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    a. Has all of the relevant evidence been taken into account?

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    b. Are the summaries of safety and efficacy reasonable interpretations of the evidence?

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Guidance assessment consultation document for HTG10870 Melphalan chemosaturation with percutaneous hepatic artery perfusion and hepatic vein isolation for primary or metastatic cancer in the liver

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1 Recommendations

For ocular melanoma liver metastases

1.1

Melphalan chemosaturation with percutaneous hepatic artery perfusion and hepatic vein isolation can be used in the NHS during the evidence generation period as an option to treat ocular melanoma liver metastases. There must be enhanced informed consent and auditing of outcomes.

For primary liver cancer or liver metastases other than ocular melanoma metastases

1.2

More research is needed on melphalan chemosaturation with percutaneous hepatic artery perfusion and hepatic vein isolation to treat primary liver cancer or liver metastases other than ocular melanoma metastases before it can be used in the NHS.

1.3

This procedure should only be done as part of formal research and a research ethics committee needs to have approved its use.

What this means in practice

For ocular melanoma liver metastases

There are uncertainties around the safety and efficacy of this procedure. It can be used if needed while more evidence is generated.

After this, NICE will review this guidance and the recommendations may change.

Healthcare professionals do not have to offer this procedure and should always discuss the available options with the person with ocular melanoma liver metastases before a joint decision is made.

Hospital trusts will have their own policies on funding procedures and monitoring results. NHS England may also have policies on funding of procedures.

Enhanced informed consent

Because there are uncertainties about the procedure's safety and efficacy, there must be an emphasis on informed consent. Healthcare professionals must make sure that people (and their families and carers as appropriate) understand the uncertainty and lack of evidence around a procedure's safety and efficacy using NICE's advice on shared decision making and NICE's information for the public. Healthcare professionals must also inform the clinical governance leads in their organisation if they want to do the procedure.

Auditing of outcomes

Healthcare professionals doing this procedure should collect data on safety and outcomes of the procedure. Details about everyone having this procedure should be entered into an appropriate registry. If there is no data collection method already available, NICE's interventional procedure outcomes audit tool should be used. Healthcare professionals should regularly review the data on outcomes and safety.

Who should be involved with the procedure

Patient selection should be done by a multidisciplinary team. This procedure should only be done in specialist centres by healthcare professionals with specific training in this procedure. This should include licensed clinical perfusionists.

For primary liver cancer or liver metastases other than ocular melanoma metastases

There is not enough evidence to know if this procedure is safe and efficacious. Melphalan chemosaturation with percutaneous hepatic artery perfusion and hepatic vein isolation should only be done as part of formal research.

Auditing of outcomes

Healthcare professionals doing this procedure should collect data on safety and outcomes of the procedure. Details about everyone having this procedure should be entered into an appropriate registry. If there is no data collection method already available, NICE's interventional procedure outcomes audit tool should be used. Healthcare professionals should regularly review the data on outcomes and safety.

Who should be involved with the procedure

Patient selection should be done by a multidisciplinary team. This procedure should only be done in specialist centres by healthcare professionals with specific training in this procedure. This should include licensed clinical perfusionists.

What evidence generation is needed

Healthcare professionals must collect data specifically around the safety and efficacy of this procedure for ocular melanoma liver metastases. This can be in the form of registry studies or formal research studies that include comparative data.

This includes data on:

  • patient selection, including:

    • eligibility for standard first-line treatment (tebentafusp immunotherapy) in people who test positive for the HLA-A*02 allele

    • how much of the liver is involved (tumour burden)

    • presence of metastases outside the liver

  • response rate stratified by the number of treatment cycles of melphalan chemosaturation with percutaneous hepatic artery perfusion and hepatic vein isolation

  • short- and long-term quality of life

  • other treatments used before or after melphalan chemosaturation with percutaneous hepatic artery perfusion and hepatic vein isolation

  • safety outcomes

    • during the procedure

    • related to chemotherapy

  • how long people have before their cancer gets worse and how long people live after the procedure.

What research is needed

More research, preferably in the form of randomised controlled trials, is needed on this procedure for primary liver cancer or liver metastases other than ocular melanoma metastases. This includes data on:

  • patient selection, including

    • type of tumour, including primary cancer site

    • how much of the liver is involved (tumour burden)

    • presence of metastases outside the liver

  • number of treatments

  • short- and long-term quality of life

  • other treatments used before or after melphalan chemosaturation with percutaneous hepatic artery perfusion and hepatic vein isolation

  • safety outcomes

    • during the procedure

    • related to chemotherapy

  • how long people have before their cancer gets worse and how long people live after the procedure.

Why the committee made these recommendations

There are limited treatment options for people with ocular melanoma liver metastases, particularly for people without the HLA‑A*02:01 genotype, who have no other treatment option.

A randomised controlled trial on uveal melanoma liver metastases suggests that this procedure increases how long people have before their liver cancer gets worse compared with best alternative care. But the results are uncertain because:

  • the trial did not include enough people to make meaningful statistical comparisons on key outcomes

  • the proportion of people with cancer outside the liver at the start of the trial was not the same in the different groups

  • data on treatments offered after the procedure was not collected, so the potential effect of these on how long people live is unknown.

The trial did not show a statistically significant improvement in how long people live after the procedure. It is also unclear whether delaying cancer progression in the liver directly helps people to maintain their quality of life. So, it is uncertain whether the procedure offers any sustained benefit.

There is some evidence from observational studies that shows quality of life after the procedure was not negatively affected, even though the procedure may have serious complications. But the studies are not consistent in who was eligible for the procedure and the number of treatment sessions given.

Despite this uncertainty, the evidence is sufficient for this procedure to be used for people with ocular melanoma liver metastases while more evidence is generated. This includes registry data or studies that include comparative data.

For primary liver cancer or liver metastases other than ocular melanoma metastases, there was a lack of evidence on safety and efficacy. There are other treatment options for people with primary liver cancer or non-ocular-melanoma liver metastases. So, this procedure should only be done as part of formal research in this group of people.