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N Engl J Med. 2009 Aug 20;361(8):766-76. doi: 10.1056/NEJMoa0810818.

Letrozole therapy alone or in sequence with tamoxifen in women with breast cancer.

Collaborators (900)

Thürlimann B, Aebi S, Blacher L, Castiglione M, Coates AS, Cufer T, Forbes JF, Gelber RD, Giobbie-Hurder A, Goldhirsch A, Hiltbrunner A, Holmberg SB, Maibach R, Martoni A, Mauriac L, MacGrogan G, Mouridsen HT, Paridaens R, Phuong D, 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, Mouridsen H, Giobbie-Hurder A, Goldhirsch A, Thürlimann B, Paridaens R, Smith I, Mauriac L, Forbes JF, Price KN, Regan MM, Gelber RD, Coates AS, 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, de Stoppani FP, Rudenstam CM, Senn HJ, Stahel R, Thürlimann B, Veronesi A, Castiglione 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, 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, Gallowa 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, Trostmann U, Schmidt W, Bolton A, Hackl W, Snyder RD, Chirgwin J, Forbes JF, Coates AS, Boyle F, Lindsay D, 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 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 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 D, 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, 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, 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 C, 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:

The aromatase inhibitor letrozole, as compared with tamoxifen, improves disease-free survival among postmenopausal women with receptor-positive early breast cancer. It is unknown whether sequential treatment with tamoxifen and letrozole is superior to letrozole therapy alone.

METHODS:

In this randomized, phase 3, double-blind trial of the treatment of hormone-receptor-positive breast cancer in postmenopausal women, we randomly assigned women to receive 5 years of tamoxifen monotherapy, 5 years of letrozole monotherapy, or 2 years of treatment with one agent followed by 3 years of treatment with the other. We compared the sequential treatments with letrozole monotherapy among 6182 women and also report a protocol-specified updated analysis of letrozole versus tamoxifen monotherapy in 4922 women.

RESULTS:

At a median follow-up of 71 months after randomization, disease-free survival was not significantly improved with either sequential treatment as compared with letrozole alone (hazard ratio for tamoxifen followed by letrozole, 1.05; 99% confidence interval [CI], 0.84 to 1.32; hazard ratio for letrozole followed by tamoxifen, 0.96; 99% CI, 0.76 to 1.21). There were more early relapses among women who were assigned to tamoxifen followed by letrozole than among those who were assigned to letrozole alone. The updated analysis of monotherapy showed that there was a nonsignificant difference in overall survival between women assigned to treatment with letrozole and those assigned to treatment with tamoxifen (hazard ratio for letrozole, 0.87; 95% CI, 0.75 to 1.02; P=0.08). The rate of adverse events was as expected on the basis of previous reports of letrozole and tamoxifen therapy.

CONCLUSIONS:

Among postmenopausal women with endocrine-responsive breast cancer, sequential treatment with letrozole and tamoxifen, as compared with letrozole monotherapy, did not improve disease-free survival. The difference in overall survival with letrozole monotherapy and tamoxifen monotherapy was not statistically significant. (ClinicalTrials.gov number, NCT00004205.)

PMID:
19692688
PMCID:
PMC2921823
DOI:
10.1056/NEJMoa0810818
[PubMed - indexed for MEDLINE]
Free PMC Article
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