Author:
Nankivell Paul,Gaunt Piers,Gaunt Claire,Sissons Julia,Liaskou Evaggelia,Jefferson Yolande,Fulton-Lieuw Tessa,Mittal Saloni,Mehanna Hisham,Abou-Foul Ahmad,Karwath Andreas,Lorenc Ava,Main Barry,Greaves Colin,Moore David,Secher Denis,Watson Eila,Gkoutos Georgios,Ozakinci Gozde,Wolstenholme Jane,Dretzke Janine,Brett Jo,Duda Joan,Matheson Lauren,Jepson Marcus,Wells Mary,Calvert Melanie,Rhodes Pat,Kiely Philip,Thomas Steve,Winter Stuart,Wong Wai-lup,
Abstract
Abstract
Background
Approximately 40% of treated head and neck cancer (HNC) patients develop recurrence. The risk of recurrence declines with time from treatment. Current guidelines recommend clinical follow-up every two months for the first two years after treatment, with reducing intensity over the next three years. However, evidence for the effectiveness of these regimes in detecting recurrence is lacking, with calls for more flexible, patient-centred follow-up strategies.
Methods
PETNECK2 is a UK-based multi-centre programme examining a new paradigm of follow-up, using positron emission tomography-computed tomography (PET-CT)-guided, symptom-based, patient-initiated surveillance. This paradigm is being tested in a unblinded, non-inferiority, phase III, randomised controlled trial (RCT). Patients with HNC, one year after completing curative intent treatment, with no clinical symptoms or signs of loco-regional or distant metastasis will be randomised using a 1:1 allocation ratio to either regular scheduled follow-up, or to PET-CT guided, patient-initiated follow-up. Patients at a low risk of recurrence (negative PET-CT) will receive a face-to-face education session along with an Information and Support (I&S) resource package to monitor symptoms and be in control of initiating an urgent appointment when required. The primary outcome of the RCT is overall survival. The RCT also has an in-built pilot, a nested QuinteT Recruitment Intervention (QRI), and a nested mixed-methods study on patient experience and fear of cancer recurrence (FCR). An initial, single-arm feasibility study has been completed which determined the acceptability of the patient-initiated surveillance intervention, the completion rates of baseline questionnaires, and optimised the I&S resource prior to implementation in the RCT.
Discussion
We hypothesise that combining an additional 12-month post-treatment PET-CT scan and I&S resource will both identify patients with asymptomatic recurrence and identify those at low risk of future recurrence who will be empowered to monitor their symptoms and seek early clinical follow-up when recurrence is suspected. This change to a patient-centred model of care may have effects on both quality of life and fear of cancer recurrence.
Trial registration
ISRCTN: 13,709,798; 15-Oct-2021.
Funder
National Institute for Health and Care Research
Publisher
Springer Science and Business Media LLC
Reference57 articles.
1. Sung H, Ferlay J, Siegel RL, et al. Global Cancer statistics 2020: GLOBOCAN estimates of incidence and Mortality Worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71(3):209–49. https://doi.org/10.3322/caac.21660.
2. Cancer Research UK. Head and neck cancers statistics [ https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/head-and-neck-cancers#:~:text=Head%20and%20neck%20cancer%20is%20the%2015th%20most%20common%20cause,year%20(2017%2D2019). Last Accessed: 18-Aug-2023.
3. Ang KK, Harris J, Wheeler R, et al. Human papillomavirus and survival of patients with oropharyngeal cancer. N Engl J Med. 2010;363(1):24–35. https://doi.org/10.1056/NEJMoa0912217.
4. Forastiere AA, Goepfert H, Maor M, et al. Concurrent chemotherapy and radiotherapy for organ preservation in advanced laryngeal cancer. N Engl J Med. 2003;349(22):2091–8. https://doi.org/10.1056/NEJMoa031317.
5. Wensing BM, Merkx MAW, Krabbe PFM, et al. Oral squamous cell carcinoma and a clinically negative neck: the value of follow-up. Head Neck. 2011;33(10):1400–5. https://doi.org/10.1002/hed.21642.