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Quality of Life of Postmenopausal Women in the ATAC (“Arimidex”, Tamoxifen, Alone or in Combination) Trial after Completion of 5 years' Adjuvant Treatment for Early Breast Cancer

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Abstract

The impact of treatment on health-related quality of life (HRQoL) is an important consideration in the adjuvant treatment of operable breast cancer. Here we report mature HRQoL outcomes from the ATAC trial, comparing anastrozole with tamoxifen as primary adjuvant therapy for postmenopausal women with localized breast cancer. Patients completed the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire plus endocrine subscale (ES) at baseline, 3 and 6 months, and every 6 months thereafter. Baseline characteristics in the HRQoL sub-protocol were well balanced between the anastrozole (n = 335) and tamoxifen (n = 347) groups in the primary analysis population. As with previously published results at 2 years, there was no statistically significant difference in the Trial Outcome Index of the FACT-B, the primary endpoint of the study, between treatments at 5 years. There were no statistically significant differences between treatment groups in ES total scores. Consistent with the 2-year analysis, there were differences between treatment groups in patient-reported side effects: diarrhea (anastrozole 3.1% vs. tamoxifen 1.3%), vaginal dryness (18.5% vs. 9.1%), diminished libido (34.0% vs. 26.1%), and dyspareunia (17.3% vs. 8.1%) were significantly more frequent with anastrozole compared to tamoxifen. Dizziness (3.1% vs. 5.4%) and vaginal discharge (1.2% vs. 5.2%) were significantly less frequent with anastrozole compared to tamoxifen. In this, the first report of HRQoL over 5 years of initial adjuvant therapy with an aromatase inhibitor, we conclude that anastrozole and tamoxifen had similar impacts on HRQoL, which was maintained or slightly improved during the treatment period for both groups.

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Acknowledgements

We thank the patients for their participation in the trial and all those listed below. Members of the Writing Group for this paper are asterisked. We thank Dr JH Bull, from Complete Medical Communications, who provided medical writing support on behalf of AstraZeneca.

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Correspondence to David Cella.

Appendix

Appendix

The ATAC Trialists group

ATAC Steering Committee

Prof J Adams: University of Manchester, Manchester, UK; Professor M Baum: University College London, London, UK; Prof AR Bianco: Universita Degli Studi Di Napoli Federico II, Napoli Italy; Prof A Buzdar (Chairman): The University of Texas, M.D. Anderson Cancer Center, Houston, USA; *Prof D Cella: Northwestern University, Evanston, Illinois, USA; Dr M Coibion: Institut Bordet, Bruxelles, Belgium; Professor R Coleman: Cancer Research Centre, Weston Park Hospital, Sheffield, UK; Dr M Constenla: Hospital Montecelo, Pontevedra, Spain; *Prof J Cuzick: Cancer Research UK, London, UK; Prof Dr W Distler: Universitätsklinikum Dresden, Dresden, Germany; Prof M Dowsett: The Royal Marsden Hospital, London, UK; Mr S Duffy: St Jamesȁ9s University Hospital, Leeds, UK; Prof R Eastell: University of Sheffield, Sheffield, UK; *Prof LJ Fallowfield, University of Sussex, Brighton, UK; Prof J Forbes: Newcastle Mater Misericordiae Hospital, NSW, Australia; Prof WD George: Beatson Oncology Centre, Western Infirmary, Glasgow, UK; Sr J Grey: Belfast City Hospital, Belfast, UK; Dr J-P Guastalla: Centre Léon Bérard, Lyon, France; Mr R Hellmund, Dr G Hoctin-Boes: AstraZeneca Pharmaceuticals, Wilmington, USA; Mrs J Houghton, Dr N Williams: Clinical Trials Group of the Department of Surgery, UCL, London, UK; *Prof A Howell: Christie Hospital, Manchester, UK; Prof Dr JGM Klijn: Dr Daniel den Hoed Kliniek and University Hospital, Rotterdam, The Netherlands; *Dr GY Locker: Evanston Northwestern Healthcare, Northwestern University Feinberg School of Medicine, Evanston, IL, USA; Dr J Mackey: Cross Cancer Institute, Edmonton, Alberta, Canada; *Prof RE Mansel: University of Wales College of Medicine, Cardiff, UK; Prof JM Nabholtz: Hartman Oncology Institute, Levallois-Perret, France; Dr T Nagykalnai: Uzsoki U Hospital, Budapest, Hungary; Dr A Nicolucci: GIVIO Co-ordinating Centre, Consorzio Mario Negri Sud, Centro Di Ricerchi Farmacologichi, E Biomedichi, Chieta, Italy; Dr U Nylen: Radiumhemmet, Karolinska Sjukhuset, Stockholm, Sweden; Mr R Sainsbury: University College London (UCL), London, UK; Dr F Sapunar, Dr VJ Suarez-Mendez: AstraZeneca Pharmaceuticals, Macclesfield, UK; Prof JS Tobias: The Meyerstein Institute of Clinical Oncology, Middlesex Hospital, London, UK.

Principal and main co-investigators in the ATAC quality-of-life sub-protocol

Australia—P Grantley-Gill: Royal Adelaide Hospital, Adelaide, SA, Australia; J Beith: Royal Prince Alfred Hospital, Camperdown, NSW, Australia; S Della-Fiorentina, A Goldrick: Liverpool Hospital, Liverpool, NSW, Australia; G Richardson: Monash Medical Centre, East Bentleigh, VIC, Australia; G Toner: Peter MacCallum Cancer Institute, Melbourne, VIC, Australia; R Snyder: St Vincentȁ9s Hospital, Fitzroy, VIC, Australia; M Friedlander: Prince of Wales Hospital, Randwick, NSW, Australia; J Forbes: Newcastle Mater Misericordiae Hospital, Waratah, NSW, Australia. Canada—R Simard: Complexe Hospitalier de la Sagami, Chicoutimi, Quebec, Canada; JR MacKey (J-M Nabholtz former PI): Cross Cancer Institute, Edmonton, Alberta, Canada; WS Lofters: Kingston Regional Cancer Center, Kingston, Ontario, Canada; LC Panasci: McGill Department of Oncology, Montreal, Quebec, Canada; LA Zibdawi: Southlake Regional Health Centre, Newmarket, Ontario, Canada; RF Wierzbicki: Peterborough Regional Health Center Oncology Clinic, Peterborough, Ontario, Canada; J Robert: CHA Pavillion St Sacrement, Quebec City, Quebec, Canada; S Lebel (M Potvin former PI): Hospital Laval, Ste Foy, Quebec, Canada; M Jancerwicz: Allan Blair Cancer Center, Regina, Saskatchewan, Canada; A Sami (BA Walley former PI): Saskatoon Cancer Center, University of Saskatoon, Saskatoon, Saskatchewan, Canada; PK Ganguly: H Bliss Murphy Cancer Centre, St Johns, Newfoundland, Canada; Y Rahim: Toronto East General Hospital, Toronto, Ontario, Canada; JJ Wilson: Humber River Regional Hospital, Weston, Ontario, Canada. France—D Serin, Y Goubely-Brewer: Clinique Ste Catherine, Avignon, France; R Coquard (P Martin former PI), Dr Portois, Dr Guillot: Clinique St Jean, Lyon, France; M Rios: Centre Alexis Vautrin, Nancy, France; J-M Vannetzel: Centre Chirurgical Henri Hartmann, Neuilly sur Seine, France. Italy—F Recchia, S De Filippis: Ospedale Civile, Avezzano, Italy; A Martoni, E Piana: Ospedale S Orsola-M Malpighi, Bologna, Italy; M Giordano, G Luchena: Ospedale S Anna, Como, Italy; A Nuzzo, L Laudadio: Ospedale Floraspe Renzetti, Lanciano, Italy; G Gardani: Ospedale S Gerardo, Monza (Milan), Italy; A De Matteis: Istituto Nazionale Tumori “G Pascale”, Napoli, Italy; AR Bianco: Università Federico II, Napoli, Italy; G Brignone, L Mesi: Ospedale Oncologico M Ascoli, Palermo, Italy; M Mattarei: Ospedale Civile Piazzale, Rovereto, Italy; A Farris: Istituto Clinica Medica, Sassari, Italy. New Zealand—I Campbell: Breast Care Centre, Waikato Hospital, Hamilton, New Zealand. South Africa—L Goedhals, L Smith: Nationale Hospital, Bloemfontein, South Africa; I Werner, E Murray: Groote Schuur Hospital, Cape Town, South Africa; D Hacking: Durban Oncology Centre, Westridge, Durban, South Africa; D Vorobiof, M Chasen: Sandton Oncology Centre, Sandton, Johannesburg, South Africa. Spain—A Barnadas Molins: Hosp. Germans Trias i Pujol, Badalona (Barcelona), Spain; L Calvo: Hosp. Juan Canalejo, La Coruña, Spain; JR Mel, G Quintero: Hosp. Xeral Calde de Lugo, Lugo, Spain; P España, R Cubedo: Cervera: Hosp. Puerta de Hierro, Madrid, Spain; P Aramburo: Hosp. Ruber Internacional, Madrid, Spain; JJ Valerdi: Hosp. de Navarra, Pamplona, Spain; J Lizon y Giner: Hosp. San Juan, San Juan (Alicante), Spain; MD Menendez: Hosp. Provincial de Conxo, Santiago de Compostela, Spain; G Huidobro Vence: Hosp. Meixoeiro, Vigo, Spain. The Netherlands—R Boom: Ziekenhuis Amstelveen, Amstelveen, The Netherlands; MB Polēe, H de Graaf: Medisch Centrum Leeuwarden, Leeuwarden, The Netherlands; F Erdkamp: Maasland Ziekenhuis, Sittard, The Netherlands; A van Reisen: Ziekenhuis Zeeuws Vlaanderen, loc. de Honte, Terneuzen, The Netherlands; C van der Heul: St Elisabeth Ziekenhuis, Tilburg, The Netherlands; L Kerhofs (G-J Creemers former PI): Ziekenhuis Walcheren, Vlissingen, The Netherlands; J Coenen: Isala Klinieken, loc. Sophia, Zwolle, The Netherlands. UK—A Hutcheon, T Sarkar: Aberdeen Royal Infirmary, Aberdeen, UK; T Bates, N Griffiths: South Kent Hospitals NHS Trust, William Harvey Hospital, Ashford, UK; N Stuart, D Crawford: Gwynedd Hospital NHS Trust, Bangor, UK; B Lavery, E Sugden: Horton General Hospital, Banbury, UK; S Dolan, A Wilkinson (G Odling-Smee former PI): Belfast City Hospital NHS Trust, Belfast, UK; T Hickish, A Skene: Royal Bournemouth & Christchurch NHS Trust, Royal Bournemouth Hospital, Bournemouth, UK; *L Fallowfield, Cancer Research UK Psychosocial Oncology Group, Brighton & Sussex Medical School, University of Sussex, Brighton, UK; R Mansel, H Sweetland: University Hospital of Wales NHS Trust, Cardiff, UK; D Cameron: Western General Hospital, Edinburgh, UK; WD George, G Fraser: Western Infirmary, Glasgow, UK; B Lavery, A Harris, D Talbot, A Jones: Oxford Radcliffe Hospital NHS Trust, John Radcliffe Hospital, Headington, UK; B Lavery: South Bucks NHS Trust, Wycombe General Hospital, High Wycombe, UK; J LeVay, T Archer: Ipswich Hospitals NHS Trust, Ipswich, UK; A Nejim, I Hutchinson: Airedale General Hospital, Keighley, UK; K Horgan, D Dodwell: Leeds General Infirmary, Leeds, UK; C Holcombe: Royal Liverpool University Hospital NHS Trust, Royal Liverpool Hospital, Liverpool, UK; J Tobias, M Gaze (M Baum former PI): UCL Hospitals NHS Trust, The Middlesex Hospital, London, UK; J Mansi, N Sacks: St Georgesȁ9 NHS Trust Hospital, Tooting, London, UK; A Jones, T Davidson: Royal Free Hampstead NHS Trust, The Royal Free Hospital, London, UK; A Wardley (A Howell former PI): Withington Hospital, Manchester, UK; C Griffith, A Griffiths: Newcastle Hospitals NHS Trust, Royal Victoria Infirmary, Newcastle-upon-Tyne, UK; C Gaffney: Glan Hafren NHS Trust, Royal Gwent Hospital, Newport, UK; JR Robertson: Nottingham City Hospital NHS Trust, Nottingham, UK; D Pinto: Sperrin Lakelands Health & Social Care Trust, Tyrone County Hospital, Omagh, UK; B Lavery, A Harris, D Talbot, A Jones: Oxford Radcliffe Hospital NHS Trust, The Churchill Hospital, Oxford, UK; R Coleman, S Kohlhardt: Weston Park Hospital, Sheffield, UK; B Harrison: Northern General Hospital, Sheffield, UK; R Agrawal: Royal Shrewsbury NHS Trust, Shrewsbury, UK; C Hennessy (A Peel former PI): North Tees General Hospital, Stockton-on-Tees, UK; A Paterson (S Kelly former PI), K Stepp: Royal Cornwall Hospitals NHS Trust, Treliske Hospital, Truro, UK; R Grieve, T Waterworth: Walsgrave Hospitals NHS Trust, Walsgrave, UK; P Barrett-Lee: Velindre NHS Trust Hospital, Whitchurch, UK; D Berstock, R Errington: Wirral Hospital NHS Trust, Wirral, UK; A Salman, A Johri: Worthing Southlands Hospital NHS Trust, Worthing Hospital, Worthing, UK; S Goodman (EC Whipp former PI), G Sparrow: East Somerset NHS Trust, Yeovil District Hospital, Yeovil, UK; S Nicholson: York District Hospital, York, UK. USA—RO Kerr: Southwest Regional Cancer Center, Austin, TX, USA; GP Miletello: Hematology/Oncology Clinic, Baton Rouge, LA, USA; LR Laufman: Columbus CCOP, Columbus, OH, USA; GY Locker: Evanston Northwestern Health Care, Kellogg Cancer Care Center, Evanston, IL, USA; RH Clark: Hematology/Oncology Associates, Jackson, MI, USA; K B Pendergrass: Kansas City Internal Medicine, Kansas City, MO, USA; JJ Sternberg: Arkansas Oncology Associates, 1000 N. University, Little Rock, AR, USA; W Bate: North Iowa Mercy Health Center, Mason City, IA, USA; PV Pickens: Abington Hematology–Oncology, Meadowbrook, PA, USA; MW Meshad: Providence Hospital, Mobile, AL, USA; KK Boatman: INTERGIS Oncology Services, Oklahoma City, OK, USA; MS Roberts: Hematology & Oncology Associates Ltd, Phoenix, AZ, USA; JI Spector: Berkshire Hematology Oncology, Pittsfield, MA, USA; MA Deutsch: Raleigh Hematology Oncology, Raleigh, NC, USA; P Bushunow (M Brower former PI): Rochester General Hospital, Rochester, NY, USA; WR Edwards: ACT Medical Group, 2473 MacFarland Road, Rockford Clinic, Rockford, IL, USA; IA Jaiyesimi: Cancer Care Associates PC, Royal Oak, MI, USA; FC Kass: Santa Barbara Hematology–Oncology Medical Group, Santa Barbara, CA, USA; PD Byeff: Hematology/Oncology, Southington, CT, USA; *D Cella, Center on Outcomes Research and Education (CORE), Evanston Northwestern Healthcare and Northwestern University, IL, USA; KL Hoelzer: Springfield Clinic, Springfield, IL, USA; EP Lester: Oncology Care Associates PLLC, St Joseph, MI, USA; AP Lyss: Missouri Baptist Cancer Center, St Louis, MO, USA; EP Gelman (DF Hayes former PI) (MJC Ellis former PI): Georgetown University Medical Lombardi Cancer Center, Washington, DC, USA; MA Vukelich: Kettle Moraine Oncology SC, West Bend, WI, USA; K Seetharaman (LL Stolbach former PI): St Vincentȁ9s Hospital, Worcester, MA, USA.

International Project Team

A Doe, Dr F Sapunar, Dr VJ Suarez-Mendez: AstraZeneca Pharmaceuticals, Macclesfield, UK; E Foster: ISD Cancer Clinical Trials Team, Edinburgh, UK; J Houghton, N Williams: Clinical Trials Group of the Department of Surgery, UCL, London, UK; A Nicolucci: Mario Negri Institute, Chieta, Italy; S Pollard: Clinical Trials Research Unit, Leeds, UK.

Data Monitoring Committee

Dr M Buyse: International Institute for Drug Development (ID squared), Brussels, Belgium; *Prof J Cuzick (Independent statistician), Cancer Research UK, London, UK; Dr R Margolese: McGill University, The Sir Mortimer B Davis Jewish General Hospital, Montreal, Québec, Canada; Prof JJ Body: Institute J Bordet, Bruxelles, Belgium.

Collaborative/Operational Groups

JF Forbes (Group Co-ordinator), JK Wakeham (Study Coordinator): Australian New Zealand Breast Cancer Trials Group Operations Office; S de Placido (Study Co-ordinator), C Carlomagno (Study Co-ordinator): Universita Degli Studi Di Napoli Federico II, Italy; A Nicolucci (Group Co-ordinator), M Belfiglio (Study Co-ordinator), M Valentini (Study Co-ordinator): GIVIO Group, Consorzio Mario Negri Sud, Italy; E Foster (Principal Trial Co-ordinator and CCTT contact): ISD Cancer Clinical Trials Team, Edinburgh, UK, C Lacey (Trial monitor): North West Breast Group, Burnley, Lancashire, UK; S Pollard (Head of Pharmaceutical Collaboration): Clinical Trials Research Unit, University of Leeds, Leeds, UK; J Houghton (Senior Lecturer in Clinical Trials and CTG contact), N Williams (Trial Co-ordinator): Clinical Trials Group of the Department of Surgery, UCL, London, UK.

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Cella, D., Fallowfield, L., Barker, P. et al. Quality of Life of Postmenopausal Women in the ATAC (“Arimidex”, Tamoxifen, Alone or in Combination) Trial after Completion of 5 years' Adjuvant Treatment for Early Breast Cancer. Breast Cancer Res Treat 100, 273–284 (2006). https://doi.org/10.1007/s10549-006-9260-6

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