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Article ; Online: Prognostic biomarkers for malignant progression of oral epithelial dysplasia: an updated systematic review and meta-analysis.

Turton, Natalie / Payne, Karl / Higginson, James / Praveen, Prav / Mehanna, Hisham / Nankivell, Paul

The British journal of oral & maxillofacial surgery

2024

Abstract: Oral epithelial dysplasia (OED) is a premalignant condition that carries an appreciable risk of malignant progression. The current grading system for severity, as defined by the World Health Organization, is a valuable clinical tool, but further work is ... ...

Abstract	Oral epithelial dysplasia (OED) is a premalignant condition that carries an appreciable risk of malignant progression. The current grading system for severity, as defined by the World Health Organization, is a valuable clinical tool, but further work is required to improve the accuracy of predicting OED malignant progression. This systematic review aimed to assess progress in prognostic biomarker discovery in OED over the past 16 years. The primary objective was to update the latest evidence on prognostic biomarkers that may predict malignant progression of OED, with strict inclusion criteria of studies with a longitudinal design and long-term follow-up data to enhance the robustness and translational clinical potential of the findings. Of 2829 studies identified through the searching of five databases, 20 met our inclusion criteria. These studies investigated a total of 32 biomarkers, 20 of which demonstrated significant potential to predict malignant progression of OED. Meta-analysis demonstrated the significant prognostic value of four biomarkers: podoplanin, EGFR expression, p16 methylation, and DNA aneuploidy. Our review has identified 20 reported biomarkers with prognostic potential to predict malignant progression in OED, but their translation into clinical practice remains elusive. Further research is required, and this should focus on validating the promising biomarkers identified in large cohort studies, with adherence to standardised reporting guidelines.
Language	English
Publishing date	2024-03-07
Publishing country	Scotland
Document type	Journal Article ; Review
ZDB-ID	605685-4
ISSN	1532-1940 ; 0266-4356
ISSN (online)	1532-1940
ISSN	0266-4356
DOI	10.1016/j.bjoms.2024.03.001
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Article ; Online: Clinicians' Views of Patient-initiated Follow-up in Head and Neck Cancer: a Qualitative Study to Inform the PETNECK2 Trial.

Lorenc, A / Wells, M / Fulton-Lieuw, T / Nankivell, P / Mehanna, H / Jepson, M

Clinical oncology (Royal College of Radiologists (Great Britain))

2021 Volume 34, Issue 4, Page(s) 230–240

Abstract: Aims: Current follow-up for head and neck cancer (HNC) is ineffective, expensive and fails to address patients' needs. The PETNECK2 trial will compare a new model of patient-initiated follow-up (PIFU) with routine scheduled follow-up. This article ... ...

Abstract	Aims: Current follow-up for head and neck cancer (HNC) is ineffective, expensive and fails to address patients' needs. The PETNECK2 trial will compare a new model of patient-initiated follow-up (PIFU) with routine scheduled follow-up. This article reports UK clinicians' views about HNC follow-up and PIFU, to inform the trial design. Materials and methods: Online focus groups with surgeons (ear, nose and throat/maxillofacial), oncologists, clinical nurse specialists and allied health professionals. Clinicians were recruited from professional bodies, mailing lists and personal contacts. Focus groups explored views on current follow-up and acceptability of the proposed PIFU intervention and randomised controlled trial design (presented by the study co-chief investigator), preferences, margins of equipoise, potential organisational barriers and thoughts about the content and format of PIFU. Data were interpreted using inductive thematic analysis. Results: Eight focus groups with 34 clinicians were conducted. Clinicians highlighted already known limitations with HNC follow-up - lack of flexibility to address the wide-ranging needs of HNC patients, expense and lack of evidence - and agreed that follow-up needs to change. They were enthusiastic about the PETNECK2 trial to develop and evaluate PIFU but had concerns that PIFU may not suit disengaged patients and may aggravate patient anxiety/fear of recurrence and delay detection of recurrence. Anticipated issues with implementation included ensuring a reliable route back to clinic and workload burden on nurses and allied health professionals. Conclusions: Clinicians supported the evaluation of PIFU but voiced concerns about barriers to help-seeking. An emphasis on patient engagement, psychosocial issues, symptom reporting and reliable, quick routes back to clinic will be important. Certain patient groups may be less suited to PIFU, which will be evaluated in the trial. Early, meaningful, ongoing engagement with clinical teams and managers around the trial rationale and recruitment process will be important to discourage selective recruitment and address risk-averse behaviour and potential workload burden.
MeSH term(s)	Follow-Up Studies ; Head and Neck Neoplasms/therapy ; Humans ; Qualitative Research
Language	English
Publishing date	2021-12-01
Publishing country	England
Document type	Journal Article ; Randomized Controlled Trial
ZDB-ID	1036844-9
ISSN	1433-2981 ; 0936-6555
ISSN (online)	1433-2981
ISSN	0936-6555
DOI	10.1016/j.clon.2021.11.010
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Article ; Online: A systematic review of the effectiveness of patient-initiated follow-up after cancer.

Dretzke, Janine / Chaudri, Talhah / Balaji, Rishab / Mehanna, Hisham / Nankivell, Paul / Moore, David J

Cancer medicine

2023 Volume 12, Issue 18, Page(s) 19057–19071

Abstract: Background: The traditional cancer follow-up (FU) model for cancer survivors is by scheduled clinic appointments; however, this is not tailored to patient needs and is becoming unsustainable. Patient-initiated follow-up (PIFU) may be a more effective ... ...

Abstract	Background: The traditional cancer follow-up (FU) model for cancer survivors is by scheduled clinic appointments; however, this is not tailored to patient needs and is becoming unsustainable. Patient-initiated follow-up (PIFU) may be a more effective and flexible alternative. This systematic review aims to analyse all existing evidence from randomised controlled trials (RCTs) on the effectiveness of PIFU compared with other FU models that include routinely scheduled appointments in adults who have been treated with curative intent for any type of cancer. Methods: Standard systematic review methodology aimed at limiting bias was used for study identification, selection and data extraction. MEDLINE, Embase, CINAHL, the Cochrane Database of Systematic Reviews and Epistemonikos were searched for systematic reviews to March 2022, and Cochrane CENTRAL was searched for RCTs from 2018 (April 2023). Ongoing trial registers were searched (WHO ICTRP, ClinicalTrials.gov, April 2023). Eligible studies were randomised controlled trials comparing PIFU with an alternative FU model in adult cancer survivors. Risk of bias assessment was via the Cochrane risk of bias tool-2. Meta-analysis was precluded by clinical heterogeneity and results were reported narratively. Results: Ten RCTs were included (six breast, two colorectal, one endometrial cancer and one melanoma, total n = 1754); all studies had risk of bias concerns, particularly relating to how missing data were handled, and populations were unlikely to be representative. Limited findings in breast cancer suggested that type of FU does not affect recurrence detection or patient-related outcomes, while PIFU may reduce the number of clinic visits. Adding patient-led surveillance to routine FU may increase melanoma detection. Evidence for other types of cancer is too limited to draw firm conclusions. Conclusions: PIFU may be a viable FU model in breast cancer, but further research is needed for other types of cancer and on long-term outcomes. A protocol was registered with PROSPERO (CRD42020181424).
Language	English
Publishing date	2023-08-21
Publishing country	United States
Document type	Journal Article
ZDB-ID	2659751-2
ISSN	2045-7634 ; 2045-7634
ISSN (online)	2045-7634
ISSN	2045-7634
DOI	10.1002/cam4.6462
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Article ; Online: Conservative management of oesophageal soft food bolus impaction.

Hardman, John / Sharma, Neil / Smith, Joel / Nankivell, Paul

The Cochrane database of systematic reviews

2020 Volume 5, Page(s) CD007352

Abstract: Background: Impaction of a soft food bolus in the oesophagus causes dysphagia and regurgitation. If the bolus does not pass spontaneously, then the patient is at risk of aspiration, dehydration, perforation, and death. Definitive management is with ... ...

Abstract	Background: Impaction of a soft food bolus in the oesophagus causes dysphagia and regurgitation. If the bolus does not pass spontaneously, then the patient is at risk of aspiration, dehydration, perforation, and death. Definitive management is with endoscopic intervention, recommended within 24 hours. Prior to endoscopy, many patients undergo a period of observation, awaiting spontaneous disimpaction, or may undergo enteral or parenteral treatments to attempt to dislodge the bolus. There is little consensus as to which of these conservative strategies is safe and effective to be used in this initial period, before resorting to definitive endoscopic management for persistent impaction. Objectives: To evaluate the efficacy of non-endoscopic conservative treatments in the management of soft food boluses impacted within the oesophagus. Search methods: We searched the following databases, using relevant search terms: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase and CINAHL. The date of the search was 18 August 2019. We screened the reference lists of relevant studies and reviews on the topic to identify any additional studies. Selection criteria: We included randomised controlled trials of the management of acute oesophageal soft food bolus impaction, in adults and children, reporting the incidence of disimpaction (confirmed radiologically or clinically by return to oral diet) without the need for endoscopic intervention. We did not include studies focusing on sharp or solid object impaction. Data collection and analysis: We used standard methodological procedures recommended by Cochrane. Main results: We identified 890 unique records through the electronic searches. We excluded 809 clearly irrelevant records and retrieved 81 records for further assessment. We subsequently included one randomised controlled trial that met the eligibility criteria, which was conducted in four Swedish centres and randomised 43 participants to receive either intravenous diazepam followed by glucagon, or intravenous placebos. The effect of the active substances compared with placebo on rates of disimpaction without intervention is uncertain, as the numbers from this single study were small, and the rates were similar (38% versus 32%; risk ratio 1.19, 95% confidence interval 0.51 to 2.75, P = 0.69). The certainty of the evidence using GRADE for this outcome is low. Data on adverse events were lacking. Authors' conclusions: There is currently inadequate data to recommend the use of any enteral or parenteral treatments in the management of acute oesophageal soft food bolus impaction. There is also inadequate data regarding potential adverse events from the use of these treatments, or from potential delays in definitive endoscopic management. Caution should be exercised when using any conservative management strategies in these patients.
MeSH term(s)	Conservative Treatment/methods ; Deglutition Disorders/etiology ; Deglutition Disorders/therapy ; Diazepam/administration & dosage ; Food/adverse effects ; Gastrointestinal Agents/administration & dosage ; Glucagon/administration & dosage ; Humans ; Multicenter Studies as Topic ; Muscle Relaxants, Central/administration & dosage ; Placebos/administration & dosage ; Randomized Controlled Trials as Topic
Chemical Substances	Gastrointestinal Agents ; Muscle Relaxants, Central ; Placebos ; Glucagon (9007-92-5) ; Diazepam (Q3JTX2Q7TU)
Language	English
Publishing date	2020-05-11
Publishing country	England
Document type	Journal Article ; Systematic Review
ISSN	1469-493X
ISSN (online)	1469-493X
DOI	10.1002/14651858.CD007352.pub3
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Article ; Online: Characterizing the epithelial-mesenchymal transition status of circulating tumor cells in head and neck squamous cell carcinoma.

Payne, Karl / Brooks, Jill / Batis, Nikolaos / Taylor, Graham / Nankivell, Paul / Mehanna, Hisham

Head & neck

2022 Volume 44, Issue 11, Page(s) 2545–2554

Abstract: Background: Circulating tumor cells (CTCs), in particular those undergoing an epithelial-mesenchymal transition (EMT), are a promising source of biomarkers in head and neck squamous cell carcinoma (HNSCC). Our aim was to validate a protocol using ... ...

Abstract	Background: Circulating tumor cells (CTCs), in particular those undergoing an epithelial-mesenchymal transition (EMT), are a promising source of biomarkers in head and neck squamous cell carcinoma (HNSCC). Our aim was to validate a protocol using microfluidic enrichment (Parsortix platform) with flow-cytometry CTC characterization. Method: Blood samples from 20 treatment naïve HNSCC patients underwent Parsortix enrichment and flow cytometry analysis to quantify CTCs and identify epithelial or EMT subgroups-correlated to clinical outcomes and EMT gene-expression in tumor tissue. Results: CTCs were detected in 65% of patients (mean count 4 CTCs/ml). CTCs correlated with advanced disease (p = 0.0121), but not T or N classification. Epithelial or EMT CTCs did not correlate with progression-free or overall survival. Tumor mesenchymal gene-expression did not correlate with CTC EMT expression (p = 0.347). Discussion: Microfluidic enrichment and flow cytometry successfully characterizes EMT CTCs in HNSCC. The lack of association between tumor and CTC EMT profile suggests CTCs may undergo an adaptive EMT in response to stimuli within the circulation.
MeSH term(s)	Biomarkers, Tumor/metabolism ; Epithelial-Mesenchymal Transition ; Head and Neck Neoplasms ; Humans ; Neoplastic Cells, Circulating/pathology ; Squamous Cell Carcinoma of Head and Neck
Chemical Substances	Biomarkers, Tumor
Language	English
Publishing date	2022-08-05
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	645165-2
ISSN	1097-0347 ; 0148-6403 ; 1043-3074
ISSN (online)	1097-0347
ISSN	0148-6403 ; 1043-3074
DOI	10.1002/hed.27167
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Article ; Online: Symptom-based remote assessment in post-treatment head and neck cancer surveillance: A prospective national study.

Zhang, Henry / Hardman, John C / Tikka, Theofano / Nankivell, Paul / Mehanna, Hisham / Paleri, Vinidh

Clinical otolaryngology : official journal of ENT-UK ; official journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery

2022 Volume 47, Issue 5, Page(s) 561–567

Abstract: Objectives: To report the incidence of locoregional recurrence in head and neck cancer (HNC) patients under surveillance following treatment undergoing symptom-based remote assessment.: Design: A 16-week multicentre prospective cohort study.: ... ...

Abstract	Objectives: To report the incidence of locoregional recurrence in head and neck cancer (HNC) patients under surveillance following treatment undergoing symptom-based remote assessment. Design: A 16-week multicentre prospective cohort study. Setting: UK ENT departments. Participants: HNC patients under surveillance following treatment undergoing symptom-based telephone assessment. Main outcome measures: Incidence of locoregional recurrent HNC after minimum 6-month follow-up. Results: Data for 1078 cases were submitted by 16 centres, with follow-up data completed in 98.9% (n = 1066). Following telephone consultation, 83.7% of referrals had their face-to-face appointments deferred (n = 897/1072). New symptoms were reported by 11.6% (n = 124/1072) at telephone assessment; 72.6% (n = 90/124) of this group were called for urgent assessments, of whom 48.9% (n = 44/90) came directly for imaging without preceding clinical review. The sensitivity and specificity for new symptoms as an indicator of cancer recurrence were 35.3% and 89.4%, respectively, with a negative predictive value of 99.7% (p = .002). Locoregional cancer identification rates after a minimum of 6 months of further monitoring, when correlated with time since treatment, were 6.0% (n = 14/233) <1 year; 2.1% (n = 16/747) between 1 and 5 years; and 4.3% (n = 4/92) for those >5 years since treatment. Conclusions: Telephone assessment, using patient-reported symptoms, to identify recurrent locoregional HNC was widely adopted during the initial peak of the COVID-19 pandemic in the United Kingdom. The majority of patients had no face-to-face reviews or investigations. New symptoms were significantly associated with the identification of locoregional recurrent cancers with a high specificity, but a low sensitivity may limit symptom assessment being used as the sole surveillance method.
MeSH term(s)	COVID-19/epidemiology ; Head and Neck Neoplasms/diagnosis ; Head and Neck Neoplasms/epidemiology ; Head and Neck Neoplasms/therapy ; Humans ; Neoplasm Recurrence, Local/diagnosis ; Neoplasm Recurrence, Local/epidemiology ; Neoplasm Recurrence, Local/therapy ; Pandemics ; Prospective Studies ; Referral and Consultation ; Symptom Assessment ; Telephone
Language	English
Publishing date	2022-06-09
Publishing country	England
Document type	Journal Article
ZDB-ID	2205891-6
ISSN	1749-4486 ; 1749-4478 ; 0307-7772 ; 1365-2273
ISSN (online)	1749-4486
ISSN	1749-4478 ; 0307-7772 ; 1365-2273
DOI	10.1111/coa.13948
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Article ; Online: Feasibility of mass cytometry proteomic characterisation of circulating tumour cells in head and neck squamous cell carcinoma for deep phenotyping.

Payne, Karl / Brooks, Jill / Batis, Nikolaos / Khan, Naeem / El-Asrag, Mohammed / Nankivell, Paul / Mehanna, Hisham / Taylor, Graham

British journal of cancer

2023 Volume 129, Issue 10, Page(s) 1590–1598

Abstract: Background: Circulating tumour cells (CTCs) are a potential cancer biomarker, but current methods of CTC analysis at single-cell resolution are limited. Here, we describe high-dimensional single-cell mass cytometry proteomic analysis of CTCs in HNSCC.!## ...

Abstract	Background: Circulating tumour cells (CTCs) are a potential cancer biomarker, but current methods of CTC analysis at single-cell resolution are limited. Here, we describe high-dimensional single-cell mass cytometry proteomic analysis of CTCs in HNSCC. Methods: Parsortix microfluidic-enriched CTCs from 14 treatment-naïve HNSCC patients were analysed by mass cytometry analysis using 41 antibodies. Immune cell lineage, epithelial-mesenchymal transition (EMT), stemness, proliferation and immune checkpoint expression was assessed alongside phosphorylation status of multiple signalling proteins. Patient-matched tumour gene expression and CTC EMT profiles were compared. Standard bulk CTC RNAseq was performed as a baseline comparator to assess mass cytometry data. Results: CTCs were detected in 13/14 patients with CTC counts of 2-24 CTCs/ml blood. Unsupervised clustering separated CTCs into epithelial, early EMT and advanced EMT groups that differed in signalling pathway activation state. Patient-specific CTC cluster patterns separated into immune checkpoint low and high groups. Patient tumour and CTC EMT profiles differed. Mass cytometry outperformed bulk RNAseq to detect CTCs and characterise cell phenotype. Discussion: We demonstrate mass cytometry allows high-plex proteomic characterisation of CTCs at single-cell resolution and identify common CTC sub-groups with potential for novel biomarker development and immune checkpoint inhibitor treatment stratification.
MeSH term(s)	Humans ; Neoplastic Cells, Circulating/pathology ; Squamous Cell Carcinoma of Head and Neck ; Feasibility Studies ; Proteomics ; Biomarkers, Tumor ; Head and Neck Neoplasms ; Epithelial-Mesenchymal Transition/genetics
Chemical Substances	Biomarkers, Tumor
Language	English
Publishing date	2023-09-21
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	80075-2
ISSN	1532-1827 ; 0007-0920
ISSN (online)	1532-1827
ISSN	0007-0920
DOI	10.1038/s41416-023-02428-2
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Article ; Online: Functional Laryngeal Assessment in Patients with Tracheostomy Following COVID-19 a Prospective Cohort Study.

Dawson, C / Nankivell, P / Pracy, J P / Capewell, R / Wood, M / Weblin, J / Parekh, D / Patel, J / Skoretz, S A / Sharma, N

Dysphagia

2022 Volume 38, Issue 2, Page(s) 657–666

Abstract: To explore laryngeal function of tracheostomised patients with COVID-19 in the acute phase, to identify ways teams may facilitate and expedite tracheostomy weaning and rehabilitation of upper airway function. Consecutive tracheostomised patients ... ...

Abstract	To explore laryngeal function of tracheostomised patients with COVID-19 in the acute phase, to identify ways teams may facilitate and expedite tracheostomy weaning and rehabilitation of upper airway function. Consecutive tracheostomised patients underwent laryngeal examination during mechanical ventilation weaning. Primary outcomes included prevalence of upper aerodigestive oedema and airway protection during swallow, tracheostomy duration, ICU frailty scores, and oral intake type. Analyses included bivariate associations and exploratory multivariable regressions. 48 consecutive patients who underwent tracheostomy insertion as part of their respiratory wean following invasive ventilation in a single UK tertiary hospital were included. 21 (43.8%) had impaired airway protection on swallow (PAS ≥ 3) with 32 (66.7%) having marked airway oedema in at least one laryngeal area. Impaired airway protection was associated with longer total artificial airway duration (p = 0.008), longer tracheostomy tube duration (p = 0.007), multiple intubations (p = 0.006) and was associated with persistent ICU acquired weakness at ICU discharge (p = 0.03). Impaired airway protection was also an independent predictor for longer tracheostomy tube duration (p = 0.02, Beta 0.38, 95% CI 2.36 to 27.16). The majority of our study patients presented with complex laryngeal findings which were associated with impaired airway protection. We suggest a proactive standardized scoring and review protocol to manage this complex group of patients in order to maximize health outcomes and ICU resources. Early laryngeal assessment may facilitate weaning from invasive mechanical ventilation and liberation from tracheostomy, as well as practical and objective risk stratification for patients regarding decannulation and feeding.
MeSH term(s)	Humans ; Prospective Studies ; Tracheostomy/methods ; COVID-19 ; Respiration, Artificial ; Ventilator Weaning/methods
Language	English
Publishing date	2022-07-16
Publishing country	United States
Document type	Journal Article
ZDB-ID	632764-3
ISSN	1432-0460 ; 0179-051X
ISSN (online)	1432-0460
ISSN	0179-051X
DOI	10.1007/s00455-022-10496-4
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Article ; Online: Lack of predictive tools for conventional and targeted cancer therapy: Barriers to biomarker development and clinical translation.

Batis, Nikolaos / Brooks, Jill M / Payne, Karl / Sharma, Neil / Nankivell, Paul / Mehanna, Hisham

Advanced drug delivery reviews

2021 Volume 176, Page(s) 113854

Abstract: Predictive tools, utilising biomarkers, aim to objectively assessthe potentialresponse toa particular clinical intervention in order to direct treatment.Conventional cancer therapy remains poorly served by predictive biomarkers, despite being the ... ...

Abstract	Predictive tools, utilising biomarkers, aim to objectively assessthe potentialresponse toa particular clinical intervention in order to direct treatment.Conventional cancer therapy remains poorly served by predictive biomarkers, despite being the mainstay of treatment for most patients. In contrast, targeted therapy benefits from a clearly defined protein target for potential biomarker assessment. We discuss potential data sources of predictive biomarkers for conventional and targeted therapy, including patient clinical data andmulti-omicbiomarkers (genomic, transcriptomic and protein expression).Key examples, either clinically adopted or demonstrating promise for clinical translation, are highlighted. Following this, we provide an outline of potential barriers to predictive biomarker development; broadly discussing themes of approaches to translational research and study/trial design, and the impact of cellular and molecular tumor heterogeneity. Future avenues of research are also highlighted.
MeSH term(s)	Biomarkers, Tumor/metabolism ; Gene Expression Profiling ; Genomics/methods ; Humans ; Molecular Targeted Therapy ; Neoplasms/genetics ; Neoplasms/pathology ; Neoplasms/therapy ; Proteins/metabolism ; Translational Research, Biomedical/methods
Chemical Substances	Biomarkers, Tumor ; Proteins
Language	English
Publishing date	2021-06-27
Publishing country	Netherlands
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	639113-8
ISSN	1872-8294 ; 0169-409X
ISSN (online)	1872-8294
ISSN	0169-409X
DOI	10.1016/j.addr.2021.113854
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Article ; Online: Re: Audit of specifically designed adenotonsillectomy operation sheet.

Emmett, S R / Nankivell, P

Clinical otolaryngology : official journal of ENT-UK ; official journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery

2010 Volume 35, Issue 3, Page(s) 241–242

MeSH term(s)	Adenoidectomy ; Documentation/standards ; Humans ; Medical Audit/methods ; Postoperative Complications/prevention & control ; Tonsillectomy
Language	English
Publishing date	2010-06
Publishing country	England
Document type	Comment ; Letter
ZDB-ID	2205891-6
ISSN	1749-4486 ; 1749-4478 ; 0307-7772 ; 1365-2273
ISSN (online)	1749-4486
ISSN	1749-4478 ; 0307-7772 ; 1365-2273
DOI	10.1111/j.1749-4486.2010.02145.x
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