The Findings Of the Research Study (SEND) – Update 27/04/2023
Original post can be found here.
The findings of the Selective Elective Neck Dissection (SEND study) funded by Elliott Bernerd, Robbie and Lisa Tchenguiz in memory of their mother Violet, Cancer Research UK, and Saving Faces, was published in the British Journal of Cancer.
This research studied how to improve the treatment of early Mouth Cancer by scientifically comparing the results of the two most commonly used treatments for small cancers in the mouth.
Our research emphatically showed that taking out the neck glands at the same time as the cancer in the mouth (Elective Neck Dissection – END) cured 15% more patients.
When we published our results in The British Journal of cancer in late 2019 it created a storm of activity around the world. Over 11,000 people have read the paper!
- The President of the Union for International Cancer Control in Geneva was one of over 11,000 specialists who read our research. He singled it out for special praise saying we had produced irrefutable evidence for the benefit of END. He wrote “We stand the risk of subjecting our patients to poorer disease control by observing the neck in spite of having irrefutable evidence in favour of END”
- More than 73 oncologists, surgeons and scientists have written articles quoting it. One group in India wrote “The SEND trial… merits the fame of a practice-changing trial.”
- We were commissioned to write articles for the organisations that recommend the guidelines for treating patients with cancer. Guidelines in America, Europe, India, Japan, China and the UK have now been changed to recommend treatment according to our findings.
As a direct result of the findings of the SEND study, 30,000 more people around the world with early mouth cancer are being cured every year. Put another way, this means that every 15 minutes, somewhere in the world, the life of one more person with mouth cancer is saved because they are now treated with the better of the two treatments that were compared
Saving Faces and NFORC succeeded because we collaborated with 68 UK oral and maxillofacial surgeons treating 614 patients at 27 hospitals. We conducted the first-ever (and still the only) multi-centre nationwide study (PRS) comparing two different surgical treatments for any type of head and neck cancer.
In the 40 years before we published our study, over 500 hospitals have conducted similar studies, even some of the most famous hospitals in the world, but none of them had collaborated. This is why they failed to resolve the debate about which of these two treatments was best for the patients.
The large numbers of surgeons who joined us also means the findings are applicable to all surgeons and hospitals worldwide.
- Our research incontrovertibly shows for the very first time that removing the neck glands of patients at the same time as removing their small cancers in the mouth improves their chances of cure by 1/3rd even if the neck scans show no sign of secondary deposits of cancer in the glands.
- Mouth cancer and its treatment can result in severe problems with speech, eating and appearance so our research also looked at the social, emotional and functional outcomes of leaving or removing the neck glands. Patients reported no increase in serious side effects nor any significant emotional or sociological disturbance when they had the extra surgery of neck gland removal.
- Quality of life outcomes was the same amongst the 2 groups of patients.
- There were no difference in costs to the health service between the two treatment.
- Many people think they should identify the most skillful surgeon or go to the best hospital. However, what they really need to know is what is the best treatment for their condition. Even the most skillful surgeon can’t compensate for using the less successful treatment.
- Studying with so many surgeons means we can judge a successful treatment irrespective of which surgeon performs it.
Benefit to surgeons and patients
For the very first time all surgeons now have quantifiable evidence about the risks and benefits of removing the neck glands in early mouth cancer. So, surgeons can give actual facts to their patients about cure rates and side effects of the 2 treatments. This will help patients participate in decisions about their treatment.
Future projects with the data
- 10-year follow up results as per 5-year follow up
- Translational research comparing clinical outcomes with biological and genetic markers to find better treatment for mouth cancer.
- Report on patients’ attitudes to trial participation
- Paper on sites in the mouth that are more prone to have incomplete margin clearance of the cancer
Commenting on the findings, Professor Iain Hutchison, who co-wrote the paper with Professor Allan Hackshaw, research staff at Saving Faces and 32 surgeons:
“Mouth cancer is often neglected when it comes to research into finding better ways of treating it. We now have clarity over an issue which has vexed surgeons for over 20 years about how best to treat patients with small cancers who may have undetectable tiny cancer deposits in their neck glands. The results show that removing the lymph glands at the same time as the mouth tumour almost halves the chance of the cancer coming back or the patient dying. If all patients who are eligible for this operation have it, it could save 30,000 lives worldwide every year.”
“Surgeons now have reliable evidence about the risks and benefits of removing the neck glands in early stage mouth cancer. This provides better information to help surgeons and patients make decisions about their treatment. This is a good day for mouth cancer patients”.
Elliott Bernerd (Saving Faces Chair of Trustees) said: “When I agreed to help fund this research, I hoped the results would help fellow cancer sufferers. This has exceeded my expectations and I encourage other people to support Saving Faces to help them change the future”.
The SEND trial would not have been possible without the funding from Cancer Research UK, Elliott Bernerd and Robbie and Lisa Tchenguiz, and access to the ONS mortality data delivered by NHS Digital.
This work uses data provided by patients and collected by the NHS as part of their care and support.
Patient and Quotes:
To contact the patients. please ring Saving Faces or 020 3417 7757.
Maureen was randomised to receive removal of neck glands but patient only wanted removal of the mouth cancer.
Maureen says: “I agreed to participate in the trial. I should have had the mouth cancer and neck glands removed but I was too scared and vain to have such extensive surgery so I only had the mouth cancer removed. My surgery was 9 years ago in 2010. My husband and I stopped smoking and the cancer hasn’t come back. I speak and eat normally and have no scars”
Helen was randomised to only have the mouth cancer removed with no treatment of the neck glands. December 2014 Right-sided tongue cancer completely removed. March 2016 just over one year later developed a new cancer right tongue. Again completely removed. Clear of cancer for last 3.5 years.
Helen says: “the randomisation felt like a lottery not knowing what the outcome would bring. I was keen to do the study but was not so keen to have the neck dissection but my husband was keen. I think the word cancer is what makes it frightening but in some way the study was a distraction and a comfort to me as I felt I was giving back something.
When the cancer returned it affected me psychologically because I knew what I went through first time and I was anxious and frightened I would not get better. I think I got depressed as well as taking more time off work. My speech was also slightly slurred. I had some counselling sessions this time. First time around I didn’t really talk about the cancer and very few people knew why I was ill. After the counselling sessions I was able to be more open and speak about it which makes it more real and in a strange way less intimidating.
Overall I am proud to have been part of such a great research study. I can speak pretty clearly and eat normally now, I’m still working full time in the NHS.”
Ray was randomised to have the mouth cancer and neck glands removed at the same time.
Ray says: “I was warned that I might have speech problems, nerve damage in the neck and part of the face afterwards. I was in hospital for one week after the operation. During the first year afterwards I had difficulty raising my right arm above my shoulder but exercises and physiotherapy resolved this. I also had a speech problem but this improved quite quickly. I carried on working and essentially lead a normal life
Nationwide randomised trial evaluating elective neck dissection for early stage oral cancer (SEND study) with meta-analysis and concurrent real-world cohort
Iain L. Hutchison, Fran Ridout, Sharon M. Y. Cheung, Neil Shah, Peter Hardee, Christian Surwald, Janavikulam Thiruchelvam, Leo Cheng, Tim K. Mellor, Peter A. Brennan, Andrew J. Baldwin, Richard J. Shaw, Wayne Halfpenny, Martin Danford, Simon Whitley, Graham Smith, Malcolm W. Bailey, Bob Woodwards, Manu Patel, Joseph McManners, Chi-Hwa Chan, Andrew Burns, Prav Praveen, Andrew C. Camilleri, Chris Avery, Graham Putnam, Keith Jones, Keith Webster, William P. Smith, Colin Edge, Iain McVicar, Nick Grew, Stuart Hislop, Nicholas Kalavrezos, Ian C. Martin and Allan Hackshaw (2019)
British Journal of Cancer
Management of the clinically N0 neck in early-stage Oral Squamous Cell Carcinoma (OSCC). An EACMFS Position Paper
Journal of Cranio-Maxillo-facial Surgery
Reply to Comment(s) on “Nationwide randomised trial evaluating elective neck dissection for early stage oral cancer (SEND study) with meta-analysis and concurrent real-world cohort”
I. Hutchison and A. Hackshaw (2020)
British Journal of Cancer
More Evidence From a US Nationwide Cohort Study for the Survival Benefit of END in Early Mouth Cancer: Time for a Change in Guidelines
Iain Hutchison (2021)
Journal of the National Comprehensive Cancer Network (JNCCN)
About Saving Faces
The mission of Saving Faces-The Facial Surgery Research Foundation is to combat cancer, injury and disfigurement in the most socially important part of our bodies – the face and mouth.
Saving Faces is a unique charity. It is the only charity in the UK whose research focus is the face, mouth and jaws. Conditions such as cancer, disfigurement, infections and injuries interfere with our appearance and ability to eat and speak. Research into facial disease and deformity is essential and Saving Faces generates this research through its National Facial, Oral and Oculoplastic Research Centre (NFORC). This research improves the lives of thousands of people worldwide.
NFORC is a unique research centre. Saving Faces created the world’s first and only National Facial, Oral and Oculoplastic Research Centre (NFORC) in partnership with: The British Association of Oral and Maxillofacial Surgeons (BAOMS), The British Oculoplastic Surgical Society (BOPSS), The Cancer Research UK Cancer Prevention Trials Unit (CPTU) and The Royal College of Surgeons of England selected NFORC as its Head and Neck Research Centre.
Saving Faces is cost effective because:
- We partner surgeons (more than 350) at multiple hospitals across the UK and abroad. The cost of the research is low as the surgeons and patients give their time free-of-charge
- Patients are at the heart of the research selecting the most important studies with the surgeons.
- Patients contribute knowledge and experience and help with study design and implementation
- Saving Faces provides the scientists, statisticians and data managers to run the studies and analysis.