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J Clin Oncol. 2008 Dec 1;26(34):5569-75. doi: 10.1200/JCO.2008.17.0829. Epub 2008 Nov 3.

Prognostic and predictive value of centrally reviewed Ki-67 labeling index in postmenopausal women with endocrine-responsive breast cancer: results from Breast International Group Trial 1-98 comparing adjuvant tamoxifen with letrozole.

Collaborators (892)

Thürlimann B, Aebi S, Blacher L, Castiglione-Gertsch M, Coates AS, Cufer T, Forbes JF, Gelber RD, Giobbie-Hurder A, Goldhirsch A, Hiltbrunner A, Holmberg SB, Maibach R, Martoni A, Mauriac L, McGrogan G, Mouridsen HT, Paridaens R, Price KN, Rabaglio M, Rasmussen BB, Regan MM, Santoro A, Smith IE, Wardley A, Vantongelen K, Viale G, Chaudri-Ross HA, Emanuel D, Evans DB, Sguotti C, Trostmann U, Goldhirsch A, Coates AS, Blacher L, Castiglione-Gertsch M, Forbes J, Gelber RD, Gusterson BA, Hiltbrunner A, Hürny C, Murray E, Price KN, Rabaglio M, Studer R, Viale G, Wallgren A, Stahel R, Castiglione-Gertsch M, Coates AS, Collins JP, Gelber RD, Goldhirsch A, Green M, Hiltbrunner A, Holmberg SB, Hossfeld DK, Karlsson P, Láng I, de Stoppani M, Rudenstam CM, Thürlimann B, Veronesi A, Hiltbrunner A, Rabaglio M, Egli G, Cliffe B, Ribeli-Hofmann S, Kammler R, Studer R, Ruepp B, Maibach R, Munarini N, Castiglione-Gertsch M, Hiltbrunner A, Rabaglio M, Egli G, Cliffe B, Ribeli-Hofmann S, Munarini F, Kammler R, Studer R, Ruepp B, Maibach R, Munarini N, Gelber RD, Price KN, Giobbie-Hurder A, Regan M, Sun Z, Keshaviah A, Litman H, Huang H, Somos LJ, Timmers B, Nickerson L, Blacher L, Scolese TH, Belisle M, Caporale M, Celano J, Dalfonso L, Dooley L, Fischer S, Galloway K, Gould J, Hinkle R, Holody M, Jones G, Krall R, Lippert S, Meshulam J, Mundy L, Pavlov-Shapiro A, Scott K, Scott M, Shepard S, Swick J, Uhteg L, Weinbaum D, Westby C, Zielinski T, Gusterson BA, Mallon E, Viale G, Dell'Orto P, Mastropasqua M, Del Curto B, Hayes DF, Garber JE, Lagakos SW, Lindgren I, Waldie E, van Hoomissen I, De Smet M, Schmidt W, Bolton A, Hackl W, Chirgwin JH, Forbes JF, Boyle FM, Lindsay D, Preece D, Oleksyn K, Abell F, Basser R, Bell R, Brady B, Blakey D, Briggs P, Burns I, Campbell P, Chao M, Chirgwin J, Chua B, Clarke K, Collins J, De Boer R, Din JC, Doig R, Dowling A, Drummond R, Efe N, Fan ST, Francis M, Francis P, Ganju V, Gibbs P, Goss G, Green M, Gregory P, Griffiths J, Haines I, Henderson M, Holmes R, James P, Kiffler J, Lehman M, Leyden M, Lim L, Lindeman G, Lynch R, Mann B, McKendrick J, McLachlan S, McLennan R, Mitchell G, Mitra S, Murphy C, Parker I, Phillips K, Porter I, Richardson G, Scarlet J, Sewak S, Shapiro J, Snyder R, Stanley R, Steer C, Stoney D, Strickland A, Toner G, Underhill C, White K, White M, Wirth A, Wong S, Byram D, Byard I, Della-Fiorentina S, Goldrick A, Hovey E, Moylan E, Segelov E, Chan A, Buck M, Hastrich D, Ingram D, Van Hazel G, Willsher P, Wilcken N, Crombie C, Forbes JF, Abell F, Ackland S, Bonaventura A, Cox S, Denham J, Gourlay R, Jackson D, Sillar R, Stewart J, Lewis C, Brigham B, Goldstein D, Friedlander M, Walpole E, Thompson D, Gill PG, Bochner M, Coventry J, Kollias J, Malycha P, Olver I, Colosimo M, Cheuk R, Kenny L, McCarthy N, Wyld D, Young R, Harrup R, Kimber R, Lowenthal R, Trotter J, Bayliss E, Chan A, Ransom D, Byrne M, Buck M, Dewar J, Nowak A, Powell A, Van Hazel G, Abdi EA, Brodribb R, Volobueva Z, Harnett P, Ahern V, Gurney H, Wilcken N, Harvey VJ, Evans B, Jones W, McCrystal M, Porter D, Thompson P, Vaughan M, Gibbs D, Atkinson C, Burcombe R, Fitzharris B, Hickey B, Jeffery M, Robinson B, McLaren B, Costello S, North J, Perez D, Campbell ID, Gilbert L, Gannaway R, Jameson M, Kennedy I, Long J, Round G, Spellman L, Whittle D, Woolerton D, Menke C, Biazús J, Cericatto R, Cavalheiro J, Xavier N, Bittelbrunn A, Rabin E, Gutiérrez J, Arriagada R, Bronfman L, Zuñiga M, Gutiérrez J, Acevedo JC, Torres S, León A, Salazar E, Soto Diaz L, Duval R, Oddeshede N, Venti MC, Peña K, Puente L, Maidana V, Baeza R, Arriagada R, Olfos P, Solé J, Vinés E, Mariani C, Láng I, Hitre E, Szabó E, Horváth Z, Ganofszky E, Juhos E, Veronesi A, Crivellari D, Magri MD, Buonadonna A, Coran F, Borsatti E, Candiani E, Massarut S, Roncadin M, Arcicasa M, Carbone A, Perin T, Gloghini A, Tondini C, Labianca R, Poletti P, Bettini A, Clerico M, Vincenti M, Malossi A, Seles E, Perfetti E, Sartorello B, Simoncini E, Marini G, Marpicati P, Farfaglia R, Bianchi AM, Grigolato P, Lucini L, Frata P, Huscher A, Micheletti E, Fogazzi C, Artioli F, Cagossi K, Scaltriti L, Bandieri E, Botticelli L, Giovanardi G, Ravaioli A, Pasquini E, Rudnas B, Foghin L, Visini M, Zavallone L, Ucci G, Colleoni M, Viale G, Veronesi P, Peruzzotti G, Corsetto L, Ghisini R, Renne G, Luini A, Orlando L, Torrisi R, Rocca A, De Pas T, Munzone E, Galimberti V, Zurrida S, Intra M, Nolé F, Orecchia R, Martinelli G, de Braud F, Goldhirsch A, Ravaioli A, Gianni L, Gome H, Cufer T, Pajk B, Cervek J, Werner ID, Murray E, Govender D, Dalvie S, Erasmus T, Robertson B, Read B, Nel E, Toop J, Nedeva N, Panieri E, Vorobiof D, Chasen M, McMichael G, Mohammed C, Holmberg SB, Holmberg SB, Mattsson J, Sellström H, Lindberg B, Goldhirsch A, Herrmann R, Schönenberger A, Mingrone W, Honegger Ch, Bärtschi E, Neter M, Rederer M, Schär G, Rochlitz C, Herrmann R, Oertli D, Wight E, Moch H, Bernier J, Bronz L, Cavalli F, Gallerani E, Richetti A, Franzetti A, Conti-Beltraminelli M, Ghielmini M, Gyr T, Mauri S, Saletti PC, Goldhirsch A, Pagani O, Graffeo R, Locatelli M, Longhi S, Rey PC, Ruggeri M, Zucca E, Wyss D, Mazzucchelli L, Pedrinis E, Rusca T, Aebi S, Fey MF, Castiglione-Gertsch M, Rabaglio M, Aebi S, Fey MF, Zuber M, Beck G, Aebi S, Fey MF, Schönenberger R, Lüthi JM, Rauch D, Bonnefoi H, Egli F, Steiner R, Fehr P, Perey L, de Grandi P, Jeanneret W, Leyvraz S, Delaloye JF, Thürlimann B, Köberle D, Weisser F, Mattmann S, Müller A, Cerny T, Späti B, Höfliger M, Fürstenberger G, Bolliger B, Ohlschlegel C, Lorenz U, Bamert M, Kehl-Blank J, Vogel E, Thürlimann B, Hess D, Senn I, Köberle D, Ehrsam A, Nauer C, Ohlschlegel C, Kehl-Blank J, Vogel E, Widmer L, Häfner M, Pestalozzi BC, Fehr M, Caduff R, Varga Z, Trüb R, Fink D, Bättig BA, Buser K, Bürki N, Dieterle A, Hasler L, Mannhart-Harms M, Rageth C, Richner J, Spataro V, Umbricht M, Ellis P, Harris S, Akbar N, McVicars H, Lees C, Raman R, Crane G, Mouridsen HT, Mouridsen HT, Jakobsen E, Cold S, Kamby C, Ewertz M, Vestlev PM, Andersen J, Grundtvig P, Sandberg E, Philip P, Madsen EL, Moeller KA, Haahr V, Johansson J, Mauriac L, Debled M, Campo P, Larregain-Fournier BD, Remy S, Auvray H, De Gislain C, Delille F, Porteret MC, Servent V, Chapoutier M, Tubiana-Mathieu N, Lavau-Denes S, Bosc P, Guastalla JP, Bachelot T, Arbault C, Netter-Pinon G, André Boulloche CH, Perrin V, Monnier A, Hammoud Y, Romieu G, Culine L, Pinosa V, Cany L, Maguire C, Daban A, Le Saux M, Grandon C, Kerbrat P, Catheline C, Veyret C, Jugieau E, Talon V, Le Mevel A, Maury S, Gladieff L, Lignon N, Dodwell D, Dodwell D, Joffe J, Drew P, Nejim A, Dodwell D, Horgan K, Lansdown M, Perren T, Coleman RE, Campos D, Cóppola F, Martinez J, Freue M, Wainstein C, Zori Comba A, Cazap E, Mickiewicz E, Balbiani L, Osuna A, Palazzo E, de Romedis M, Cagnolati S, Delfino CA, Caccia G, de Angelis RL, Fein L, Sala R, Nassurdi C, Colombo Berra A, Viroglio R, Blajman C, Requejo H, Silberman L, Birrell S, Eaton M, Hoffman C, Humeniuk V, Craft P, Stuart-Harris R, Yip D, Bell R, Abell F, Francis M, Kiffer J, Lynch R, McLennan R, White K, Green M, Basser R, Collins J, De Boer R, Din JC, Efe N, Fan ST, Lindeman G, Wong S, Green M, Basser R, Collins J, De Boer R, Din JC, Efe N, Fan ST, Lindeman G, Wong S, Stewart J, Abell F, Ackland S, Bonaventura A, Trotter J, Bayliss E, Chan A, Ransom D, Redfern A, de Souza P, Links M, Dalley D, Grygiel J, Ward R, Underhill C, Clarke K, Steer C, Walpole E, Thompson D, Nogaret JM, Christiaens MR, Neven P, Paridaens R, Smeets A, Vergote I, Weltens C, Wildiers H, Focan C, Marcelis L, Etterbeek-Ixelles CH, Kains JP, Canon JL, Brohèe D, Gowing J, Yelle Y, Dubé P, Vogel C, León Prieto M, Petrakova K, Palacova M, Demlova R, Siffnerova H, Fischer J, Bustova I, Kankova H, Pintova M, Vitek P, Abrahamova J, Kordikova D, Petruzelka L, Sedlackova E, Honova H, Heinrich B, Wischnik A, Oberhoff C, Schindler AE, Münstedt K, Meyer D, Grosse R, Kölbl H, Schmidt W, Mink D, Jänicke F, Lück HJ, Dornoff W, Hoffmann G, Hackmann J, Bader W, Kahan Z, Pajkos G, Kristo K, Dank M, Nagykalnai T, Landherr L, Kner E, Kispál M, Dani A, Martoni A, Zamagni C, Giaquinta S, Piana E, Mattioli R, Imperatori L, Santoro A, Carnaghi C, Rimassa L, Gasparini G, Sciarretta G, Morabito A, Barni S, Cazzaniga M, Cabiddu M, Puglisi F, Cellerino R, Antognoli S, Freddari F, Mantovani G, Massa E, Astara G, Segati R, Rosso R, Del Mastro L, Venturini M, Bighin C, Bajetta E, Zilembo N, Paleari D, Procopio G, Salvagni S, Perrone MA, Franciosi V, Catalano G, Luzi Fedeli S, Pinotti G, Giardina G, Vallini I, Massidda B, Ionta MT, Deidda MC, Nalli G, Sita G, Carreca I, Cucciarré S, Burgio D, Lombardo M, Pandoli G, Di Stefano P, Boni C, Bisagni G, Banzi MC, Linarello P, Colosini G, Spasiano A, Caldonazzo A, Pacquola MG, Ziekenhuis C, Rutten HJ, Luiten EJ, Roerdink HT, Roumen RH, McLaren B, Costello S, North J, Perez D, Bayston K, Pfieffer M, Kennedy I, Campbell ID, Gilbert L, Gannaway R, Jameson M, Long J, Round G, Spellman L, Whittle D, Woolerton D, Jassem J, Welnicka-Jaskiewicz M, Senkus-Konefka E, Matuszewska K, Koralewski P, Pernal J, Pienkowski T, Brewczynska E, Bauer-Kosinska B, Sienkiewicz-Kozlowska R, Jagiello-Gruszfeld A, Sudol K, Tujakowski J, Zurawski B, Pawlega J, Jablonska E, Zygulska A, Górnasiowa M, Filypczyk-Cisarz E, Pajak K, Damasceno M, Albano JQ, da Costa B, Costa L, Henriques A, Amaral H, Marques F, Komov DV, Polikarpova SB, Makhson AN, Zabaznyi NV, Vozny EK, Dobrovolskaya NY, Bolshakova S, Yurgina OV, Korman DB, Maslova IA, Semiglazov V, Ivanov V, Manikhas G, Dolmatov G, Apffelstaedt J, Eedes D, Slabber C, Coccia-Portugal MA, Maart K, Alés Martinez JE, Aramburo P, Sánchez R, Rifa J, Martin J, Pérez-Carrión R, González Larriba JL, Cubillo A, Jiménez MM, Casado A, Fra J, Vieitez JM, Esteban E, Lacave AJ, Wight E, Bartens S, Decio R, Güth U, Breitenstein U, Icli F, Dincol D, Baltali E, Ozisik Y, Topuz E, Basaran M, Aydiner A, Ozdedeli E, Harmancioglu O, Yilmaz AU, Smith IE, Thompson AM, Wardley A, Hickish T, Neave F, Sabini G.

Abstract

PURPOSE:

To evaluate the prognostic and predictive value of Ki-67 labeling index (LI) in a trial comparing letrozole (Let) with tamoxifen (Tam) as adjuvant therapy in postmenopausal women with early breast cancer.

PATIENTS AND METHODS:

Breast International Group (BIG) trial 1-98 randomly assigned 8,010 patients to four treatment arms comparing Let and Tam with sequences of each agent. Of 4,922 patients randomly assigned to receive 5 years of monotherapy with either agent, 2,685 had primary tumor material available for central pathology assessment of Ki-67 LI by immunohistochemistry and had tumors confirmed to express estrogen receptors after central review. The prognostic and predictive value of centrally measured Ki-67 LI on disease-free survival (DFS) were assessed among these patients using proportional hazards modeling, with Ki-67 LI values dichotomized at the median value of 11%.

RESULTS:

Higher values of Ki-67 LI were associated with adverse prognostic factors and with worse DFS (hazard ratio [HR; high:low] = 1.8; 95% CI, 1.4 to 2.3). The magnitude of the treatment benefit for Let versus Tam was greater among patients with high tumor Ki-67 LI (HR [Let:Tam] = 0.53; 95% CI, 0.39 to 0.72) than among patients with low tumor Ki-67 LI (HR [Let:Tam] = 0.81; 95% CI, 0.57 to 1.15; interaction P = .09).

CONCLUSION:

Ki-67 LI is confirmed as a prognostic factor in this study. High Ki-67 LI levels may identify a patient group that particularly benefits from initial Let adjuvant therapy.

[PubMed - indexed for MEDLINE]
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