Comparative Evaluation of Digistain and Oncotype DX in Predicting Metastasis-Free Survival in Early Stage Hormone-Receptor Positive Breast Cancer: A Randomized Study at Charing Cross Hospital

 

  • Authors: Arnav Gautam, Manveer Sroya, Zamzam Al-khalili, William Matthieson, Hemmel Amrania, Darius Francescatti, Chris Phillips, Anthony Magliocco, Chang Yoo Young, Louise Jones, Swapnil Rane, Abeer Shabhaan, Nick Wright, Charles Coombes

  • Presented at: San Antonio Breast Cancer Symposium 2024, San Antonio, TX

  • Journal: Clinical Cancer Research (2025) 31 (12_Supplement): P1-11-27

  • Publisher: American Association for Cancer Research

  • Publication Date: 2025/6/13

Background:

Oncotype DX is an established genomic test for risk stratification in early-stage hormone-receptor positive, HER2-negative breast cancer. Digistain employs mid-infrared spectroscopy to assess tumor aneuploidy, offering a rapid, cost-effective alternative with potential for higher sensitivity. This study aims to compare the predictive accuracy of Digistain against Oncotype DX for metastasis-free survival. Methods: In this double-blinded study, 233 randomly selected lymph node-negative patients from Charing Cross Hospital, previously scored by Oncotype DX, were reassessed using Digistain. The primary endpoint was metastasis-free survival, with a median follow-up of 6 years. Results: The comparative analysis revealed a high degree of consistency in risk classification between Oncotype DX and Digistain. After adjusting for missing data, 50% of patients were classified as low-risk by Oncotype DX (defined as <10% risk of recurrence), while Digistain classified 44% of patients within the same risk category. Importantly all patients deemed low-risk by Oncotype DX were consistently categorized as low-risk by Digistain, confirming a robust concordance in risk stratification by both tests. A noteworthy observation involved a single patient classified as low-risk by Oncotype DX but assessed as high-risk by Digistain, who subsequently developed metastatic breast cancer within five years. This case underscores a potentially heightened sensitivity of Digistain in identifying risks of metastasis, suggesting that Digistain may offer critical advantages in precise risk assessment in certain clinical scenarios. Conclusions: These findings underscore Digistain's potential as a valid alternative to Oncotype DX, with a possible edge in sensitivity for identifying metastasis risk. The congruence in high-risk patient identification and the critical observation of an at-risk patient missed by Oncotype DX highlight Digistain's promise for enhancing clinical decision-making in breast cancer management.

 
Anthony Magliocco