A trial looking at bortezomib and CHOP chemotherapy for relapsed mantle cell lymphoma

The trial team found that adding bortezomib to chemotherapy improved the treatment for people with mantle cell lymphoma. 

The original aim of the trial was for 66 people to take part. The trial team found that people who had bortezomib and chemotherapy were doing better than those who had chemotherapy alone. So the trial closed early.  

This phase 3 trial recruited 46 people. This means the people taking part were put into 1 of 2 treatment groups by a computer. Neither they nor their doctor chose which group they were in.

• 23 people had CHOP chemotherapy   
• 23 people had CHOP and bortezomib

CHOP chemotherapy includes the following drugs:

• cyclophosphamide
• doxorubicin (Adriamycin)
• vincristine
• prednisolone – a type of steroid

The trial team were able to measure the cancer in 41 of the patients. They looked at how many people had no signs of lymphoma. This is called a complete response .

• 4 out of the 19 people (about 22%) who had CHOP alone
• 8 out of 22 people (about 35%) who had CHOP and bortezomib

The researchers also looked at whose lymphoma got a bit better. This is called a partial response .

• 4 out of the 19 people (about 26%) who had CHOP alone
• 11 out of 22 people (about 48%) who had CHOP and bortezomib

The researchers looked at the time it took for the cancer to start growing again. On average it was

• just over 8 months for people who had CHOP alone
• 16 ½ months for people who had CHOP and bortezomib

The researchers concluded that these results were not significant because they could have happened by chance. One reason for this was because more people who had CHOP on its own withdrew early from the trial.

The trial team looked at how long people lived for. They found that on average: 

• people having CHOP lived for just under 1 year
• people having CHOP and bortezomib lived for just under 3 years

The researchers decided these results were significant and that no more people should be recruited to the CHOP alone treatment group. So the trial closed early.

The most common side effects reported in both groups were: 

• a drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
• tiredness (fatigue)

More people who had CHOP and bortezomib developed

• infections 
• Numbness and tingling in their hands and feet (peripheral neuropathy) 

Infections in both groups were not serious and treated successfully. Numbness and tingling were also mild and often only lasted for a short period of time.

The researchers concluded that generally people who had chemotherapy and bortezomib coped well with the increase in side effects.

The researchers recognise that adding another drug to chemotherapy, called rituximab, has also shown promise in trials. Rituximab is a type of biological therapy called a monoclonal antibody . Another trial is looking at the use of bortezomib and rituximab with chemotherapy and the results may shape treatment in the future. 

We have based this summary on information from the research team. 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 who did the research. We have not analysed the data ourselves.