Advertisement

Archives of Gynecology and Obstetrics

, Volume 297, Issue 2, pp 443–447 | Cite as

Oncotype DX® in breast cancer patients: clinical experience, outcome and follow-up—a case–control study

  • Michelle G. Rath
  • Lorenz Uhlmann
  • Marita Fiedler
  • Joerg Heil
  • Michael Golatta
  • Christine Dinkic
  • Andre Hennigs
  • Sarah Schott
  • Veronika Ernst
  • Thorsten Koch
  • Christof Sohn
  • Cosima Brucker
  • Joachim RomEmail author
Gynecologic Oncology

Abstract

Purpose

Breast cancer is the leading cause of death from cancer in women and the most common cancer in the world [1]. To date, many patients with estrogen-receptor-positive (ER+) breast cancer are overtreated with chemotherapy when the rationale for adjuvant chemotherapy is based on clinicopathologic parameters. Different studies were able to demonstrate that a 21-gene expression assay (Oncotype DX® Genomic Health, Redwood City, CA) can predict the benefit from adjuvant chemotherapy in ER+ breast cancers [2, 3] and provide additional prognostic information independent of clinicopathological features [4].

Results

Data from all patients with ER+ Her2neu− breast cancer undergoing Oncotype DX® testing between 2011 and 2014 at a tertiary referral center in Germany were analyzed. Oncotype DX® was performed in 69 cases, in 2 cases data were missing and in 3 cases Oncotype DX® could not be performed by the company. The results showed a low risk in 39 cases, an intermediate risk in 22 cases and a high risk in 3 cases. Based on Oncotype results, treatment recommendations were changed in 39 of 64 patients (61%). Before Oncotype DX® testing, chemotherapy was recommended in 67 patients, afterwards only in 25 patients. Data from 44 of 67 patients were matched to controls for stage, tumor grade, menopausal and hormone receptor status. Within a mean observation time of 19.7 months, cancer recurrence was observed in two patients.

Conclusions

Oncotype DX® testing can be recommended for risk-tailored chemotherapy. Results should be validated in larger prospective studies.

Keywords

Breast cancer Oncotype DX® Gene expression assay Case–control study 

Notes

Author contributions

MR: project development, Data collection and analysis, manuscript writing. LU: statistics, manuscript writing. MF: data collection. JH: data analysis. MG: data analysis. CD: manuscript editing. AH: manuscript editing. SS: manuscript editing. VE: data collection. TK: Project development. CS: project development. CB: project development, manuscript editing. JR: project development manuscript writing.

Compliance with ethical standards

Conflict of interest

MRath declares that she has no conflict of interest. L Uhlmann declares that he has no conflict of interest. M Fiedler declares that she has no conflict of interest. J Heil declares that he has no conflict of interest. M Golatta declares that he has no conflict of interest. C Dinkic declares that she has no conflict of interest. A Hennigs declares that he has no conflict of interest. S Schott declares that she has no conflict of interest. V Ernst declares that she has no conflict of interest. T Koch declares that he has no conflict of interest. C Sohn declares that he has no conflict of interest. C Brucker declares that she has no conflict of interest. J Rom declares that he has no conflict of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

Data were anonymized, therefore no Informed consent was necessary.

References

  1. 1.
    Jemal A, Center MM, DeSantis C, Ward EM (2010) Global patterns of cancer incidence and mortality rates and trends. Cancer Epidemiol Biomarkers Prev 19(8):1893–1907.  https://doi.org/10.1158/1055-9965.EPI-10-0437 CrossRefPubMedGoogle Scholar
  2. 2.
    Albain KS, Barlow WE, Shak S, Hortobagyi GN, Livingston RB, Yeh IT, Ravdin P, Bugarini R, Baehner FL, Davidson NE, Sledge GW, Winer EP, Hudis C, Ingle JN, Perez EA, Pritchard KI, Shepherd L, Gralow JR, Yoshizawa C, Allred DC, Osborne CK, Hayes DF, Breast Cancer Intergroup of North A (2010) 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.  https://doi.org/10.1016/S1470-2045(09)70314-6 CrossRefPubMedGoogle Scholar
  3. 3.
    Paik S, Tang G, Shak S, Kim C, Baker J, Kim W, Cronin M, Baehner FL, Watson D, Bryant J, Costantino JP, Geyer CE Jr, Wickerham DL, Wolmark N (2006) Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer. J Clin Oncol 24(23):3726–3734.  https://doi.org/10.1200/JCO.2005.04.7985 CrossRefPubMedGoogle Scholar
  4. 4.
    Paik S, Shak S, Tang G, Kim C, Baker J, Cronin M, Baehner FL, Walker MG, Watson D, Park T, Hiller W, Fisher ER, Wickerham DL, Bryant J, Wolmark N (2004) A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer. N Engl J Med 351(27):2817–2826.  https://doi.org/10.1056/NEJMoa041588 CrossRefPubMedGoogle Scholar
  5. 5.
    Siegel R, Ma J, Zou Z, Jemal A (2014) Cancer statistics. CA Cancer J Clin 64(1):9–29.  https://doi.org/10.3322/caac.21208 CrossRefPubMedGoogle Scholar
  6. 6.
    Early Breast Cancer Trialists’ Collaborative G (2005) Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet 365(9472):1687–1717.  https://doi.org/10.1016/S0140-6736(05)66544-0 CrossRefGoogle Scholar
  7. 7.
    Early Breast Cancer Trialists’ Collaborative G, Davies C, Godwin J, Gray R, Clarke M, Cutter D, Darby S, McGale P, Pan HC, Taylor C, Wang YC, Dowsett M, Ingle J, Peto R (2011) Relevance of breast cancer hormone receptors and other factors to the efficacy of adjuvant tamoxifen: patient-level meta-analysis of randomised trials. Lancet 378(9793):771–784.  https://doi.org/10.1016/s0140-6736(11)60993-8 CrossRefGoogle Scholar
  8. 8.
    Sparano JA, Paik S (2008) Development of the 21-gene assay and its application in clinical practice and clinical trials. J Clin Oncol 26(5):721–728.  https://doi.org/10.1200/JCO.2007.15.1068 CrossRefPubMedGoogle Scholar
  9. 9.
  10. 10.
    Goldhirsch A, Wood WC, Coates AS, Gelber RD, Thurlimann B, Senn HJ, Panel M (2011) 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 22(8):1736–1747.  https://doi.org/10.1093/annonc/mdr304
  11. 11.
    Harris L, Fritsche H, Mennel R, Norton L, Ravdin P, Taube S, Somerfield MR, Hayes DF, Bast RC Jr, American Society of Clinical O (2007) 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.  https://doi.org/10.1200/jco.2007.14.2364 CrossRefPubMedGoogle Scholar
  12. 12.
    Gligorov J, Pivot XB, Jacot W, Naman HL, Spaeth D, Misset JL, Largillier R, Sautiere JL, de Roquancourt A, Pomel C, Rouanet P, Rouzier R, Penault-Llorca FM, Francilian Breast I (2015) Prospective Clinical utility study of the use of the 21-gene assay in adjuvant clinical decision making in women with estrogen receptor-positive early invasive breast cancer: results from the SWITCH study. Oncologist 20(8):873–879.  https://doi.org/10.1634/theoncologist.2014-0467 CrossRefPubMedPubMedCentralGoogle Scholar
  13. 13.
    Smyth L, Watson G, Walsh EM, Kelly CM, Keane M, Kennedy MJ, Grogan L, Hennessy BT, O’Reilly S, Coate LE, O’Connor M, Quinn C, Verleger K, Schoeman O, O’Reilly S, Walshe JM (2015) Economic impact of 21-gene recurrence score testing on early-stage breast cancer in Ireland. Breast Cancer Res Treat 153(3):573–582.  https://doi.org/10.1007/s10549-015-3555-4 CrossRefPubMedGoogle Scholar
  14. 14.
    Carlson JJ, Roth JA (2013) The impact of the Oncotype Dx breast cancer assay in clinical practice: a systematic review and meta-analysis. Breast Cancer Res Treat 141(1):13–22.  https://doi.org/10.1007/s10549-013-2666-z CrossRefPubMedPubMedCentralGoogle Scholar
  15. 15.
    Gyanchandani R, Lin Y, Lin HM, Cooper K, Normolle DP, Brufsky A, Fastuca M, Crosson W, Oesterreich S, Davidson NE, Bhargava R, Dabbs DJ, Lee AV (2016) intratumor heterogeneity affects gene expression profile test prognostic risk stratification in early breast cancer. Clin Cancer Res 22(21):5362–5369.  https://doi.org/10.1158/1078-0432.CCR-15-2889 CrossRefPubMedPubMedCentralGoogle Scholar

Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2017

Authors and Affiliations

  • Michelle G. Rath
    • 1
    • 2
  • Lorenz Uhlmann
    • 3
  • Marita Fiedler
    • 2
  • Joerg Heil
    • 1
  • Michael Golatta
    • 1
  • Christine Dinkic
    • 1
  • Andre Hennigs
    • 1
  • Sarah Schott
    • 1
  • Veronika Ernst
    • 2
  • Thorsten Koch
    • 2
  • Christof Sohn
    • 1
  • Cosima Brucker
    • 2
  • Joachim Rom
    • 1
    Email author
  1. 1.Department of Gynecology and ObstetricsUniversity of HeidelbergHeidelbergGermany
  2. 2.Department of Gynecology and ObstetricsParacelsus Medical UniversityNurembergGermany
  3. 3.Institute of Medical Biometry and InformaticsUniversity of HeidelbergHeidelbergGermany

Personalised recommendations