Does RSClin provide additional information over classic clinico-pathologic scores (PREDICT 2.1, Influence, CTS-5)? A TEAM Pathology substudy.

Journal of Clinical Oncology, vol. 41, pp. 533

Abstract

533 Background: Gene-expression profiling tests (e.g. Oncotype, Mammaprint, Prosignia, Breast Cancer Index and EndoPredict) are widely used in the care of patients with early-stage hormone positive breast cancer (node negative or 1-3 lymph nodes). However, these tests are resource intensive, and few studies have compared their value with either free and widely available clinico-pathologic risk calculators (e.g. PREDICT 2.1, INFLUENCE 2.0, and CTS-5) or tools that combine genomic testing with clinico-pathologic data (e.g. RSClin). The TEAM pathology substudy population was used to compare these different predicted model scores with outcomes. Methods: The TEAM pathology study consists of 3284 postmenopausal hormone positive breast cancer patients treated with either exemestane or tamoxifen followed by exemestane. Accrual was from 2001 to 2006. Genes comprising the multi-parametric Oncotype Dx were used to train signatures to create true assay results. Patient data was then used to calculate recurrence scores through various tools. This included clinico-pathologic models and their respective endpoints PREDICT 2.1 (overall survival at 5 years), INFLUENCE 2.0 (distant metastasis at 5 years), CTS-5 (distant recurrence risk at year 5-10), the purely genomic Oncotype Dx trained results (distant recurrence risk at 9 years), as well as the new clinico-pathologic RSClin (distant recurrence risk at 10 years). We compared the level of association between these predictive model scores using Spearman correlation coefficients. The prognostic ability of each model was contrasted for each outcome using Harrell’s C-statistic. Results: Results were available for CTS-5 (3022 patients), INFLUENCE 2.0 (3485 patients), ODx-trained (3825 patients), and RSClin (3029 patients). Correlation coefficients showed low correlation between Influence ( r= 0.25) and CTS-5 ( r= 0.17) with Oncotype-Dx trained results, and high correlation between RSClin ( r = 0.84) and Oncotype-Dx trained results. The concordance index was similar (0.65 to 0.68) for all models with distant metastasis-free survival as the outcome. Analysis is ongoing and further results will be available at the time of presentation. Conclusions: Other clinico-pathologic tools such as Influence 2.0 and CTS-5 have good prognostic ability when compared to Oncotype Dx-trained results and RSClin. [Table: see text]

Authors 17

1. Ana-Alicia Beltran-Bless

   Ottawa Hospital

   Affiliation as printed

   The Ottawa Hospital, Ottawa, ON, Canada

2. Gregory R. Pond

   McMaster University

   Affiliation as printed

   McMaster University, Hamilton, ON, Canada

3. Jane Bayani

   Ontario Institute for Cancer Research

   Affiliation as printed

   Ontario Institute for Cancer Research, Toronto, ON, Canada

4. Sarah Barker

   Ontario Institute for Cancer Research

   Affiliation as printed

   Diagnostic Development, Ontario Institute for Cancer Research, Toronto. ON, Canada, Toronto, ON, Canada

5. Melanie Spears

   Ontario Institute for Cancer Research

   Affiliation as printed

   Ontario Institute for Cancer Research, Toronto, ON, Canada

6. Elizabeth Mallon

   University of Glasgow

   Affiliation as printed

   Department of Pathology, Glasgow, United Kingdom, Glasgow, United Kingdom

7. Karen J. Taylor

   Edinburgh Cancer Research · University of Edinburgh

   Affiliation as printed

   Cancer Research UK Scotland Centre, University of Edinburgh, Edinburgh, United Kingdom

8. Annette Hasenburg

   University Medical Center of the Johannes Gutenberg University Mainz

   Affiliation as printed

   University Medical Center Mainz, Mainz, Germany

9. Christos J. Markopoulos

   National and Kapodistrian University of Athens

   Affiliation as printed

   National and Kapodistrian University of Athens, Medical School, Athens, Greece, Athens, Greece

10. Luc Yves Dirix

    GZA Ziekenhuizen Campus Sint-Augustinus · GZA Ziekenhuizen

    Affiliation as printed

    GZA Ziekenhuizen Antwerpen campus Sint-Augustinus, Antwerpen, Belgium

11. Caroline Seynaeve

    Erasmus MC Cancer Institute · Daniel den Hoed Kliniek

    Affiliation as printed

    Erasmus MC - Kanker Instituut locatie Danïel den Hoed, Rotterdam, Netherlands

12. Cornelis J.�H. van de Velde Aachen

    Leiden University Medical Center

    Affiliation as printed

    Leiden University Medical Center, Leiden, Netherlands

13. Daniel William Rea

    Cancer Research UK

    Affiliation as printed

    Cancer Research UK Institute for Cancer Studies, Birmingham, United Kingdom

14. Lisa Vandermeer

    Ottawa Hospital Research Institute

    Affiliation as printed

    Ottawa Hospital Research Institute, Ottawa, ON, Canada

15. John Frederick Hilton

    Ottawa Hospital

    Affiliation as printed

    The Ottawa Hospital Cancer Center, Ottawa, ON, Canada

16. John M.S. Bartlett

    Ontario Institute for Cancer Research

    Affiliation as printed

    Ontario Institute for Cancer Research, Toronto, ON, Canada

17. Mark J. Clemons

    Ottawa Hospital

    Affiliation as printed

    The Ottawa Hospital Cancer Centre, Ottawa, ON, Canada