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Ann Oncol. 2009 Sep;20(9):1489-98. doi: 10.1093/annonc/mdp033. Epub 2009 May 27.

Bone fractures among postmenopausal patients with endocrine-responsive early breast cancer treated with 5 years of letrozole or tamoxifen in the BIG 1-98 trial.

Collaborators (886)

Thürlimann B, Aebi S, Blacher L, Castiglione M, Coates AS, Cufer T, Dinh P, 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, Viale G, Chaudri-Ross HA, Dias R, Evans DB, Sguotti C, Trostmann U, Goldhirsch A, Coates AS, Blacher L, Forbes JF, Gelber RD, Gusterson BA, Hiltbrunner A, Hürny C, Murray E, Price KN, Rabaglio M, Studer R, Viale G, Wallgren A, Aebi S, Coates AS, Colleoni M, Collins JP, Cortés Funes H, Gelber RD, Goldhirsch A, Green M, Hiltbrunner A, Holmberg SB, Karlsson P, Kössler I, Láng I, Lindtner J, Paganetti F, de Stoppani M, Rudenstam CM, Senn H-, Stahel R, Thürlimann B, Veronesi A, Hiltbrunner A, Rabaglio M, Egli G, Cliffe B, Ribeli-Hofmann S, Munarini F, Kammler R, Studer R, Ruepp B, Maibach R, Munarini N, Castiglione M, Gelber RD, Price KN, Giobbie-Hurder A, Keshaviah A, Litman H, Regan MM, Sun Z, Huang H, Somos LJ, Timmers B, Nickerson L, Blacher L, Heckman Scolese T, 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, Garber JE, Gradishar W, Lagakos SW, Lindgren I, Waldie E, van Hoomissen I, De Smet M, Schmidt W, Bolton A, Bolton W, Snyder RD, Forbes JF, Coates AS, Preece D, Cowell J, Talbot D, Whipp A, 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 T, 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, 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 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, 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, Yorkshire W, Nejim A, Dodwell D, Horgan K, Lansdown M, Perren M, 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, Kains JP, Canon JL, Brohèe D, Gowing J, Yelle L, 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 D, Bisagni G, Banzi MC, Linarello P, Colosini G, Spasiano A, Caldonazzo A, Pacquola MG, Sleeboom HP, 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

BACKGROUND:

To compare the incidence and timing of bone fractures in postmenopausal women treated with 5 years of adjuvant tamoxifen or letrozole for endocrine-responsive early breast cancer in the Breast International Group (BIG) 1-98 trial.

METHODS:

We evaluated 4895 patients allocated to 5 years of letrozole or tamoxifen in the BIG 1-98 trial who received at least some study medication (median follow-up 60.3 months). Bone fracture information (grade, cause, site) was collected every 6 months during trial treatment.

RESULTS:

The incidence of bone fractures was higher among patients treated with letrozole [228 of 2448 women (9.3%)] versus tamoxifen [160 of 2447 women (6.5%)]. The wrist was the most common site of fracture in both treatment groups. Statistically significant risk factors for bone fractures during treatment included age, smoking history, osteoporosis at baseline, previous bone fracture, and previous hormone replacement therapy.

CONCLUSIONS:

Consistent with other trials comparing aromatase inhibitors to tamoxifen, letrozole was associated with an increase in bone fractures. Benefits of superior disease control associated with letrozole and lower incidence of fracture with tamoxifen should be considered with the risk profile for individual patients.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00004205.

PMID:
19474112
PMCID:
PMC2731016
DOI:
10.1093/annonc/mdp033
[Indexed for MEDLINE]
Free PMC Article
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