A trial looking at PUVA with or without bexarotene for people with Mycosis Fungoides (EORTC 21011)

Cancer type:

Blood cancers
Low grade lymphoma
Lymphoma
Non-Hodgkin lymphoma

Status:

Results

Phase:

Phase 3

This trial compared PUVA alone with PUVA and bexarotene (Targretin) for mycosis fungoides T cell lymphoma of the skin.

Mycosis fungoides is a rare type of non Hodgkin lymphoma that affects the skin. It belongs to a group of conditions called cutaneous T cell lymphoma. Cutaneous T cell lymphomas are cancers of a type of white blood cell, called T lymphocytes.

If you have early stage mycosis fungoides, you may have a treatment using a light activated drug to target the cancer, called PUVA. Although this treatment works well at first, the cancer usually comes back (recurs) and then you need more treatments with PUVA. If you have repeated courses of PUVA, your risk of developing non melanoma skin cancer increases. Doctors would like to be able to reduce the dose of PUVA and so reduce this risk.

This trial looked at a drug called bexarotene. This is a new type of ‘rexinoid’ drug. Rexinoids contain chemicals that are similar to vitamin A. The researchers compared PUVA with a combination of bexarotene and PUVA. They tried to find out

  • Whether PUVA with bexarotene works better than PUVA alone
  • Which treatment had the fewest side effects
  • Whether the combination of bexarotene and PUVA meant that the dose of PUVA could be reduced

Summary of results

The trial team found that PUVA with bexarotene worked just as well as PUVA alone and the side effects were acceptable.

This was an international phase 3 trial. 93 people were recruited to take part. It was a randomised trial. The people who took part were put into 1 of 2 treatment groups.

Of the 45 people randomised to have PUVA, the researchers were able to look at the results of 38. They found that

  • 10 had no sign of their cancer – this called a complete response
  • 22 had cancer that had shrunk – this is called a partial response
  • 3 had cancer that had stayed the same size – this is called stable disease
  • 3 had cancer that had continued to grow

Of the 48 people randomised to have PUVA with bexarotene, the researchers were able to look at the results of 40. They found that

  • 15 had a complete response
  • 22 had a partial response
  • 2 had stable disease
  • 1 their cancer had continued to grow

The researchers noted a trend towards people needing fewer PUVA sessions. But they said that they could not rule out this happening by chance because not enough people took part in the trial. So it was not a statistically significant result.  

The researchers concluded that PUVA with bexarotene worked just as well as PUVA to treat mycosis fungoides.

We have based this summary on information from the team who ran the trial. The information they sent us has been reviewed by independent specialists (peer reviewed) and published in a medical journal. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Sean Whittaker

Supported by

European Organisation for Research and Treatment of Cancer (EORTC)
National Institute for Health Research Cancer Research Network (NCRN)

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 501

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Wendy took part in a new trial studying the possible side effect of hearing loss

A picture of Wendy

"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

Last reviewed:

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