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Poster display session

1524 - The first report of multicenter validation study of 95-Gene Classifier, a multi-gene prognostic assay of estrogen receptor positive and node negative breast cancer patients

Date

11 Sep 2017

Session

Poster display session

Presenters

Takayuki Kinoshita

Citation

Annals of Oncology (2017) 28 (suppl_5): v43-v67. 10.1093/annonc/mdx362

Authors

T. Kinoshita1, K. Aogi2, M. Takahashi3, K. Ito4, T. Oba4, N. Shiroma5, K. Arihiro5, F. Tsukamoto6, S. Shiino1, M. Yoshida7, S. Ohsumi2

Author affiliations

  • 1 Division Of Breast Surgery, National Cancer Center Hospital, 104-0045 - Tokyo/JP
  • 2 Division Of Breast Surgery, Shikoku Cancer Center, 791-0280 - Matsuyama/JP
  • 3 Department Of Breast Surgery, Shikoku Cancer Center, 791-0280 - Matsuyama/JP
  • 4 Division Of Breast, Endocrine & Respiratory Surgery, Shinshu University School of Medicine, 3908621 - Matsumoto/JP
  • 5 Department Of Anatomical Pathology, Hiroshima University Hospital, 734-8551 - Hiroshima/JP
  • 6 Department Of Breast And Endocrine Surgery, Japan Community Health care Organization (JCHO) Osaka Hospital, 553-0003 - Osaka/JP
  • 7 Department Of Pathology And Clinical Laboratories, National Cancer Center Hospital, 104-0045 - Tokyo/JP
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Resources

Abstract 1524

Background

95-Gene Classifier (95GC; Curebest™ 95GC Breast) is one of the multi-gene prognostic assays of estrogen receptor (ER) positive and node negative breast cancer patients, developed 95 gene-set without overlap with that used in another RT-PCR based product (Oncotype DX®). According to the original paper, the prognostic capability of 95GC has been shown even in the “intermediate” patients by microarray-based simulation model, “Recurrence Online”, of above RT-PCR product. But still 95GC has been validated only using the data from single institute and public database. Here we report the result of the first multi-center validation study for this multi-gene assay.

Methods

ER-positive and T1-2/N0/M0 breast cancer patients who received only hormonal therapy, without chemotherapy, in adjuvant were enrolled retrospectively. For each patient, fresh frozen tissue was applied to the assay and the classification result of 95GC, “L” or “H”, was used for the validation on 5 year recurrence free survival (5Y-RFS).

Results

We analyzed 75 eligible cases out of 150 enrolled, and found 47 patients classified as “L” showed 96.5% of 5Y-RFS (95%CI:89.5-98.9) while 28 patients of “H” showed 79.1% of 5Y-RFS (95%CI:63.8-88.5). There was a statistically significant difference between RFS of “L” and “H” groups by Log-Rank test (p = 0.0017). Other factors having significant association with 95GC were histological grade (p = 0.0012), “Recurrence Online” (p 

Conclusions

95GC was well validated by this first multi-centered retrospective study on 5Y-RFS of ER-positive, node-negative patients who received only hormonal therapy in adjuvant. The result indicates the usefulness of this novel multi-gene assay, as it can classify target patients into 2 groups, “L” and “H”, according to the prognosis of 5Y-RFS.

Clinical trial identification

Legal entity responsible for the study

Takayuki Kinoshita

Funding

None

Disclosure

All authors have declared no conflicts of interest.

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