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Expert Review of Anticancer Therapy Volume 13, 2013 - Issue 2
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Theme: Breast Cancer - Review

Overview of the use of Oncotype DX® as an additional treatment decision tool in early breast cancer

Christos Markopoulos Athens University Medical School, 8 Lassiou Street, 11521, Athens, Greece. [email protected]
Pages 179-194 | Published online: 10 Jan 2014

References

  • Coleman MP, Quaresma M, Berrino F et al.; CONCORD Working Group. Cancer survival in five continents: a worldwide population-based study (CONCORD). Lancet Oncol. 9(8), 730–756 (2008).
  • Peasgood T, Ward SE, Brazier J. Health-state utility values in breast cancer. Expert Rev. Pharmacoecon. Outcomes Res. 10(5), 553–566 (2010).
  • Conner-Spady BL, Cumming C, Nabholtz JM, Jacobs P, Stewart D. A longitudinal prospective study of health-related quality of life in breast cancer patients following high-dose chemotherapy with autologous blood stem cell transplantation. Bone Marrow Transplant. 36(3), 251–259 (2005).
  • Goldhirsch A, Ingle JN, Gelber RD, Coates AS, Thürlimann B, Senn HJ; Panel members. Thresholds for therapies: highlights of the St Gallen International Expert Consensus on the primary therapy of early breast cancer 2009. Ann. Oncol. 20(8), 1319–1329 (2009).
  • Aebi S, Davidson T, Gruber G, Castiglione M; ESMO Guidelines Working Group. Primary breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann. Oncol. 21(Suppl. 5), v9–v14 (2010).
  • Harris L, Fritsche H, Mennel R et al.; American Society of Clinical Oncology. American Society of Clinical Oncology 2007 update of recommendations for the use of tumor markers in breast cancer. J. Clin. Oncol. 25(33), 5287–5312 (2007).
  • Dignam JJ, Dukic V, Anderson SJ, Mamounas EP, Wickerham DL, Wolmark N. Hazard of recurrence and adjuvant treatment effects over time in lymph node-negative breast cancer. Breast Cancer Res. Treat. 116(3), 595–602 (2009).
  • Cronin M, Pho M, Dutta D et al. Measurement of gene expression in archival paraffin-embedded tissues: development and performance of a 92-gene reverse transcriptase-polymerase chain reaction assay. Am. J. Pathol. 164(1), 35–42 (2004).
  • Cobleigh MA, Tabesh B, Bitterman P et al. Tumor gene expression and prognosis in breast cancer patients with 10 or more positive lymph nodes. Clin. Cancer Res. 11(24 Pt 1), 8623–8631 (2005).
  • 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. 351(27), 2817–2826 (2004).
  • Cronin M, Sangli C, Liu ML et al. Analytical validation of the Oncotype DX genomic diagnostic test for recurrence prognosis and therapeutic response prediction in node-negative, estrogen receptor-positive breast cancer. Clin. Chem. 53(6), 1084–1091 (2007).
  • Simon R. Roadmap for developing and validating therapeutically relevant genomic classifiers. J. Clin. Oncol. 23(29), 7332–7341 (2005).
  • Simon R. Development and validation of biomarker classifiers for treatment selection. J. Stat. Plan. Inference 138(2), 308–320 (2008).
  • Habel LA, Shak S, Jacobs MK et al. A population-based study of tumor gene expression and risk of breast cancer death among lymph node-negative patients. Breast Cancer Res. 8(3), R25 (2006).
  • Dowsett M, Cuzick J, Wale C 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. 28(11), 1829–1834 (2010).
  • Albain KS, Barlow WE, 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. 11(1), 55–65 (2010).
  • Goldstein LJ, Gray R, Badve S et al. Prognostic utility of the 21-gene assay in hormone receptor-positive operable breast cancer compared with classical clinicopathologic features. J. Clin. Oncol. 26(25), 4063–4071 (2008).
  • 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. 127(1), 133–142 (2011).
  • Shak S, Baehner FL, Stein M et al. Quantitative gene expression analysis in a large cohort of estrogen-receptor positive breast cancers: characterization of the tumor profiles in younger patients (≤ 40 yrs) and in older patients (≥70 yrs). Presented at: 33rd San Antonio Breast Cancer Symposium. San Antonio, TX, USA, 8–12 December 2010.
  • 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. 24(23), 3726–3734 (2006).
  • Mamounas EP, Tang G, Paik S et al. Prognostic impact of the 21-gene Recurrence Score on disease-free and overall survival of node-positive, ER-positive breast cancer patients treated with adjuvant chemotherapy: results from NSABP B-28. Presented at: ASCO Breast. San Francisco, CA, USA, 13–15 September 2012.
  • 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. 23(29), 7265–7277 (2005).
  • Chang JC, Makris A, Gutierrez MC et al. Gene expression patterns in formalin-fixed, paraffin-embedded core biopsies predict docetaxel chemosensitivity in breast cancer patients. Breast Cancer Res. Treat. 108(2), 233–240 (2008).
  • Yardley DA, Peacock NW, Hendricks C et al. Ixabepilone and cyclophosphamide as neoadjuvant therapy in HER2-negative breast cancer with exploratory Oncotype DX® assessments: a sarah cannon research institute Phase II Trial. Presented at: 34th Annual San Antonio Breast Cancer Symposium. San Antonio, TX, USA, 6–10 December 2011.
  • Albanell J, Colomer R, Ruiz Borrego M et al. Prospective trans-GEICAM study of the impact of the 21-gene Recurrence Score assay and traditional clinico-pathological factors on clinical decision-making in women with estrogen receptor-positive, HER2-negative, node-negative breast cancer. Presented at: 12th St Gallen International Breast Cancer Conference. St. Gallen, Switzerland, 16–19 March 2011.
  • Asad J, Jacobson AF, Estabrook A et al. Does Oncotype DX recurrence score affect the management of patients with early-stage breast cancer? Am. J. Surg. 196(4), 527–529 (2008).
  • Blohmer J-U, Ataseven B, Kühn T et al. German multicentre decision impact study of Oncotype DX® Recurrence Score® (RS) on adjuvant treatment in estrogen receptor-positive (ER+) node-negative (N0) and node-positive (N+) early breast cancer. Presented at: 12th St Gallen International Breast Cancer Conference. St Gallen, Switzerland, 16–19 March 2011.
  • Geffen DB, Abu-Ghanem S, Sion-Vardy N et al. The impact of the 21-gene recurrence score assay on decision-making about adjuvant chemotherapy in early-stage estrogen-receptor-positive breast cancer in an oncology practice with a unified treatment policy. Ann. Oncol. 22(11), 2381–2386 (2011).
  • Henry LR, Stojadinovic A, Swain SM, Prindiville S, Cordes R, Soballe PW. The influence of a gene expression profile on breast cancer decisions. J. Surg. Oncol. 99(6), 319–323 (2009).
  • Holt SDH, Pudney D, Rolles M et al. Results from a prospective clinical study on the impact of Oncotype DX® on adjuvant treatment decision and risk classification by Nottingham Prognostic Index (NPI) and Adjuvant! Online. Presented at: 12th St Gallen International Breast Cancer Conference. St Gallen, Switzerland, 16–19 March 2011.
  • Klang SH, 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 13(4), 381–387 (2010).
  • Liang H, Brufsky AM, Lembersky BB. A retrospective analysis of the impact of Oncotype DX low recurrence score results on treatment decisions in a single academic breast cancer center. Presented at: 30th Annual San Antonio Breast Cancer Symposium. San Antonio, TX, USA, 13–16 December 2007.
  • Lo SS, Mumby PB, Norton J et al. Prospective multicenter study of the impact of the 21-gene recurrence score assay on medical oncologist and patient adjuvant breast cancer treatment selection. J. Clin. Oncol. 28(10), 1671–1676 (2010).
  • Oratz R, Paul D, Cohn AL, Sedlacek SM. Impact of a commercial reference laboratory test recurrence score on decision-making in early-stage breast cancer. J. Oncol. Pract. 3(4), 182–186 (2007).
  • Thanasoulis LC, Brown A, Frazier T. The role of Oncotype DX TM assay on appropriate treatment for estrogen positive, lymph node negative invasive breast cancer. Presented at: 9th Annual Meeting of the American Society of Breast Surgeons. New York City, NY, USA, 30 April–4 May 2008.
  • Hornberger J, Chien R. Meta-analysis of the decision impact of the 21-gene breast cancer Recurrence Score in clinical practice. Presented at: 12th St Gallen International Breast Cancer Conference. St. Gallen, Switzerland, 16–19 March 2011.
  • Rezai M, Eiermann W, Kümmel S et al. Impact of the Recurrence Score on adjuvant decision-making in ER-positive early breast cancer – results of a large prospective multicentre decision impact study in node negative and node positive disease. Presented at: 34th Annual San Antonio Breast Cancer Symposium. San Antonio, TX, USA, 6–10 December 2011.
  • Markopoulos C, Xepapadakis G, Venizelos V et al. Clinical experience of using Oncotype DX as an additional treatment decision tool in early breast cancer – a retrospective analysis from 5 Greek institutions. Eur. J. Surg. Oncol. 38(5), 413–419 (2012).
  • Markopoulos C, Xepapadakis G, Venizelos V et al. Clinical use of Oncotype DX Recurrence Score as an adjuvant-treatment decision tool in early breast cancer patients. Presented at: European Multidisciplinary Cancer Congress. Stockholm, Sweden, 23–27 September 2011.
  • Markopoulos C. Impact of the 21-gene Recurrence Score Assay on treatment decision in early breast cancer (EBC) patients with favorable prognostic factor. Presented at: 12th St Gallen International Breast Cancer Conference. St Gallen, Switzerland, 16–19 March 2011.
  • 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. 104(1), 56–66 (2012).
  • 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 11(5), 313–324 (2005).
  • Lyman GH, Cosler LE, Kuderer NM, Hornberger J. Impact of a 21-gene RT-PCR assay on treatment decisions in early-stage breast cancer: an economic analysis based on prognostic and predictive validation studies. Cancer 109(6), 1011–1018 (2007).
  • 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. 127(3), 739–749 (2011).
  • Tsoi DT, Inoue M, Kelly CM, Verma S, Pritchard KI. Cost–effectiveness analysis of recurrence score-guided treatment using a 21-gene assay in early breast cancer. Oncologist 15(5), 457–465 (2010).
  • Madaras B, Rózsa P, Gerencsér Z et al. Evaluation of the cost–effectiveness of the Oncotype DX® multigene assay in Hungary. Presented at: 12th St Gallen International Breast Cancer Conference. St Gallen, Switzerland, 16–19 March 2011.
  • de Lima Lopez G, Chien R, Hornberger J. Cost–effectiveness analysis of the 21-gene Recurrence Score® for early stage breast cancer in Singapore. Presented at: 12th St Gallen International Breast Cancer Conference. St Gallen, Switzerland, 16–19 March 2011.
  • Eiermann W, Rezai M, Kümmel S et al. Using the 21-gene breast cancer assay in adjuvant decision-making in ER-positive (ER+) early breast cancer (EBC) is cost-effective: Results of a large prospective German multicenter study. Presented at: 34th Annual San Antonio Breast Cancer Symposium. San Antonio, TX, USA, 6–10 December 2011.
  • Chereau E, Rouzier R, Bennett H. Cost–effectiveness of using the 21-gene breast cancer assay in France. Presented at: 34th Annual San Antonio Breast Cancer Symposium. San Antonio, TX, USA, 6–10 December 2011.
  • Cuzick J, Dowsett M, Wale C et al. Prognostic value of a combined ER, PgR, Ki67, HER2 immunohistochemical (IHC4) score and comparison with the GHI recurrence score – results from TransATAC. Presented at: 32nd Annual San Antonio Breast Cancer Symposium. San Antonio, TX, USA, 10–13 December 2009.
  • Ross DT, Kim CY, Tang G et al. Chemosensitivity and stratification by a five monoclonal antibody immunohistochemistry test in the NSABP B14 and B20 trials. Clin. Cancer Res. 14(20), 6602–6609 (2008).
  • Viale G, Regan MM, Mastropasqua MG et al.; International Breast Cancer Study Group. Predictive value of tumor Ki-67 expression in two randomized trials of adjuvant chemoendocrine therapy for node-negative breast cancer. J. Natl. Cancer Inst. 100(3), 207–212 (2008).
  • Glutz O, Kreipe HH, Degenhart T et al. Prospective comparison of risk assessment tools in early breast cancer (recurrence score, uPA/PAI-1, central grade, and luminal subtypes): final correlation analysis from the Phase III WSG planB trial. Presented at: 34th San Antonio Breast Cancer Symposium. San Antonio, TX, USA, 6–10 December 2011.
  • Marchionni L, Wilson RF, Marinopoulos SS et al. Impact of gene expression profiling tests on breast cancer outcomes. Evidence Reports/Technology Assessments, No. 160. Agency for Healthcare Research and Quality (USA), Rockville, MD, USA (2008).
  • van de Vijver MJ, He YD, van’t Veer LJ et al. A gene-expression signature as a predictor of survival in breast cancer. N. Engl. J. Med. 347(25), 1999–2009 (2002).
  • Buyse M, Loi S, van’t Veer L et al. Validation and clinical utility of a 70-gene prognostic signature for women with node-negative breast cancer. J. Natl Cancer Inst. 98(17), 1183–1192 (2006).
  • Jemal A, Tiwari RC, Murray T et al. Cancer statistics, 2004. CA Cancer J. Clin. 54(1), 8–29 (2004).
  • Solin L, Gray R, Baehner FL et al. A quantitative multigene RT-PCR assay for predicting recurrence risk after surgical excision alone without irradiation for ductal carcinoma in situ (DCIS): a prospective validation study of the DCIS score from ECOG E5194. Presented at: 34th San Antonio Breast Cancer Symposium. San Antonio, TX, USA, 6–10 December 2011.
  • Mansfield E, O’Leary TJ, Gutman SI. Food and Drug Administration regulation of in vitro diagnostic devices. J. Mol. Diagn. 7(1), 2–7 (2005).
  • Isler JA, Vesterqvist OE, Burczynski ME. Analytical validation of genotyping assays in the biomarker laboratory. Pharmacogenomics 8(4), 353–368 (2007).
  • Esteva FJ, Sahin AA, Cristofanilli M et al. Prognostic role of a multigene reverse transcriptase-PCR assay in patients with node-negative breast cancer not receiving adjuvant systemic therapy. Clin. Cancer Res. 11(9), 3315–3319 (2005).
  • Mina L, Soule SE, Badve S et al. Predicting response to primary chemotherapy: gene expression profiling of paraffin-embedded core biopsy tissue. Breast Cancer Res. Treat. 103(2), 197–208 (2007).
  • Anderson JM, Shak S, Millward C et al. Molecular characterization of breast cancer core biopsy specimens by gene expression analysis using standardized quantitative RT-PCR. Presented at: 32nd Annual San Antonio Breast Cancer Symposium. San Antonio, TX, USA, 10–13 December 2009.
  • Badve SS, Baehner FL, Gray RP et al. Estrogen- and progesterone-receptor status in ECOG 2197: comparison of immunohistochemistry by local and central laboratories and quantitative reverse transcription polymerase chain reaction by central laboratory. J. Clin. Oncol. 26(15), 2473–2481 (2009).
  • Toi M, Iwata H, Masuda N et al. Clinical significance of the 21-gene signature (Oncotype DX) in hormone receptor-positive early stage primary breast cancer in the Japanese population. Cancer 116(13), 3112–3118 (2010).

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