A trial of pasireotide for people who have symptoms of carcinoid syndrome that are not controlled with other drugs (SIG-NET)

Cancer type:

Carcinoid

Neuroendocrine tumour (NET)

Status:

Results

Phase:

Phase 3

This trial looked at a drug called pasireotide to see if it controlled symptoms of carcinoid syndrome.

Neuroendocrine tumours (NETs) are a rare group of cancers that make and release hormones Open a glossary item . They are normally found in the digestive system . The most common type of NET is called carcinoid.

Carcinoid tumours can spread to other parts of the body such as the liver, lymph nodes Open a glossary item or lungs. If a carcinoid tumour spreads to the liver, it often produces a hormone called serotonin (also known as 5HT) and causes symptoms such as flushing, wheezing, diarrhoea and an irregular heartbeat (palpitations). This is known as carcinoid syndrome.

Doctors may treat carcinoid syndrome with drugs called somatostatin analogues. These drugs can help, but do not control diarrhoea or flushing.

In this trial, researchers looked at a somatostatin analogue called pasireotide. They compared it with another drug called octreotide. Octreotide is already used to treat carcinoid syndrome but in this trial, people had a higher dose than doctors usually give.

The aim of the trial was to see which of these 2 treatments was better for people who had symptoms of carcinoid syndrome that were not controlled with other drugs.

Summary of results

The trial team found that pasireotide was similar to octreotide for controlling the symptoms of carcinoid syndrome.

This was a phase 3 trial. It recruited 110 people. It was a randomised trial. The people taking part were put into treatment groups by a computer. Neither they nor their doctor were able to decide which group they were in.

The 2 groups were

53 people who had pasireotide
57 people who had octreotide

After 6 months of treatment the researchers looked at how many people had their symptoms controlled. They found that it was

21 out of every 100 people (21%) who had pasireotide
27 out of every 100 people (27%) who had octreotide

The most common symptoms in both groups were diarrhoea and tummy (abdominal) pain. Some people who had pasireotide also had high blood sugar levels but most of those who had octreotide didn’t.

After these results the team decided to close the trial early.

The trial team concluded that pasireotide was similar to octreotide in controlling symptoms of carcinoid syndrome. They also said that another phase 3 trial with a larger number of people was needed to make clearer what role pasireotide might have as treatment for carcinoid syndrome.

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 ) but may not have been published in a medical journal. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.