Recommendations for research

The guideline committee has made the following recommendations for research.

Key recommendations for research

1 Monitoring and response biomarkers

Can biomarkers accurately classify recurrence, progression and response to treatment? [2022]

For a short explanation of why the committee made the recommendation for research, see the rationale section on BRAF analysis of melanoma tissue samples.

Full details of the evidence and the committee's discussion are in evidence review A: genetic testing for melanoma.

2 Safety, prognostic and predictive biomarkers

Can biomarkers be used for risk stratification and treatment planning for people with melanoma? [2022]

For a short explanation of why the committee made the recommendation for research, see the rationale section on BRAF analysis of melanoma tissue samples.

Full details of the evidence and the committee's discussion are in evidence review A: genetic testing for melanoma.

3 Effectiveness of localised treatments

What is the effectiveness of localised treatment for people with stages III and IV melanoma? [2022]

For a short explanation of why the committee made this recommendation for research, see the rationale section on treating in-transit metastases in stages III and IV melanoma.

Full details of the evidence and the committee's discussion are in evidence review F: systematic and localised anticancer treatment for people with stage IV and unresectable stage III melanoma.

4 Histological margins

What is the optimal histological excision margin in stage 0 melanoma? [2022]

For a short explanation of why the committee made this recommendation for research, see the rationale section on excision for stages 0 to II melanoma.

Full details of the evidence and the committee's discussion are in evidence review C: surgical and histopathological excision margins for people with stage 0 to II melanoma.

5 Surveillance strategies

How frequently should surveillance imaging be conducted, and which imaging modality should be used for people with stage IIB to IIIC melanoma? [2022]

For a short explanation of why the committee made this recommendation for research, see the rationale and section on follow-up after treatment for melanoma.

Full details of the evidence and the committee's discussion are in evidence review G: follow-up of people with melanoma.

Other recommendations for research

Survivorship

What are the experiences of people who are living with, through and beyond a melanoma diagnosis in terms of survivorship and their disease journey? [2022]

For a short explanation of why the committee made this recommendation for research, see the rationale and section on follow-up after treatment for melanoma.

Full details of the evidence and the committee's discussion are in evidence review G: follow-up of people with melanoma.

Techniques for confirming a diagnosis in people with suspected atypical Spitzoid melanocytic lesions

In people with reported atypical Spitzoid lesions, how effective are fluorescence in situ hybridization (FISH), comparative genomic hybridization (CGH) and tests to detect driver mutations compared with histopathological examination alone in predicting disease specific survival?

This should be investigated in a prospective diagnostic study. Secondary outcomes should include sensitivity, specificity, accuracy, positive predictive value, disease specific survival and progression free survival. [2015]

Why this is important

Atypical Spitzoid lesions continue to be diagnostically challenging. There are no reliably reproducible histological, immunohistochemistry or molecular features that allow exact typing and prognostic assessment of these lesions. The current 'gold standard' is histological examination with expert review, but it is not always possible to distinguish Spitzoid melanoma from benign Spitzoid melanocytic lesions.

Current molecular technologies such as FISH and CGH provide some help, but the results are difficult to interpret and may not be conclusive. Understanding and mapping changes in molecular pathways could predict outcome and inform individual treatment planning.

Surgical excision for people with lentigo maligna

For people with lentigo maligna (stage 0 in sun damaged skin, usually on the face) how effective is Mohs micrographic surgery, compared with excision with a 0.5 cm clinical margin, in preventing biopsy proven local recurrence at 5 years?

This should be investigated in a randomised controlled trial. Secondary outcomes should include cosmetic and functional outcomes. [2015]

Why this is important

Mohs micrographic surgery is a microscopically controlled surgical technique designed to allow complete excision of the tumour with minimal tissue loss. The technique can be useful for people with lentigo maligna because their lesions can be very large and located in a cosmetically sensitive site where surgery may cause significant scarring. However, the histological detection of small numbers of melanocytes at the edge of a sample is difficult, and can lead to false negative results. In addition, lentigo maligna may occur in an area of field change with a risk of skip lesions at the edge. Therefore, although Mohs micrographic surgery may ensure complete excision of lentigo maligna, it can be accompanied by the recurrence of a similar lesion in adjacent skin.

Vitamin D supplementation

In people with stage I to III melanoma does vitamin D supplementation improve overall survival?

This should be investigated in a placebo controlled randomised trial. Secondary outcomes should include disease specific survival and toxicity, including the development of renal stones and hypercalcaemia. [2015]

Why this is important

It has been reported that suboptimal levels of vitamin D at diagnosis are common in people with melanoma from the north of England and that higher levels are associated with lower melanoma related mortality. However, vitamin D levels are higher in leaner, fitter people and the nature of the relationship between vitamin D levels and melanoma survival is unclear.

There are 2 adjuvant trials of vitamin D supplementation listed as active currently, 1 in Italy and 1 in Australia. However, there are many uncertainties about the design of vitamin D trials, which might become clearer in the next few years. These include the dose of vitamin D, use of concurrent aspirin therapy and the baseline level at which vitamin D supplementation would be started.

The effect of drug therapy for concurrent conditions on melanoma survival

In people diagnosed with melanoma what is the effect of drug therapy to treat concurrent conditions on disease specific survival?

This should be investigated in a national prospective cohort study. Secondary outcomes should include overall survival and quality of life. [2015]

Why this is important

Drugs such as immunosuppressants and those used to treat conditions such as diabetes have effects that may affect survival in people with melanoma. For example, metformin, the most frequently prescribed drug for type 2 diabetes, is thought to reduce overall cancer rates in people with diabetes but to increase mortality from melanoma in approximately 40% of these people who have a somatic BRAF mutation.

There is a need to balance the risk of melanoma deaths with the benefits from the most effective treatment of the concurrent conditions. But there is currently no evidence to inform this decision.

  • National Institute for Health and Care Excellence (NICE)