Guidance

Recommendations for research

Recommendations for research

The 2016 guideline committee made the following recommendations for research, marked [2016]. The guideline committee's full set of research recommendations is detailed in the full version of the guideline. As part of the 2018 update, the standing committee further research recommendations, marked [2018]. Full details of these can be found in evidence review A.

1 Indeterminate FDG PET-CT after radical chemoradiotherapy: long-term outcomes

What are the long-term outcomes for people with an indeterminate fluorodeoxyglucose positron emission tomography (FDG PET)-CT scan result (a residual mass with no abnormal FDG uptake) after radical chemoradiotherapy?

Why this is important

People with indeterminate FDG PET-CT results receive neck dissection surgery according to current practice in the UK. However, there is no standardised practice on long-term follow-up for people with negative disease and persistent nodes on FDG PET-CT scan. Research to investigate long-term outcomes could improve clinical outcomes and efficient use of resources. Randomised controlled trials or prospective cohort studies would be used to answer this research question. Outcomes of interest include recurrence rates, overall survival, quality of life, surgical complications, and adverse events. [2018]

2 Indeterminate FDG PET-CT after radical chemoradiotherapy: investigations

What are the most appropriate investigations for people with an indeterminate FDG PET-CT scan result (a residual mass with no abnormal FDG uptakes) after radical chemoradiotherapy?

Why this is important

People with indeterminate FDG PET-CT results receive neck dissection surgery according to current practice in the UK. However, there is no standardised practice on long-term follow-up for people with negative disease and persistent nodes on FDG PET-CT scan. Research to investigate appropriate investigations could improve clinical outcomes and efficient use of resources. Randomised controlled trials or prospective cohort studies would be used to answer this research question. Investigations include interval FDG PET-CT, ultrasound with or without biopsy, multi-parametric MRI, and serial imaging. [2018]

3 Management of nodal metastasis in nasopharynx cancer after chemoradiotherapy

What is the optimal management strategy of nodal metastasis in nasopharynx cancer after chemoradiotherapy?

Why this is important

There is evidence that FDG PET-CT is cost-saving, prevents unnecessary surgeries and reduces recurrence and overall mortality compared with neck dissection surgery in people who have received chemoradiotherapy. However, the evidence is only for people with oropharyngeal, laryngeal and hypopharyngeal cancer and there is no evidence on people with nasopharynx cancer. Natural history and response to treatment of cervical nodal metastases from nasopharynx primary sites are different, in terms of their impact on prognosis (TNM 7 cancer staging manual), and nasopharynx cancer is highly sensitive to radiotherapy and should not be treated by neck dissection (PET-NECK NIHR report). Research to investigate the optimal management of nodal metastasis in people with primary nasopharynx cancer after chemoradiotherapy could improve clinical outcomes and the use of resources. Outcomes of interest include recurrence rates, overall survival, quality of life, surgical complications, and adverse events. [2018]

4 Effectiveness of FDG PET-CT to guide follow-up

What is the effectiveness and cost-effectiveness of using FDG PET-CT to guide follow-up after treatment for people with head and neck cancer?

Why this is important

There is evidence that FDG PET-CT is cost-saving, prevents unnecessary surgeries and has similar results for recurrence and overall mortality compared with neck dissection surgery in people with oropharyngeal, laryngeal and hypopharyngeal cancer who have received chemoradiotherapy. However, there is no evidence on FDG PET-CT for follow-up after other head and neck cancer treatments. Research to investigate the effectiveness of FDG PET-CT to guide follow-up could improve clinical outcomes and the use of resources. Outcomes of interest include recurrence rates, overall survival, and quality of life. [2018]

5 Systemic imaging – who and why?

What factors determine the risk of a person presenting with cancer of the upper aerodigestive tract having metastasis or a second primary cancer?

Why this is important

Outcomes of interest include prevalence, predictive value and how the abnormalities identified influence patient management. The presence of metastasis or a synchronous second primary cancer at presentation is rare in patients with cancer of the upper aerodigestive tract. Subgroups of patients have been identified in whom the risk is clearly elevated. However, it is not clear at which level of risk detailed staging investigations are justified and the impact the results of these would have on decision making by the clinicians and the patient. Health economic modelling is needed to inform this process. [2016]

6 HPV testing

What is the comparative effectiveness of single‑step laboratory diagnostic tests to identify human papillomavirus (HPV) against current diagnostic test algorithms and reference standards in people with cancer of the oropharynx?

Why this is important

Outcomes of interest are sensitivity, specificity and resource use. HPV testing is currently recommended in cancer of the oropharynx because it has significant prognostic implication. Current methods use a 2‑step procedure that is not widely available in all treatment centres. A single‑step test is likely to be more widely adopted and could have significant budgetary implications for the NHS. The study should also consider the prognostic value and the economic benefits of novel tests. [2016]

7 Unknown primary of presumed upper aerodigestive tract origin

In people with cancer of the upper aerodigestive tract of unknown primary, can radiotherapy target volumes be selected based on clinical and pathological factors?

Why this is important

Outcomes of interest include local control, progression‑free survival, overall survival, and treatment‑related morbidity and mortality. In a very small percentage of patients with squamous carcinoma involving a cervical lymph node the primary site remains occult despite intensive investigations. The optimum treatment for these patients is uncertain. Some clinical teams will treat the neck disease alone and others will treat some or all potential primary sites with the radiotherapy with or without chemotherapy. The latter strategy is associated with a high level of side effects that may have lifelong consequences, for example xerostomia. A better understanding of the clinic‑pathological factors associated with treatment outcomes would improve treatment selection with the potential to reduce these side effects. [2016]

8 Enteral nutrition support

What specific clinical and non‑clinical factors allow risk stratification when selecting which people with cancer of the upper aerodigestive tract would benefit from short‑ or long‑term enteral nutrition?

Why this is important

Outcomes of interest include resource use, morbidity of tube placement, duration of enteral feeding and nutritional status. There are no nationally agreed selection criteria for the type of feeding tube placed at diagnosis for people who need enteral nutrition support during curative treatment. Variation across the UK exists as a result of clinician‑led practices and local policy. The systematic review by NICE in 2015 found some evidence but no specific list was identified because of limitations with study design, and inability to stratify clinical and non‑clinical factors meaningfully. These factors included restricted populations for tumour staging, patient demographics, treatment plan and intent, definitions of malnutrition, timing and method of tube placement, and duration of enteral nutrition. [2016]

9 Follow‑up

What is the optimal method, frequency and duration of follow‑up for people who are disease‑free after treatment for cancer of the upper aerodigestive tract?

Why this is important

Outcomes of interest include quality of life, local control and overall survival. The optimal methods, frequency, and duration of follow‑up in people who are clinically disease‑free and who have undergone treatment for squamous cell cancer of the upper aerodigestive tract with curative intent are not known. Considerable resources are expended throughout the country on the follow‑up of people who have completed potentially curative treatment. Local follow‑up protocols are based more on historical practice than evidence and are often disease‑ rather than patient‑centred. Research to investigate how and when follow‑up should optimally be carried out could improve clinical outcomes and the use of resources. [2016]

  • National Institute for Health and Care Excellence (NICE)