A trial of buparlisib with paclitaxel for head and neck cancer that has come back or spread to another part of the body (BERIL-1)

Cancer type:

Head and neck cancers

Laryngeal cancer

Mouth (oral) cancer

Nasal and paranasal sinus cancer

Nasopharyngeal cancer

Pharyngeal cancer

Status:

Results

Phase:

Phase 2

This trial looked at buparlisib for squamous cell cancer of the head and neck. This included people with cancer that had started in the mouth, the throat or the voice box (larynx).

It was open for people to join between 2013 and 2015, and the research team published results in 2017.

More about this trial

Doctors usually treat squamous cell head and neck cancer with surgery, radiotherapy or chemotherapy. Or a combination of these.

When this trial was done, doctors often used a platinum chemotherapy drug such as carboplatin or cisplatin to begin with. And a taxane chemotherapy drug such as paclitaxel if the cancer came back.

In this phase 2 trial, researchers looked at the combination of buparlisib (BKM120) and paclitaxel. They wanted to see if it can help people whose cancer has started to grow again, or has spread to another part of the body.

Buparlisib (pronounced boo-parl-is-ib) is a type of targeted cancer treatment called a cancer growth blocker. It blocks the action of P13K proteins, so is called a PI3K inhibitor.

The main aim of this trial was to see if paclitaxel and buparlisib works better than paclitaxel alone for head and neck cancer.

Summary of results

The research team found that the combination of paclitaxel and buparlisib did work better than paclitaxel alone, for head and neck cancer.

About this trial
The people who took part in this trial had head and neck cancer, such as cancer of the:

mouth (oral cavity)
voice box (larynx)
throat (nasopharynx, oropharynx and hypopharynx)

Everyone taking part had already had chemotherapy. But their cancer had come back or spread to another part of the body.

The 158 people who joined the trial were put into 1 of 2 treatment groups at random:

79 people had paclitaxel chemotherapy and buparlisib tablets
79 people had paclitaxel chemotherapy and dummy (placebo) tablets

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Results
The research team looked at how long it was before people’s cancer started to grow. They call this progression free survival. They found it was:

4.6 months for those who had buparlisib
3.5 months for those who had placebo

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The team looked at how well the treatment worked. They found that the cancer had got smaller or gone away in:

31 people who’d had buparlisib
11 people who’d had placebo

In 2016 they looked at how many people had died, and found it was:

53 people who’d had buparlisib
60 people who’d had placebo

Side effects
Most people who took part had at least 1 side effect. But some were mild or short lived. Just over 8 out 10 people (82%) who had buparlisib and just over 7 out of 10 people (72%) who had the placebo, had more severe side effects.

Some side effects were more common in the buparlisib group, including:

increased blood sugar level (hyperglycaemia)
a drop in red blood cells and white blood cells
extreme tiredness (fatigue)

More people in the buparlisib group had a reduced dose of chemotherapy, or waited longer between chemotherapy treatments, because of side effects. And a few people in each group decided to stop treatment because of the side effects they were having.

Quality of Life
The people taking part filled out regular questionnaires which asked them how they were feeling and about any side effects they were having. These are called quality of life questionnaires. The results showed that there wasn’t much difference between the 2 groups.

Conclusion
The trial team concluded that the combination of paclitaxel and buparlisib was a useful treatment for head and neck cancer that had come back or spread to another part of the body. And that people were able to cope with the side effects.

They suggest that this combination is looked at further in a larger phase 3 trial.

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