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 Open a glossary item 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 Open a glossary item 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 Open a glossary item ) and published in a medical journal. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.