mdm001 Viale, 2011, Which patients benefit most from adjuvant aromatase inhibitors? Results using a composite measure of prognostic risk in the BIG 1-98 randomized trial, Ann Oncol, 22, 2216, 10.1093/annonc/mdq738 Goldhirsch, 2007, Progress and promise: highlights of the international expert consensus on the primary therapy of early breast cancer 2007, Ann Oncol, 18, 1133, 10.1093/annonc/mdm271 Lazar, 2010, Evaluation of treatment-effect heterogeneity using biomarkers measured on a continuous scale: subpopulation treatment effect pattern plot, J Clin Oncol, 28, 4539, 10.1200/JCO.2009.27.9182 Amir, 2011, Toxicity of adjuvant endocrine therapy in postmenopausal breast cancer patients: a systematic review and meta-analysis, J Natl Cancer Inst, 103, 1, 10.1093/jnci/djr242 Goss, 2003, A randomized trial of letrozole in postmenopausal women after five years of tamoxifen therapy for early-stage breast cancer, N Engl J Med, 349, 1793, 10.1056/NEJMoa032312 Mamounas, 2008, 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, 26, 1965, 10.1200/JCO.2007.14.0228 Jordan, 2008, The 38th David A. Karnofsky lecture: the paradoxical actions of estrogen in breast cancer-survival or death?, J Clin Oncol, 26, 3073, 10.1200/JCO.2008.17.5190 Sabnis, 2008, Stopping treatment can reverse acquired resistance to letrozole, Cancer Res, 68, 4518, 10.1158/0008-5472.CAN-07-5999