Summary

Summary

  • The technology described in this briefing is Immunoscore. It could be used as a risk assessment tool to predict the risk of relapse in people with localised colon cancer.

  • The innovative aspects are that it uses digital pathology and artificial intelligence (AI)‑based algorithms to assess the density of CD3+ and CD8+ T‑cells in the tumour and its invasive margins. It represents a novel way of classifying risk of relapse by measuring the person's immune response to the tumour.

  • The intended place in therapy would be in addition to the tumour, node, metastasis (TNM) classification system in people with stage 2 or 3 colon cancer.

  • The main points from the evidence summarised in this briefing are from 6 studies, comprising 5 retrospective cohort studies and 1 clinician survey. The evidence base includes over 4,000 people with stage 1 to 3 colon cancer. It shows that Immunoscore, when used with the TNM classification system, is a predictor for time to recurrence, disease-free survival and overall survival. It can also help predict chemotherapy response in people with stage 3 colon cancer having oxaliplatin with 5‑fluorouracil and folinic acid (FOLFOX) therapy.

  • Key uncertainties around the evidence or technology are that none of the published studies included people having treatment in the NHS and the technology's ability to predict chemotherapy response has been shown in people mainly having treatment with FOLFOX.

  • The cost of Immunoscore is £2,250 per test (VAT exempt).