Expert comments

Comments on this technology were invited from clinical experts working in the field and relevant patient organisations. The comments received are individual opinions and do not represent NICE's view.

All 3 experts were familiar with the technology but only 1 had used the technology in clinical practice.

Level of innovation

All experts agreed that the technology is novel. Two experts noted that T‑cell infiltration is a known phenomenon and can be assessed by pathologists. The innovative aspect of Immunoscore is that it uses digital technology to quantify T‑cell infiltration, which experts believe could provide more reproducible assessments. All experts agreed that the technology would be used in addition to standard care staging (tumour, node, metastasis; TNM) to assess risk of relapse.

Potential patient impact

The main patient benefit identified by the experts is improved patient selection for adjuvant chemotherapy. Two experts noted that this may help people with a low risk of recurrence to avoid having chemotherapy. Another expert said that use of the technology could strengthen the rationale for some people with stage 3 colon cancer only having 3 months of adjuvant chemotherapy. People with stage 2 or 3 resected colon cancer were identified by 1 of the experts as people most likely to benefit from the technology. Another expert did not believe the technology has a role in people with stage 1 or 3 cancer but could be used to better define prognosis and inform chemotherapy decisions in people with stage 2 cancer. The expert noted, however, that chemotherapy is only offered to a small number of people with stage 2 colon cancer who have high-risk features, are fit for chemotherapy and who are often under 70. The remaining expert said the population of people who would benefit is unclear. They also highlighted that stage 2 colon cancer is normally not treated with chemotherapy unless it has very high‑risk features.

Potential system impact

One expert said that the technology could lead to fewer hospital visits and fewer chemotherapy side effects, because less chemotherapy would be offered. Another expert said that it is unclear how much additional value using the test would give in addition to standard care in people with stage 2 cancer. Another expert did not think that Immunoscore has the potential to change the current pathway or clinical outcomes to benefit the healthcare system at present. When asked about the cost consequences of adopting the technology, 1 expert thought that it would be cost saving because less chemotherapy would be offered in the adjuvant setting, whereas 2 said it would be more costly than standard care. One expert noted that it is highly unlikely that the technology would result in substantial cost savings through the avoidance of chemotherapy. This is because of the low cost of chemotherapy for stage 2 colon cancer, as well as the high cost of the test and the potentially large numbers of people who may need testing. The expert noted, however, that the number needed to test and the proportion of people where the test would alter treatment is unclear.

General comments

Experts noted that the technology is not currently widely used in the NHS but has been used in the private healthcare setting in the UK. Two of the experts thought adopting the technology would be more resource intensive; 1 expert noted that some infrastructure would be needed to prepare and send samples for testing. The experts said training to use Immunoscore was minimal or not required and no additional facilities were needed. Potential issues preventing adoption were identified as costs, uncertainty regarding benefits and the adoption of measuring circulating tumour DNA as an alternative. In terms of safety, no adverse effects were anticipated because the test is non-invasive and done on tumour samples. One expert noted a potential risk of the tumour sample being lost during transportation to the testing laboratory. Two of the experts had no concerns regarding the safety and efficacy of the technology. One expert did not think its clinical and cost effectiveness has been sufficiently shown in people with stage 2 colorectal cancer having treatment in the NHS. The expert noted that additional UK‑based prospective evidence is needed. This should compare the technology with high-quality pathology reporting (as set out in the Royal College of Pathologists' minimum dataset for histopathological reporting of colorectal cancer, which includes TNM staging as well as other prognostic factors) to define effectiveness and the number needed to test to affect decision making.