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N Engl J Med. 2014 Jul 10;371(2):107-18. doi: 10.1056/NEJMoa1404037. Epub 2014 Jun 1.

Adjuvant exemestane with ovarian suppression in premenopausal breast cancer.

Collaborators (609)

Francis PA, Fleming GF, Pagani O, Walley B, Regan MM, Torrisi R, Bellet M, Blacher L, Bonnefoi H, Ciruelos E, Coates AS, Colleoni M, Dif N, Gelber RD, Goldhirsch A, Heckman-Scolese T, Hiltbrunner A, Kammler R, Maibach R, Messina C, Ortmann O, Perez EA, Price KN, Rabaglio M, Ruepp B, Saini K, Shaw H, Viale G, von Minckwitz G, Cisar L, Chetaille E, Goldhirsch A, Coates AS, Colleoni M, Stahl R, Aebi S, Coates AS, Colleoni M, Gelber RD, Goldhirsch A, Green M, Karlsson P, Kössler I, Láng I, Hiltbrunner A, Kammler R, Maibach R, Rabaglio M, Roux S, Ruepp B, Sicher P, Gelber RD, Regan MM, Aldridge J, Bonetti M, Feng Y, Giobbie-Hurder A, Gray K, Huang H, Luo W, Price KN, Zickl L, Blacher L, Scott K, Blackwell M, Cesario A, Dickinson A, Donahue K, Greco M, Gonzalez P, Heckman-Scolese T, Hecker R, Hinkle R, Kalera M, Lupejkis K, Mora de Karausch A, Palermo V, Shaw H, Swick-Jemison J, Viale G, Lepanto D, Pala O, Bernhard J, Ribi K, Abrams J, Zujewski JA, Hering M, Greene M, Nelson A, Balois-Ouellette M, Riordan S, Mahon W, Whitney E, Bryant J, Catalano R, Marinucci D, Niewood B, Lambersky R, Frankel W, Jewell S, Winer EP, Savoie J, Campanelli B, Graham JA, Klingele B, Chetaille E, Soares J, Descot C, Hemont-Dacosta S, Bismuth F, Chevreau P, Bibas H, Forbes J, Lindsay D, Boyes L, Stewart J, Chirgwin J, van der Westhuizen A, Briscoe K, Koczwara B, Gauden S, Moylan E, Della-Fiorentina S, Chirgwin J, Francis P, Nottage M, Boadle D, Bayliss E, Snyder R, Sardelic F, Abdi E, Chipman M, Gombos A, Barbeaux A, Salmon JP, Jerusalem G, Neven P, Azim H, Láng I, Parmar V, Plugisi F, Crivellari D, Pavesi L, Colleoni M, Gianni L, Pinotti G, Tondini C, Di Leo A, Simoncini E, Fabrizio A, Graiff C, Santoro A, Gomez H, Skof E, Vorobiof D, Karlsson P, Linderholm B, Zamin K, Rabaglio M, Buser K, Pagani O, Ruhstaller T, von Moos R, Rochlitz C, Rauch D, Gabriel N, Buchholz S, Reißmüller K, Loibl S, von Minckwitz G, Buchholz S, Augustin D, Tomé O, Lorenz-Salehi F, Hahn A, Lüdders D, Earl H, Bliss J, Gillman A, Atkins N, Earl H, McAdam K, Davidson N, Stearns V, O'Regan RM, Gluck S, Pritchard KI, Whelan T, Gelmon K, Webster M, Hortobagyi GN, Martino S, Gralow JR, Scott AF, Tonkin KS, Walley BA, Webster M, Potvin KR, Tozer RG, Gapski JA, Prady C, Salim M, Sami A, Whitlock P, Roy J, Hamm C, Freimann JH, Mortimer JE, Rugo HS, Ryan CJ, Parker BA, Elias AD, Elias AD, Tannenbaum S, Van Echo DC, Gluck S, Perez E, Wender DB, Walters TA, Merkel DE, Zaren HA, Rose C, Kindler HL, Ansari RH, Ansari RH, Nattam SR, Ansari RH, Vogel SJ, McIntyre AP, Erban JK, Burstein HJ, Burstein HJ, Burstein HJ, Burstein HJ, Krag KJ, Burstein HJ, Hendricks CB, Tkaczuk KH, Riseberg DA, Zakalik D, Flynn PJ, Flynn PJ, Flynn PJ, Ingle JN, Schneider DJ, Flynn PJ, Naughton MJ, Stephenson WT, Marchello BT, Feldmann JE, Messino MJ, Hetzel DJ, Wos EJ, Sen K, Reed EC, Bonnem EM, Blom DH, Entmacher MS, Tiersten AD, Pellegrino CM, Levine EG, Schmotzer JA, Padula GD, Mazurczak MA, Burdette-Radoux S, Burdette-Radoux S, Rivkin SE, Rivkin SE, Gautam U, Hart RD, Abraham J, Forbes J, Lindsay D, Boyes L, Stewart J, Kannourakis G, Underhill C, van der Westhuizen A, Davis A, Briscoe K, Beale P, Gauden S, Moylan E, Della-Fiorentina S, Livshin E, Chirgwin J, Boyle F, White M, Chan A, Hawson G, Francis PA, Hill J, Gill P, Nottage M, Boadle D, Baron-Hay S, Beith J, Vasey P, Lynch J, Buck M, Ng S, Snyder R, Epstein R, Abdi E, Chipman M, Harvey VJ, Fitzharris B, Campbell I, Biazús J, Corvalan A, Muller B, Torres R, Torres S, Letzkus J, Barajas O, Rojas H, Bravo ME, Cardemil B, Baeza R, Láng I, Parmar V, Crivellari D, Graiff C, Tondini C, Clerico M, Fabrizio A, Mattioli R, Visini M, Pavesi L, Gianni L, Pinotti G, Puglisi F, Gomez HL, Vorobiof D, Karlsson P, Loden B, Bergh J, Malmström P, Nissborg A, Karlsson P, Zaman K, Rabaglio M, Ruhstaller T, von Moos R, Rochlitz C, Rauch D, Buser K, Gabriel N, Rageth C, Schoenenberger A, Popescu R, Caspar C, Senn HJ, Ciruelos E, Muñoz M, Bellet M, Ciruelos E, Martín A, Catalán J, Aramendia J, Climent MA, Rifà J, López R, Llombart A, Virizuela JA, Lluch A, Jañez N, Melé M, de la Haba JR, Bohn U, Segura C, Jassem J, Jassem J, Neskovic-Konstantinovic Z, Dif N, Bogaerts J, Marreaud S, Vandebroek A, Berliere M, Neven P, Jerusalem G, Mitine C, Vuylsteke P, Dirix L, Moldovan C, de Lafontan B, Jouannaud C, Bachelot T, Bonnefoi H, Desmoulins I, Brain E, Pierga JY, Kerbrat P, Tubiana-Mathieu N, Delecroix V, Fignon A, Saghatchian M, Fried G, Sonke S, Leeksma O, Kroep J, Moreira A, Dane F, Buchholz S, Reißmüller K, Loibl S, von Minckwitz G, Kleine-Tebbe A, Tessen HW, Thomssen C, Beckman MW, Hahn A, Lorenz-Salehi F, Tomé O, Bauerfeind I, Schnappauf B, Buchholz S, Stauder H, Grogan L, McCaffrey J, McCaffrey J, Keane M, O'Reilly S, Walshe J, Coleman R, Bliss J, Gillman A, Atkins N, Mazdai G, Coleman R, Makris A, Makris A, O'Reilly S, Cole D, Churn M, Ines H, Todd R, Smith IE, Smith IE, Joji J, Perren T, Joji J, Chittalia A, Ramachanara P, Davidson N, Stearns V, O'Regan RM, Gluck S, Pritchard KI, Whelan T, Gelmon K, Webster M, Hortobagyi GN, Martino S, Gralow JR, Scott AF, McCarthy JS, Kennecke H, Robidoux A, Roy JA, Prady C, Kumar V, Dent SF, Vergidis D, Lopez PG, Tozer R, Pritchard KI, Potvin KR, Grenier D, Tonkin KS, Webster M, Ellard S, Pansegrau G, Salim M, Anderson JE, Diasio R, Ganz PA, Russel CA, Kroener JF, Parker BA, Ganey JT, Fehrenbacher L, Irwin DH, Fehrenbacher L, Javeed M, Fehrenbacher L, Anderson IC, Wapnir IL, Polikoff JA, Al-Jazayrly G, Pajon ER, Medgyesy D, Pajon ER, Elias AD, Drucker BJ, Frank RC, Tepler I, Jagathambal K, Brandt DS, Isaacs C, Aggarwal A, Barr F, Biggs DD, Schwartz MA, Lilenbaum RC, Seay TE, O'Regan RM, Lebos HC, Seay TE, Keaton MR, Taylor MA, Bate WW, Holm C, Albain KS, Cobleigh MA, Kindler HL, Nora RE, Wade JL, Wade JL, Kozloff MF, Rowland KM, Walling R, Miller KD, Nattam SR, Ansari RH, Dakhil SR, Dakhil SR, Mills GM, Erban JK, Burstein HJ, Burstein HJ, Burstein HJ, Krag KJ, Hendricks CB, Wolff AC, Watkins SP, Hwang LC, Segal HM, Inhorn RC, Zakalik D, Schott AF, Morris RT, Hurtubise MR, Schneider DJ, Flynn PJ, Dalton RJ, Ingle JN, Schneider DJ, Naughton MJ, Goodwin JW, Lyss AP, Marchello BT, Shea TC, Messino MJ, Hopkins JO, Wall JG, Hertzel DJ, Dentchev T, Weckstein D, Kaufman PA, Michaelson RA, Biggs DD, Toppmeyer DL, Toppmeyer DL, Klein P, Hudis CA, Leonard J, Odaimi M, Pellegrino CM, Pellegrino CM, Budman DR, Kalavar MR, Levine EG, Bloomfield CD, Budd GT, Silverman P, Budd GT, Schmotzer JA, Gross HM, Schaefer PL, Budd GT, Tirumali NR, Wolmark N, Brufsky AM, Gottlieb RJ, Domchek SM, Goldstein LJ, Luginbuhl WE, Reilly RE, Andrews WG, Hyzinski M, Sikov WM, Dizon DS, Mazurczak MA, Schlabach LL, Mullins BA, Strauss JF, Green MC, Elledge RM, Unzeitig GW, Burdette-Radoux S, Rivkin SE, Rivkin SE, Lanier KS, Stewart JA, Saphner TJ, Nambudiri GS, Saphner TJ, Tirona MR.

Abstract

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.).

PMID:
24881463
PMCID:
PMC4175521
DOI:
10.1056/NEJMoa1404037
[Indexed for MEDLINE]
Free PMC Article

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