Abstract 5014
Background
CanAssist-Breast (CAB) is a prognostic test for predicting risk of distant recurrence within five years in hormone receptor positive early stage breast cancer patients. It is unique in that the test uses immunohistochemistry coupled with a support vector machine learning based algorithm to predict risk score and category (High or Low). It has been developed and validated on a mix of Asian and Caucasian patients. The test has been clinically validated in over 1000 retrospective patient samples. In this study, we present for the first time data on the performance of CAB in a single center study from Spain (Vall D’Hebron Institute of Oncology, Barcelona).
Methods
Post-surgical FFPE tumor blocks along with patient demographics and clinical follow up data up to a mínimum of five years were obtained from the hospital. CAB was performed on the tumor samples at the CAP and ISO 15189 accredited OncoStem reference laboratory in India. Distant Metastasis Free Survival (DMFS) and Hazard Ratio were used were computed using survival analysis. MedCalc software (Version 18.10.2) was used for all statistical analysis. The negative predictive value (NPV) was computed for establish the accuracy of prediction in the low risk group.
Results
Sixty-two percent of this cohort had stage II disease. Sixty-nine percent and 61% had node negative and Grade 2 disease respectively. The median at onset was 61 years. The DMFS in the low risk category was 98% and 85% for the high risk (P = 0.0032). The Hazard Ratio was 7.04 (95% CI: 1.93-25.73). The NPV was calculated to be 98%. To exclude any confounding effect of chemotherapy, survival analysis was done in the chemotherapy naïve sub-group. In the chemotherapy naïve sub-group, the DMFS for the low risk group was 100% and 85% for the high risk (P = 0.02). These are results of the interim analysis of the study at half way mark and complete study data will be presented at the time ESMO meeting.
Conclusions
CAB performs well in stratifying risk of recurrence in this Spanish cohort with the data matching performance shown earlier with the mix of Asian and Caucasian patients. In the absence of any inter-mediate risk category in CAB, it offers a cost effective alternative to existing prognostic tests providing definitive results to plan treatment of early stage breast cancer patients.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Manjiri M. Bakre.
Funding
Has not received any funding.
Disclosure
M. Bakre: Leadership role, Full / Part-time employment, Officer / Board of Directors, CEO and Founder: OncoStem Diagnostics Pvt Limted.
Resources from the same session
5737 - PAM50 and CGH-array genomic characterization of HER2-Equivocal Breast Cancers defined by the 2018 ASCO/CAP recommendations.
Presenter: Carine Ngo
Session: Poster Display session 2
Resources:
Abstract
1096 - OncotypeDX® predictive nomogram for recurrence score output: a machine learning system based on quantitative immunochemistry analysis - ADAPTED01
Presenter: Fabio Marazzi
Session: Poster Display session 2
Resources:
Abstract
5426 - Geriatric parameters predict both disease-related and patient-reported outcomes in older patients with breast cancer
Presenter: Willeke van der Plas-Krijgsman
Session: Poster Display session 2
Resources:
Abstract
5865 - Patients with a 21-gene assay in South East London differ from the TAILORx trial population
Presenter: Charalampos Gousis
Session: Poster Display session 2
Resources:
Abstract
1312 - Predictive tools in adjuvant breast cancer – what is the standard of evidence supporting their utility? A literature review examining validation of Adjuvant!, Cancermath and NHS Predict
Presenter: Alice Loft
Session: Poster Display session 2
Resources:
Abstract
2445 - Oncologic outcome of invasive lobular carcinoma: Is it different from that of invasive ductal carcinoma?
Presenter: Hee Jun Choi
Session: Poster Display session 2
Resources:
Abstract
2476 - Pathologic response and survival efficacy in patients with initial nodal involvement after neoadjuvant chemotherapy in early breast cancer
Presenter: SERAFIN MORALES Murillo
Session: Poster Display session 2
Resources:
Abstract
3761 - Chemotherapy-induced amenorrhea: prognostic impact on premenopausal Egyptian patients with breast cancer
Presenter: Khaled Abdel Karim
Session: Poster Display session 2
Resources:
Abstract
4687 - Predicting the presence of breast cancer using circulating small RNA in the serum
Presenter: Yumiko Koi
Session: Poster Display session 2
Resources:
Abstract
5612 - Evaluation of germ line mutational status among women with triple-negative breast cancer in Russia
Presenter: Elena Shagimardanova
Session: Poster Display session 2
Resources:
Abstract