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Background: The Suppression of Ovarian Function Trial (SOFT) found adding ovarian function suppression (OFS) to tamoxifen (T) reduced breast cancer recurrence, and exemestane (E)+OFS further reduced recurrence. A combined analysis of SOFT and TEXT showed a significant reduction in distant recurrence with E+OFS versus T+OFS. We now report final 15-year outcomes. Patients and methods: Premenopausal women with hormone receptor-positive early breast cancer were enrolled, with 3047 in SOFT and 2660 in TEXT intention-to-treat populations. SOFT randomized to 5 years of T versus T+OFS versus E+OFS. TEXT randomized to 5 years of T+OFS versus E+OFS. Chemotherapy was optional, before SOFT entry with subsequent premenopausal oestradiol or concurrent with OFS in TEXT. Endpoints included disease-free survival, breast cancer-free interval (BCFI), distant recurrence-free interval (DRFI), and overall survival (OS). Additionally, 15-year Kaplan–Meier estimates, hazard ratios (HRs), and 95% confidence intervals (CIs) are reported. Results: In SOFT, escalating endocrine therapy (ET) continued to reduce recurrence with 15-year BCFI of 78.6% for E+OFS, 75.7% for T+OFS, and 72.1% for T (T+OFS versus T: HR 0.82, 95% CI, 0.69-0.98, P = 0.03). In the SOFT no-chemotherapy cohort, OFS reduced breast cancer events at 15 years, while DRFI and OS remained high regardless of ET assignment. After prior chemotherapy for HER2-negative tumors (n = 1257), the 15-year OS rate in SOFT was 81.0% with E+OFS, 77.1% with T+OFS and 76.8% with tamoxifen alone. In women under age 35 years with HER2-negative tumors (n = 241), the 15-year OS rate was 82.5% with E+OFS, 77.9% with T+OFS, and 68.1% with tamoxifen. In combined SOFT and TEXT analysis, among those with HER2-negative tumors (n = 4035), E+OFS versus T+OFS reduced distant recurrence (HR 0.75, 95% CI 0.63-0.90), with a smaller reduction in deaths (HR 0.89, 95% CI 0.74-1.06), with absolute survival benefits largest with high-risk features, particularly young age or high-grade tumors. Conclusion: Meaningful OS benefit in hormone receptor-positive, HER2-negative breast cancer from adjuvant exemestane and/or OFS compared with tamoxifen alone is limited to high-risk premenopausal subgroups. Tamoxifen-based ET may not result in optimal outcomes in premenopausal high-grade HER2-negative tumors.
Final outcomes of the SOFT and TEXT phase III trials in premenopausal hormone receptor-positive early breast cancer☆
Francis P. A.
;Pagani O.;Fleming G. F.;Walley B. A.;Colleoni M.;Rubovszky G.;Tondini C.;Ciruelos E. M.;Gomez H. L.;Bonnefoi H. R.;Burstein H. J.;Chini C.;Puglisi F.;Spazzapan S.;Bernardo A.;Climent M. A.;Bellet M.;Ruhstaller T.;Bermejo B.;Chia S. K. L.;Martino S.;Geyer C. E.;Goetz M. P.;Ingle J. N.;Stearns V.;Davidson N. E.;Le Du F.;Muller B.;Coleman R. E.;Loibl S.;Winer E. P.;Ruepp B.;Loi S.;Lang I.;Coates A. S.;Gelber R. D.;Goldhirsch A.;Regan M. M.;Colleoni M.;Loi S.;Hiltbrunner A.;Allemann S.;Gasca A.;Kammler R.;Maibach R.;Rabaglio-Poretti M.;Roschitzki H.;Roux S.;Ruepp B.;Schroeder J.;Regan M.;Bouzan C.;Gelber R.;Giobbie-Hurder A.;Huang H.;Price K.;Shaw H.;Blacher L.;Blackwell M.;Greco M.;Mora de Karausch A.;Narayanan D.;Polizzi D.;Scott K.;Starkweather R.;Viale G.;Arrigoni L.;Benini E.;Dell'Orto P.;Russo L.;Bernhard J.;Ribi K.;Piccart-Gebhart M.;Cameron D.;El-Abed S.;Abrams J.;Korde L.;Mooney M.;Zujewski J. A.;Winer E.;Savoie J.;Francis P.;Fleming G.;Pagani O.;Walley B.;Regan M.;Bonnefoi L.;Colleoni M.;De Meulemeester L.;Ciruelos E.;Coates A.;El-Abed S.;Gelber R.;Hiltbrunner A.;Roschitzki-Voser H.;Kammler R.;Loi S.;Loibl S.;Ruepp B.;Shaw H.;Stearns V.;Torrisi R.;Viale G.;Badger H.;Laycock I.;Dempsey A.;Stewart J.;Kannourakis G.;Underhill C.;Chan A.;van der Westhuizen A.;Forbes J.;Davis A.;Beith J.;Briscoe K.;Beale P.;Sullivan A.;Power J.;Gauden S.;Byard I.;Moylan E.;Della-Fiorentina S.;Livshin E.;Bonaventura A.;Chua S.;Chirgwin J.;Boyle F.;White M.;Hawson G.;Francis P. A.;Bochner M.;Gill P. G.;Nottage M.;McCarthy N.;Colosimo M.;Boadle D.;Lowenthal R.;Baron-Hay S.;Vasey P.;Lynch J.;Kiberu A.;Buck M.;Tsoi D.;Ng S.;Snyder R.;Dear R.;Epstein R.;Dalley D.;Srivastav R.;Abdi E.;Chipman M.;Wilson S.;Harvey V.;Gardner K.;Fitzharris B.;Campbell I.;Villanova Biazus J.;Torres R.;Torres S.;Letzkus J.;Barajas O.;Rojas H.;Bravo M. E.;Cardemil B.;Sole S.;Lang I.;Spazzapan S.;Graiff C.;Tondini C.;Clerico M.;Fabrizio A.;Mattioli R.;Visini M.;Gianni L.;Gomez H. L.;Vorobiof D.;Karlsson P.;Loden B.;Bergh J.;Malmstrom P.;Nissborg A.;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 H. J.;Munoz M.;Bellet M.;Ciruelos E.;Marquez R.;Catalan J. G.;Aramendia J. M.;Climent M. A.;Perello A.;Lopez R.;Morales S.;Virizuela J. A.;Bermejo B.;Martinez Janez N.;Mele M.;de la Haba J. R.;Negrin;Saura S.;Perez Segura C.;Jassem J.;Neskovic-Konstantinovic Z.;Marreaud S.;Bogaerts J.;Vandebroek A.;Berliere M.;Jerusalem G.;Mitine C.;Henry S.;Dirix L.;Ziad E. A.;Moldovan C.;Dalenc F.;Jouannaud C.;Bachelot T.;Bonnefoi H.;Desmoulins I.;Brain E.;Pierga J. Y.;de la Motte Rouge T.;Venat-Bouvet L.;Delecroix V.;Fignon A.;Saghatchian M.;Fried G.;Sonke S.;Meerum Terwogt J.;Kroep J.;Moreira A.;Ortmann O.;Reissmuller K.;Kleine-Tebbe A.;Tessen H. W.;Thomssen C.;Beckmann M. W.;Hahn A.;Tome O.;Bauerfeind I.;Solbach C.;Stauder H.;Grogan L.;McCaffrey J.;Keane M.;O'Reilly S.;Walshe J.;Coleman R.;Bliss J.;Kernaghan S.;Atkins N.;Mazdai G.;Makris A.;Cole D.;Churn M.;Ines H.;Todd R.;Smith I. E.;Joji J.;Perren T.;Chittalia A.;Ramachanara P.;Winer E.;Carey L.;Partridge A.;Ingle J.;Davidson N.;O'Regan R.;Gluck S.;Pritchard K.;Whelan T.;Gelmon K.;Webster M.;Geyer C. E.;Wolmark N.;Mamounas E. P.;Swain S. M.;Hortobagyi G.;Martino S.;Gralow J.;Scott A.;McCarthy J.;Kennecke H.;Robidoux A.;Roy J.;Prady C.;Kumar V.;Dent S. F.;Vergidis D.;Lopez P. G.;Tozer R. G.;Potvin K. R.;Grenier D.;Tonkin K. S.;Walley B. A.;Ellard S.;Pansegrau G. K.;Salim M.;Anderson J. E.;Diasio R.;Ganz P. A.;Russel C. A.;Kroener J. F.;Parker B. A.;Ganey J. T.;Fehrenbacher L.;Irwin D. H.;Javeed M.;Anderson I. C.;Wapnir I. L.;Polikoff J. A.;Al-Jazayrly G.;Medgyesy D.;Pajon E. R.;Elias A. D.;Drucker B. J.;Frank C.;Tepler I.;Jagathambal K.;Brandt D. S.;Isaacs C.;Aggarwal A.;Barr F.;Schwartz M. A.;Lilenbaum R. C.;O'Regan R. M.;Lebos H. C.;Seay T. E.;Keaton M. R.;Taylor M. A.;Bate W. W.;Holm C.;Albain K. S.;Cobleigh M. A.;Kindler H. L.;Nora R. E.;Wade J. L.;Kozloff M. F.;Rowland K. M.;Walling R.;Miller K. D.;Ansari R. H.;Dakhil S. R.;Mills G. M.;Erban J. K.;Burstein H. J.;Wolff A. C.;Watkins S. P.;Hwang L. C.;Segal H. M.;Inhorn R. C.;Zakalik D.;Schott A. F.;Morris R. T.;Hurtubise M. R.;Schneider D. J.;Dalton R. J.;Ingle J. N.;Flynn P. J.;Naughton M. J.;Goodwin J. W.;Lyss A. P.;Marchello B. T.;Shea T. C.;Hopkins J. O.;Wall J. G.;Hertzel D. J.;Dentchev T.;Weckstein D.;Kaufman P. A.;Catcher C.;Michaelson R. A.;Biggs D. D.;Toppmeyer D. L.;Klein P.;Hudis C. A.;Leonard J.;Odaimi M.;Pellegrino C. M.;Budman D. R.;Kalavar M. R.;Levine G.;Bloomfield C. D.;Budd G. T.;Silverman P.;Gross H. M.;Schaefer P. L.;Tirumali N. R.;Brufsky A. M.;Gottlieb R. J.;Domchek S. M.;Goldstein L. J.;Luginbuhl W. E.;Reilly R. E.;Andrews W. G.;Hyzinski M.;Sikov W. M.;Dizon D. S.;Mazurczak M. A.;Schlabach L. L.;Mullins B. A.;Strauss J. F.;Green M. C.;Elledge R. M.;Unzeitig G. W.;Burdette-Radoux S.;Rivkin S. E.;Lanier K. S.;Stewart J. A.;Saphner T. J.;Nambudiri G. S.;Tria Tirona M. R. B.;Rennie L.;Tindal D.;Redfern A.;Koczwara B.;Hill J.;Sardelic F.;Goldstein D.;Gombos A.;Barbeaux A.;Salmon J. P.;Neven P.;Azim H.;Parmar V.;Puglisi F.;Bernardo A.;Pinotti G.;Di Leo A.;Simoncini E.;Santoro A.;Gomez H.;Skof E.;Linderholm B.;Pagani O.;Loibl S.;Augustin D.;Lorenz-Salehi F.;Rody A.;Earl H.;Hughes-Davies L.;McAdam K.;Goetz M.;Pritchard K. I.;White J.;Gapski J. A.;Sami A.;Whitlock P.;Roy J. A.;Hamm C.;Freimann J. H.;Mortimer J. E.;Rugo H. S.;Ryan C. J.;Tannenbaum S.;Van Echo D. C.;Perez E.;Wender D. B.;Walters T. A.;Merkel D. E.;Zaren H. A.;Rose C. G.;Ansari R. H.;Ansari R. H.;Nattam S. R.;Ansari R. H.;Vogel S. J.;McIntyre A. P.;Burstein H. J.;Burstein H. J.;Burstein H. J.;Burstein H. J.;Krag K. J.;Burstein H. J.;Hendricks C. B.;Rak Tkaczuk K. H.;Riseberg D. A.;Flynn P. J.;Flynn P. J.;Flynn P. J.;Schneider D. J.;Flynn P. J.;Naughton M. J.;Stephenson W. T.;Feldmann J. E.;Messino M. J.;Hetzel D. J.;Wos E. J.;Sen K.;Reed E. C.;Bonnem E. M.;Blom D. H.;Entmacher M. S.;Tiersten A. D.;Pellegrino M.;Levine E. G.;Schmotzer J. A.;Padula G. D. A.;Mazurczak M. A.;Burdette-Radoux S.;Burdette-Radoux S.;Rivkin S. E.;Rivkin S. E.;Gautam U.;Hart R. D.;Abraham J.
2026-01-01
Abstract
Background: The Suppression of Ovarian Function Trial (SOFT) found adding ovarian function suppression (OFS) to tamoxifen (T) reduced breast cancer recurrence, and exemestane (E)+OFS further reduced recurrence. A combined analysis of SOFT and TEXT showed a significant reduction in distant recurrence with E+OFS versus T+OFS. We now report final 15-year outcomes. Patients and methods: Premenopausal women with hormone receptor-positive early breast cancer were enrolled, with 3047 in SOFT and 2660 in TEXT intention-to-treat populations. SOFT randomized to 5 years of T versus T+OFS versus E+OFS. TEXT randomized to 5 years of T+OFS versus E+OFS. Chemotherapy was optional, before SOFT entry with subsequent premenopausal oestradiol or concurrent with OFS in TEXT. Endpoints included disease-free survival, breast cancer-free interval (BCFI), distant recurrence-free interval (DRFI), and overall survival (OS). Additionally, 15-year Kaplan–Meier estimates, hazard ratios (HRs), and 95% confidence intervals (CIs) are reported. Results: In SOFT, escalating endocrine therapy (ET) continued to reduce recurrence with 15-year BCFI of 78.6% for E+OFS, 75.7% for T+OFS, and 72.1% for T (T+OFS versus T: HR 0.82, 95% CI, 0.69-0.98, P = 0.03). In the SOFT no-chemotherapy cohort, OFS reduced breast cancer events at 15 years, while DRFI and OS remained high regardless of ET assignment. After prior chemotherapy for HER2-negative tumors (n = 1257), the 15-year OS rate in SOFT was 81.0% with E+OFS, 77.1% with T+OFS and 76.8% with tamoxifen alone. In women under age 35 years with HER2-negative tumors (n = 241), the 15-year OS rate was 82.5% with E+OFS, 77.9% with T+OFS, and 68.1% with tamoxifen. In combined SOFT and TEXT analysis, among those with HER2-negative tumors (n = 4035), E+OFS versus T+OFS reduced distant recurrence (HR 0.75, 95% CI 0.63-0.90), with a smaller reduction in deaths (HR 0.89, 95% CI 0.74-1.06), with absolute survival benefits largest with high-risk features, particularly young age or high-grade tumors. Conclusion: Meaningful OS benefit in hormone receptor-positive, HER2-negative breast cancer from adjuvant exemestane and/or OFS compared with tamoxifen alone is limited to high-risk premenopausal subgroups. Tamoxifen-based ET may not result in optimal outcomes in premenopausal high-grade HER2-negative tumors.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11390/1337544
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Il report seguente simula gli indicatori relativi alla propria produzione scientifica in relazione alle soglie ASN 2023-2025 del proprio SC/SSD. Si ricorda che il superamento dei valori soglia (almeno 2 su 3) è requisito necessario ma non sufficiente al conseguimento dell'abilitazione. La simulazione si basa sui dati IRIS e sugli indicatori bibliometrici alla data indicata e non tiene conto di eventuali periodi di congedo obbligatorio, che in sede di domanda ASN danno diritto a incrementi percentuali dei valori. La simulazione può differire dall'esito di un’eventuale domanda ASN sia per errori di catalogazione e/o dati mancanti in IRIS, sia per la variabilità dei dati bibliometrici nel tempo. Si consideri che Anvur calcola i valori degli indicatori all'ultima data utile per la presentazione delle domande.
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