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N Engl J Med. 2015 Jan 29;372(5):436-46. doi: 10.1056/NEJMoa1412379. Epub 2014 Dec 11.

Adjuvant ovarian suppression in premenopausal breast cancer.

Collaborators (454)

Francis PA, Fleming GF, Regan MM, Torrisi R, Blacher L, Bonnefoi H, Ciruelos E, Coates AS, Colleoni M, Dif N, Gelber RD, Goldhirsch A, Goulioti T, Heckman-Scolese T, Hiltbrunner A, Kammler R, Maibach R, Ortmann O, Pagani O, Perez EA, Price KN, Rabaglio M, Ruepp B, Tryfonidis K, Scott K, Shaw H, Viale G, von Minckwitz G, Walley B, Zardavas D, 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, Starkweather R, 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, 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, Beckmann 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, Ingle JN, 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, Walley BA, 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, Kuter I, 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:

Suppression of ovarian estrogen production reduces the recurrence of hormone-receptor-positive early breast cancer in premenopausal women, but its value when added to tamoxifen is uncertain.

METHODS:

We randomly assigned 3066 premenopausal women, stratified according to prior receipt or nonreceipt of chemotherapy, to receive 5 years of tamoxifen, tamoxifen plus ovarian suppression, or exemestane plus ovarian suppression. The primary analysis tested the hypothesis that tamoxifen plus ovarian suppression would improve disease-free survival, as compared with tamoxifen alone. In the primary analysis, 46.7% of the patients had not received chemotherapy previously, and 53.3% had received chemotherapy and remained premenopausal.

RESULTS:

After a median follow-up of 67 months, the estimated disease-free survival rate at 5 years was 86.6% in the tamoxifen-ovarian suppression group and 84.7% in the tamoxifen group (hazard ratio for disease recurrence, second invasive cancer, or death, 0.83; 95% confidence interval [CI], 0.66 to 1.04; P=0.10). Multivariable allowance for prognostic factors suggested a greater treatment effect with tamoxifen plus ovarian suppression than with tamoxifen alone (hazard ratio, 0.78; 95% CI, 0.62 to 0.98). Most recurrences occurred in patients who had received prior chemotherapy, among whom the rate of freedom from breast cancer at 5 years was 82.5% in the tamoxifen-ovarian suppression group and 78.0% in the tamoxifen group (hazard ratio for recurrence, 0.78; 95% CI, 0.60 to 1.02). At 5 years, the rate of freedom from breast cancer was 85.7% in the exemestane-ovarian suppression group (hazard ratio for recurrence vs. tamoxifen, 0.65; 95% CI, 0.49 to 0.87).

CONCLUSIONS:

Adding ovarian suppression to tamoxifen did not provide a significant benefit in the overall study population. However, for women who were at sufficient risk for recurrence to warrant adjuvant chemotherapy and who remained premenopausal, the addition of ovarian suppression improved disease outcomes. Further improvement was seen with the use of exemestane plus ovarian suppression. (Funded by Pfizer and others; SOFT ClinicalTrials.gov number, NCT00066690.).

PMID:
25495490
[PubMed - indexed for MEDLINE]
PMCID:
PMC4341825
Free PMC Article
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