Clinical validation of Histotype Px as a prognostic and predictive biomarker in colorectal cancer

Offentlig prosjektsammendrag

There is a large need and potential for better and more cost-effective care for cancer patients by personalized treatment decisions. In colcorectal cancer (CRC), surgical resection is the standard-of-care (SoC) for patients with stage II or III CRC, and for most patients surgery surgery is followed by adjuvant chemotherapy (ACT) to reduce the risk of recurrence. ACT is currently prescribed based on clinicopathologic factors, which unfortunately offers an inaccurate risk stratification. In stage II CRC, ACT prescription is controversial and often seen as an “overtreatment” as only 3,6% benefit from it. In stage III, only 20% of patients benefit from ACT, exposing 80% of patients to unnecessary toxicity. Thus, the main problem with the current SoC is the inability to accurately identify which patients will and will not benefit from chemotherapy. Recent breakthroughs in digital pathology and AI opens new opportunities to develop digital biomarkers to extract and utilize information from tumour tissue not visible to the human eye. Histotype Px, DoMore Diagnostics’ AI-driven digital pathology technology platform has the potential to provide clinicians with rapid, cost-effective and highly accurate prognostic and predictive biomarkers to guide personalized treatment decisions. The biomarker was developed on 90 million image tiles from 2500 patients with known survival outcome data, validated in a cohort of >1000 patients, and it was shown to be able to predict the risk of cancer specific death and recurrence. However, as this is a major clinical decision for each patient, additional validation studies may be required before the biomarker can be included in clinical guidelines. The proposed project consists of a series of validation studies across a range of populations to generate the evidence necessary for wide adoption of Histotype Px, to the benefit of cancer patients and their families, the broader oncology and medical community, and society as a whole.