A trial of chemotherapy for people over 60 with aggressive non Hodgkin lymphoma (The Sixty Plus Trial)

Cancer type:

Blood cancers
High grade lymphoma
Lymphoma
Non-Hodgkin lymphoma

Status:

Results

Phase:

Phase 3

This trial was comparing CHOP to PMitCEBo with or without G-CSF for people over 60 with aggressive non Hodgkin lymphoma.

Doctors often use chemotherapy to treat non Hodgkin lymphoma (NHL). Older people don’t always cope as well with chemotherapy as younger people.

This trial was comparing 2 different combinations of chemotherapy drugs called CHOP and PMitCEBO. The researchers wanted to find out which combination was best for treating aggressive NHL in people over 60, and which caused fewer side effects. They were also looking into the benefit of having a growth factor called G-CSF. Growth factors are drugs which help the bone marrow to recover more quickly after chemotherapy.

The aims of the trial were to

  • See which combination of chemotherapy drugs worked best
  • Find out if adding G-CSF helped

Summary of results

The trial team found that in the long term, there was no difference in how well the 2 types of chemotherapy worked. They also found that people in this trial did not benefit from having G-CSF.

The trial recruited 784 people who were over 60 years old and had recently been diagnosed with NHL.

  • Half the people had CHOP chemotherapy and half had PMitCEBO
  • Half of the people having each type of chemotherapy also had G-CSF

The number of people whose NHL responded to treatment was about the same with both types of chemotherapy. Having G-CSF did not affect the response rate.

The side effects of the treatments were different. More people having PMitCEBO had a drop in the number of blood cells. People who had CHOP chemotherapy had more sickness and hair loss.

In those having G-CSF, fewer people had a drop in the number of blood cells, but this did not seem to affect the number of people who had a serious infection. Having G-CSF did not affect the number of people who had to have their chemotherapy dose reduced because of side effects.

The researchers monitored people in this trial for an average of nearly 4 years. The number of people whose NHL hadn’t come back was the same with both types of chemotherapy.

These results show that PMitCEBO worked as well as CHOP for this group of patients. The 2 treatments last different lengths of time, involve different numbers of hospital visits and cause slightly different side effects. So, the researchers suggest either treatment may be appropriate, depending on somebody’s preference or situation.

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.

Recruitment start:

Recruitment end:

How to join a clinical trial

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

Chief Investigator

Professor David Cunningham

Supported by

Haematology Trials Group
NIHR Clinical Research Network: Cancer

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Last review date

CRUK internal database number:

Oracle 84

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

Charlie took part in a trial to try new treatments

A picture of Charlie

“I think it’s really important that people keep signing up to these type of trials to push research forward.”

Last reviewed:

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