A trial looking at chemotherapy before surgery for oesophageal cancer (OE05 trial)

Cancer type:

Oesophageal cancer

Status:

Results

Phase:

Phase 3

This trial compared 2 combinations of chemotherapy before surgery for cancer of the food pipe (oesophageal cancer). It was for people with cancer of the oesophagus or cancer that starts where the food pipe meets the stomach (oesophageal gastric junction). This trial was supported by Cancer Research UK.

More about this trial

Doctors often treat cancer of the oesophagus with chemotherapy or surgery. Some patients have chemotherapy before surgery to shrink the size of the cancer. This is called neo adjuvant therapy Open a glossary item . It can help to make the operation easier and reduce the risk of the cancer coming back after surgery.

Chemotherapy for oesophageal cancer is usually given over 3 weeks and this 3 week period is called a cycle of chemotherapy. In this trial

About half of the patients had the chemotherapy drugs cisplatin and fluorouracil, called CF. They had up to 2 cycles of CF
The other half had epirubicin, cisplain and capecitabine (called ECX). They had up to 4 cycles of ECX

The aims of this trial were to

Find out whether giving different chemotherapy drugs for longer worked better for people with oesophageal cancer and gastro oesophageal junction cancer
Learn more about the side effects and how this affected quality of life

Summary of results

The trial team found that people in both treatment groups did better than expected. This shows that people with oesophageal cancer in the UK are doing better than in the past. They also found no difference in how long people lived between the 2 treatment groups.

897 people took part in this randomised trial.

451 people had CF chemotherapy
446 people had ECX chemotherapy

diagram_for_oe05.png

798 people went on to have surgery. Of these, 411 people had CF and 387 people had ECX chemotherapy.

The results of the trial were presented at a conference in June, 2015. The researchers followed the people who took part for an average of 5 years.

They found

115 people who had CF and surgery
136 people who had ECX and surgery

were alive with no signs of their cancer growing again or coming back.

The researchers concluded that the difference between the two groups was not significant. So they were not able to say that one treatment was better than the other.

The researchers also looked at side effects and quality of life Open a glossary item . The side effects of chemotherapy included

A drop in white blood cells causing an increased risk of infection
Sore mouth

Problems following surgery included

Breathing problems
Infection
Leaking from the connection of 2 parts of the oesophagus or stomach (anastomosis )

People who had CF chemotherapy had more problems with a sore mouth than the group having ECX. But those people who had 4 cycles of ECX experienced more side effects overall as a result of their chemotherapy.

There was no difference between the groups when looking at the side effects of surgery.

The trial results support previous research, showing that neo adjuvant chemotherapy is a useful treatment for oesophageal cancer. No significant difference was found between the type of chemotherapy and number of cycles given.

The researchers are continuing to study samples of cancer (biopsies Open a glossary item ) and blood samples collected from the patients who took part. They hope this will help doctors identify which patients are more likely to benefit from neo adjuvant chemotherapy 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 Open a glossary item ) but may not have been published in a medical journal. The figures we quote above were provided by the research team. We have not analysed the data ourselves.