The trial team found it was safe to have irinotecan beads before surgery to remove the tumours in the liver. And the side effects were mild.
The researchers published the results in 2016. 40 people took part in this phase 2 trial
Everyone had a single treatment with irinotecan beads 4 weeks before their planned surgery. They then had surgery to remove the tumours although this wasn’t possible in 2 people.
Unfortunately, 2 people died a short time after surgery but this wasn’t related to having the beads. And 1 person had cancer that started in the liver. So, the trial team had the results for 35 people.
The surgeon removed the cancer with a border (margin) of tissue from around it. They tested the cells in the surrounding tissue (margin) for cancer cells. It is called a clear margin if there are no cancer cells. In this trial:
- just over 7 out of 10 (74%) samples had clear margins
- just under 3 out of 10 (26%) samples had a few cancer cells in the margins
A specialist doctor (a pathologist
) analysed all the tissue samples from the tumours that the surgeons removed. They examined 63 tumours or lesions in total. A lesion is an area of abnormal tissue that may be benign or malignant. The researchers found in:
- 11 samples there were no signs of cancer in the tumour (a complete pathological response)
- 37 samples most of the cancer had disappeared (a major pathological response)
- 4 samples a little bit of the cancer had disappeared (a minor pathological response)
- 1 sample treatment hadn’t worked at all
Everyone had a scan 1 month after having the beads and before their surgery. The trial team looked at scans to see if the tumours had shrunk. They had the results for 34 people’s scans. They found in:
- 1 person the cancer had gone away a little bit
- 22 people the cancer stayed the same
- 11 people the cancer got worse
The trial team think that the scan results are quite different to the tissue sample results. They think the tissue sample results are much better. The trial team say this might be because:
- they scanned the tumours very early and they hadn’t had time to shrink
- the beads caused a short term increase in the size of the tumour due to swelling
But the researchers are a little unclear about the tumour responses and why these differences happened.
The trial team looked at how long people lived for after treatment. This is called overall survival. They found that on average, this was 50.9 months. These results were similar to people having chemotherapy to the whole body (systemic treatment
The researchers looked at the number of people living at 5 years. This was just under 5 out of 10 people (49%).
They also looked at how long before the cancer started to grow again. They found this was just under 20 months.
The trial team found that people coped well with having the beads and most of the side effects were mild.
The trial team found that it was possible and safe to have irinotecan beads before surgery. It didn’t delay planned surgery dates or impact on how well people did afterwards. They also found that the side effects were mild.
Researchers are planning further trials looking at these beads before surgery for people with bowel cancer that has spread to the liver. This will help them work out who will benefit most from this treatment.
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.