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Lancet. 2014 Mar 22;383(9922):1041-8. doi: 10.1016/S0140-6736(13)62292-8. Epub 2013 Dec 12.

Anastrozole for prevention of breast cancer in high-risk postmenopausal women (IBIS-II): an international, double-blind, randomised placebo-controlled trial.

Collaborators (410)

Bonanni B, Buchanan M, Bundred N, Cawthorn S, Coleman RE, Cuzick J, Dowsett M, Eastell R, Ejlertsen B, Ellis I, Forbes JF, Howell A, Kahan Z, Leonard G, Levy C, Mansel RE, Marshall J, Neven P, Palva T, Rukazenkov Y, Rydén L, Senn HJ, Sestak I, Stierer M, Vaz F, von Minckwitz G, Abdi E, Aktas B, Artioli F, Augustin D, Baker C, Beckmann M, Bennett I, Bertelli G, Blum R, Bolliger B, Bonanni B, Boyce A, Bradpiece H, Bramley M, Breitbach GP, Brincat S, Briscoe K, Buchholz O, Buser KS, Bucher S, Campbell I, Carmalt H, Cawthorn S, Bristol J, Chappuis PO, Clark D, Coleman RE, Collins J, Conrad B, Costa SD, Daoud R, Della-Fiorentina S, Deryal M, Donovan M, Drew P, Dubey S, Ellenbogen S, Evoy D, Federico M, Ferguson D, Forbes JF, Fox JN, Gamboa J, Garne JP, Gebski V, Gendy R, Graiff C, Gill PG, Gross S, Gupta R, Gutteridge E, Hamed H, Hanusch CA, Hans-Jorg S, Harding-McKean C, Heinrich G, Hill J, Hill A, Hoffmann G, Holcombe C, Howell A, Jibril JA, Kahan Z, Kast K, Kaufmann M, Kennedy J, Kerin M, Khaled H, Klare P, Kokan J, Krabisch P, Lanng C, Lannigan A, Lansdown M, Law M, Lemster S, Lennard T, Linforth R, Mansel RE, Marmé F, Martignoni F, Masters R, McCrystal M, McIntosh S, Miedzybrodzka Z, Moid I, Mok K, Mundhenke C, Neades GT, Nejim A, Neunhöffer T, Neven P, O'Hanlon D, Ooi JL, Paepke S, Pagani O, Palva T, Patel A, Pavlakis N, Phillips KA, Pinotti G, Ponzone R, Porpiglia M, Pourfard JY, Rabaglio M, Iqbal S, Rauch D, Rayter Z, Redmond E, Redmond P, Reichert R, Reimer T, Rezai M, Roche N, Rogers C, Royle G, Sardelic F, Saunders C, Scharl A, Schmutzler R, Schwartz R, Segelov E, Chandrasekharan S, Shah E, Shimell C, Sibbering M, Simpson A, Skene AI, Smith S, Snyder R, Sommer H, Sparrow G, Splitt G, Stauß E, Stefek A, Stickeler E, Strittmatter HJ, Thompson A, Thomssen C, Thuraisingam K, Tondini C, Tulusan A, Uleer C, Vaidya J, Vaz F, Walshe J, Wamberg PA, Wiest W, White S, Wilkinson S, Wolstenholme V, Wynne C, Zaman K, Zammit C, Thornton R, Probert F, Morrison A, Fong A, Chamen M, Griffiths R, Benson A, Holland J, Rundle A, Tang A, Silcock J, Harrower Y, Sproule V, Baldo C, Pickett A, Byrne S, King P, Warburton K, Aung J, Subramani S, Vandine D, Whatman A, Walsh K, Preston C, Sharma S, Tan C, Lashbrook M, Rosmini J, Quarmby D, Garrett L, Lieschke M, D'Aulerio G, Davis I, Ranieri N, Uhe M, Jolly L, Clark S, Dunne K, Howells C, Robinson K, Flay H, Scarlet J, Bowers J, Morriss D, Neilson K, Stevens N, Nisbet S, Wood J, Lefever I, Supply D, Zlatar Z, Müller B, Välimaa M, Toivonen R, Beckel H, Feer P, Judit S, Kahan Z, Guerrieri-Gonzaga A, Bollani G, Varricchio C, Maggioni P, Cretella E, Guerzoni R, Marchi I, Cortesi L, Picardo E, Maggiorotto F, Vallini I, Cilia N, Costa C, Cassoly E, Beamish R, O'Hare D, Cole A, Lenihan E, Cronin E, Beamish R, Roche T, Corcoran A, Kiernan I, Maguire M, Egan L, Boland E, Killilea N, Jennings M, Lowry L, Gillespie M, Bazin A, D'Alessandro M, Cheung M, PenaRemorin AM, Scovell S, McKirdy F, Benton R, Robertshaw H, Bamford L, Inman H, Akbar Q, Hill N, Hanna E, Thompson J, Yoong B, Mitchell H, Corbett L, Etherington B, Batty I, Patel H, Cocks S, Shackleton J, Henson V, Boal H, Dawe C, Kirby K, Garlicka H, Elliott J, Cox H, Hathaway-Lees S, Rooke K, Morris C, Gibson S, Lester Y, Stuart-Grumbar C, Anderson S, Chittock J, Bakawala R, Trigg-Hogarth K, Aldous M, Archer D, Eccleson H, Spriggs J, Beveridge H, Bradshaw S, Cumming H, Carroll M, Reid R, Geddes F, Turner C, Howard J, Goodwin S, Taylor JA, Tasker S, Downer S, Baines K, Edwards D, Fletcher-Foale C, Brighton J, Burgess C, Osborne L, Patel A, Partridge C, Perrin M, Hancock D, Ryan S, Melia D, Gullaksen E, Alford A, Waldron E, Hothersall H, Shaw A, Lockwood C, Archer S, Francis O, Mashegede B, Thomas I, Hartup S, Gibb J, Henson A, Makinson K, Francis L, Kano Y, Brooks K, Self J, Townley B, Adinkra V, McCurrie M, Hill P, Hardstaff L, Greenhalgh R, Affen J, Bennett-Cowell JB, Puvanendran R, Murdoch H, Walker K, Sutherland A, Gordon C, Stevenson H, Asif-Suleman S, Dennis S, Gibbins T, Rouse C, Kanani R, Johnson J, Jones R, Foster M, Rowley H, Pascoe J, Whelan S, Withers D, Pitcher S, Cook M, Brinkworth E, Beachill J, Crabtree C, Clarke A, Stevens K, Stacey J, Parton C, Mitchell S, Beech D, Maidens V, Conteh V, Botham P, Kotze M, Rennie K, Chattoo J, Edwards R, Ferguson S, Hickman J, Ndoutoumou A, Rockliffe L, Sahota N, Searles P, Aigret B, Farrance C, Gaviria J, Idris J, Kealy R, Ostler R, Sasieni P.

Author information

1
Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK. Electronic address: j.cuzick@qmul.ac.uk.
2
Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.
3
Australian New Zealand Breast Cancer Trials Group, Calvary Mater Newcastle, University of Newcastle, Waratah, NSW, Australia.
4
Academic Department of Biochemistry, The Royal Marsden NHS Trust, London, UK.
5
Breast Care Centre, Southmead Hospital, Bristol, UK.
6
University of Western Australia, Crawley, WA, Australia.
7
Breast Unit, The Royal Marsden NHS Trust, London, UK.
8
Department of Surgery, University of Wales College of Medicine, Cardiff, UK.
9
German Breast Group, Neu-Isenburg, Germany; University Women's Hospital, Frankfurt, Germany.
10
Division of Chemoprevention and Genetics, European Institute of Oncology, Milan, Italy.
11
Pirkanmaa Cancer Society, Tampere, Finland.
12
Genesis Breast Cancer Prevention Centre, Manchester, UK.

Erratum in

Abstract

BACKGROUND:

Aromatase inhibitors effectively prevent breast cancer recurrence and development of new contralateral tumours in postmenopausal women. We assessed the efficacy and safety of the aromatase inhibitor anastrozole for prevention of breast cancer in postmenopausal women who are at high risk of the disease.

METHODS:

Between Feb 2, 2003, and Jan 31, 2012, we recruited postmenopausal women aged 40-70 years from 18 countries into an international, double-blind, randomised placebo-controlled trial. To be eligible, women had to be at increased risk of breast cancer (judged on the basis of specific criteria). Eligible women were randomly assigned (1:1) by central computer allocation to receive 1 mg oral anastrozole or matching placebo every day for 5 years. Randomisation was stratified by country and was done with blocks (size six, eight, or ten). All trial personnel, participants, and clinicians were masked to treatment allocation; only the trial statistician was unmasked. The primary endpoint was histologically confirmed breast cancer (invasive cancers or non-invasive ductal carcinoma in situ). Analyses were done by intention to treat. This trial is registered, number ISRCTN31488319.

FINDINGS:

1920 women were randomly assigned to receive anastrozole and 1944 to placebo. After a median follow-up of 5·0 years (IQR 3·0-7·1), 40 women in the anastrozole group (2%) and 85 in the placebo group (4%) had developed breast cancer (hazard ratio 0·47, 95% CI 0·32-0·68, p<0·0001). The predicted cumulative incidence of all breast cancers after 7 years was 5·6% in the placebo group and 2·8% in the anastrozole group. 18 deaths were reported in the anastrozole group and 17 in the placebo group, and no specific causes were more common in one group than the other (p=0·836).

INTERPRETATION:

Anastrozole effectively reduces incidence of breast cancer in high-risk postmenopausal women. This finding, along with the fact that most of the side-effects associated with oestrogen deprivation were not attributable to treatment, provides support for the use of anastrozole in postmenopausal women at high risk of breast cancer.

FUNDING:

Cancer Research UK, the National Health and Medical Research Council Australia, Sanofi-Aventis, and AstraZeneca.

PMID:
24333009
DOI:
10.1016/S0140-6736(13)62292-8
[Indexed for MEDLINE]
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