NIHR DC Discover

NIHR Signal A scan may help decide if surgery is required as follow-on treatment for head and neck cancer

Published on 7 June 2016

doi: 10.3310/signal-000250

People with head and neck cancer in the UK usually receive chemotherapy and radiotherapy followed by surgery. Using a scan to assess cancer status after this first line chemoradiotherapy and only suggesting surgery to those with a clear indication led to similar survival rates, complications and fewer operations compared with planned cancer surgery for everyone.

After receiving similar initial treatment, this trial compared routine neck dissection surgery to surgery only if the scan showed residual cancer 12 weeks after chemoradiotherapy.

Head and neck surgery can be invasive and disfiguring, so doctors and patients alike want to minimise unnecessary operations, this potentially saves money.

The scanning tested was PET-CT scanning, a newer type of highly detailed CT scanning. This scan guided surveillance is not currently covered by NICE guidance. These findings suggest there may be a place for it and that by saving surgery for some people it could also save costs, compared to planning surgery for everyone without a surveillance scan.

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Why was this study needed?

Head and neck cancer is uncommon. New cases range from 8 per 100,000 adults in the Thames and Oxford regions, to 5 per 100,000 in Wales and in the North Western region.

Studies have shown that some residual cancer is found during surgery in around 40% of patients after chemoradiotherapy, indicating surgery was warranted. But advances in chemoradiotherapy suggest that more patients will be largely free of cancer, and PET-CT has the potential to give more detailed imaging than previous techniques.

PET-CT is gaining in popularity, and these researchers wanted to test its effectives and safety in this type of cancer.

This trial aimed to compare the outcomes of having a surveillance scan before surgery compared with planned neck surgery without a scan in people with advanced head and neck cancer after initial chemoradiotherapy.

What did this study do?

This UK-based randomised control trial recruited 564 people with advanced head and neck cancer; specifically, those where the tumour had spread to their lymph nodes.

Participants were randomly assigned, half and half, to have planned neck surgery 12 weeks after the last chemoradiotherapy session or to have a PET-CT scan before a decision to operate. Scans showing remaining cancer or inconclusive results were a reason to continue to surgery.

The main outcome was overall survival, with complication rates and quality of life also assessed.

The trial was not blinded meaning patients, clinicians and evaluators were aware of the treatments received. Blinding in practice would be hard to achieve and would have been unlikely to have had a major effect on the results.

What did it find?

  • Survival rates and quality of life were no different between the groups after an average (median) follow up of three years. For example, two year overall survival was 84.9% (95% confidence interval [CI], 80.7 to 89.1) in the scanned group and 81.5% (95% CI, 76.9 to 86.3) in the planned surgery group.
  • Scans resulted in far fewer operations than the planned surgery group (19.1% versus 78.4% based on initial randomisation).
  • Not all of those in the planned surgery group had their procedure: some declined and others had rapid progression of their cancer or other serious health problems. These people were included in the planned surgery group analysis.
  • Estimates of complication rates were imprecise but showed no difference between groups: 42% (95% CI, 24 to 59) in those scanned compared with 38% (95% CI, 30 to 46) in the planned group.
  • Scanning saved £1,492 per-person compared with planned surgery without a scan over a minimum of two years, adding an additional 0.08 quality-adjusted life year per person.

What does current guidance say on this issue?

PET-CT is described in 2010 NICE guidance as a potential second diagnostic phase special investigation for metastatic malignant disease of unknown primary origin.

Recent guidance published by NICE on the assessment and management of cancer of the throat recommends offering people with advanced disease a choice of radiotherapy with chemotherapy or surgery with radiotherapy, with or without chemotherapy.

There is no NICE guidance for the use of PET-CT scan to track progression of cancer before surgery.

What are the implications?

Scanning before surgery could avoid disfiguring and invasive surgery in many people after successful primary treatment.

This trial indicates this might be achieved with similar survival and complication outcomes as planned surgery over three years, with potential cost savings.

The study examined the first few years of management and longer term safety, survival or quality of life differences might not have been uncovered.

Citation and Funding

H Mehanna, W Wong, C McConkey, et al. PET-CT surveillance versus neck dissection in advanced head and neck cancer. N Engl J Med. 2016;374(15):1444-54.

Supported by academic grants from the National Institute for Health Research Health Technology Assessment Programme (06/302/129) and Cancer Research UK (C19677/A9674, for tissue sample collection).

Bibliography

NICE. Cancer of the upper aerodigestive tract: assessment and management in people aged 16 and over. NG36. London: National Institute for Health and Care Excellence; 2016.

NICE. Metastatic malignant disease of unknown primary origin in adults: diagnosis and management. CG104. National Institute for Health and Care Excellence; 2010.

NHS Choices. Head and neck cancer. London: Department of Health; last updated 2015.

Why was this study needed?

Head and neck cancer is uncommon. New cases range from 8 per 100,000 adults in the Thames and Oxford regions, to 5 per 100,000 in Wales and in the North Western region.

Studies have shown that some residual cancer is found during surgery in around 40% of patients after chemoradiotherapy, indicating surgery was warranted. But advances in chemoradiotherapy suggest that more patients will be largely free of cancer, and PET-CT has the potential to give more detailed imaging than previous techniques.

PET-CT is gaining in popularity, and these researchers wanted to test its effectives and safety in this type of cancer.

This trial aimed to compare the outcomes of having a surveillance scan before surgery compared with planned neck surgery without a scan in people with advanced head and neck cancer after initial chemoradiotherapy.

What did this study do?

This UK-based randomised control trial recruited 564 people with advanced head and neck cancer; specifically, those where the tumour had spread to their lymph nodes.

Participants were randomly assigned, half and half, to have planned neck surgery 12 weeks after the last chemoradiotherapy session or to have a PET-CT scan before a decision to operate. Scans showing remaining cancer or inconclusive results were a reason to continue to surgery.

The main outcome was overall survival, with complication rates and quality of life also assessed.

The trial was not blinded meaning patients, clinicians and evaluators were aware of the treatments received. Blinding in practice would be hard to achieve and would have been unlikely to have had a major effect on the results.

What did it find?

  • Survival rates and quality of life were no different between the groups after an average (median) follow up of three years. For example, two year overall survival was 84.9% (95% confidence interval [CI], 80.7 to 89.1) in the scanned group and 81.5% (95% CI, 76.9 to 86.3) in the planned surgery group.
  • Scans resulted in far fewer operations than the planned surgery group (19.1% versus 78.4% based on initial randomisation).
  • Not all of those in the planned surgery group had their procedure: some declined and others had rapid progression of their cancer or other serious health problems. These people were included in the planned surgery group analysis.
  • Estimates of complication rates were imprecise but showed no difference between groups: 42% (95% CI, 24 to 59) in those scanned compared with 38% (95% CI, 30 to 46) in the planned group.
  • Scanning saved £1,492 per-person compared with planned surgery without a scan over a minimum of two years, adding an additional 0.08 quality-adjusted life year per person.

What does current guidance say on this issue?

PET-CT is described in 2010 NICE guidance as a potential second diagnostic phase special investigation for metastatic malignant disease of unknown primary origin.

Recent guidance published by NICE on the assessment and management of cancer of the throat recommends offering people with advanced disease a choice of radiotherapy with chemotherapy or surgery with radiotherapy, with or without chemotherapy.

There is no NICE guidance for the use of PET-CT scan to track progression of cancer before surgery.

What are the implications?

Scanning before surgery could avoid disfiguring and invasive surgery in many people after successful primary treatment.

This trial indicates this might be achieved with similar survival and complication outcomes as planned surgery over three years, with potential cost savings.

The study examined the first few years of management and longer term safety, survival or quality of life differences might not have been uncovered.

Citation and Funding

H Mehanna, W Wong, C McConkey, et al. PET-CT surveillance versus neck dissection in advanced head and neck cancer. N Engl J Med. 2016;374(15):1444-54.

Supported by academic grants from the National Institute for Health Research Health Technology Assessment Programme (06/302/129) and Cancer Research UK (C19677/A9674, for tissue sample collection).

Bibliography

NICE. Cancer of the upper aerodigestive tract: assessment and management in people aged 16 and over. NG36. London: National Institute for Health and Care Excellence; 2016.

NICE. Metastatic malignant disease of unknown primary origin in adults: diagnosis and management. CG104. National Institute for Health and Care Excellence; 2010.

NHS Choices. Head and neck cancer. London: Department of Health; last updated 2015.

PET-CT Surveillance versus Neck Dissectionin Advanced Head and Neck Cancer

Published on 23 March 2016

H Mehanna, W Wong, C McConkey, J Rahman, M Robinson,A Hartley, C Nutting, N Powell,H Booz, M Robinson, E Junor, M Rizwanullah, S von Zeidler, H Wieshmann, C Hulme, A Smith, P Hall, J Dunn, and the PET-NECK Trial Management Group*

New England Journal of Medicine , 2016

BACKGROUND The role of image-guided surveillance as compared with planned neck dissection in the treatment of patients with squamous-cell carcinoma of the head and neck who have advanced nodal disease (stage N2 or N3) and who have received chemoradiotherapy for primary treatment is a matter of debate. METHODS In this prospective, randomized, controlled trial, we assessed the noninferiority of positron-emission tomography–computed tomography (PET-CT)–guided surveillance (performed 12 weeks after the end of chemoradiotherapy, with neck dissection performed only if PET-CT showed an incomplete or equivocal response) to planned neck dissection in patients with stage N2 or N3 disease. The primary end point was overall survival. RESULTS From 2007 through 2012, we recruited 564 patients (282 patients in the planned-surgery group and 282 patients in the surveillance group) from 37 centers in the United Kingdom. Among these patients, 17% had nodal stage N2a disease and 61% had stage N2b disease. A total of 84% of the patients had oropharyngeal cancer, and 75% had tumor specimens that stained positive for the p16 protein, an indicator that human papillomavirus had a role in the causation of the cancer. The median follow-up was 36 months. PET-CT–guided surveillance resulted in fewer neck dissections than did planned dissection surgery (54 vs. 221); rates of surgical complications were similar in the two groups (42% and 38%, respectively). The 2-year overall survival rate was 84.9% (95% confidence interval [CI], 80.7 to 89.1) in the surveillance group and 81.5% (95% CI, 76.9 to 86.3) in the planned-surgery group. The hazard ratio for death slightly favored PET-CT–guided surveillance and indicated noninferiority (upper boundary of the 95% CI for the hazard ratio, <1.50; P=0.004). There was no significant difference between the groups with respect to p16 expression. Quality of life was similar in the two groups. PET-CT–guided surveillance, as compared with neck dissection, resulted in savings of £1,492 (approximately $2,190 in U.S. dollars) per person over the duration of the trial. CONCLUSIONS Survival was similar among patients who underwent PET-CT–guided surveillance and those who underwent planned neck dissection, but surveillance resulted in considerably fewer operations and it was more cost-effective. (Funded by the National Institute for Health Research Health Technology Assessment Programme and Cancer Research UK; PET-NECK Current Controlled Trials number,

Expert commentary

This study would suggest that quality of life outcomes was similar in the two groups, PET-CT–guided surveillance, as compared with neck dissection. This in part reflects the inability of the questionnaires to discriminate between groups, the relatively small additional detriment a neck dissection confers to quality of life outcomes, patients’ adaption and response shift. Patient’s priority is for cure and survival and the main outcome of this study can be viewed in that context. Of course any benefit seen must translate from a clinical trial setting into routine clinical care.

Professor Simon N Rogers, Consultant Maxillofacial Surgeon, Aintree University Hospital

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