Adjuvant Exemestane with Ovarian Suppression in Premenopausal Breast Cancer

被引：671

作者：

Pagani, Olivia ^{[1
]}

Regan, Meredith M. ^{[2
,3
,4
]}

Walley, Barbara A. ^{[9
]}

Fleming, Gini F. ^{[10
]}

Colleoni, Marco ^{[11
]}

Lang, Istvan ^{[18
]}

Gomez, Henry L. ^{[19
]}

Tondini, Carlo ^{[13
]}

Burstein, Harold J. ^{[5
]}

Perez, Edith A. ^{[20
]}

Ciruelos, Eva ^{[21
]}

Stearns, Vered ^{[22
]}

Bonnefoi, Herve R. ^{[23
]}

Martino, Silvana ^{[24
]}

Geyer, Charles E., Jr. ^{[25
]}

Pinotti, Graziella ^{[14
,15
]}

Puglisi, Fabio ^{[16
]}

Crivellari, Diana ^{[17
]}

Ruhstaller, Thomas

Winer, Eric P. ^{[5
]}

Rabaglio-Poretti, Manuela

Maibach, Rudolf ^{[3
]}

Ruepp, Barbara ^{[3
]}

Giobbie-Hurder, Anita ^{[6
]}

Price, Karen N. ^{[7
]}

Bernhard, Juerg ^{[2
,3
]}

Luo, Weixiu ^{[6
]}

Ribi, Karin ^{[3
]}

Viale, Giuseppe

Coates, Alan S. ^{[26
]}

Gelber, Richard D. ^{[8
]}

Goldhirsch, Aron ^{[12
]}

Francis, Prudence A. ^{[27
]}

机构：

[1] Kantonsspital St Gallen, Breast Ctr, Inst Oncol Southern Switzerland, St Gallen, Switzerland

[2] Univ Hosp Inselspital, Bern, Switzerland

[3] Coordinating Ctr, Int Breast Canc Study Grp IBCSG, Bern, Switzerland

[4] Harvard Univ, Sch Med, Dana Farber Canc Inst, IBCSG Stat Ctr, Boston, MA 02115 USA

[5] Harvard Univ, Sch Med, Dana Farber Canc Inst, Susan F Smith Ctr Womens Canc, Boston, MA 02115 USA

[6] Harvard Univ, Sch Med, Dana Farber Canc Inst, IBCSG Stat Ctr, Boston, MA 02115 USA

[7] Harvard Univ, Sch Med, Dana Farber Canc Inst, IBCSG Stat Ctr,Frontier Sci & Technol Res Fdn, Boston, MA 02115 USA

[8] Harvard Univ, Sch Publ Hlth, Sch Med, IBCSG Stat Ctr,Dana Farber Canc Inst,Frontier Sci, Boston, MA 02115 USA

[9] Tom Baker Canc Clin, Calgary, AB, Canada

[10] Univ Chicago, Med Ctr, Chicago, IL 60637 USA

[11] Univ Milan, European Inst Oncol, IBCSG Cent Pathol Ctr, Div Med Senol, Milan, Italy

[12] European Inst Oncol, Milan, Italy

[13] Osped Papa Giovanni XXIII, Bergamo, Italy

[14] Osped Circolo Varese, Varese, Italy

[15] Fdn Macchi, Varese, Italy

[16] Univ Udine, Dept Oncol, Univ Hosp Udine, I-33100 Udine, Italy

[17] Ctr Riferimento Oncol, Aviano, Italy

[18] Natl Inst Oncol, Budapest, Hungary

[19] Inst Nacl Enfermedades Neoplas, Lima, Peru

[20] Mayo Clin, Jacksonville, FL 32224 USA

[21] Hosp Univ 12 Octubre, Madrid, Spain

[22] Johns Hopkins Sidney Kimmel Comprehens Canc Ctr, Baltimore, MD USA

[23] Univ Bordeaux, Inst Bergonie Comprehens Canc Ctr, INSERM, U916, Bordeaux, France

[24] Angeles Clin & Res Inst, Santa Monica, CA USA

[25] Virginia Commonwealth Univ, Sch Med, Massey Canc Ctr, Richmond, VA 23284 USA

[26] Univ Sydney, Sydney, NSW 2006, Australia

[27] Univ Melbourne, St Vincents Hosp, Peter MacCallum Canc Ctr, Melbourne, Vic, Australia

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2014年 / 371卷 / 02期

关键词：

POSTMENOPAUSAL WOMEN; ENDOCRINE THERAPY; AMERICAN-SOCIETY; FOLLOW-UP; TAMOXIFEN; TRIAL; METAANALYSIS; LETROZOLE; SEQUENCE;

D O I：

10.1056/NEJMoa1404037

中图分类号：

R5 [内科学];

学科分类号：

100201 [内科学];

摘要：

BACKGROUND Adjuvant therapy with an aromatase inhibitor improves outcomes, as compared with tamoxifen, in postmenopausal women with hormone-receptor-positive breast cancer. METHODS In two phase 3 trials, we randomly assigned premenopausal women with hormone-receptor-positive early breast cancer to the aromatase inhibitor exemestane plus ovarian suppression or tamoxifen plus ovarian suppression for a period of 5 years. Suppression of ovarian estrogen production was achieved with the use of the gonadotropin-releasing-hormone agonist triptorelin, oophorectomy, or ovarian irradiation. The primary analysis combined data from 4690 patients in the two trials. RESULTS After a median follow-up of 68 months, disease-free survival at 5 years was 91.1% in the exemestane-ovarian suppression group and 87.3% in the tamoxifen-ovarian suppression group (hazard ratio for disease recurrence, second invasive cancer, or death, 0.72; 95% confidence interval [CI], 0.60 to 0.85; P<0.001). The rate of freedom from breast cancer at 5 years was 92.8% in the exemestane-ovarian suppression group, as compared with 88.8% in the tamoxifen-ovarian suppression group (hazard ratio for recurrence, 0.66; 95% CI, 0.55 to 0.80; P<0.001). With 194 deaths (4.1% of the patients), overall survival did not differ significantly between the two groups (hazard ratio for death in the exemestane-ovarian suppression group, 1.14; 95% CI, 0.86 to 1.51; P = 0.37). Selected adverse events of grade 3 or 4 were reported for 30.6% of the patients in the exemestane-ovarian suppression group and 29.4% of those in the tamoxifen-ovarian suppression group, with profiles similar to those for postmenopausal women. CONCLUSIONS In premenopausal women with hormone-receptor-positive early breast cancer, adjuvant treatment with exemestane plus ovarian suppression, as compared with tamoxifen plus ovarian suppression, significantly reduced recurrence. (Funded by Pfizer and others; TEXT and SOFT ClinicalTrials.gov numbers, NCT00066703 and NCT00066690, respectively.)

引用

页码：107 / 118

页数：12

共 16 条

[1]

Patient-reported endocrine symptoms, sexual functioning, and quality of life (QoL) in the IBCSG TEXT and SOFT trials: Adjuvant treatment with exemestane (E) plus ovarian function suppression (OFS) versus tamoxifen (T) plus OFS in premenopausal women with hormone receptor-positive (HR plus ) early breast cancer (BC) [J].

Bernhard, Juerg ;

Luo, Weixiu ;

Ribi, Karin ;

Eon, Marco Col ;

Burstein, Harold J. ;

Tondini, Carlo ;

Pinotti, Graziella ;

Spazzapan, Simon ;

Ruhstaller, Thomas ;

Puglisi, Fabio ;

Paves, Lorenzo ;

Parmar, Vani ;

Regan, Meredith M. ;

Pagani, Olivia ;

Fleming, Gini F. ;

Francis, Prudence A. ;

Coates, Alan S. ;

Gelber, Richard D. ;

Goldhirsch, Aron ;

Walley, Barbara .

JOURNAL OF CLINICAL ONCOLOGY, 2014, 32 (15)

[2]

Burstein HJ, 2010, J CLIN ONCOL, V28, P3784, DOI [10.1200/JCO.2009.26.3756, 10.1200/JOP.000082]

[3]

Breast Cancer [J].

Carlson, Robert W. ;

Allred, D. Craig ;

Anderson, Benjamin O. ;

Burstein, Harold J. ;

Carter, W. Bradford ;

Edge, Stephen B. ;

Erban, John K. ;

Farrar, William B. ;

Goldstein, Lori J. ;

Gradishar, William J. ;

Hayes, Daniel F. ;

Hudis, Clifford A. ;

Jahanzeb, Mohammad ;

Kiel, Krystyna ;

Ljung, Britt-Marie ;

Marcom, P. Kelly ;

Mayer, Ingrid A. ;

McCormick, Beryl ;

Nabell, Lisle M. ;

Pierce, Lori J. ;

Reed, Elizabeth C. ;

Smith, Mary Lou ;

Somlo, George ;

Theriault, Richard L. ;

Topham, Neal S. ;

Ward, John H. ;

Winer, Eric P. ;

Wolff, Antonio C. .

JOURNAL OF THE NATIONAL COMPREHENSIVE CANCER NETWORK, 2009, 7 (02) :122-+

[4]

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

[5]

Survival and safety of exemestane versus tamoxifen after 2-3 years' tamoxifen treatment (Intergroup Exemestane Study): a randomised controlled trial [J].

Coombes, R. C. ;

Kilburn, L. S. ;

Snowdon, C. F. ;

Paridaens, R. ;

Coleman, R. E. ;

Jones, S. E. ;

Jassem, J. ;

Van de Velde, C. J. H. ;

Delozier, T. ;

Alvarez, I. ;

Del Mastro, L. ;

Ortmann, O. ;

Diedrich, K. ;

Coates, A. S. ;

Bajetta, E. ;

Holmberg, S. B. ;

Dodwell, D. ;

Mickiewicz, E. ;

Andersen, J. ;

Lonning, P. E. ;

Cocconi, G. ;

Forbes, J. ;

Castiglione, M. ;

Stuart, N. ;

Stewart, A. ;

Fallowfield, L. J. ;

Bertelli, G. ;

Hall, E. ;

Bogle, R. G. ;

Carpentieri, M. ;

Colajori, E. ;

Subar, M. ;

Ireland, E. ;

Bliss, J. M. .

LANCET, 2007, 369 (9561) :559-570

[6]

Cuzick J, 2007, LANCET, V369, P1711

[7]

Relevance of breast cancer hormone receptors and other factors to the efficacy of adjuvant tamoxifen: patient-level meta-analysis of randomised trials [J].

Davies, C. ;

Godwin, J. ;

Gray, R. ;

Clarke, M. ;

Darby, S. ;

McGale, P. ;

Wang, Y. C. ;

Peto, R. ;

Pan, H. C. ;

Cutter, D. ;

Taylor, C. ;

Ingle, J. .

LANCET, 2011, 378 (9793) :771-784

[8]

Adjuvant endocrine therapy plus zoledronic acid in premenopausal women with early-stage breast cancer: 62-month follow-up from the ABCSG-12 randomised trial [J].

Gnant, Michael ;

Mlineritsch, Brigitte ;

Stoeger, Herbert ;

Luschin-Ebengreuth, Gero ;

Heck, Dietmar ;

Menzel, Christian ;

Jakesz, Raimund ;

Seifert, Michael ;

Hubalek, Michael ;

Pristauz, Gunda ;

Bauernhofer, Thomas ;

Eidtmann, Holger ;

Eiermann, Wolfgang ;

Steger, Guenther ;

Kwasny, Werner ;

Dubsky, Peter ;

Hochreiner, Gerhard ;

Forsthuber, Ernst-Pius ;

Fesl, Christian ;

Greil, Richard .

LANCET ONCOLOGY, 2011, 12 (07) :631-641

[9]

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

[10]

Exemestane Versus Anastrozole in Postmenopausal Women With Early Breast Cancer: NCIC CTG MA.27-A Randomized Controlled Phase III Trial [J].

Goss, Paul E. ;

Ingle, James N. ;

Pritchard, Kathleen I. ;

Ellis, Matthew J. ;

Sledge, George W. ;

Budd, G. Thomas ;

Rabaglio, Manuela ;

Ansari, Rafat H. ;

Johnson, David B. ;

Tozer, Richard ;

D'Souza, David P. ;

Chalchal, Haji ;

Spadafora, Silvana ;

Stearns, Vered ;

Perez, Edith A. ;

Liedke, Pedro E. R. ;

Lang, Istvan ;

Elliott, Catherine ;

Gelmon, Karen A. ;

Chapman, Judy-Anne W. ;

Shepherd, Lois E. .

JOURNAL OF CLINICAL ONCOLOGY, 2013, 31 (11) :1398-1404

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