Personalizing the treatment of women with early breast cancer: highlights of the St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2013

A Goldhirsch, E P Winer, A S Coates, R D Gelber, M Piccart-Gebhart, B Thürlimann, H-J Senn, Panel members, Kathy S Albain, Fabrice André, Jonas Bergh, Hervé Bonnefoi, Denisse Bretel-Morales, Harold Burstein, Fatima Cardoso, Monica Castiglione-Gertsch, Alan S Coates, Marco Colleoni, Alberto Costa, Giuseppe Curigliano, Nancy E Davidson, Angelo Di Leo, Bent Ejlertsen, John F Forbes, Richard D Gelber, Michael Gnant, Aron Goldhirsch, Pamela Goodwin, Paul E Goss, Jay R Harris, Daniel F Hayes, Clifford A Hudis, James N Ingle, Jacek Jassem, Zefei Jiang, Per Karlsson, Sibylle Loibl, Monica Morrow, Moise Namer, C Kent Osborne, Ann H Partridge, Frédérique Penault-Llorca, Charles M Perou, Martine J Piccart-Gebhart, Kathleen I Pritchard, Emiel J T Rutgers, Felix Sedlmayer, Vladimir Semiglazov, Zhi-Ming Shao, Ian Smith, Beat Thürlimann, Masakazu Toi, Andrew Tutt, Michael Untch, Giuseppe Viale, Toru Watanabe, Nicholas Wilcken, Eric P Winer, William C Wood, A Goldhirsch, E P Winer, A S Coates, R D Gelber, M Piccart-Gebhart, B Thürlimann, H-J Senn, Panel members, Kathy S Albain, Fabrice André, Jonas Bergh, Hervé Bonnefoi, Denisse Bretel-Morales, Harold Burstein, Fatima Cardoso, Monica Castiglione-Gertsch, Alan S Coates, Marco Colleoni, Alberto Costa, Giuseppe Curigliano, Nancy E Davidson, Angelo Di Leo, Bent Ejlertsen, John F Forbes, Richard D Gelber, Michael Gnant, Aron Goldhirsch, Pamela Goodwin, Paul E Goss, Jay R Harris, Daniel F Hayes, Clifford A Hudis, James N Ingle, Jacek Jassem, Zefei Jiang, Per Karlsson, Sibylle Loibl, Monica Morrow, Moise Namer, C Kent Osborne, Ann H Partridge, Frédérique Penault-Llorca, Charles M Perou, Martine J Piccart-Gebhart, Kathleen I Pritchard, Emiel J T Rutgers, Felix Sedlmayer, Vladimir Semiglazov, Zhi-Ming Shao, Ian Smith, Beat Thürlimann, Masakazu Toi, Andrew Tutt, Michael Untch, Giuseppe Viale, Toru Watanabe, Nicholas Wilcken, Eric P Winer, William C Wood

Abstract

The 13th St Gallen International Breast Cancer Conference (2013) Expert Panel reviewed and endorsed substantial new evidence on aspects of the local and regional therapies for early breast cancer, supporting less extensive surgery to the axilla and shorter durations of radiation therapy. It refined its earlier approach to the classification and management of luminal disease in the absence of amplification or overexpression of the Human Epidermal growth factor Receptor 2 (HER2) oncogene, while retaining essentially unchanged recommendations for the systemic adjuvant therapy of HER2-positive and 'triple-negative' disease. The Panel again accepted that conventional clinico-pathological factors provided a surrogate subtype classification, while noting that in those areas of the world where multi-gene molecular assays are readily available many clinicians prefer to base chemotherapy decisions for patients with luminal disease on these genomic results rather than the surrogate subtype definitions. Several multi-gene molecular assays were recognized as providing accurate and reproducible prognostic information, and in some cases prediction of response to chemotherapy. Cost and availability preclude their application in many environments at the present time. Broad treatment recommendations are presented. Such recommendations do not imply that each Panel member agrees: indeed, among more than 100 questions, only one (trastuzumab duration) commanded 100% agreement. The various recommendations in fact carried differing degrees of support, as reflected in the nuanced wording of the text below and in the votes recorded in supplementary Appendix S1, available at Annals of Oncology online. Detailed decisions on treatment will as always involve clinical consideration of disease extent, host factors, patient preferences and social and economic constraints.

Keywords: St Gallen Consensus; early breast cancer; radiation therapy; subtypes; surgery; systemic adjuvant therapies.

References

    1. Goldhirsch A, Wood WC, Coates AS, et al. Strategies for subtypes—dealing with the diversity of breast cancer: highlights of the St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2011. Ann Oncol. 2011;22:1736–1747. .
    1. The Cancer Genome Atlas Network. Comprehensive molecular portraits of human breast tumours. Nature. 2012;490:61–70. .
    1. Dunbier AK, Anderson H, Ghazoui Z, et al. Association between breast cancer subtypes and response to neoadjuvant anastrozole. Steroids. 2011;76:736–740. .
    1. Ellis MJ, Ding L, Shen D, et al. Whole-genome analysis informs breast cancer response to aromatase inhibition. Nature. 2012;486:353–360.
    1. Galimberti V, Botteri E, Chifu C, et al. Can we avoid axillary dissection in the micrometastatic sentinel node in breast cancer? Breast Cancer Res Treat. 2012;131:819–825. .
    1. Martelli G, Boracchi P, Ardoino I, et al. Axillary dissection versus no axillary dissection in older patients with T1N0 breast cancer: 15-year results of a randomized controlled trial. Ann Surg. 2012;256:920–924.
    1. Goldhirsch A, Gelber RD, Piccart-Gebhart MJ, et al. 2 years versus 1 year of adjuvant trastuzumab for HER2-positive breast cancer (HERA): an open-label, randomised controlled trial. The Lancet 2013 July 18 [epub ahead of print] doi: 10.1016/S0140-6736(13)61094-6.
    1. Pivot X, Romieu G, Debled M, et al. 6 months versus 12 months of adjuvant trastuzumab for patients with HER2-positive early breast cancer (PHARE): a randomised phase 3 trial. Lancet Oncol. 2013;14:741–748.
    1. Davies C, Pan H, Godwin J, et al. Long-term effects of continuing adjuvant tamoxifen to 10 years versus stopping at 5 years after diagnosis of oestrogen receptor-positive breast cancer: ATLAS, a randomised trial. Lancet. 2013;381:805–816. .
    1. Baselga J, Campone M, Piccart M, et al. Everolimus in postmenopausalhormone-receptor-positive advanced breast cancer. N Engl J Med. 2012;366:520–529. .
    1. Osborne CK, Schiff R. Overcoming resistance to endocrine therapy due to PI3K/AKT pathway activation by combinations of mTOR, AKT or MEK inhibitors. The Breast. 2013;22(Supp 1):S2. Abstr. SP1.04)
    1. Ibrahim YH, Garcia-Garcia C, Serra V, et al. PI3K Inhibition impairs BRCA1/2 expression and sensitizes BRCA proficient triple negative breast cancer to PARP inhibition. Cancer Discov. 2012;2:1036–1047. .
    1. Juvekar A, Burga LN, Hu H, et al. Combining a PI3K inhibitor with a PARP inhibitor provides an effective therapy for BRCA1-related breast cancer. Cancer Discov. 2012;2:1048–1063. .
    1. Varna M, Bousquet G, Plassa LF, et al. TP53 status and response to treatment in breast cancers. J Biomed Biotechnol. 2011 May 9 [epub ahead of print] doi: 10.1155/2011/284584.
    1. Jackson JG, Pant V, Li Q, et al. p53-mediated senescence impairs the apoptotic response to chemotherapy and clinical outcome in breast cancer. Cancer Cell. 2012;21:793–806. .
    1. Bailey ST, Shin H, Westerling T, et al. Estrogen receptor prevents p53-dependent apoptosis in breast cancer. Proc Natl Acad Sci USA. 2012;109:18060–5. .
    1. Bonnefoi H, Piccart M, Bogaerts J, et al. TP53 Status for prediction of sensitivity to taxane versus non-taxane neoadjuvant chemotherapy in breast cancer (EORTC 10994/BIG 1–00): a randomised phase 3 trial. Lancet Oncol. 2011;12:527–539. .
    1. Early Breast Cancer Trialists’ Collaborative Group. 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;379:432–444. .
    1. Di Leo A. The continued evidence from overviews: what is the clinical utility? The Breast. 2013;22(Supp 1):S2. Abstr. SP1.02)
    1. Ellis MJ, Perou CM. The genomic landscape of breast cancer as a therapeutic roadmap. Cancer Discov. 2013;3:27–34. .
    1. Hayes DF. From the genome to bedside: are we lost in translation? The Breast. 2013;22(Supp 1):S3. Abstr. SP2.02)
    1. Parker JS, Mullins M, Cheang MC, et al. Supervised risk predictor of breast cancer based on intrinsic subtypes. J Clin Oncol. 2009;27:1160–1167. .
    1. Cheang MCU, Chia SK, Voduc D, et al. Ki67 index, HER2 status, and prognosis of patients with luminal B breast cancer. J Natl Cancer Inst. 2009;101:736–750. .
    1. Prat A, Cheang MC, Martin M, et al. Prognostic significance of progesterone receptor-positive tumor cells within immunohistochemically defined luminal A breast cancer. J Clin Oncol. 2013;31:203–209. .
    1. Dowsett M, Nielsen TO, A'Hern R, et al. Assessment of Ki67 in breast cancer: recommendations from the international Ki67 in breast cancer working group. J Natl Cancer Inst. 2011;103:1656–1664. .
    1. Nielsen TO, Polley M-YC, Leung SCY, et al. An international Ki-67 reproducibility study. Presented at the 35th San Antonio Breast Cancer Symposium; December 4–8, 2012. Abstr S4–6.
    1. Luporsi E, Andre F, Spyratos F, et al. Ki-67: level of evidence and methodological considerations for its role in the clinical management of breast cancer: analytical and critical review. Breast Cancer Res Treat. 2012;132:895–915. .
    1. Buckland G, Travier N, Cottet V, et al. Adherence to the Mediterranean diet and risk of breast cancer in the European prospective investigation into cancer and nutrition cohort study. Int J Cancer. 2013;132:2918–2927.
    1. Chlebowski RT. Nutrition and physical activity influence on breast cancer incidence and recurrence. The Breast. 2013;22(Supp 1):S5. Abstr. SP3.01)
    1. Folkerd EJ, Dixon JM, Renshaw L, et al. Suppression of plasma estrogen levels by letrozole and anastrozole is related to body mass index in patients with breast cancer. J Clin Oncol. 2012;30:2977–2980. .
    1. Dowsett M, Folkerd E. Sex hormones and breast cancer risk and prognosis. The Breast. 2013;22(Supp 1):S5. Abstr. SP3.02)
    1. Mavaddat N, Barrowdale D, Andrulis IL, et al. Pathology of breast and ovarian cancers among BRCA1 and BRCA2 mutation carriers: results from the consortium of investigators of modifiers of BRCA1/2 (CIMBA) Cancer Epidemiol Biomarkers Prev. 2012;21:134–147. .
    1. Niraula S, Ocana A, Ennis M, et al. Body size and breast cancer prognosis in relation to hormone receptor and menopausal status: a meta-analysis. Breast Cancer Res Treat. 2012;134:769–781. .
    1. Sestak I, Distler W, Forbes JF, et al. Effect of body mass index on recurrences in tamoxifen and anastrozole treated women: an exploratory analysis from the ATAC trial. J Clin Oncol. 2010;28:3411–3415. .
    1. Ewertz M, Gray KP, Regan MM, et al. Obesity and risk of recurrence or death after adjuvant endocrine therapy with letrozole or tamoxifen in the Breast International Group 1–98 trial. J Clin Oncol. 2012;30:3967–3975. .
    1. Goodwin PJ, Pritchard KI. Obesity and hormone therapy in breast cancer: an unfinished puzzle. J Clin Oncol. 2010;28:3405–3407. .
    1. Pfeiler G, Koenigsberg R, Fesl C, et al. Impact of body mass index on the efficacy of endocrine therapy in premenopausal patients with breast cancer: an analysis of the prospective ABCSG-12 trial. J Clin Oncol. 2011;29:2653–2659. .
    1. Bertolini F. Adipose tissue and breast cancer progression: a link between metabolism and cancer. The Breast. 2013;22(Supp 1):S6. Abstr. SP4.01)
    1. Bertolini F, Lohsiriwat V, Petit JY, et al. Adipose tissue cells, lipotransfer and cancer: a challenge for scientists, oncologists and surgeons. Biochim Biophys Acta. 2012;1826:209–214.
    1. Petit JY, Botteri E, Lohsiriwat V, et al. Locoregional recurrence risk after lipofilling in breast cancer patients. Ann Oncol. 2012;23:582–588. .
    1. Oskarsson T, Acharyya S, Zhang XH, et al. Breast cancer cells produce tenascin C as a metastatic niche component to colonize the lungs. Nat Med. 2011;17:867–874. .
    1. Oskarsson T. Extracellular matrix players in breast cancer progression and metastasis. The Breast. 2013;22(Supp 1):S7. Abstr. SP4.04)
    1. Coleman RE, Marshall H, Cameron D, et al. Breast-cancer adjuvant therapy with zoledronic acid. N Engl J Med. 2011;365:1396–1405. .
    1. Coleman R, de Boer R, Eidtmann H, et al. Zoledronic acid (zoledronate) for postmenopausal women with early breast cancer receiving adjuvant letrozole (ZO-FAST study): final 60-month results. Ann Oncol. 2013;24:398–405. .
    1. Gnant M, Mlineritsch B, Stoeger H, et al. Adjuvant endocrine therapy plus zoledronic acid in premenopausal women with early-stage breast cancer: 62-month follow-up from the ABCSG-12 randomised trial. Lancet Oncology. 2011;12:631–641. .
    1. Goldhirsch A. Personalized adjuvant therapies: lessons from the past. The Breast. 2013;22(Supp 1):S1. Abstr. SP0.01)
    1. Kerbel RS. Preclinical recapitulation of antiangiogenic drug clinical efficacies using models of early or late stage breast cancer metastasis. The Breast. 2013;22(Supp 1):S7. Abstr. SP4.03)(manuscript in preparation.
    1. Hassett MJ, Silver SM, Hughes ME, et al. Adoption of gene expression profile testing and association with use of chemotherapy among women with breast cancer. J Clin Oncol. 2012;30:2218–2226. .
    1. Drukker CA, Bueno-de-Mesquita JM, Retel VP, et al. A prospective evaluation of a breast cancer prognosis signature in the observational RASTER study. Int J Cancer. 2013;131:929–936.
    1. Pusztai L. Influence of genomics on adjuvant treatments for pre-invasive and invasive breast cancer. The Breast. 2013;22(Supp 1):S9. Abstr. SP5.03)
    1. Nielsen TO, Parker JS, 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;16:5222–5232. .
    1. Dubsky P, Filipits M, Jakesz R, et al. Endopredict improves the prognostic classification derived from common clinical guidelines in ER-positive, HER2-negative early breast cancer. Ann Oncol. 2013;24:640–647. .
    1. Sgroi D, Sestak I, Cuzick J, et al. Comparative performance of breast cancer index (BCI) versus oncotype DX and IHC4 in the prediction of late recurrence in hormonal receptor-positive lymph node negative breast cancer patients: a transATAC study. Presented at the 35th San Antonio Breast Cancer Symposium; December 4–8, 2012. Abstr S1–9.
    1. Viale G. Characterization and clinical impact of residual disease after neoadjuvant chemotherapy. The Breast. 2013;22(Supp 1):S9. Abstr. SP5.04)
    1. von Minckwitz G, Untch M, Blohmer JU, et al. Definition and impact of pathologic complete response on prognosis after neoadjuvant chemotherapy in various intrinsic breast cancer subtypes. J Clin Oncol. 2012;30:1796–1804. .
    1. Loi S, Sirtaine N, Piette F, et al. Prognostic and predictive value of tumor-infiltrating lymphocytes in a phase III randomized adjuvant breast cancer trial in node-positive breast cancer comparing the addition of docetaxel to doxorubicin with doxorubicin-based chemotherapy: BIG 02–98. J Clin Oncol. 2013;31:860–867. .
    1. Andre F. Risk stratification for treatment choice: opportunities, challenges and tools. The Breast. 2013;22(Supp 1):S10. Abstr. SP6.01)
    1. Sotiriou C. Immune signatures: prognostic and predictive role in breast cancer. The Breast. 2013;22(Supp 1):S11. Abstr. SP6.04)
    1. Curigliano G. Developing an effective breast cancer vaccine. The Breast. 2013;22(Supp 1):S10. Abstr. SP6.02)(manuscript in preparation.
    1. Denkert C, Loibl S, Noske A, et al. Tumor-associated lymphocytes as an independent predictor of response to neoadjuvant chemotherapy in breast cancer. J Clin Oncol. 2010;28:105–113. .
    1. Morrow M. Personalizing extent of breast cancer surgery according to molecular subtypes. The Breast. 2013;22(Supp 1):S12. Abstr. SP7.03)
    1. Kiess AP, McArthur HL, Mahoney K, et al. Adjuvant trastuzumab reduces locoregional recurrence in women who receive breast-conservation therapy for lymph node-negative, human epidermal growth factor receptor 2-positive breast cancer. Cancer. 2012;118:1982–1988. .
    1. Rutgers E. Who should not undergo breast conservation? The Breast. 2013;22(Supp 1):S13. Abstr. SP7.04)
    1. Wood WC. Close/positive margins after breast-conserving therapy. The Breast. 2013;22(Supp 1):S13. Abstr. SP7.05)
    1. Galimberti V, Cole BF, Zurrida S, et al. Axillary dissection versus no axillary dissection in patients with sentinel-node micrometastases (IBCSG 23–01): a phase 3 randomised controlled trial. Lancet Oncol. 2013;14:297–305.
    1. Giuliano AE, Hunt KK, Ballman KV, et al. Axillary dissection versus no axillary dissection in women with invasive breast cancer and sentinel node metastasis. JAMA. 2011;305:569–575. .
    1. Gentilini O, Veronesi U. Abandoning sentinel lymph node biopsy in early breast cancer? A new trial in progress at the European Institute of Oncology of Milan (SOUND: sentinel node versus observation after axillary UltraSouND) Breast. 2012;21:678–681. .
    1. Whelan TJ, Pignol JP, Levine MN, et al. Long-term results of hypofractionated radiation therapy for breast cancer. N Engl J Med. 2010;362:513–520. .
    1. Yarnold JR. The UK START (standardisation of breast radiotherapy) trials: 10-year follow-up results. Presented at the 35th San Antonio Breast Cancer Symposium; December 4–8, 2012. Abstr. S4–1.
    1. Harris JR. Hypofractionation in the era of modulated radiotherapy. The Breast. 2013;22(Supp 1):S14. Abstr. SP8.02)
    1. Orecchia R. Partial breast irradiation: targeting volume or breast molecular subtypes? The Breast. 2013;22(Supp 1):S14. Abstr. SP8.01)
    1. Smith BD, Arthur DW, Buchholz TA, et al. Accelerated partial breast irradiation consensus statement from the American Society for Radiation Oncology (ASTRO) Int J Radiat Oncol Biol Phys. 2009;74:987–1001. .
    1. Polgar C, Van limbergen E, Potter R, et al. Patient selection for accelerated partial-breast irradiation (APBI) after breast-conserving surgery: recommendations of the Groupe Européen de Curiethérapie-European Society for Therapeutic Radiology and Oncology (GEC-ESTRO) breast cancer working group based on clinical evidence (2009) Radiother Oncol. 2010;94:264–273. .
    1. Sedlmayer F. Partial breast re-irradiation for local recurrence of breast carcinoma: benefit and potential long term side effects. The Breast. 2013;22(Supp 1):S15. Abstr. SP8.04)
    1. 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;24:3726–3734. .
    1. Albain KS, Barlow WE, Shak S, 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. .
    1. Cheang MC, Voduc KD, Tu D, et al. Responsiveness of intrinsic subtypes to adjuvant anthracycline substitution in the NCIC.CTG MA.5 randomized trial. Clin Cancer Res. 2012;18:2402–2412. .
    1. Burstein HJ. Patients with triple-negative breast cancer: is there an optimal adjuvant treatment? The Breast. 2013;22(Supp 1):S16. Abstr. SP9.02)
    1. Colleoni M. Extended adjuvant chemotherapy in endocrine non-responsive disease. The Breast. 2013;22(Supp 1):S17. Abstr. SP10.01)
    1. von Minckwitz G. Selecting the neoadjuvant treatment by molecular subtype: how to maximise the benefit. The Breast. 2013;22(Supp 1):S16. Abstr. SP9.03)
    1. Gianni L, Zambetti M, Clark K, 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;23:7265–7277. .
    1. Straver ME, Glas AM, Hannemann J, et al. The 70-gene signature as a response predictor for neoadjuvant chemotherapy in breast cancer. Breast Cancer Res Treat. 2010;119:551–558. .
    1. Piccart M. Patients with HER2 positive breast cancer: delivery, duration and combination therapies. The Breast. 2013;22(Supp 1):S16. Abstr. SP9.04)
    1. Davidson NE. Optimal systemic therapy for premenopausal women with hormone receptor-positive breast cancer. The Breast. 2013;22(Supp 1):S18. Abstr. SP10.02)
    1. Goss PE, Ingle JN, Martino S, et al. A randomized trial of letrozole in postmenopausal women after five years of tamoxifen therapy for early-stage breast cancer. N Engl J Med. 2003;349:1793–1802. .
    1. Goss PE, Ingle JN, Martino S, et al. Impact of premenopausal status at breast cancer diagnosis in women entered on the placebo-controlled NCIC CTG MA17 trial of extended adjuvant letrozole. Ann Oncol. 2013;24:355–361. .
    1. Ingle JN. Postmenopausal women with hormone receptor-positive breast cancer: balancing benefit and toxicity from aromatase inhibitors. The Breast. 2013;22(Supp 1):S19. Abstr. SP10.05)
    1. Amir E, Seruga B, Niraula S, et al. Toxicity of adjuvant endocrine therapy in postmenopausal breast cancer patients: a systematic review and meta-analysis. J Natl Cancer Inst. 2011;103:1299–1309. .
    1. Clarke CA, Keegan TH, Yang J, et al. Age-specific incidence of breast cancer subtypes: understanding the black-white crossover. J Natl Cancer Inst. 2012;104:1094–1101. .
    1. Loibl S, Jackisch C, Gade S. Neoadjuvant chemotherapy in the very young, 35 years of age or younger. Presented at the 35th San Antonio Breast Cancer Symposium; December 4–8, 2012. Abstr. S3–1.
    1. Partridge AH. Management of breast cancer in the very young. The Breast. 2013;22(Supp 1):S18. Abstr. SP10.04)
    1. Smith I. Follow-up tests to detect recurrent disease: patient's reassurance or medical need? The Breast. 2013;22(Supp 1):S17. Abstr. SP9.05)
    1. Hayes DF. Targeting adjuvant chemotherapy: a good idea that needs to be proven! J Clin Oncol. 2012;30:1264–1267. .
    1. Coates AS, Colleoni M, Goldhirsch A. Is adjuvant chemotherapy useful for women with luminal A breast cancer? J Clin Oncol. 2012;30:1260–1263. .
    1. Prat A, Parker JS, Fan C, et al. Concordance among gene expression-based predictors for ER-positive breast cancer treated with adjuvant tamoxifen. Ann Oncol. 2012;23:2866–2873. .
    1. Regan MM, Pagani O, Walley B, et al. Premenopausal endocrine-responsive early breast cancer: who receives chemotherapy? Ann Oncol. 2008;19:1231–1241. .
    1. Wirapati P, Sotiriou C, Kunkel S, et al. Meta-analysis of gene expression profiles in breast cancer: toward a unified understanding of breast cancer subtyping and prognosis signatures. Breast Cancer Res. 2008;10:R65. .
    1. Reed SD, Dinan MA, Schulman KA, et al. Cost-effectiveness of the 21-gene recurrence score assay in the context of multifactorial decision making to guide chemotherapy for early-stage breast cancer. Genet Med. 2013;15:203–211. .
    1. Vanderlaan BF, Broder MS, Chang EY, et al. Cost-effectiveness of 21-gene assay in node-positive, early-stage breast cancer. Am J Manag Care. 2011;17:455–464.
    1. Davidson JA, Cromwell I, Ellard SL, et al. A prospective clinical utility and pharmacoeconomic study of the impact of the 21-gene recurrence score(R) assay in oestrogen receptor positive node negative breast cancer. Eur J Cancer. 2013 April 20 [epub ahead of print] doi: 10.1016/j.ejca.2013.03.009.
    1. Hannouf MB, Xie B, Brackstone M, et al. Cost-effectiveness of a 21-gene recurrence score assay versus Canadian clinical practice in women with early-stage estrogen- or progesterone-receptor-positive, axillary lymph-node negative breast cancer. BMC Cancer. 2012;12:447. .
    1. Lamond NW, Skedgel C, Rayson D, et al. Cost-utility of the 21-gene recurrence score assay in node-negative and node-positive breast cancer. Breast Cancer Res Treat. 2012;133:1115–1123. .
    1. Tsoi DT, Inoue M, Kelly CM, et al. Cost-effectiveness analysis of recurrence score-guided treatment using a 21-gene assay in early breast cancer. Oncologist. 2010;15:457–465. .
    1. Hornberger J, Cosler LE, Lyman GH. Economic analysis of targeting chemotherapy using a 21-gene RT-PCR assay in lymph-node-negative, estrogen-receptor-positive, early-stage breast cancer. Am J Manag Care. 2005;11:313–324.
    1. Klang SH, Hammerman A, Liebermann N, et al. Economic implications of 21-gene breast cancer risk assay from the perspective of an Israeli-managed health-care organization. Value Health. 2010;13:381–387. .
    1. Hall PS, McCabe C, Stein RC, et al. Economic evaluation of genomic test-directed chemotherapy for early-stage lymph node-positive breast cancer. J Natl Cancer Inst. 2012;104:56–66. .
    1. Blohmer JU, Rezai M, Kummel S, et al. Using the 21-gene assay to guide adjuvant chemotherapy decision-making in early-stage breast cancer: a cost-effectiveness evaluation in the German setting. J Med Econ. 2013;16:30–40. .
    1. Eiermann W, Rezai M, Kummel S, 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;24:618–624. .
    1. Kondo M, Hoshi SL, Ishiguro H, et al. Economic evaluation of the 70-gene prognosis-signature (MammaPrint(R)) in hormone receptor-positive, lymph node-negative, human epidermal growth factor receptor type 2-negative early stage breast cancer in Japan. Breast Cancer Res Treat. 2012;133:759–768. .
    1. Sahin AA, Ro J, Ro JY, et al. Ki-67 immunostaining in node-negative stage I/II breast carcinoma: significant correlation with prognosis. Cancer. 1991;68:549–557. .
    1. Railo M, Lundin J, Haglund C, et al. Ki-67, p53, ER-receptors, ploidy and S-phase as prognostic factors in T1 node negative breast cancer. Acta Oncol. 1997;36:369–374. .
    1. Jansen RL, Hupperets PS, Arends JW, et al. MIB-1 labelling index is an independent prognostic marker in primary breast cancer. Br J Cancer. 1998;78:460–465. .
    1. Mirza AN, Mirza NQ, Vlastos G, et al. Prognostic factors in node-negative breast cancer: a review of studies with sample size more than 200 and follow-up more than 5 years. Ann Surg. 2002;235:10–26. .
    1. Trihia H, Murray S, Price K, et al. Ki-67 expression in breast carcinoma. Cancer. 2003;97:1321–1331. .
    1. de Azambuja E, Cardoso F, de CG, Jr, et al. Ki-67 as prognostic marker in early breast cancer: a meta-analysis of published studies involving 12 155 patients. Br J Cancer. 2007;96:1504–1513. .
    1. Dowsett M, Smith IE, Ebbs SR, et al. Prognostic value of Ki67 expression after short-term presurgical endocrine therapy for primary breast cancer. J Natl Cancer Inst. 2007;99:167–170. .
    1. Viale G, Regan MM, Mastropasqua MG, et al. Value of Ki-67 in two randomized trials of adjuvant chemo-endocrine therapies for node-negative breast cancer. J Natl Cancer Inst. 2008;100:207–212. .
    1. Viale G, Giobbie-Hurder A, Regan MM, et al. Prognostic and predictive value of centrally reviewed Ki-67 labeling index in postmenopausal women with endocrine-responsive breast cancer: results from Breast International Group trial 1–98 comparing adjuvant tamoxifen with letrozole. J Clin Oncol. 2008;26:5569–5575. .
    1. Muss HB, Berry DA, Cirrincione CT, et al. Adjuvant chemotherapy in older women with early stage breast cancer. N Engl J Med. 2009;360:2055–2065. .

Source: PubMed

3
Tilaa