Proposed research study investigating the relationship between Ruxolitinib and non-melanoma skin cancers, led by UK MPN doctors
We need your help with some feedback. A group of UK MPN doctors are planning research to investigate the relationship between Ruxolitinib and skin cancers and they would be grateful for your views on their plans.
Please can you take some time to answer some questions, all answers will be anonymous, the survey should take less than 10 minutes to complete. We are asking everyone in our MPN community, wherever you live, to complete the survey, please click on the link below to access the survey. (you do not have to be taking ruxolitinib to complete this survey)
Closing date for the survey is Friday 22 September 2023.
Background to the proposed research study
Ruxolitinib, a JAK inhibitor drug, is often very effective in treating many of the symptoms associated with myeloproliferative neoplasms (MPNs) and can prolong life expectancy. Like any medication, however, it can sometimes cause side effects.
A rare but potentially serious side effect of ruxolitinib is an increased risk of certain skin cancers, known as non-melanoma skin cancers (NMSCs). Usually these respond well to treatment but can occasionally recur or even become life-threatening. It isn’t clear how ruxolitinib leads to this increased risk and whether any patients taking the drug are at higher risk of NMSCs than others.
We think investigating the relationship between ruxolitinib and NMSCs can improve patient care in three main ways:
- If we work out if any patients are at particular risk of ruxolitinib-related skin cancers, then in future MPN doctors can advise them more accurately before starting ruxolitinib and monitor them especially closely for the first signs of skin cancer.
- If we understand how ruxolitinib increases the risk of NMSC we can assess whether other JAK inhibitors also increase this risk or not. Any that don’t might be a better choice for patients at high risk of skin cancer.
- Currently, we don’t know if people who develop skin cancers whilst taking ruxolitinib should stop it to reduce the risk of skin cancer recurrence. If we understand the link between ruxolitinib and NMSCs, we may be able to decide whether stopping the drug is helpful.
We plan to conduct this research by adding on an extra module (sub-study) to the existing MITHRIDATE clinical study which is already up and running in over 30 hospitals across the UK, comparing ruxolitinib with best available treatment in people with polycythaemia vera.
Patients enrolling onto MITHRIDATE will be invited to opt into the skin cancer sub-study. If they do, they will undergo four skin biopsies – two at the start of the trial (one from the forearm and one from the buttock) and two at the end of the trial, three years later. A skin biopsy is a minor procedure, done under local anaesthetic, takes about 10 minutes, and is less invasive than, say, a bone marrow biopsy.
Skin samples will be analysed for genetic mutations, as will skin cancer samples from any patients who develop NMSCs during trial treatment. We will also ask patients to complete a questionnaire asking about skin cancer risk factors at trial entry.
In summary, NMSCs are a rare but important potential side effect of ruxolitinib. We hope this research will provide benefits to people living with MPNs and the teams looking after them.
Thank you for your help and continued support.
If you have any concerns regarding NMSCs please contact your haematology team.