A trial looking at side effects of treatment for throat cancer (De-ESCALaTE HPV)

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Cancer type:

Head and neck cancers
Mouth (oral) cancer

Status:

Results

Phase:

Phase 3

This trial looked at the side effects of treatment. It was for people who have cancer of the part of the throat just behind the mouth (oropharyngeal cancer). 

It was for people who had the human papillomavirus and whose cancer had spread to nearby lymph nodes Open a glossary item

Cancer Research UK supported this trial. 

More about this trial

The oropharynx is the part of the throat just behind the mouth. Cancer starting in this area is called oropharyngeal cancer (pronounced oar-oh-fah-rin-jee-al).
 
The oropharynx includes the:
  • back 1/3 of the tongue 
  • soft area at the back of the roof of the mouth (soft palate)
  • tonsils and 2 ridges of tissue in front of and behind the tonsils (tonsillar pillars)
  • back wall of the throat

The human papillomavirus (HPV) is a common virus. There are different types of HPV and most don’t cause any serious problems. But some can cause changes to cells that can develop into cancer. HPV causes some oropharyngeal cancers.

The usual treatment for oropharyngeal cancer is chemotherapy and radiotherapy. This is called chemoradiation. The usual chemotherapy drug is cisplatin. The treatment is the same whether you have HPV positive cancer or not. 
 
HPV positive oropharyngeal cancer responds well to treatment. But cisplatin can cause unpleasant side effects. These include a dry mouth and difficulty swallowing. So, researchers are looking for treatments with fewer side effects. In this trial, they looked at a drug called cetuximab. 
 
Cetuximab is a targeted drug called a monoclonal antibody. When researchers did this trial, earlier research had shown that cetuximab and radiotherapy may cause fewer side effects than cisplatin and radiotherapy. So, researchers wanted to find out more.
 
The main aims of the trial were to:
  • compare the side effects between the 2 different treatment groups
  • find out which treatment worked best 

Summary of results

The trial team found that cetuximab didn’t have fewer side effects than cisplatin. And cisplatin and radiotherapy worked better than cetuximab and radiotherapy for people with HPV positive oropharyngeal cancer. 
 
This trial was open for people to join between 2012 and 2016 and published in 2018. 
 
About this trial
This was a phase 3 trial. 334 people took part and were put into 1 of 2 treatment groups at random, and:
  • 166 had cisplatin and radiotherapy (standard treatment)
  • 168 had cetuximab and radiotherapy 

The trial included people who had low risk oropharyngeal cancer. For example, people who were non smokers or who didn’t smoke more than a certain amount for more than 10 years. 
 
Results
The trial team looked at all the side effects of treatment. To do this, they counted the number of side effects each person reported. They looked at the side effects during treatment and for 2 years afterwards. 
 
They looked at: 
  • side effects that developed during treatment and shortly afterwards (short term)
  • side effects that developed more than 3 months after treatment (long term)
  • how severe the side effects were
On average, they didn’t find a difference in any of these between the 2 treatment groups. 
 
The researchers also looked at how well treatment worked. They looked at how many people were alive after 2 years. This is called overall survival. 
 
This was:
  • just under 10 out of 10 people (97.5%) who had cisplatin
  • just under 9 out of 10 people (89.4%) who had cetuximab 
They also looked at whose cancer had come back. This is called recurrence. At 2 years this happened in:
  • 6 out of 100 people (6%) who had cisplatin
  • 16 out of 100 people (16%) who had cetuximab 

So, the researchers found that people having cisplatin and radiotherapy lived longer after treatment. And the cancer came back in fewer people. 
 
Quality of life
Everyone taking part filled out 2 quality of life questionnaires. This asked about treatment and how people had been feeling. It also asked about swallowing problems. The researchers didn’t find any differences in quality of life or swallowing. This was both during treatment or afterwards.
 
Side effects
Although the average number of side effects weren’t different. Some of the side effects were. 
 
The more severe side effects of cisplatin were:
  • tummy problems
  • hearing loss, ringing in the ears (tinnitus) and dizziness (vertigo)
  • kidney problems
The more severe side effects of cetuximab were:
  • tummy problems
  • skin problems such as rashes
  • a reaction to having the drug
Conclusion
The trial team found that cetuximab didn’t have fewer side effects than cisplatin. Nor did it help people live longer or lengthen the time without a recurrence of their cancer.
 
The trial team concluded that cisplatin and radiotherapy should continue to be the standard of care for people with low risk HPV positive oropharyngeal cancer. 
 
Where do these results come 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.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Hisham Mehanna

Supported by

Cancer Research UK
The Radiotherapy Trials Quality Assurance Group
University of Birmingham
University of Warwick
 

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Last review date

CRUK internal database number:

7400

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Wendy took part in a new trial studying the possible side effect of hearing loss

A picture of Wendy

"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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