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N Engl J Med. 2017 Nov 9;377(19):1836-1846. doi: 10.1056/NEJMoa1701830.

20-Year Risks of Breast-Cancer Recurrence after Stopping Endocrine Therapy at 5 Years.

Collaborators (632)

Albain K, Anderson S, Arriagada R, Barlow W, Bartlett J, Bergsten‐Nordström E, Bliss J, Boccardo F, Bradley R, Brain E, Cameron D, Clarke M, Coates A, Coleman R, Correa C, Costantino J, Cuzick J, Davidson N, Dodwell D, Di Leo A, Ewertz M, Forbes J, Gelber R, Gnant M, Goldhirsch A, Goodwin P, Hill C, Ingle J, Jagsi R, Janni W, Loibl S, MacKinnon E, Martin M, Mukai H, Norton L, Ohashi Y, Paik S, Perez E, Piccart M, Pierce L, Poortmans P, Raina V, Ravdin P, Regan M, Robertson J, Rutgers E, Slamon D, Sparano J, Swain S, Tutt A, Viale G, von Minckwitz G, Wang X, Whelan T, Wilcken N, Winer E, Wolmark N, Wood W, Zambetti M, Alberro JA, Ballester B, Deulofeu P, Fábregas R, Fraile M, Gubern JM, Janer J, Moral A, de Pablo JL, Peñalva G, Puig P, Ramos M, Rojo R, Santesteban P, Serra C, Solà M, Solarnau L, Solsona J, Veloso E, Vidal S, Abe O, Abe R, Enomoto K, Kikuchi K, Koyama H, Masuda H, Nomura Y, Sakai K, Sugimachi K, Toi M, Tominaga T, Uchino J, Yoshida M, Haybittle JL, Leonard CF, Calais G, Garaud P, Collett V, Delmestri A, Sayer J, Harvey VJ, Holdaway IM, Kay RG, Mason BH, Forbes JF, Balic M, Bartsch R, Fesl C, Fitzal F, Fohler H, Greil R, Jakesz R, Marth C, Mlineritsch B, Pfeiler G, Singer CF, Steger GG, Stöger H, Canney P, Yosef HMA, Focan C, Peek U, Oates GD, Powell J, Durand M, Mauriac L, Dolci S, Larsimont D, Nogaret JM, Philippson C, Piccart MJ, Masood MB, Parker D, Price JJ, Lindsay MA, Mackey J, Hupperets PSGJ, Bates T, Blamey RW, Chetty U, Ellis IO, Mallon E, Morgan DAL, Patnick J, Pinder S, Lohrisch C, Nichol A, Bramwell VH, Chen BE, Gelmon K, Goss PE, Levine MN, Parulekar W, Pater JL, Shepherd LE, Tu D, Berry D, Broadwater G, Cirrincione C, Muss H, Weiss RB, Abu‐Zahra HT, Portnoj SM, Bowden S, Brookes C, Dunn J, Fernando I, Lee M, Poole C, Rea D, Spooner D, Barrett‐Lee PJ, Mansel RE, Monypenny IJ, Gordon NH, Davis HL, Sestak I, Lehingue Y, Romestaing P, Dubois JB, Delozier T, Griffon B, Mace Lesec’h J, de La Lande B, Mouret‐Fourme E, Mustacchi G, Petruzelka L, Pribylova O, Owen JR, Harbeck N, Jänicke F, Meisner C, Schmitt M, Thomssen C, Meier P, Shan Y, Shao YF, Zhao DB, Chen ZM, Howell A, Swindell R, Boddington C, Burrett JA, Cutter D, Duane F, Evans V, Gettins L, Godwin J, James S, Kerr A, Liu H, Mannu G, McHugh T, Morris P, Read S, Wang Y, Wang Z, Albano J, de Oliveira CF, Gervásio H, Gordilho J, Ejlertsen B, Jensen MB, Johansen H, Mouridsen H, Palshof T, Gelman RS, Harris JR, Henderson C, Shapiro CL, Christiansen P, Mouridsen HT, Fehm T, Trampisch HJ, Dalesio O, de Vries EGE, Rodenhuis S, van Tinteren H, Comis RL, Davidson NE, Robert N, Sledge G, Solin LJ, Sparano JA, Tormey DC, Dixon JM, Forrest P, Jack W, Kunkler I, Rossbach J, Klijn JGM, Treurniet‐Donker AD, van Putten WLJ, Rotmensz N, Veronesi U, Bartelink H, Bijker N, Bogaerts J, Cardoso F, Cufer T, Julien JP, van de Velde CJH, Cunningham MP, Brufsky AM, Coleman RE, Llombart HA, Huovinen R, Joensuu H, Costa A, Bonadonna G, Gianni L, Valagussa P, Goldstein LJ, Bonneterre J, Fargeot P, Fumoleau P, Kerbrat P, Luporsi E, Namer M, Carrasco E, Segui MA, Eiermann W, Hilfrich J, Jonat W, Kaufmann M, Kreienberg R, Schumacher M, Bastert G, Rauschecker H, Sauer R, Sauerbrei W, Schauer A, Blohmer JU, Costa SD, Eidtmann H, Gerber B, Jackisch C, de Schryver A, Vakaet L, Belfiglio M, Nicolucci A, Pellegrini F, Pirozzoli MC, Sacco M, Valentini M, McArdle CS, Smith DC, Stallard S, Dent DM, Gudgeon CA, Hacking A, Murray E, Panieri E, Werner ID, Galligioni E, Leone B, Vallejo CT, Zwenger A, Lopez M, Erazo A, Medina JY, Horiguchi J, Takei H, Fentiman IS, Hayward JL, Rubens RD, Skilton D, Scheurlen H, Sohn HC, Untch M, Dafni U, Markopoulos C, Fountzilas G, Mavroudis D, Klefstrom P, Blomqvist C, Saarto T, Gallen M, Tinterri C, Margreiter R, de Lafontan B, Mihura J, Roché H, Asselain B, Salmon RJ, Vilcoq JR, André F, Delaloge S, Koscielny S, Michiels S, Rubino C, A'Hern R, Ellis P, Kilburn L, Yarnold JR, Benraadt J, Kooi M, van de Velde AO, van Dongen JA, Vermorken JB, Castiglione M, Colleoni M, Collins J, Gelber RD, Lindtner J, Price KN, Regan MM, Rudenstam CM, Senn HJ, Thuerlimann B, Bliss JM, Chilvers CED, Coombes RC, Hall E, Marty M, Buyse M, Possinger K, Schmid P, Wallwiener D, Bighin C, Bruzzi P, Del Mastro L, Dozin B, Pastorino S, Pronzato P, Sertoli MR, Foster L, George WD, Stewart HJ, Stroner P, Borovik R, Hayat H, Inbar MJ, Peretz T, Robinson E, Camerini T, Formelli F, Martelli G, Di Mauro MG, Perrone F, Amadori D, Martoni A, Pannuti F, Camisa R, Musolino A, Passalacqua R, Iwata H, Shien T, Ikeda T, Inokuchi K, Sawa K, Sonoo H, Sadoon M, Tulusan AH, Kohno N, Miyashita M, Takao S, Ahn JH, Jung KH, Korzeniowski S, Skolyszewski J, Ogawa M, Yamashita J, Bastiaannet E, Liefers GJ, Christiaens R, Neven P, Paridaens R, Van den Bogaert W, Braun S, Martin P, Romain S, Janauer M, Seifert M, Sevelda P, Zielinski CC, Hakes T, Hudis CA, Wittes R, Giokas G, Kondylis D, Lissaios B, de la Huerta R, Sainz MG, Ro J, Camphausen K, Danforth D, Lichter A, Lippman M, Smart D, Steinberg S, D’Amico C, Lioce M, Paradiso A, Ohno S, Bass G, Brown A, Bryant J, Dignam J, Fisher B, Geyer C, Mamounas EP, Redmond C, Wickerham L, Aihara T, Hozumi Y, Baum M, Jackson IM, Palmer MK, Ingle JN, Suman VJ, Bengtsson NO, Emdin S, Jonsson H, Venturini M, Lythgoe JP, Kissin M, Erikstein B, Hannisdal E, Jacobsen AB, Reinertsen KV, Varhaug JE, Gundersen S, Hauer‐Jensen M, Høst H, Nissen‐Meyer R, Mitchell AK, Robertson JFR, Ueo H, Di Palma M, Mathé G, Misset JL, Levine M, Morimoto K, Takatsuka Y, Crossley E, Harris A, Talbot D, Taylor M, Cocconi G, di Blasio B, Ivanov V, Paltuev R, Semiglazov V, Brockschmidt J, Cooper MR, Falkson CI, Hadji P, A’Hern R, Makris A, Parton M, Pennert K, Powles TJ, Smith IE, Gazet JC, Browne L, Graham P, Corcoran N, Clack G, Van Poznak C, Deshpande N, di Martino L, Douglas P, Lindtner A, Notter G, Bryant AJS, Ewing GH, Firth LA, Krushen‐Kosloski JL, Anderson H, Killander F, Malmström P, Rydén L, Arnesson LG, Carstensen J, Dufmats M, Fohlin H, Nordenskjöld B, Söderberg M, Carpenter JT, Murray N, Royle GT, Simmonds PD, Crowley J, Gralow J, Hortobagyi G, Livingston R, Martino S, Osborne CK, Ravdin PM, Bondesson T, Celebioglu F, Dahlberg K, Fornander T, Fredriksson I, Frisell J, Göransson E, Iiristo M, Johansson U, Lenner E, Löfgren L, Nikolaidis P, Perbeck L, Rotstein S, Sandelin K, Skoog L, Svane G, af Trampe E, Wadström C, Maibach R, Thürlimann B, Holli K, Rouhento K, Safra T, Brenner H, Hercbergs A, Yoshimoto M, Paterson AHG, Fyles A, Meakin JW, Panzarella T, Bahi J, Lemonnier J, Martin AL, Reid M, Spittle M, Bishop H, Bundred NJ, Forsyth S, Pinder SE, Deutsch GP, Kwong DLW, Pai VR, Senanayake F, Rubagotti A, Hackshaw A, Houghton J, Ledermann J, Monson K, Tobias JS, Carlomagno C, De Laurentiis M, De Placido S, Williams L, Bell R, Hinsley S, Marshall HC, Pierce LJ, Solomayer E, Horsman JM, Lester J, Winter MC, Buzdar AU, Hsu L, Love RR, Ahlgren J, Garmo H, Holmberg L, Liljegren G, Lindman H, Wärnberg F, Asmar L, Jones SE, Aft R, Gluz O, Liedtke C, Nitz U, Litton A, Wallgren A, Karlsson P, Linderholm BK, Chlebowski RT, Caffier H.

Abstract

BACKGROUND:

The administration of endocrine therapy for 5 years substantially reduces recurrence rates during and after treatment in women with early-stage, estrogen-receptor (ER)-positive breast cancer. Extending such therapy beyond 5 years offers further protection but has additional side effects. Obtaining data on the absolute risk of subsequent distant recurrence if therapy stops at 5 years could help determine whether to extend treatment.

METHODS:

In this meta-analysis of the results of 88 trials involving 62,923 women with ER-positive breast cancer who were disease-free after 5 years of scheduled endocrine therapy, we used Kaplan-Meier and Cox regression analyses, stratified according to trial and treatment, to assess the associations of tumor diameter and nodal status (TN), tumor grade, and other factors with patients' outcomes during the period from 5 to 20 years.

RESULTS:

Breast-cancer recurrences occurred at a steady rate throughout the study period from 5 to 20 years. The risk of distant recurrence was strongly correlated with the original TN status. Among the patients with stage T1 disease, the risk of distant recurrence was 13% with no nodal involvement (T1N0), 20% with one to three nodes involved (T1N1-3), and 34% with four to nine nodes involved (T1N4-9); among those with stage T2 disease, the risks were 19% with T2N0, 26% with T2N1-3, and 41% with T2N4-9. The risk of death from breast cancer was similarly dependent on TN status, but the risk of contralateral breast cancer was not. Given the TN status, the factors of tumor grade (available in 43,590 patients) and Ki-67 status (available in 7692 patients), which are strongly correlated with each other, were of only moderate independent predictive value for distant recurrence, but the status regarding the progesterone receptor (in 54,115 patients) and human epidermal growth factor receptor type 2 (HER2) (in 15,418 patients in trials with no use of trastuzumab) was not predictive. During the study period from 5 to 20 years, the absolute risk of distant recurrence among patients with T1N0 breast cancer was 10% for low-grade disease, 13% for moderate-grade disease, and 17% for high-grade disease; the corresponding risks of any recurrence or a contralateral breast cancer were 17%, 22%, and 26%, respectively.

CONCLUSIONS:

After 5 years of adjuvant endocrine therapy, breast-cancer recurrences continued to occur steadily throughout the study period from 5 to 20 years. The risk of distant recurrence was strongly correlated with the original TN status, with risks ranging from 10 to 41%, depending on TN status and tumor grade. (Funded by Cancer Research UK and others.).

PMID:
29117498
DOI:
10.1056/NEJMoa1701830
[PubMed - in process]
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