Selecting Breast Cancer Patients for Chemotherapy: The Opening of the UK OPTIMA Trial

Clinical Oncology

Volumn 25, Issue 2, 2013, Pages 109-116

  Bartlett, J ^a   Canney, P ^b   Campbell, A ^c   Cameron, D ^d   Donovan, J ^e   Dunn, J ^c   Earl, H ^f   Francis, A ^g   Hall, P ^h   Harmer, V ⁱ   Higgins, H ^c   Hillier, L ^c   Hulme, C ^h   Hughes Davies, L ^f   Makris, A ^j   Morgan, A ^k   McCabe, C ^l   Pinder, S ^m   Poole, C ⁿ   Rea, D ^o   Stallard, N ^c   Stein, R ^p   more..

^a ONTARIO INSTITUTE FOR CANCER RESEARCH   (Canada)

^b BEATSON WEST OF SCOTLAND CANCER CENTRE   (United Kingdom)

^c UNIVERSITY OF WARWICK   (United Kingdom)

^d UNIVERSITY OF EDINBURGH   (United Kingdom)

^e UNIVERSITY OF BRISTOL   (United Kingdom)

^f ADDENBROOKE S HOSPITAL   (United Kingdom)

^g QUEEN ELIZABETH HOSPITAL   (United Kingdom)

^h UNIVERSITY OF LEEDS   (United Kingdom)

ⁱ ST MARY S HOSPITAL   (United Kingdom)

^j MOUNT VERNON HOSPITAL   (United Kingdom)

^k Independent Cancer Patients' Voice   (United Kingdom)

^l Department of Emergency Medicine Research ^*  (Canada)

^m KING'S COLLEGE LONDON   (United Kingdom)

ⁿ UNIVERSITY HOSPITALS COVENTRY AND WARWICKSHIRE NHS TRUST   (United Kingdom)

^o UNIVERSITY OF BIRMINGHAM   (United Kingdom)

^p UNIVERSITY COLLEGE LONDON HOSPITALS   (United Kingdom)

more..

Author keywords

Adjuvant; Breast; Chemotherapy; Predictive

Indexed keywords

ARTICLE; ASSAY; BREAST CANCER; CANCER ADJUVANT THERAPY; CANCER CHEMOTHERAPY; CANCER MORTALITY; CANCER PATIENT; CANCER PROGNOSIS; COST EFFECTIVENESS ANALYSIS; HUMAN; MEDICAL TECHNOLOGY; PATIENT SELECTION; PREDICTION; PRIORITY JOURNAL; UNITED KINGDOM;

BREAST NEOPLASMS; CHEMOTHERAPY, ADJUVANT; FEMALE; GREAT BRITAIN; HUMANS; PATIENT SELECTION; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 84872403625     PISSN: 09366555     EISSN: 14332981     Source Type: Journal    
DOI: 10.1016/j.clon.2012.10.005     Document Type: Article

References (51)

1. Fisher B., Carbone P., Economou S.G., et al. l-Phenylalanine mustard (l-PAM) in the management of primary breast cancer. A report of early findings. N Engl J Med 1975, 292(3):117-122.
2. Bonadonna G., Brusamolino E., Valagussa P., et al. Combination chemotherapy as an adjuvant treatment in operable breast cancer. N Engl J Med 1976, 294(8):405-410.
3. Review of mortality results in randomized trials in early breast cancer. Lancet 1984, 2:1205. Early Breast Cancer Trialists Collaborative Group.
4. Ellisen L, Haber D. Recent progress in the understanding and treatment of breast cancer. Nature Medicine 4, Breast Cancer. Published online: 16 April 2001. http://dx.doi.org/10.1038/20000257.
5. Kiberstis P., Marshall E. Cancer crusade at 40. Science 2011, 331(6024):1539.
6. 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(9814):432-444. Early Breast Cancer Trialists' Collaborative Group (EBCTCG).
7. National Institute for Clinical Excellence Guideline. Breast cancer (early and locally advanced) (CG80). Available at:. http://www.nice.org.uk/CG80.
8. Ring A., Reed M., Leonard R., et al. The treatment of early breast cancer in women over the age of 70. Br J Cancer 2011, 105(2):189-193.
9. Biganzoli L., Wildiers H., Oakman C., et al. Management of elderly patients with breast cancer: updated recommendations of the International Society of Geriatric Oncology (SIOG) and European Society of Breast Cancer Specialists (EUSOMA). Lancet Oncol 2012, 13(4):148-160.
10. 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(4):350-363.
11. O'Connor M., Christensen S., Jensen A.B., Møller 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(3):419-426.
12. 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, 135:335-346.
13. Pinder M.C., Duan Z., Goodwin J.S., Hortobagyi G.N., Giordano S.H. Congestive heart failure in older women treated with adjuvant anthracycline chemotherapy for breast cancer. J Clin Oncol 2007, 25(25):3808-3815.
14. Rouzier R., Perou C.M., Symmans W.F., et al. Breast cancer molecular subtypes respond differently to preoperative chemotherapy. Clin Cancer Res 2005, 11(16):5678-5685.
15. Kim S.R., Paik S. Genomics of adjuvant therapy for breast cancer. Cancer J 2011, 17(6):500-504.
16. Perou C.M., Sørlie T., Eisen M.B., et al. Molecular portraits of human breast tumours. Nature 2000, 406(6797):747-752.
17. Sørlie T., Perou C.M., Tibshirani R., et al. Gene expression patterns of breast carcinomas distinguish tumor subclasses with clinical implications. Proc Natl Acad Sci USA 2001, 98(19):10869-10874.
18. Curtis C., Shah S.P., Chin S.F., et al. The genomic and transcriptomic architecture of 2,000 breast tumours reveals novel subgroups. Nature 2012, 486(7403):346-352.
19. Parker J.S., Mullins M., Cheang M.C., et al. Supervised risk predictor of breast cancer based on intrinsic subtypes. J Clin Oncol 2009, 27(8):1160-1167.
20. Nielsen T.O., Parker J.S., Leung S., 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(21):5222-5232.
21. Chia S.K., Bramwell V.H., Tu D., et al. A 50-gene intrinsic subtype classifier for prognosis and prediction of benefit from adjuvant tamoxifen. Clin Cancer Res 2012, 18(16):4465-4472.
22. Paik S., Shak S., Tang G., et al. A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer. N Engl J Med 2004, 351(27):2817-2826.
23. Paik S., Tang G., Shak S., et al. Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer. J Clin Oncol 2006, 24(23):3726-3734.
24. Albain K.S., Barlow W.E., Shak S., et al. Breast Cancer Intergroup of North America. 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(1):55-65.
25. Mamounas E.P., Tang G., Fisher B., 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(10):1677-1683.
26. Dowsett M., Nielsen T.O., A'Hern R., et al. International Ki-67 in Breast Cancer Working Group. Assessment of Ki67 in breast cancer: recommendations from the International Ki67 in Breast Cancer working group. J Natl Cancer Inst 2011, 103(22):1656-1664.
27. Tang G., Shak S., Paik S., 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(1):133-142.
28. Schneider J.G., Khalil D.N. Why does Oncotype DX recurrence score reduce adjuvant chemotherapy use?. Breast Cancer Res Treat 2012, 134(3):1125-1132.
29. Ademuyiwa F.O., Miller A., O'Connor T., 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(3):797-802.
30. Albanell J., González A., Ruiz-Borrego M., 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(3):625-631.
31. Harris L., Fritsche H., Mennel R., 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(33):5287-5312.
32. Bernards R. Reaction to American Society of Clinical Oncology 2007 update of recommendations for the use of tumor markers in breast cancer. J Clin Oncol 2008, 26(12):2057-2058. author reply 2060-2061.
33. Cardoso F., Saghatchian M., Thompson A., Rutgers E. TRANSBIG Consortium Steering Committee. Inconsistent criteria used in American Society of Clinical Oncology 2007 update of recommendations for the use of tumor markers in breast cancer. J Clin Oncol 2008, 26(12):2058-2059. author reply 2060-2061.
34. Klang S.H., Hammerman A., Liebermann N., Efrat N., Doberne J., Hornberger J. Economic implications of 21-gene breast cancer risk assay from the perspective of an Israeli-managed health-care organization. Value Health 2010, 13(4):381-387.
35. Kondo M., Hoshi S.L., 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(3):739-749.
36. Lamond N.W., 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(3):1115-1123.
37. National Institute for Health and Clinical Excellence Diagnostics Consultation Document. Gene expression profiling and expanded immunohistochemistry tests to guide the use of adjuvant chemotherapy in breast cancer management: MammoPrint, OncotypeDx, IHC4 and Mammostrat. Available at:. http://www.nice.org.uk/nicemedia/live/13283/58040/58040.pdf.
38. Hall P.S., McCabe C., Stein R.C., Cameron D. Economic evaluation of genomic test-directed chemotherapy for early-stage lymph node-positive breast cancer. J Natl Cancer Inst 2012, 104(1):56-66.
39. Prat A., Parker J.S., Fan C., Perou C.M. PAM50 assay and the three-gene model for identifying the major and clinically relevant molecular subtypes of breast cancer. Breast Cancer Res Treat 2012, 135(1):301-306.
40. Cuzick J., Dowsett M., Pineda S., 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(32):4273-4278.
41. Ring B.Z., Seitz R.S., Beck R., et al. Novel prognostic immunohistochemical biomarker panel for estrogen receptor-positive breast cancer. J Clin Oncol 2006, 24(19):3039-3047.
42. Bartlett J.M., Thomas J., Ross D.T., et al. Mammostrat as a tool to stratify breast cancer patients at risk of recurrence during endocrine therapy. Breast Cancer Res 2010, 12(4):R47.
43. Ross D.T., Kim C.Y., Tang G., et al. Chemosensitivity and stratification by a five monoclonal antibody immunohistochemistry test in the NSABP B14 and B20 trials. Clin Cancer Res 2008, 14(20):6602-6609.
44. Bouzubar N., Walker K.J., Griffiths K., et al. Ki67 immunostaining in primary breast cancer: pathological and clinical associations. Br J Cancer 1989, 59(6):943-947.
45. Nicholson R.I., Bouzubar N., Walker K.J., et al. Hormone sensitivity in breast cancer: influence of heterogeneity of oestrogen receptor expression and cell proliferation. Eur J Cancer 1991, 27(7):908-913.
46. Dowsett M., Salter J., Zabaglo L., et al. Predictive algorithms for adjuvant therapy: TransATAC. Steroids 2011, 76(8):777-780.
47. Barton S., Zabaglo L., A'Hern R., 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(11):1760-1765.
48. Dowsett M, Lopez-Knowles E, Sidhu K, et al. Comparison of PAM50 risk of recurrence (ROR) score with OncotypeDx and IHC4 for predicting residual risk of RFS and distant-(D)RFS after endocrine therapy: a TransATAC study. SABCS 2011 Abstract S4-S5.
49. Cheang M.C., Chia SK., Voduc D., et al. Ki67 index, HER2 status, and prognosis of patients with luminal B breast cancer. J Natl Cancer Inst 2009, 101(10):736-750.
50. http://www.independentcancerpatientsvoice.org.uk.
51. Bartlett J.M., Bloom K.J., Piper T., 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 Oct 8, [Epub ahead of print].