- 1.
- 2.
Cheang
MC, Voduc
D, Bajdik
C, Leung
S, McKinney
S, Chia
SK, et al.
Basal-like breast cancer defined by five biomarkers has superior prognostic value than triple-negative phenotype.
Clin Cancer Res
2008;14:368–76. 10.1158/1078-0432.CCR-07-1658. [
PubMed: 18316557] [
CrossRef]
- 3.
Early Breast Cancer Trialists’ Collaborative Group.
Aromatase inhibitors versus tamoxifen in early breast cancer: patient-level meta-analysis of the randomised trials.
Lancet
2015;386:1341–52. 10.1016/S0140-6736(15)61074-1. [
PubMed: 26211827] [
CrossRef]
- 4.
National Institute for Health and Care Excellence. Early and Locally Advanced Breast Cancer: Diagnosis and Treatment (CG80).
London:
NICE; 2009.
- 5.
Day
FL, Bull
JM, Lombard
JM, Stewart
JF.
Changes in medical oncology admissions for the management of breast cancer complications: an Australian institution’s experience.
Asia Pac J Clin Oncol
2011;7:46–53. 10.1111/j.1743-7563.2011.01391.x. [
PubMed: 21585694] [
CrossRef]
- 6.
Oladipo
O, Coyle
V, McAleer
JJ, McKenna
S.
Achieving optimal dose intensity with adjuvant chemotherapy in elderly breast cancer patients: a 10-year retrospective study in a UK institution.
Breast J
2012;18:6–22. 10.1111/j.1524-4741.2011.01177.x. [
PubMed: 21999862] [
CrossRef]
- 7.
Carroll
JP, Protani
MM, Nguyen
L, Cheng
ME, Fay
M, Saleem
M, et al.
Toxicity and tolerability of adjuvant breast cancer chemotherapy in obese women.
Med Oncol
2014;31:81. 10.1007/s12032-014-0881-z. [
PubMed: 24549982] [
CrossRef]
- 8.
Petrelli
F, Borgonovo
K, Cabiddu
M, Lonati
V, Barni
S.
Mortality, leukemic risk, and cardiovascular toxicity of adjuvant anthracycline and taxane chemotherapy in breast cancer: a meta-analysis.
Breast Cancer Res Treat
2012;135:35–46. 10.1007/s10549-012-2121-6. [
PubMed: 22689092] [
CrossRef]
- 9.
Early Breast Cancer Triallists’ Collaborative Group, Peto
R, Davies
C, Godwin
J, Grey
R, Pan
HC, et al.
Comparisons between different polychemotherapy regimens for early breast cancer: meta-analyses of long-term outcome among 100,000 women in 123 randomised trials.
Lancet
2012;379:32–44. [
PMC free article: PMC3273723] [
PubMed: 22152853]
- 10.
Jagsi
R, Pottow
JA, Griffith
KA, Bradley
C, Hamilton
AS, Graff
J, et al.
Long-term financial burden of breast cancer: experiences of a diverse cohort of survivors identified through population-based registries.
J Clin Oncol
2014;32:269–76. 10.1200/JCO.2013.53.0956. [
PMC free article: PMC3986387] [
PubMed: 24663041] [
CrossRef]
- 11.
Elklit
A, Blum
A.
Psychological adjustment one year after the diagnosis of breast cancer: a prototype study of delayed post-traumatic stress disorder.
Br J Clin Psychol
2011;50:350–63. 10.1348/014466510X527676. [
PubMed: 22003946] [
CrossRef]
- 12.
O’Connor
M, Christensen
S, Jensen
AB, Moller
S, Zachariae
R.
How traumatic is breast cancer? Post-traumatic stress symptoms (PTSS) and risk factors for severe PTSS at 3 and 15 months after surgery in a nationwide cohort of Danish women treated for primary breast cancer.
Br J Cancer
2011;104:19–26. 10.1038/sj.bjc.6606073. [
PMC free article: PMC3049569] [
PubMed: 21224851] [
CrossRef]
- 13.
Wolff
AC, Blackford
AL, Visvanathan
K, Rugo
HS, Moy
B, Goldstein
LJ, et al.
Risk of marrow neoplasms after adjuvant breast cancer therapy: the National Comprehensive Cancer Network experience.
J Clin Oncol
2015;33:40–8. 10.1200/JCO.2013.54.6119. [
PMC free article: PMC4302215] [
PubMed: 25534386] [
CrossRef]
- 14.
Pinder
MC, Duan
Z, Goodwin
JS, Hortobagyi
GN, Giordano
SH.
Congestive heart failure in older women treated with adjuvant anthracycline chemotherapy for breast cancer.
J Clin Oncol
2007;25:3808–15. 10.1200/JCO.2006.10.4976. [
PubMed: 17664460] [
CrossRef]
- 15.
Hall
PS, McCabe
C, Stein
RC, Cameron
D.
Economic evaluation of genomic test-directed chemotherapy for early-stage lymph node-positive breast cancer.
J Natl Cancer Inst
2012;104:56–66. 10.1093/jnci/djr484. [
PubMed: 22138097] [
CrossRef]
- 16.
Cheung
S, Greenway
N, Lagord
C, Williams
L, Keirins
O, Lawrence
G. All Breast Cancer Report: A UK Analysis of All Symptomatic and Screen-Detected Breast Cancers Diagnosed in 2006.
London:
West Midlands Cancer Intelligence Unit, Public Health England; 2009.
- 17.
Ravdin
PM, Siminoff
LA, Davis
GJ, Mercer
MB, Hewlett
J, Gerson
N, et al.
Computer program to assist in making decisions about adjuvant therapy for women with early breast cancer.
J Clin Oncol
2001;19:980–91. [
PubMed: 11181660]
- 18.
Wishart
GC, Bajdik
CD, Dicks
E, Provenzano
E, Schmidt
MK, Sherman
M, et al.
PREDICT plus: development and validation of a prognostic model for early breast cancer that includes HER2.
Br J Cancer
2012;107:800–7. 10.1038/bjc.2012.338. [
PMC free article: PMC3425970] [
PubMed: 22850554] [
CrossRef]
- 19.
Blamey
RW, Ellis
IO, Pinder
SE, Lee
AH, Macmillan
RD, Morgan
DA, et al.
Survival of invasive breast cancer according to the Nottingham Prognostic Index in cases diagnosed in 1990–1999.
Eur J Cancer
2007;43:1548–55. 10.1016/j.ejca.2007.01.016. [
PubMed: 17321736] [
CrossRef]
- 20.
Yerushalmi
R, Woods
R, Ravdin
PM, Hayes
MM, Gelmon
KA.
Ki67 in breast cancer: prognostic and predictive potential.
Lancet Oncol
2010;11:174–83. 10.1016/S1470-2045(09)70262-1. [
PubMed: 20152769] [
CrossRef]
- 21.
- 22.
Dowsett
M, Nielsen
TO, A’Hern
R, Bartlett
J, Coombes
RC, Cuzick
J, et al.
Assessment of Ki67 in breast cancer: recommendations from the International Ki67 in Breast Cancer Working Group.
J Natl Cancer Inst
2011;103:1656–64. 10.1093/jnci/djr393. [
PMC free article: PMC3216967] [
PubMed: 21960707] [
CrossRef]
- 23.
Varga
Z, Diebold
J, Dommann-Scherrer
C, Frick
H, Kaup
D, Noske
A, et al.
How reliable is Ki-67 immunohistochemistry in grade 2 breast carcinomas? A QA study of the Swiss Working Group of Breast- and Gynecopathologists.
PLOS ONE
2012;7:e37379. 10.1371/journal.pone.0037379. [
PMC free article: PMC3360682] [
PubMed: 22662150] [
CrossRef]
- 24.
Polley
MY, Leung
SC, Gao
D, Mastropasqua
MG, Zabaglo
LA, Bartlett
JM, et al.
An international study to increase concordance in Ki67 scoring.
Mod Pathol
2015;28:778–86. 10.1038/modpathol.2015.38. [
PubMed: 25698062] [
CrossRef]
- 25.
Perou
CM, Sorlie
T, Eisen
MB, van de Rijn
M, Jeffrey
SS, Rees
CA, et al.
Molecular portraits of human breast tumours.
Nature
2000;406:747–52. 10.1038/35021093. [
PubMed: 10963602] [
CrossRef]
- 26.
Sorlie
T, Tibshirani
R, Parker
J, Hastie
T, Marron
JS, Nobel
A, et al.
Repeated observation of breast tumor subtypes in independent gene expression data sets.
Proc Natl Acad Sci USA
2003;100:8418–23. 10.1073/pnas.0932692100. [
PMC free article: PMC166244] [
PubMed: 12829800] [
CrossRef]
- 27.
Sorlie
T, Perou
CM, Tibshirani
R, Aas
T, Geisler
S, Johnsen
H, et al.
Gene expression patterns of breast carcinomas distinguish tumor subclasses with clinical implications.
Proc Natl Acad Sci USA
2001;98:10869–74. 10.1073/pnas.191367098. [
PMC free article: PMC58566] [
PubMed: 11553815] [
CrossRef]
- 28.
- 29.
Caan
BJ, Sweeney
C, Habel
LA, Kwan
ML, Kroenke
CH, Weltzien
EK, et al.
Intrinsic subtypes from the PAM50 gene expression assay in a population-based breast cancer survivor cohort: prognostication of short- and long-term outcomes.
Cancer Epidemiol Biomark Prev
2014;23:725–34. 10.1158/1055-9965.EPI-13-1017. [
PMC free article: PMC4105204] [
PubMed: 24521998] [
CrossRef]
- 30.
Sweeney
C, Bernard
PS, Factor
RE, Kwan
ML, Habel
LA, Quesenberry
CP, et al.
Intrinsic subtypes from PAM50 gene expression assay in a population-based breast cancer cohort: differences by age, race, and tumour characteristics.
Cancer Epidemiol Biomark Prev
2014;23:714–24. 10.1158/1055-9965.EPI-13-1023. [
PMC free article: PMC4011983] [
PubMed: 24521995] [
CrossRef]
- 31.
Cheang
MC, Chia
SK, Voduc
D, Gao
D, Leung
S, Snider
J, et al.
Ki67 index, HER2 status, and prognosis of patients with luminal B breast cancer.
J Natl Cancer Inst
2009;101:736–50. 10.1093/jnci/djp082. [
PMC free article: PMC2684553] [
PubMed: 19436038] [
CrossRef]
- 32.
Curtis
C, Shah
SP, Chin
SF, Turashvili
G, Rueda
OM, Dunning
MJ, et al.
The genomic and transcriptomic architecture of 2,000 breast tumours reveals novel subgroups.
Nature
2012;486:346–52. 10.1038/nature10983. [
PMC free article: PMC3440846] [
PubMed: 22522925] [
CrossRef]
- 33.
Coates
AS, Colleoni
M, Goldhirsch
A.
Is adjuvant chemotherapy useful for women with luminal a breast cancer?
J Clin Oncol
2012;30:1260–3. 10.1200/JCO.2011.37.7879. [
PubMed: 22355052] [
CrossRef]
- 34.
Hayes
DF, Thor
AD, Dressler
LG, Weaver
D, Edgerton
S, Cowan
D, et al.
HER2 and response to paclitaxel in node-positive breast cancer.
N Engl J Med
2007;357:1496–506. 10.1056/NEJMoa071167. [
PubMed: 17928597] [
CrossRef]
- 35.
Gennari
A, Sormani
MP, Pronzato
P, Puntoni
M, Colozza
M, Pfeffer
U, et al.
HER2 status and efficacy of adjuvant anthracyclines in early breast cancer: a pooled analysis of randomised trials.
J Natl Cancer Inst
2008;100:14–20. 10.1093/jnci/djm252. [
PubMed: 18159072] [
CrossRef]
- 36.
Colleoni
M, Cole
BF, Viale
G, Regan
MM, Price
KN, Maiorano
E, et al.
Classical cyclophosphamide, methotrexate, and fluorouracil chemotherapy is more effective in triple-negative, node-negative breast cancer: results from two randomised trials of adjuvant chemoendocrine therapy for node-negative breast cancer.
J Clin Oncol
2010;28:2966–73. 10.1200/JCO.2009.25.9549. [
PMC free article: PMC2982784] [
PubMed: 20458051] [
CrossRef]
- 37.
International Breast Cancer Study Group.
Endocrine responsiveness and tailoring adjuvant therapy for postmenopausal lymph node- negative breast cancer: a randomized trial.
J Natl Cancer Inst
2002;94:1054–65. 10.1093/jnci/94.14.1054. [
PubMed: 12122096] [
CrossRef]
- 38.
International Breast Cancer Study Group, Castiglione-Gertsch
M, O’Neill
A, Price
KN, Goldhirsch
A, Coastes
AS, et al.
Adjuvant chemotherapy followed by goserelin versus either modality alone for premenopausal lymph node-negative breast cancer: a randomized trial.
J Natl Cancer Inst
2003;95:1833–46. 10.1093/jnci/djg119. [
PubMed: 14679153] [
CrossRef]
- 39.
Rouzier
R, Perou
CM, Symmans
WF, Ibrahim
N, Cristofanilli
M, Anderson
K, et al.
Breast cancer molecular subtypes respond differently to preoperative chemotherapy.
Clin Cancer Res
2005;11:5678–85. 10.1158/1078-0432.CCR-04-2421. [
PubMed: 16115903] [
CrossRef]
- 40.
Esserman
LJ, Berry
DA, Cheang
MC, Yau
C, Perou
CM, Carey
L, et al.
Chemotherapy response and recurrence-free survival in neoadjuvant breast cancer depends on biomarker profiles: results from the I-SPY 1 Trial (CALGB 150007/150012; ACRIN 6657).
Breast Canc Res Treat
2012;132:1049–62. 10.1007/s10549-011-1895-2. [
PMC free article: PMC3332388] [
PubMed: 22198468] [
CrossRef]
- 41.
Paik
S, Shak
S, Tang
G, Kim
C, Baker
J, Cronin
M, et al.
A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer.
N Engl J Med
2004;351:2817–26. 10.1056/NEJMoa041588. [
PubMed: 15591335] [
CrossRef]
- 42.
Ma
XJ, Salunga
R, Dahiya
S, Wang
W, Carney
E, Durbecq
V, et al.
A five-gene molecular grade index and HOXB13:IL17BR are complementary prognostic factors in early stage breast cancer.
Clin Cancer Res
2008;14:2601–8. 10.1158/1078-0432.CCR-07-5026. [
PubMed: 18451222] [
CrossRef]
- 43.
Sgroi
DC, Sestak
I, Cuzick
J, Zhang
Y, Schnabel
CA, Schroeder
B, et al.
Prediction of late distant recurrence in patients with oestrogen-receptor-positive breast cancer: a prospective comparison of the breast-cancer index (BCI) assay, 21-gene recurrence score, and IHC4 in the TransATAC study population.
Lancet Oncol
2013;14:1067–76. 10.1016/S1470-2045(13)70387-5. [
PMC free article: PMC3918681] [
PubMed: 24035531] [
CrossRef]
- 44.
- 45.
Azim
HA
Jr, Michiels
S, Bedard
PL, Singhal
SK, Criscitiello
C, Ignatiadis
M, et al.
Elucidating prognosis and biology of breast cancer arising in young women using gene expression profiling.
Clin Cancer Res
2012;18:1341–51. 10.1158/1078-0432.CCR-11-2599. [
PubMed: 22261811] [
CrossRef]
- 46.
Marchionni
L, Wilson
RF, Marinopoulos
SS, Wolff
AC, Parmigiani
G, Bass
EB, et al.
Impact of Gene Expression Profiling Tests on Breast Cancer Outcomes.
Rockville, MD:
Agency for Healthcare Research and Quality; 2007. [
PMC free article: PMC4781418] [
PubMed: 18457476]
- 47.
Smartt
P. A Comparison of Gene Expression Profiling Tests for Breast Cancer.
Christchurch:
University of Canterbury, Health Services Assessment Collaboration; 2010.
- 48.
Hornberger
J, Alvarado
MD, Rebecca
C, Gutierrez
HR, Yu
TM, Gradishar
WJ.
Clinical validity/utility, change in practice patterns, and economic implications of risk stratifiers to predict outcomes for early-stage breast cancer: a systematic review.
J Natl Cancer Inst
2012;104:1068–79. 10.1093/jnci/djs261. [
PubMed: 22767204] [
CrossRef]
- 49.
Ward
S, Scope
A, Rafia
R, Pandor
A, Harnan
S, Evans
P, et al.
Gene expression profiling and expanded immunohistochemistry tests to guide the use of adjuvant chemotherapy in breast cancer management: a systematic review and cost-effectiveness analysis.
Health Technol Assess
2013;17(44). 10.3310/hta17440. [
PMC free article: PMC4780957] [
PubMed: 24088296] [
CrossRef]
- 50.
Glas
AM, Floore
A, Delahaye
LJ, Witteveen
AT, Pover
RC, Bakx
N, et al.
Converting a breast cancer microarray signature into a high-throughput diagnostic test.
BMC Genomics
2006;7:278. 10.1186/1471-2164-7-278. [
PMC free article: PMC1636049] [
PubMed: 17074082] [
CrossRef]
- 51.
Mook
S, Knauer
M, Bueno-de-Mesquita
JM, Retel
VP, Wesseling
J, Linn
SC, et al.
Metastatic potential of T1 breast cancer can be predicted by the 70-gene MammaPrint signature.
Ann Surg Oncol
2010;17:1406–13. 10.1245/s10434-009-0902-x. [
PubMed: 20094918] [
CrossRef]
- 52.
Foekens
JA, Atkins
D, Zhang
Y, Sweep
FC, Harbeck
N, Paradiso
A, et al.
Multicenter validation of a gene expression-based prognostic signature in lymph node-negative primary breast cancer.
J Clin Oncol
2006;24:1665–71. 10.1200/JCO.2005.03.9115. [
PubMed: 16505412] [
CrossRef]
- 53.
Ring
BZ, Seitz
RS, Beck
R, Shasteen
WJ, Tarr
SM, Cheang
MC, et al.
Novel prognostic immunohistochemical biomarker panel for estrogen receptor-positive breast cancer.
J Clin Oncol
2006;24:3039–47. 10.1200/JCO.2006.05.6564. [
PubMed: 16809728] [
CrossRef]
- 54.
Geiss
GK, Bumgarner
RE, Birditt
B, Dahl
T, Dowidar
N, Dunaway
DL, et al.
Direct multiplexed measurement of gene expression with color-coded probe pairs.
Nature Biotechnol
2008;26:317–25. 10.1038/nbt1385. [
PubMed: 18278033] [
CrossRef]
- 55.
Dowsett
M, Sestak
I, Lopez-Knowles
E, Sidhu
K, Dunbier
AK, Cowens
JW, et al.
Comparison of PAM50 risk of recurrence score with oncotype DX and IHC4 for predicting risk of distant recurrence after endocrine therapy.
J Clin Oncol
2013;31:2783–90. 10.1200/JCO.2012.46.1558. [
PubMed: 23816962] [
CrossRef]
- 56.
Cuzick
J, Dowsett
M, Pineda
S, Wale
C, Salter
J, Quinn
E, et al.
Prognostic value of a combined estrogen receptor, progesterone receptor, Ki-67, and human epidermal growth factor receptor 2 immunohistochemical score and comparison with the Genomic Health recurrence score in early breast cancer.
J Clin Oncol
2011;29:4273–8. 10.1200/JCO.2010.31.2835. [
PubMed: 21990413] [
CrossRef]
- 57.
Sotiriou
C, Wirapati
P, Loi
S, Harris
A, Fox
S, Smeds
J, et al.
Gene expression profiling in breast cancer: understanding the molecular basis of histologic grade to improve prognosis.
J Natl Cancer Inst
2006;98:262–72. 10.1093/jnci/djj052. [
PubMed: 16478745] [
CrossRef]
- 58.
Filipits
M, Rudas
M, Jakesz
R, Dubsky
P, Fitzal
F, Singer
CF, et al.
A new molecular predictor of distant recurrence in ER-positive, HER2-negative breast cancer adds independent information to conventional clinical risk factors.
Clin Cancer Res
2011;17:6012–20. 10.1158/1078-0432.CCR-11-0926. [
PubMed: 21807638] [
CrossRef]
- 59.
Rakha
EA, Soria
D, Green
AR, Lemetre
C, Powe
DG, Nolan
CC, et al.
Nottingham Prognostic Index Plus (NPI+): a modern clinical decision making tool in breast cancer.
Br J Cancer
2014;110:1688–97. 10.1038/bjc.2014.120. [
PMC free article: PMC3974073] [
PubMed: 24619074] [
CrossRef]
- 60.
Aigner
J, Schneeweiss
A, Marme
F, Eidt
S, Altevogt
P, Sinn
P, et al.
Ki-67 mRNA as a predictor for response to neoadjuvant chemotherapy in primary breast cancer. Cancer Res
2012;72(Suppl. 24):P3–06–19.
- 61.
Paik
S, Tang
G, Shak
S, Kim
C, Baker
J, Kim
W, et al.
Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer.
J Clin Oncol
2006;24:3726–34. 10.1200/JCO.2005.04.7985. [
PubMed: 16720680] [
CrossRef]
- 62.
Albain
KS, Barlow
WE, Shak
S, Hortobagyi
GN, Livingston
RB, Yeh
IT, et al.
Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomised trial.
Lancet Oncol
2010;11:55–65. 10.1016/S1470-2045(09)70314-6. [
PMC free article: PMC3058239] [
PubMed: 20005174] [
CrossRef]
- 63.
Mamounas
EP, Tang
G, Fisher
B, Paik
S, Shak
S, Costantino
JP, et al.
Association between the 21-gene recurrence score assay and risk of locoregional recurrence in node-negative, estrogen receptor-positive breast cancer: results from NSABP B-14 and NSABP B-20.
J Clin Oncol
2010;28:1677–83. 10.1200/JCO.2009.23.7610. [
PMC free article: PMC2849763] [
PubMed: 20065188] [
CrossRef]
- 64.
Tang
G, Shak
S, Paik
S, Anderson
SJ, Costantino
JP, Geyer
CE
Jr, et al.
Comparison of the prognostic and predictive utilities of the 21-gene Recurrence Score assay and Adjuvant! for women with node-negative, ER-positive breast cancer: results from NSABP B-14 and NSABP B-20.
Breast Cancer Res Treat
2011;127:133–42. 10.1007/s10549-010-1331-z. [
PMC free article: PMC4266581] [
PubMed: 21221771] [
CrossRef]
- 65.
Dowsett
M, Cuzick
J, Wale
C, Forbes
J, Mallon
EA, Salter
J, et al.
Prediction of risk of distant recurrence using the 21-gene recurrence score in node-negative and node-positive postmenopausal patients with breast cancer treated with anastrozole or tamoxifen: a TransATAC study.
J Clin Oncol
2010;28:1829–34. 10.1200/JCO.2009.24.4798. [
PubMed: 20212256] [
CrossRef]
- 66.
Solin
LJ, Grey
R, Baehner
FL, Butler
SM, Hughes
LL, Yoshizawa
C, et al.
A multigene expression assay to predict local recurrence risk for ductal carcinoma in situ of the breast.
J Natl Cancer Inst
2013;105:701–10. 10.1093/jnci/djt067. [
PMC free article: PMC3653823] [
PubMed: 23641039] [
CrossRef]
- 67.
- 68.
Chang
JC, Makris
A, Gutierrez
MC, Hilsenbeck
SG, Hackett
JR, Jeong
J, et al.
Gene expression patterns in formalin-fixed, paraffin-embedded core biopsies predict docetaxel chemosensitivity in breast cancer patients.
Breast Cancer Res Treat
2008;108:233–40. 10.1007/s10549-007-9590-z. [
PubMed: 17468949] [
CrossRef]
- 69.
Gianni
L, Zambetti
M, Clark
K, Baker
J, Cronin
M, Wu
J, et al.
Gene expression profiles in paraffin-embedded core biopsy tissue predict response to chemotherapy in women with locally advanced breast cancer.
J Clin Oncol
2005;23:7265–77. 10.1200/JCO.2005.02.0818. [
PubMed: 16145055] [
CrossRef]
- 70.
Tang
G, Cuzick
J, Costantino
JP, Dowsett
M, Forbes
JF, Crager
M, et al.
Risk of recurrence and chemotherapy benefit for patients with node-negative, estrogen receptor-positive breast cancer: recurrence score alone and integrated with pathologic and clinical factors.
J Clin Oncol
2011;29:4365–72. 10.1200/JCO.2011.35.3714. [
PMC free article: PMC3221521] [
PubMed: 22010013] [
CrossRef]
- 71.
Ademuyiwa
FO, Miller
A, O’Connor
T, Edge
SB, Thorat
MA, Sledge
GW, et al.
The effects of oncotype DX recurrence scores on chemotherapy utilization in a multi-institutional breast cancer cohort.
Breast Cancer Res Treat
2011;126:797–802. 10.1007/s10549-010-1329-6. [
PubMed: 21197567] [
CrossRef]
- 72.
Albanell
J, Gonzalez
A, Ruiz-Borrego
M, Alba
E, Garcia-Saenz
JA, Corominas
JM, et al.
Prospective transGEICAM study of the impact of the 21-gene Recurrence Score assay and traditional clinicopathological factors on adjuvant clinical decision making in women with estrogen receptor-positive (ER+) node-negative breast cancer.
Ann Oncol
2012;23:625–31. 10.1093/annonc/mdr278. [
PubMed: 21652577] [
CrossRef]
- 73.
Braybrooke
J, Kuchel
A, Robinson
T, Comins
C, Shere
M, Varughese
M, et al. A prospective multi-centre study of the impact of Oncotype DX® on adjuvant treatment decisions in patients in the UK with estrogen receptor positive early breast cancer. European Cancer Congress, Amsterdam, the Netherlands, 30 September 2013.
- 74.
Holt
S, Bertelli
G, Humphreys
I, Valentine
W, Durrani
S, Pudney
D, et al.
A decision impact, decision conflict and economic assessment of routine Oncotype DX testing of 146 women with node-negative or pNImi, ER-positive breast cancer in the U.K.
Br J Cancer
2013;108:2250–8. 10.1038/bjc.2013.207. [
PMC free article: PMC3681004] [
PubMed: 23695023] [
CrossRef]
- 75.
Sestak
I, Dowsett
M, Zabaglo
L, Lopez-Knowles
E, Ferree
S, Cowens
JW, et al.
Factors predicting late recurrence for estrogen receptor-positive breast cancer.
J Natl Cancer Inst
2013;105:1504–11. 10.1093/jnci/djt244. [
PMC free article: PMC3787911] [
PubMed: 24029245] [
CrossRef]
- 76.
Prat
A, Parker
JS, Fan
C, Cheang
MC, Miller
LD, Bergh
J, et al.
Concordance among gene expression-based predictors for ER-positive breast cancer treated with adjuvant tamoxifen.
Ann Oncol
2012;23:2866–73. 10.1093/annonc/mds080. [
PMC free article: PMC3477878] [
PubMed: 22532584] [
CrossRef]
- 77.
Harris
L, Fritsche
H, Mennel
R, Norton
L, Ravdin
P, Taube
S, et al.
American Society of Clinical Oncology 2007 update of recommendations for the use of tumor markers in breast cancer.
J Clin Oncol
2007;25:5287–312. 10.1200/JCO.2007.14.2364. [
PubMed: 17954709] [
CrossRef]
- 78.
- 79.
van’t Veer
LJ, Dai
H, van de Vijver
MJ, He
YD, Hart
AA, Mao
M, et al.
Gene expression profiling predicts clinical outcome of breast cancer.
Nature
2002;415:530–6. 10.1038/415530a. [
PubMed: 11823860] [
CrossRef]
- 80.
van de Vijver
MJ, He
YD, van’t Veer
LJ, Dai
H, Hart
AA, Voskuil
DW, et al.
A gene expression signature as a predictor of survival in breast cancer.
N Engl J Med
2002;347:1999–2009. 10.1056/NEJMoa021967. [
PubMed: 12490681] [
CrossRef]
- 81.
Sapino
A, Roepman
P, Linn
SC, Snel
MH, Delahaye
LJ, van den Akker
J, et al.
MammaPrint molecular diagnostics on formalin-fixed, paraffin-embedded tissue.
J Mol Diagn
2014;16:190–7. 10.1016/j.jmoldx.2013.10.008. [
PubMed: 24378251] [
CrossRef]
- 82.
Bueno-de-Mesquita
JM, Linn
SC, Keijzer
R, Wesseling
J, Nuyten
DS, van Krimpen
C, et al.
Validation of 70-gene prognosis signature in node-negative breast cancer.
Breast Cancer Res Treat
2009;117:483–95. 10.1007/s10549-008-0191-2. [
PubMed: 18819002] [
CrossRef]
- 83.
Buyse
M, Loi
S, van’t Veer
L, Viale
G, Delorenzi
M, Glas
AM, et al.
Validation and clinical utility of a 70-gene prognostic signature for women with node-negative breast cancer.
J Natl Cancer Inst
2006;98:1183–92. 10.1093/jnci/djj329. [
PubMed: 16954471] [
CrossRef]
- 84.
Kunz
G.
Use of a genomic test (MammaPrint) in daily clinical practice to assist in risk stratification of young breast cancer patients.
Arch Gynecol Obstet
2011;283:597–602. 10.1007/s00404-010-1454-9. [
PubMed: 20383789] [
CrossRef]
- 85.
Mook
S, Schmidt
MK, Weigelt
B, Kreike
B, Eekhout
I, van de Vijver
MJ, et al.
The 70-gene prognosis signature predicts early metastasis in breast cancer patients between 55 and 70 years of age.
Ann Oncol
2010;21:717–22. 10.1093/annonc/mdp388. [
PubMed: 19825882] [
CrossRef]
- 86.
Gluck
S, de Snoo
F, Peeters
J, Stork-Sloots
L, Somlo
G.
Molecular subtyping of early-stage breast cancer identifies a group of patients who do not benefit from neoadjuvant chemotherapy.
Breast Cancer Res Treat
2013;139:759–67. 10.1007/s10549-013-2572-4. [
PubMed: 23756626] [
CrossRef]
- 87.
Straver
ME, Glas
AM, Hannemann
J, Wesseling
J, van de Vijver
MJ, Rutgers
EJ, et al.
The 70-gene signature as a response predictor for neoadjuvant chemotherapy in breast cancer.
Breast Cancer Res Treat
2010;119:551–8. 10.1007/s10549-009-0333-1. [
PubMed: 19214742] [
CrossRef]
- 88.
Knauer
M, Mook
S, Rutgers
EJ, Bender
RA, Hauptmann
M, van de Vijver
MJ, et al.
The predictive value of the 70-gene signature for adjuvant chemotherapy in early breast cancer.
Breast Cancer Res Treat
2010;120:655–61. 10.1007/s10549-010-0814-2. [
PubMed: 20204499] [
CrossRef]
- 89.
Bueno-de-Mesquita
JM, van Harten
WH, Retel
VP, van’t Veer
LJ, van Dam
FS, Karsenberg
K, et al.
Use of 70-gene signature to predict prognosis of patients with node-negative breast cancer: a prospective community-based feasibility study (RASTER).
Lancet Oncol
2007;8:1079–87. 10.1016/S1470-2045(07)70346-7. [
PubMed: 18042430] [
CrossRef]
- 90.
Drukker
CA, van den Hout
HC, Sonke
GS, Brain
E, Bonnefoi
H, Cardoso
F, et al.
Risk estimations and treatment decisions in early stage breast cancer: agreement among oncologists and the impact of the 70-gene signature.
Eur J Cancer
2014;50:1045–54. 10.1016/j.ejca.2014.01.016. [
PubMed: 24529927] [
CrossRef]
- 91.
Drukker
CA, Bueno-de-Mesquita
JM, Retel
VP, van Harten
WH, van Tinteren
H, Wesseling
J, et al.
A prospective evaluation of a breast cancer prognosis signature in the observational RASTER study.
Int J Cancer
2013;133:929–36. 10.1002/ijc.28082. [
PMC free article: PMC3734625] [
PubMed: 23371464] [
CrossRef]
- 92.
Drukker
CA, van Tinteren
H, Schmidt
MK, Rutgers
EJ, Bernards
R, van de Vijver
MJ, et al.
Long-term impact of the 70-gene signature on breast cancer outcome.
Breast Cancer Res Treat
2014;143:587–92. 10.1007/s10549-013-2831-4. [
PMC free article: PMC3907672] [
PubMed: 24445566] [
CrossRef]
- 93.
Dowsett
M, Allred
C, Knox
J, Quinn
E, Salter
J, Wale
C, et al.
Relationship between quantitative estrogen and progesterone receptor expression and human epidermal growth factor receptor 2 (HER-2) status with recurrence in the Arimidex, Tamoxifen, Alone or in Combination trial.
J Clin Oncol
2008;26:1059–65. 10.1200/JCO.2007.12.9437. [
PubMed: 18227529] [
CrossRef]
- 94.
Camp
RL, Chung
GG, Rimm
DL.
Automated subcellular localization and quantification of protein expression in tissue microarrays.
Nat Med
2002;8:1323–7. 10.1038/nm791. [
PubMed: 12389040] [
CrossRef]
- 95.
Christiansen
J, Bartlett
JMS, Gustavson
M, Rimm
D, Robson
T, Van De Velde
CJH, et al.
Validation of IHC4 algorithms for prediction of risk of recurrence in early breast cancer using both conventional and quantitative IHC approaches. J Clin Oncol
2012;30(Suppl. abstract 517).
- 96.
Barton
S, Zabaglo
L, A’Hern
R, Turner
N, Ferguson
T, O’Neill
S, et al.
Assessment of the contribution of the IHC4+C score to decision making in clinical practice in early breast cancer.
Br J Cancer
2012;106:1760–5. 10.1038/bjc.2012.166. [
PMC free article: PMC3364112] [
PubMed: 22531639] [
CrossRef]
- 97.
Wallden
B, Storhoff
J, Nielsen
T, Dowidar
N, Schaper
C, Ferree
S, et al.
Development and verification of the PAM50-based Prosigna breast cancer gene signature assay.
BMC Med Genomics
2015;8:54. [
PMC free article: PMC4546262] [
PubMed: 26297356]
- 98.
Nielsen
T, Wallden
B, Schaper
C, Ferree
S, Liu
S, Gao
D, et al.
Analytical validation of the PAM50-based Prosigna Breast Cancer Prognostic Gene Signature Assay and Counter Analysis System using formalin-fixed paraffin-embedded breast tumor specimens.
BMC Cancer
2014;14:177. 10.1186/1471-2407-14-177. [
PMC free article: PMC4008304] [
PubMed: 24625003] [
CrossRef]
- 99.
Nielsen
TO, Parker
JS, Leung
S, Voduc
D, Ebbert
M, Vickery
T, et al.
A comparison of PAM50 intrinsic subtyping with immunohistochemistry and clinical prognostic factors in tamoxifen-treated estrogen receptor-positive breast cancer.
Clin Cancer Res
2010;16:5222–32. 10.1158/1078-0432.CCR-10-1282. [
PMC free article: PMC2970720] [
PubMed: 20837693] [
CrossRef]
- 100.
Gnant
M, Filipits
M, Greil
R, Stoeger
H, Rudas
M, Bago-Horvath
Z, et al.
Predicting distant recurrence in receptor-positive breast cancer patients with limited clinicopathological risk: using the PAM50 Risk of Recurrence score in 1478 postmenopausal patients of the ABCSG-8 trial treated with adjuvant endocrine therapy alone.
Ann Oncol
2014;25:339–45. 10.1093/annonc/mdt494. [
PubMed: 24347518] [
CrossRef]
- 101.
Filipits
M, Nielsen
TO, Rudas
M, Greil
R, Stoger
H, Jakesz
R, et al.
The PAM50 risk-of-recurrence score predicts risk for late distant recurrence after endocrine therapy in postmenopausal women with endocrine-responsive early breast cancer.
Clin Cancer Res
2014;20:1298–305. 10.1158/1078-0432.CCR-13-1845. [
PubMed: 24520097] [
CrossRef]
- 102.
Prat
A, Galván
P, Jimenez
B, Buckingham
W, Jeiranian
HA, Schaper
C, et al.
Prediction of response to neoadjuvant chemotherapy using core needle biopsy samples with the Prosigna assay.
Clin Cancer Res
2016;22:560–6. 10.1158/1078-0432.CCR-15-0630. [
PubMed: 26152740] [
CrossRef]
- 103.
Cheang
MC, Voduc
KD, Tu
D, Jiang
S, Leung
S, Chia
SK, et al.
Responsiveness of intrinsic subtypes to adjuvant anthracycline substitution in the NCIC.CTG MA.5 randomized trial.
Clin Cancer Res
2012;18:2402–12. 10.1158/1078-0432.CCR-11-2956. [
PMC free article: PMC3743660] [
PubMed: 22351696] [
CrossRef]
- 104.
Martin
M, Prat
A, Rodriguez-Lescure
A, Caballero
R, Ebbert
MT, Munarriz
B, et al.
PAM50 proliferation score as a predictor of weekly paclitaxel benefit in breast cancer.
Breast Cancer Res Treat
2013;138:457–66. 10.1007/s10549-013-2416-2. [
PMC free article: PMC3608881] [
PubMed: 23423445] [
CrossRef]
- 105.
Jorgensen
CL, Nielsen
TO, Bjerre
KD, Liu
S, Wallden
B, Balslev
E, et al.
PAM50 breast cancer intrinsic subtypes and effect of gemcitabine in advanced breast cancer patients.
Acta Oncol
2014;53:776–87. 10.3109/0284186X.2013.865076. [
PubMed: 24359601] [
CrossRef]
- 106.
Bartlett
JM, Thomas
J, Ross
DT, Seitz
RS, Ring
BZ, Beck
RA, et al.
Mammostrat as a tool to stratify breast cancer patients at risk of recurrence during endocrine therapy.
Breast Cancer Res
2010;12:R47. 10.1186/bcr2604. [
PMC free article: PMC2949634] [
PubMed: 20615243] [
CrossRef]
- 107.
Bartlett
JM, Bloom
KJ, Piper
T, Lawton
TJ, van de Velde
CJ, Ross
DT, et al.
Mammostrat as an immunohistochemical multigene assay for prediction of early relapse risk in the tamoxifen versus exemestane adjuvant multicenter trial pathology study.
J Clin Oncol
2012;30:4477–84. 10.1200/JCO.2012.42.8896. [
PubMed: 23045591] [
CrossRef]
- 108.
Mislick
K, Schonfeld
W, Bodnar
C, Tong
KB.
Cost-effectiveness analysis of Mammostrat® compared with Oncotype DX(R) to inform the treatment of breast cancer.
Clinicoecon Outcomes Res
2014;6:37–47. 10.2147/CEOR.S53142. [
PMC free article: PMC3896273] [
PubMed: 24470765] [
CrossRef]
- 109.
Fan
C, Oh
DS, Wessels
L, Weigelt
B, Nuyten
DS, Nobel
AB, et al.
Concordance among gene-expression-based predictors for breast cancer.
N Engl J Med
2006;355:560–9. 10.1056/NEJMoa052933. [
PubMed: 16899776] [
CrossRef]
- 110.
Zhao
X, Rodland
EA, Sorlie
T, Vollan
HK, Russnes
HG, Kristensen
VN, et al.
Systematic assessment of prognostic gene signatures for breast cancer shows distinct influence of time and ER status.
BMC Cancer
2014;14:211. 10.1186/1471-2407-14-211. [
PMC free article: PMC4000128] [
PubMed: 24645668] [
CrossRef]
- 111.
Lamond
NW, Skedgel
C, Rayson
D, Lethbridge
L, Younis
T.
Cost-utility of the 21-gene recurrence score assay in node-negative and node-positive breast cancer.
Breast Cancer Res Treat
2012;133:1115–23. 10.1007/s10549-012-1989-5. [
PubMed: 22361999] [
CrossRef]
- 112.
Vanderlaan
BF, Broder
MS, Chang
EY, Oratz
R, Bentley
T.
Cost-effectiveness of 21-gene assay in node-positive, early-stage breast cancer.
Am J Manag Care
2010;17:455–64. [
PubMed: 21819166]
- 113.
Eiermann
W, Rezai
M, Kümmel
S, Kühn
T, Warm
M, Friedrichs
K, et al.
The 21-gene recurrence score assay impacts adjuvant therapy recommendations for ER-positive, node-negative and node-positive early breast cancer resulting in a risk-adapted change in chemotherapy use.
Ann Oncol
2013;24:618–24. 10.1093/annonc/mds512. [
PMC free article: PMC3574549] [
PubMed: 23136233] [
CrossRef]
- 114.
O’Leary
B, Foteff
C, Byron
K, Chang
C, Chao
C, Ng
C, et al.
PCN12 cost-effectiveness of the Oncotype DX® assay in Australia: an exploratory analysis.
Value Health
2010;13:A512. 10.1016/S1098-3015(11)73105-9. [
CrossRef]
- 115.
Kondo
M, Hoshi
SL, Yamanaka
T, Ishiguro
H, Toi
M.
Economic evaluation of the 21-gene signature (Oncotype DX) in lymph node-negative/positive, hormone receptor-positive early-stage breast cancer based on Japanese validation study (JBCRG-TR03).
Breast Cancer Res Treat
2011;127:739–49. 10.1007/s10549-010-1243-y. [
PubMed: 21082239] [
CrossRef]
- 116.
Oestreicher
N, Ramsey
SD, Linden
HM, McCune
JS, van’t Veer
LJ, Burke
W, et al.
Gene expression profiling and breast cancer care: what are the potential benefits and policy implications?
Genet Med
2005;7:380–9. 10.1097/01.GIM.0000170776.31248.75. [
PubMed: 16024969] [
CrossRef]
- 117.
National Institute for Health and Care Excellence. Gene Expression Profiling and Expanded Immunohistochemistry Tests for Guiding Adjuvant Chemotherapy Decisions in Early Breast Cancer Management: MammaPrint, Oncotype DX, IHC4 and Mammostrat [DG10].
London:
NICE; 2013.
- 118.
Ragaz
J, Wilson
K, Wong
H, Muraca
G, Hryniuk
W, Bajdik
C.
PD06–01: Molecular classification with 21 gene assay (Oncotype DX) shows in 196,967 ER positive patients high frequency of low recurrence score (LRS) in both node positive (N+) and negative (N-) breast cancer (BrCa) cohorts. Definitions of chemoresistance based on LRS with cost and guideline implications.
Cancer Res
2011;71:PD06–01
10.1158/0008-5472.SABCS11-PD06-01. [
CrossRef]
- 119.
Zarca
D, Stork-Sloots
L, de Snoo
F, Brink
G, Dervaux
Y, Boubli
L.
5167 French cost effectiveness study of the MammaPrint 70-gene signature in early stage breast cancer patients.
Eur J Cancer Suppl
2009;7:310. 10.1016/S1359-6349(09)71059-6. [
CrossRef]
- 120.
National Institute for Health and Care Excellence. Gene Expression Profiling and Expanded Immunohistochemistry Tests to Guide Selection of Chemotherapy Regimes in Breast Cancer Management: MammaPrint, Oncotype DX, IHC4 and Mammostrat: Amended Final Scope.
London:
NICE; 2011.
- 121.
TAILORx.
Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning Individualized Options for Treatment: The TAILORx Trial. 2014. URL:
clinicaltrials.gov/show/NCT00310180 (accessed 27 April 2014).
- 122.
MINDACT.
MINDACT (Microarray In Node-Negative and 1 to 3 Positive Lymph Node Disease May Avoid Chemotherapy): A Prospective, Randomised Study Comparing the 70-Gene Signature With the Common Clinical-Pathological Criteria in Selecting Patients for Adjuvant Chemotherapy in Breast Cancer With 0 to 3 Positive Nodes. URL:
clinicaltrials.gov/show/NCT00310180 (accessed 27 April 2014).
- 123.
RxPONDER.
A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients With 1–3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer With Recurrence Score (RS) of 25 or Less. RxPONDER: A Clinical Trial Rx for Positive Node, Endocrine Responsive Breast Cancer. URL:
clinicaltrials.gov/show/NCT01272037 (accessed 27 April 2014).
- 124.
Zujewski
JA, Kamin
L.
Trial assessing individualized options for treatment for breast cancer: the TAILORx trial.
Future Oncol
2008;4:603–10. 10.2217/14796694.4.5.603. [
PubMed: 18922117] [
CrossRef]
- 125.
The EuroQol Group.
EuroQol – a new facility for the measurement of health-related quality of life.
Health Policy
1990;16:199–208. 10.1016/0168-8510(90)90421-9. [
PubMed: 10109801] [
CrossRef]
- 126.
Cella
DF, Tulsky
DS, Grey
G, Sarafian
B, Linn
E, Bonomi
A, et al.
The Functional Assessment of Cancer Therapy scale: development and validation of the general measure.
J Clin Oncol
1993;11:570–9. [
PubMed: 8445433]
- 127.
Brady
MJ, Cella
DF, Mo
F, Bonomi
AE, Tulsky
DS, Lloyd
SR, et al.
Reliability and validity of the Functional Assessment of Cancer Therapy-Breast quality-of-life instrument.
J Clin Oncol
1997;15:974–86. [
PubMed: 9060536]
- 128.
Colleoni
M, Gelber
RD.
Time to initiation of adjuvant chemotherapy for early breast cancer and outcome: the earlier, the better?
J Clin Oncol
2014;32:717–19. 10.1200/JCO.2013.54.3942. [
PubMed: 24516011] [
CrossRef]
- 129.
Great Britain. Data Protection Act 1998. Chapter 29.
London:
The Stationery Office; 1998.
- 130.
Buckley
CJ, Rutherford
RB, Diethrich
EB, Buckley
SD.
Inherent problems with randomized clinical trials with observational/no treatment arms.
J Vasc Surg
2010;52:237–41. 10.1016/j.jvs.2010.02.255. [
PubMed: 20620768] [
CrossRef]
- 131.
Ellis
PM, Butow
PN, Tattersall
MH, Dunn
SM, Houssami
N.
Randomized clinical trials in oncology: understanding and attitudes predict willingness to participate.
J Clin Oncol
2001;19:3554–61. [
PubMed: 11481363]
- 132.
- 133.
Welton
AJ, Vickers
MR, Cooper
JA, Meade
TW, Marteau
TM.
Is recruitment more difficult with a placebo arm in randomised controlled trials? A quasirandomised, interview based study.
BMJ
1999;318:1114–17. 10.1136/bmj.318.7191.1114. [
PMC free article: PMC27847] [
PubMed: 10213724] [
CrossRef]
- 134.
Kidd
PS, Parshall
MB.
Getting the focus and the group: enhancing analytical rigor in focus group research.
Qual Health Res
2000;10:293–308. 10.1177/104973200129118453. [
PubMed: 10947477] [
CrossRef]
- 135.
Powell
RA, Single
HM.
Focus groups.
Int J Qual Health Care
1996;8:499–504. 10.1093/intqhc/8.5.499. [
PubMed: 9117204] [
CrossRef]
- 136.
Webb
C, Kevern
J.
Focus groups as a research method: a critique of some aspects of their use in nursing research.
J Adv Nurse
2001;33:798–805. 10.1046/j.1365-2648.2001.01720.x. [
PubMed: 11298218] [
CrossRef]
- 137.
Onwuegbuzie
AJ, Dickinson
WB, Leech
NL, Zoran
AG. A qualitative framework for collecting and analyzing data in focus group research. Int J Qual Methods
2009;8:1.
- 138.
Glaser
B, Strauss
A. The Discovery of Grounded Theory: Strategies for Qualitative Research.
Piscataway, NJ:
Transaction Publishers; 1967.
- 139.
Rabiee
F.
Focus-group interview and data analysis.
Proc Nutr Soc
2004;63:655–60. 10.1079/PNS2004399. [
PubMed: 15831139] [
CrossRef]
- 140.
Donovan
JL, Athene Lane
J, Peters
TJ, Brindle
L, Salter
E, Gillatt
D, et al.
Development of a complex intervention improved randomization and informed consent in a randomized controlled trial.
J Clin Epidemiol
2009;62:29–36. 10.1016/j.jclinepi.2008.02.010. [
PubMed: 18619811] [
CrossRef]
- 141.
Tong
A, Sainsbury
P, Craig
J.
Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups.
Int J Qual Health Care
2007;19:349–57. 10.1093/intqhc/mzm042. [
PubMed: 17872937] [
CrossRef]
- 142.
Heritage
J, Robinson
JD.
The structure of patients’ presenting concerns: physicians’ opening questions.
Health Commun
2006;19:89–102. 10.1207/s15327027hc1902_1. [
PubMed: 16548700] [
CrossRef]
- 143.
Wade
J, Donovan
JL, Athene Lane
J, Neal
DE, Hamdy
FC.
It’s not just what you say, it’s also how you say it: opening the ‘black box’ of informed consent appointments in randomised controlled trials.
Soc Sci Med
2009;68:2018–28. 10.1016/j.socscimed.2009.02.023. [
PubMed: 19364625] [
CrossRef]
- 144.
Bartlett
JM, Brookes
CL, Robson
T, van de Velde
CJ, Billingham
LJ, Campbell
FM, et al.
Estrogen receptor and progesterone receptor as predictive biomarkers of response to endocrine therapy: a prospectively powered pathology study in the Tamoxifen and Exemestane Adjuvant Multinational trial.
J Clin Oncol
2011;29:1531–8. 10.1200/JCO.2010.30.3677. [
PMC free article: PMC3082973] [
PubMed: 21422407] [
CrossRef]
- 145.
Coates
AS, Winer
EP, Goldhirsch
A, Gelber
RD, Gnant
M, Piccart-Gebhart
M, et al.
Tailoring therapies-improving the management of early breast cancer: St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2015.
Ann Oncol
2015;26:1533–46. 10.1093/annonc/mdv221. [
PMC free article: PMC4511219] [
PubMed: 25939896] [
CrossRef]
- 146.
Claxton
K, Sculpher
M, Drummond
M.
A rational framework for decision making by the National Institute For Clinical Excellence (NICE).
Lancet
2002;360:711–15. 10.1016/S0140-6736(02)09832-X. [
PubMed: 12241891] [
CrossRef]
- 147.
Sonnenberg
FA, Beck
JR.
Markov models in medical decision making a practical guide.
Med Decis Making
1993;13:322–38. 10.1177/0272989X9301300409. [
PubMed: 8246705] [
CrossRef]
- 148.
National Institute for Health and Care Excellence.
Guide to the Methods of Technology Appraisal.
London:
NICE; 2013. [
PubMed: 27905712]
- 149.
Hall
PS, Hulme
C, McCabe
C, Oluboyede
Y, Round
J, Cameron
DA.
Updated cost-effectiveness analysis of trastuzumab for early breast cancer.
Pharmacoeconomics
2011;29:415–32. 10.2165/11588340-000000000-00000. [
PubMed: 21504241] [
CrossRef]
- 150.
US Department of Health and Human Services. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Washington, DC:
US Department of Health and Human Services; 2012.
- 151.
Jones
S, Holmes
FA, O’Shaughnessy
J, Blum
JL, Vukelja
SJ, McIntyre
KJ, et al.
Docetaxel with cyclophosphamide is associated with an overall survival benefit compared with doxorubicin and cyclophosphamide: 7-year follow-up of US Oncology Research Trial 9735.
J Clin Oncol
2009;27:1177–83. 10.1200/JCO.2008.18.4028. [
PubMed: 19204201] [
CrossRef]
- 152.
Roché
H, Fumoleau
P, Spielmann
M, Canon
J-L, Delozier
T, Serin
D, et al.
Sequential adjuvant epirubicin-based and docetaxel chemotherapy for node-positive breast cancer patients: the FNCLCC PACS 01 Trial.
J Clin Oncol
2006;24:5664–71. 10.1200/JCO.2006.07.3916. [
PubMed: 17116941] [
CrossRef]
- 153.
Cameron
D, Barrett-Lee
P, Velikova
C, Canney
P, Moyses
H, McDermaid
M, et al.
TACT2 Randomised Adjuvant Trial in Early Breast Cancer (EBC): Tolerability and Toxicity of Standard 3 Weekly Epirubicin (E) versus Accelerated Epirubicin (AE) in 129 UK Hospitals (4391 Patients). San Antonio Breast Cancer Symposium, San Antonio, TX, USA, 11 December 2010.
- 154.
Townsend
N, Wickramasinghe
K, Bhatnagar
P, Smolina
K, Nichols
M, Leal
J, et al.
Coronary Heart Disease Statistics: A Compendium of Health Statistics.
London:
British Heart Foundation; 2012.
- 155.
Cowie
M, Wood
D, Coats
A, Thompson
S, Suresh
V, Poole-Wilson
P, et al.
Survival of patients with a new diagnosis of heart failure: a population based study.
Heart
2000;83:505–10. 10.1136/heart.83.5.505. [
PMC free article: PMC1760808] [
PubMed: 10768897] [
CrossRef]
- 156.
Baum
M, Buzdar
A, Cuzick
J, Forbes
J, Houghton
J, Howell
A, et al.
Anastrozole alone or in combination with tamoxifen versus tamoxifen alone for adjuvant treatment of postmenopausal women with early-stage breast cancer: results of the ATAC (Arimidex, Tamoxifen Alone or in Combination) trial efficacy and safety update analyses.
Cancer
2003;98:1802–10. 10.1002/cncr.11745. [
PubMed: 14584060] [
CrossRef]
- 157.
Walkington
L, Newsham
A, Deverede
L, Afshar
M, Hall
P, Perren
T, et al.
Patterns of Breast Cancer Recurrence and Associated Health Care Costs of 1000 Patients: A Longitudinal Study. National Cancer Research Annual Conference, 4–7 November 2012, Liverpool, UK.
- 158.
Office for National Statistics. Interim Life Tables for England and Wales 2006–2008.
London:
UK Government; 2009.
- 159.
- 160.
Azim
HA
Jr, de Azambuja
E, Colozza
M, Bines
J, Piccart
MJ.
Long-term toxic effects of adjuvant chemotherapy in breast cancer.
Ann Oncol
2011;22:1939–47. 10.1093/annonc/mdq683. [
PubMed: 21289366] [
CrossRef]
- 161.
Praga
C, Bergh
J, Bliss
J, Bonneterre
J, Cesana
B, Coombes
RC, et al.
Risk of acute myeloid leukemia and myelodysplastic syndrome in trials of adjuvant epirubicin for early breast cancer: correlation with doses of epirubicin and cyclophosphamide.
J Clin Oncol
2005;23:4179–91. 10.1200/JCO.2005.05.029. [
PubMed: 15961765] [
CrossRef]
- 162.
Oliver
S, Taylor
F, Bolton
ME, Brook
C, Ferguson
B, Ross
H, et al.
Haematological Malignancies in England Cancers Diagnosed 2001–2008.
London:
Northern Cancer Intelligence Network; 2013.
- 163.
Curtis
L, Netten
A. Unit Costs of Health and Social Care 2014.
Canterbury:
PSSRU, University of Kent; 2014.
- 164.
Department of Health. Drugs and Pharmaceutical Electronic Market Information (Emit).
London:
HMSO; 2011.
- 165.
- 166.
Department of Health. NHS Reference Costs 2012–2013.
London:
Department of Health; 2013.
- 167.
Hall
P, Vargas-Palacios
A, Newsham
A, Walkington
L, Glaser
A, Hall
G. Costs of Hospital Care Over 10 Years from Diagnosis of Early Breast Cancer. 9th European Breast Cancer Conference, 19–21 March 2014, Glasgow, UK.
- 168.
Department of Health. Report: A Simple Guide to Payment by Results.
London:
Department of Health; 2014.
- 169.
Lin
D, Feuer
E, Etzioni
R, Wax
Y.
Estimating medical costs from incomplete follow-up data.
Biometrics
1997;53:419–34. 10.2307/2533947. [
PubMed: 9192444] [
CrossRef]
- 170.
Her Majesty’s Revenue and Customs.
VAT: Clarification of HMRC’s Policy on Laboratory Pathology Services Provided by State-Regulated Institutions, 2013. URL:
www.hmrc.gov.uk/briefs/vat/brief1613.htm (accessed 17 May 2014).
- 171.
- 172.
Peasgood
T, Ward
SE, Brazier
J.
Health-state utility values in breast cancer.
Expert Rev Pharmacoecon Outcomes Res
2010;10:553–66. 10.1586/erp.10.65. [
PubMed: 20950071] [
CrossRef]
- 173.
- 174.
Campbell
HE, Epstein
D, Bloomfield
D, Griffin
S, Manca
A, Yarnold
J, et al.
The cost-effectiveness of adjuvant chemotherapy for early breast cancer: a comparison of no chemotherapy and first, second, and third generation regimens for patients with differing prognoses.
Eur J Cancer
2011;47:2517–30. 10.1016/j.ejca.2011.06.019. [
PubMed: 21741831] [
CrossRef]
- 175.
Kirsch
J, McGuire
A.
Establishing health state valuations for disease specific states: an example from heart disease.
Health Econ
2000;9:149–58. 10.1002/(SICI)1099-1050(200003)9:2<149::AID-HEC501>3.0.CO;2-N. [
PubMed: 10721016] [
CrossRef]
- 176.
Briggs
AH.
Handling uncertainty in cost-effectiveness models.
Pharmacoeconomics
2000;17:479–500. 10.2165/00019053-200017050-00006. [
PubMed: 10977389] [
CrossRef]
- 177.
Briggs
AH, Claxton
K, Sculpher
MJ. Decision Modelling for Health Economic Evaluation.
Oxford:
Oxford University Press; 2006.
- 178.
Briggs
A, Sculpher
M, Dawson
J, Fitzpatrick
R, Murray
D, Malchau
H.
The use of probabilistic decision models in technology assessment.
Appl Health Econ Health Policy
2004;3:79–89. 10.2165/00148365-200403020-00004. [
PubMed: 15702945] [
CrossRef]
- 179.
Strong
M, Oakley
JE, Brennan
A.
Estimating multiparameter partial expected value of perfect information from a probabilistic sensitivity analysis sample: a nonparametric regression approach.
Med Decis Making
2014;34:311–26. 10.1177/0272989X13505910. [
PMC free article: PMC4819801] [
PubMed: 24246566] [
CrossRef]
- 180.
Lohrisch
C, Paltiel
C, Gelmon
K, Speers
C, Taylor
S, Barnett
J, et al.
Impact on survival of time from definitive surgery to initiation of adjuvant chemotherapy for early-stage breast cancer.
J Clin Oncol
2006;24:4888–94. 10.1200/JCO.2005.01.6089. [
PubMed: 17015884] [
CrossRef]
- 181.
Donovan
JL, Paramasivan
S, de Salis
I, Toerien
M.
Clear obstacles and hidden challenges: understanding recruiter perspectives in six pragmatic randomised controlled trials.
Trials
2014;15:5. 10.1186/1745-6215-15-5. [
PMC free article: PMC3892115] [
PubMed: 24393291] [
CrossRef]
- 182.
Paramasivan
S, Huddart
R, Hall
E, Lewis
R, Birtle
A, Donovan
JL.
Key issues in recruitment to randomised controlled trials with very different interventions: a qualitative investigation of recruitment to the SPARE trial (CRUK/07/011).
Trials
2011;12:78. 10.1186/1745-6215-12-78. [
PMC free article: PMC3068963] [
PubMed: 21406089] [
CrossRef]
- 183.
Donovan
J, Mills
N, Smith
M, Brindle
L, Jacoby
A, Peters
T, et al.
Quality improvement report: improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. Commentary: presenting unbiased information to patients can be difficult.
BMJ
2002;325:766–70. 10.1136/bmj.325.7367.766. [
PMC free article: PMC1124277] [
PubMed: 12364308] [
CrossRef]
- 184.
de Salis
I, Tomlin
Z, Toerien
M, Donovan
J.
Qualitative research to improve RCT recruitment: issues arising in establishing research collaborations.
Contemp Clin Trials
2008;29:663–70. 10.1016/j.cct.2008.03.003. [
PubMed: 18479977] [
CrossRef]
- 185.
Mills
EJ, Seely
D, Rachlis
B, Griffith
L, Wu
P, Wilson
K, et al.
Barriers to participation in clinical trials of cancer: a meta-analysis and systematic review of patient-reported factors.
Lancet Oncol
2006;7:141–8. 10.1016/S1470-2045(06)70576-9. [
PubMed: 16455478] [
CrossRef]
- 186.
Bogaerts
J, Cardoso
F, Buyse
M, Braga
S, Loi
S, Harrison
JA, et al.
Gene signature evaluation as a prognostic tool: challenges in the design of the MINDACT trial.
Nat Clin Pract Oncol
2006;3:540–51. 10.1038/ncponc0591. [
PubMed: 17019432] [
CrossRef]
- 187.
Rutgers
E, Piccart-Gebhart
MJ, Bogaerts
J, Delaloge
S, Veer
LV, Rubio
IT, et al.
The EORTC 10041/BIG 03–04 MINDACT trial is feasible: results of the pilot phase.
Eur J Cancer
2011;47:2742–9. 10.1016/j.ejca.2011.09.016. [
PubMed: 22051734] [
CrossRef]
- 188.
Ramsey
SD, Barlow
WE, Gonzalez-Angulo
AM, Tunis
S, Baker
L, Crowley
J, et al.
Integrating comparative effectiveness design elements and endpoints into a phase III, randomized clinical trial (SWOG S1007) evaluating oncotypeDX-guided management for women with breast cancer involving lymph nodes.
Contemp Clin Trials
2013;34:1–9. 10.1016/j.cct.2012.09.003. [
PMC free article: PMC3525786] [
PubMed: 23000081] [
CrossRef]
- 189.
Elston
CW, Ellis
IO.
Pathological prognostic factors in breast cancer. I. The value of histological grade in breast cancer: experience from a large study with long-term follow-up.
Histopathology
1991;19:403–10. 10.1111/j.1365-2559.1991.tb00229.x. [
PubMed: 1757079] [
CrossRef]
- 190.
Blamey
RW, Hornmark-Stenstam
B, Ball
G, Blichert-Toft
M, Cataliotti
L, Fourquet
A, et al.
ONCOPOOL – a European database for 16,944 cases of breast cancer.
Eur J Cancer
2010;46:56–71. 10.1016/j.ejca.2009.09.009. [
PubMed: 19811907] [
CrossRef]
- 191.
Walker
RA, Bartlett
JM, Dowsett
M, Ellis
IO, Hanby
AM, Jasani
B, et al.
HER2 testing in the UK: further update to recommendations.
J Clin Pathol
2008;61:18–24. 10.1136/jcp.2007.054866. [
PubMed: 18381380] [
CrossRef]
- 192.
McCullough
AE, Dell’Orto
P, Reinholz
MM, Gelber
RD, Dueck
AC, Russo
L, et al.
Central pathology laboratory review of HER2 and ER in early breast cancer: an ALTTO trial [BIG 2–06/NCCTG N063D (Alliance)] ring study.
Breast Cancer Res Treat
2014;143:85–92. 10.1007/s10549-013-2827-0. [
PMC free article: PMC4039190] [
PubMed: 24395109] [
CrossRef]
- 193.
Bueno-de-Mesquita
J, Nuyten
D, Wesseling
J, van Tinteren
H, Linn
S, van De Vijver
M.
The impact of inter-observer variation in pathological assessment of node-negative breast cancer on clinical risk assessment and patient selection for adjuvant systemic treatment.
Ann Oncol
2010;21:40–7. 10.1093/annonc/mdp273. [
PubMed: 19622588] [
CrossRef]
- 194.
Bartlett
JM, Starczynski
J, Atkey
N, Kay
E, O’Grady
A, Gandy
M, et al.
HER2 testing in the UK: recommendations for breast and gastric in-situ hybridisation methods.
J Clin Pathol
2011;64:649–53. 10.1136/jcp.2011.089847. [
PubMed: 21690244] [
CrossRef]
- 195.
Perez
EA, Press
MF, Dueck
AC, Jenkins
RB, Kim
C, Chen
B, et al.
Immunohistochemistry and fluorescence in situ hybridization assessment of HER2 in clinical trials of adjuvant therapy for breast cancer (NCCTG N9831, BCIRG 006, and BCIRG 005).
Breast Cancer Res Treat
2013;138:99–108. 10.1007/s10549-013-2444-y. [
PMC free article: PMC3585916] [
PubMed: 23420271] [
CrossRef]
- 196.
McCabe
C, Claxton
K, Culyer
AJ.
The NICE cost-effectiveness threshold.
Pharmacoeconomics
2008;26:733–44. 10.2165/00019053-200826090-00004. [
PubMed: 18767894] [
CrossRef]
- 197.
Scottish Intercollegiate Guidelines Network.
Scottish Intercollegiate Guidelines Network. Edinburgh: Healthcare Improvement Scotland. URL:
www.sign.ac.uk/index.html (last accessed 18 December 2015).
- 198.
Shabaruddin
FH, Chen
L-C, Elliott
RA, Payne
K.
A systematic review of utility values for chemotherapy-related adverse events.
Pharmacoeconomics
2013;31:277–88. 10.1007/s40273-013-0033-x. [
PubMed: 23529208] [
CrossRef]
- 199.
Moro-Valdezate
D, Peiró
S, Buch-Villa
E, Caballero-Gárate
A, Morales-Monsalve
MD, Martínez-Agulló
Á, et al.
Evolution of health-related quality of life in breast cancer patients during the first year of follow-up.
J Breast Cancer
2013;16:104–11. 10.4048/jbc.2013.16.1.104. [
PMC free article: PMC3625756] [
PubMed: 23593090] [
CrossRef]
- 200.
Shih
V, Chan
A, Xie
F, Ko
Y.
Health state utility assessment for breast cancer.
Val Health Reg Issues
2012;1:93–7. 10.1016/j.vhri.2012.03.009. [
PubMed: 29702834] [
CrossRef]
- 201.
Matalqah
LM, Radaideh
KM, Yusoff
ZM, Awaisu
A.
Health-related quality of life using EQ-5D among breast cancer survivors in comparison with age-matched peers from the general population in the state of Penang, Malaysia.
J Public Health
2011;19:475–80. 10.1007/s10389-011-0406-6. [
CrossRef]
- 202.
Farkkila
N, Roine
R, Jahkola
T, Sintonen
H, Hanninen
J, Taari
K, et al.
Health state utilities in breast cancer.
Value Health
2011;14:A459. 10.1016/j.jval.2011.08.1238. [
CrossRef]
- 203.
Delgado-Sanz
MC, García-Mendizábal
MJ, Pollán
M, Forjaz
MJ, López-Abente
G, Aragonés
N, et al.
Heath-related quality of life in Spanish breast cancer patients: a systematic review.
Health Qual Life Outcomes
2011;9:3. 10.1186/1477-7525-9-3. [
PMC free article: PMC3031190] [
PubMed: 21235770] [
CrossRef]
- 204.
Anhoury
P, DiBonaventura
M, Wagner
R. Health-related quality of life among women with a history of breast cancer in Europe. J Clin Oncol
2011;29(Suppl. 15):e19615.
- 205.
Prescott
R, Kunkler
I, Williams
L, King
C, Jack
W, van der Pol
M, et al.
A randomised controlled trial of postoperative radiotherapy following breast-conserving surgery in a minimum-risk older population: the PRIME trial.
Health Technol Assess
2007;11(31). 10.3310/hta11310. [
PubMed: 17669280] [
CrossRef]
- 206.
- 207.
Hayman
JA, Fairclough
DL, Harris
L, Weeks
JC.
Patient preferences concerning the trade-off between the risks and benefits of routine radiation therapy after conservative surgery for early-stage breast cancer.
J Clin Oncol
1997;15:1252–60. [
PubMed: 9060570]
- 208.
Sorensen
SV, Brown
R, Benedict
A, Flood
E, Revicki
D. QL4 patient-rated utilities in postmenopausal early breast cancer (EBC): a cross-country comparison. Value Health
2004;7:641–2.
- 209.
Stalmeier
PF.
Discrepancies between chained and classic utilities induced by anchoring with occasional adjustments.
Med Decis Making
2002;22:53–64. [
PubMed: 11837249]
- 210.
Suh
WW, Hillner
BE, Pierce
LJ, Hayman
JA.
Cost-effectiveness of radiation therapy following conservative surgery for ductal carcinoma in situ of the breast.
Int J Radiat Oncol Biol Physics
2005;61:1054–61. [
PubMed: 15752884]
- 211.
Chie
WC, Huang
CS, Chen
JH, Chang
KJ.
Utility assessment for different clinical phases of breast cancer in Taiwan.
J Formos Med Assoc
2000;99:677–83. [
PubMed: 11000729]
- 212.
Cykert
S, Phifer
N, Hansen
C.
Tamoxifen for breast cancer prevention: a framework for clinical decisions.
Obstet Gynecol
2004;104:433–42. [
PubMed: 15339751]
- 213.
Grann
VR, Jacobson
JS, Sundararajan
V, Albert
SM, Troxel
AB, Neugut
A.
The quality of life associated with prophylactic treatments for women with BRAC1/2 mutations.
Cancer J Sci Am
1999;5:283–92. [
PubMed: 10526669]
