Absolute Benefit of Adjuvant Endocrine Therapies for Premenopausal Women With Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer: TEXT and SOFT Trials

被引:142
作者
Regan, Meredith M. [1 ]
Francis, Prudence A. [4 ,5 ]
Pagani, Olivia [7 ]
Fleming, Gini F. [8 ]
Walley, Barbara A. [9 ]
Viale, Giuseppe [10 ,11 ]
Colleoni, Marco [11 ]
Lang, Istvan [14 ]
Gomez, Henry L. [15 ]
Tondini, Carlo [12 ]
Pinotti, Graziella [13 ]
Price, Karen N. [2 ]
Coates, Alan S. [6 ]
Goldhirsch, Aron [11 ]
Gelber, Richard D. [1 ,2 ,3 ]
机构
[1] Harvard Univ, Sch Med, Dana Farber Canc Inst, Cambridge, MA 02138 USA
[2] Frontier Sci & Technol Res Fdn Inc, Boston, MA USA
[3] Harvard Univ, TH Chan Sch Publ Hlth, Boston, MA 02115 USA
[4] Univ Melbourne, St Vincents Hosp, MacCallum Canc Ctr, Melbourne, Vic 3010, Australia
[5] Univ Newcastle, Newcastle, NSW 2300, Australia
[6] Univ Sydney, Sydney, NSW 2006, Australia
[7] Inst Oncol Southern Switzerland, Lugano Viganello, Switzerland
[8] Univ Chicago, Med Ctr, Chicago, IL 60637 USA
[9] Natl Canc Inst Canada Clin Trials Grp, Calgary, AB, Canada
[10] Univ Milan, I-20122 Milan, Italy
[11] European Inst Oncol, Milan, Italy
[12] Osped Papa Giovanni XXIII, Bergamo, Italy
[13] Osped Circolo & Fdn Macchi, Varese, Italy
[14] Natl Inst Oncol, Budapest, Hungary
[15] Inst Nacl Enfermedades Neoplast, Lima, Peru
关键词
INTERNATIONAL EXPERT CONSENSUS; PATIENT-REPORTED OUTCOMES; OVARIAN SUPPRESSION; CLINICAL-TRIALS; TAMOXIFEN; EXEMESTANE; KI-67;
D O I
10.1200/JCO.2015.64.3171
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Purpose Risk of recurrence is the primary consideration in breast cancer adjuvant therapy recommendations. The TEXT (Tamoxifen and Exemestane Trial) and SOFT (Suppression of Ovarian Function Trial) trials investigated adjuvant endocrine therapies for premenopausal women with hormone receptor-positive breast cancer, testing exemestane plus ovarian function suppression (OFS), tamoxifen plus OFS, and tamoxifen alone. We examined absolute treatment effect across a continuum of recurrence risk to individualize endocrine therapy decision making for premenopausal women with human epidermal growth factor receptor 2 (HER2) -negative disease. Patients and Methods The TEXT and SOFT hormone receptor-positive, HER2-negative analysis population included 4,891 women. The end point was breast cancer-free interval (BCFI), defined as time from random assignment to first occurrence of invasive locoregional, distant, or contralateral breast cancer. A continuous, composite measure of recurrence risk for each patient was determined from a Cox model incorporating age, nodal status, tumor size and grade, and estrogen receptor, progesterone receptor, and Ki-67 expression levels. Subpopulation treatment effect pattern plot methodology revealed differential treatment effects on 5-year BCFI according to composite risk. Results SOFT patients who remained premenopausal after chemotherapy experienced absolute improvement of 5% or more in 5-year BCFI with exemestane plus OFS versus tamoxifen plus OFS or tamoxifen alone, reaching 10% to 15% at intermediate to high composite risk; the benefit of tamoxifen plus OFS versus tamoxifen alone was apparent at the highest composite risk. The SOFT no-chemotherapy cohort-for whom composite risk was lowest on average-did well with all endocrine therapies. For TEXT patients, the benefit of exemestane plus OFS versus tamoxifen plus OFS in 5-year BCFI ranged from 5% to 15%; patients not receiving chemotherapy and with lowest composite risk did well with both treatments. Conclusion Premenopausal women with hormone receptor-positive, HER2-negative disease and high recurrence risk, as defined by clinicopathologic characteristics, may experience improvement of 10% to 15% in 5-year BCFI with exemestane plus OFS versus tamoxifen alone. An improvement of at least 5% may be achieved for women at intermediate risk, and improvement is minimal for those at lowest risk. (C) 2016 by American Society of Clinical Oncology
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收藏
页码:2221 / +
页数:13
相关论文
共 22 条
[1]   Patient-reported outcomes with adjuvant exemestane versus tamoxifen in premenopausal women with early breast cancer undergoing ovarian suppression (TEXT and SOFT): a combined analysis of two phase 3 randomised trials [J].
Bernhard, Juerg ;
Luo, Weixiu ;
Ribi, Karin ;
Colleoni, Marco ;
Burstein, Harold J. ;
Tondini, Carlo ;
Pinotti, Graziella ;
Spazzapan, Simon ;
Ruhstaller, Thomas ;
Puglisi, Fabio ;
Pavesi, Lorenzo ;
Parmar, Vani ;
Regan, Meredith M. ;
Pagani, Olivia ;
Fleming, Gini F. ;
Francis, Prudence A. ;
Price, Karen N. ;
Coates, Alan S. ;
Gelber, Richard D. ;
Goldhirsch, Aron ;
Walley, Barbara A. .
LANCET ONCOLOGY, 2015, 16 (07) :848-858
[2]   Patterns of treatment effects in subsets of patients in clinical trials [J].
Bonetti, M ;
Gelber, RD .
BIOSTATISTICS, 2004, 5 (03) :465-481
[3]   Adjuvant Endocrine Therapy for Women With Hormone Receptor-Positive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline Focused Update [J].
Burstein, Harold J. ;
Temin, Sarah ;
Anderson, Holly ;
Buchholz, Thomas A. ;
Davidson, Nancy E. ;
Gelmon, Karen E. ;
Giordano, Sharon H. ;
Hudis, Clifford A. ;
Rowden, Diana ;
Solky, Alexander J. ;
Stearns, Vered ;
Winer, Eric P. ;
Griggs, Jennifer J. .
JOURNAL OF CLINICAL ONCOLOGY, 2014, 32 (21) :2255-+
[4]   Tailoring therapies-improving the management of early breast cancer: St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2015 [J].
Coates, A. S. ;
Winer, E. P. ;
Goldhirsch, A. ;
Gelber, R. D. ;
Gnant, M. ;
Piccart-Gebhart, M. ;
Thuerlimann, B. ;
Senn, H. -J. .
ANNALS OF ONCOLOGY, 2015, 26 (08) :1533-1546
[5]   Analyses Adjusting for Selective Crossover Show Improved Overall Survival With Adjuvant Letrozole Compared With Tamoxifen in the BIG 1-98 Study [J].
Colleoni, Marco ;
Giobbie-Hurder, Anita ;
Regan, Meredith M. ;
Thuerlimann, Beat ;
Mouridsen, Henning ;
Mauriac, Louis ;
Forbes, John F. ;
Paridaens, Robert ;
Lang, Istvan ;
Smith, Ian ;
Chirgwin, Jacquie ;
Pienkowski, Tadeusz ;
Wardley, Andrew ;
Price, Karen N. ;
Gelber, Richard D. ;
Coates, Alan S. ;
Goldhirsch, Aron .
JOURNAL OF CLINICAL ONCOLOGY, 2011, 29 (09) :1117-1124
[6]   Ki-67 as prognostic marker in early breast cancer: a meta-analysis of published studies involving 12 155 patients [J].
de Azambuja, E. ;
Cardoso, F. ;
de Castro, G., Jr. ;
Colozza, M. ;
Mano, M. S. ;
Durbecq, V. ;
Sotiriou, C. ;
Larsimont, D. ;
Piccart-Gebhart, M. J. ;
Paesmans, M. .
BRITISH JOURNAL OF CANCER, 2007, 96 (10) :1504-1513
[7]   Adjuvant Ovarian Suppression in Premenopausal Breast Cancer [J].
Francis, Prudence A. ;
Regan, Meredith M. ;
Fleming, Gini F. ;
Lang, Istvan ;
Ciruelos, Eva ;
Bellet, Meritxell ;
Bonnefoi, Herve R. ;
Climent, Miguel A. ;
Da Prada, Gian Antonio ;
Burstein, Harold J. ;
Martino, Silvana ;
Davidson, Nancy E. ;
Geyer, Charles E., Jr. ;
Walley, Barbara A. ;
Coleman, Robert ;
Kerbrat, Pierre ;
Buchholz, Stefan ;
Ingle, James N. ;
Winer, Eric P. ;
Rabaglio-Poretti, Manuela ;
Maibach, Rudolf ;
Ruepp, Barbara ;
Giobbie-Hurder, Anita ;
Price, Karen N. ;
Colleoni, Marco ;
Viale, Giuseppe ;
Coates, Alan S. ;
Goldhirsch, Aron ;
Gelber, Richard D. .
NEW ENGLAND JOURNAL OF MEDICINE, 2015, 372 (05) :436-446
[8]   Personalizing the treatment of women with early breast cancer: highlights of the St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2013 [J].
Goldhirsch, A. ;
Winer, E. P. ;
Coates, A. S. ;
Gelber, R. D. ;
Piccart-Gebhart, M. ;
Thuerlimann, B. ;
Senn, H. -J. .
ANNALS OF ONCOLOGY, 2013, 24 (09) :2206-2223
[9]   Results of the ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial after completion of 5 years' adjuvant treatment for breast cancer [J].
Howell, A ;
Cuzick, J ;
Baum, M ;
Buzdar, A ;
Dowsett, M ;
Forbes, JF ;
Hoctin-Boes, G ;
Houghton, I ;
Locker, GY ;
Tobias, JS .
LANCET, 2005, 365 (9453) :60-62
[10]   Evaluation of Treatment-Effect Heterogeneity Using Biomarkers Measured on a Continuous Scale: Subpopulation Treatment Effect Pattern Plot [J].
Lazar, Ann A. ;
Cole, Bernard F. ;
Bonetti, Marco ;
Gelber, Richard D. .
JOURNAL OF CLINICAL ONCOLOGY, 2010, 28 (29) :4539-4544