Oncotype DX RS and the prognostic value of SII in early breast cancer
Research type
Research Study
Full title
Comparison of the prognostic value of the Systemic Immune Inflammation Index with the Oncotype DX Recurrence Score and Nottingham Prognostic Index in patients with hormone receptor positive early breast cancer, with 5 to 10 year survival data
IRAS ID
262537
Contact name
Paul Lewis
Contact email
Sponsor organisation
Swansea University
Duration of Study in the UK
0 years, 6 months, 29 days
Research summary
Research Summary
Decisions regarding the benefit of chemotherapy after surgery for early hormone-receptor
positive breast cancer are currently based on final pathology. For many years the Nottingham
Prognostic Index (NPI) has helped inform practice. Research has shown that the NPI, which
is calculated from the tumour size, grade and lymph node status, may under or over-estimate
chemotherapy benefit when results from analysis of the genetic structure of the cancer is
taken into consideration. Oncotype DX Recurrence Score (RS) is a genetic signature test
performed on the final pathology which has been validated as a prognostic and predictive tool
in patients with early breast cancer. However, Oncotype DX RS testing is expensive and time
consuming. It is not readily available in all hospitals in the UK.
Inflammation and cancer are interrelated and recent evidence in other solid tumours suggests
a degree of correlation between inflammation and prognosis. Limited research in breast
cancer demonstrates similar findings. Inflammatory ratios such as the Systemic Inflammatory
Index (SII) can be calculated from parameters in routine blood tests taken prior to surgery.
These tests are performed as part of the standard management of patients with early breast
cancer.
The proposed research is a retrospective cohort study of 400 anonymised Recurrence Scores
(RS) from the established database in the breast unit. The study aims to evaluate correlation
between values of inflammation calculated from the preoperative routine blood samples, the
NPI and the Oncotype DX RS. If the research demonstrates a correlation between these
parameters this could prove beneficial for patients, and in addition, could benefit the NHS in
terms of cost and time. Low income countries would find this especially beneficial as the SII
would be an inexpensive alternative to commercial tests.
Patient opinion has been sought informally with subjects who are involved in the cancer
support group that I am involved with. This has met with interest and approval. I have offered
to present the results to the group at one of our meetings.
Dissemination of the results will be offered for presentation at local, national and
international conferences. In addition, we hope to publish the results of the study in peerreviewed
journals.Summary of results
Decisions regarding the benefit of chemotherapy after surgery for early hormone-receptor positive breast cancer are currently based on final pathology. For many years the Nottingham Prognostic Index (NPI) has helped inform practice. Research has shown that the NPI, which is calculated from the tumour size, grade and lymph node status, may under or over-estimate chemotherapy benefit when results from analysis of the genetic structure of the cancer is taken into consideration. Oncotype DX Recurrence Score (RS) is a genetic signature test performed on the final pathology which has been validated as a prognostic and predictive tool in patients with early breast cancer. However, Oncotype DX RS testing is expensive and time consuming. It is not readily available in all hospitals in the UK.
Inflammation and cancer are interrelated and recent evidence in other solid tumours suggests a degree of correlation between inflammation and prognosis. Limited research in breast cancer demonstrates similar findings. Inflammatory ratios such as the Systemic Inflammatory Index (SII) can be calculated from parameters in routine blood tests taken prior to surgery. These tests are performed as part of the standard management of patients with early breast cancer.
The study evaluated the potential of systemic peripheral blood ratios obtained from preoperative blood samples as prognostic indicators in the adjuvant setting of node negative early breast cancer, comparing two internationally validated tools, the Nottingham Prognostic Index and Oncotype DX® Recurrence Score, to assess whether the blood ratios may reduce the need for genomic testing in selected cases.
The Nottingham Prognostic Index (NPI) is a validated index that is calculated from tumour grade, tumour size and nodal status to produce a score. The higher the score the greater the risk of recurrence. Oncotype DX RS testing is a genomic test that is validated as a prognostic and predictive tool in breast cancer. The recurrence score (RS) is calculated and predicts the benefit of endocrine and chemotherapy benefit in patients with early breast cancer. Systemic inflammatory indices are calculated from the preoperative full blood count taken in patients within 2 weeks of surgery. The ratios have been shown to be of prognostic value in other solid malignancies.
The recurrence scores of 497 node negative patients with early breast cancer were compared with the Nottingham Prognostic Index and four systemic inflammatory indices calculated from the preoperative peripheral blood count. Statistical tests of correlation found that there was poor to no correlation with the Oncotype DX® Recurrence Score, the Nottingham Prognostic Index and the systemic inflammatory indices investigated, for the two common breast cancers, Invasive Ductal Carcinoma and Invasive Lobular Carcinoma.
The results of this study highlight the need for further work in this field. Lobular cancer has distinct morphomolecular and histomolecular properties that require studies specifically designed to address this.REC name
London - Dulwich Research Ethics Committee
REC reference
20/LO/0850
Date of REC Opinion
5 Oct 2020
REC opinion
Further Information Favourable Opinion