Patient characteristics, treatment patterns and healthcare resource utilization of newly diagnosed locally advanced head and neck squamous cell carcinoma: an observational retrospective cohort analysis of real-world data in England (ODR2021_255)

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Objective for processing

The aim of this study is to harness real world data from a nationwide registry to describe the characteristics of patients newly diagnosed with LA HNSCC in England, including treatment patterns, clinical outcomes and healthcare resource utilization (HCRU). Adelphi Group Ltd requires access to NHS England data for the purpose of the following research project: 2.1 Primary Objective(s) & Hypothesis(es) Patient characteristics, treatment patterns and healthcare resource utilization of newly diagnosed locally advanced head and neck squamous cell carcinoma: an observational retrospective cohort analysis of real-world data in England The specific primary research objectives for this study are: The following is a summary of the aims of the research project provided by Adelphi Group Ltd: 1. To describe the demographics and clinical characteristics of patients with newly diagnosed LA HNSCC. The aim of this project is to describe the disease characteristics of patients diagnosed with head and neck cancer that has spread to nearby areas, termed locally advanced. The study will describe the treatments they receive, how effective these treatments are and look at the use and costs associated with the healthcare provided to these patients in England. 2. To describe the treatment landscape, including pharmacological and other interventional (i.e. surgery, radiotherapy) treatments for patients newly diagnosed with LA HNSCC. This study will help inform the use of new treatments that can improve outcomes for patients with locally advanced head and neck cancer. 3. To describe the all-cause and HNSCC-related HCRU and direct medical costs, prior to and following a new diagnosis of LA HNSCC. Head and neck cancers are the eighth most common type of cancer in the UK, with 90% of these cancers developing from cells that line the inside of the mouth, nose and throat (known as squamous cell carcinomas). Of these, as many as 60% are diagnosed with locally advanced cancer whereby the tumour cells have spread to nearby areas. As cancers can originate from several areas around the head and neck, treatment depends on the location and size of the tumour. Locally advanced head and neck cancer is potentially curable, however 15-50% of patients with the disease experience repeating tumours or further spread of the disease to distant areas of the body (termed distant metastasis), which can result in poorer chances of survival and difficulty in managing the disease. As a result, fast and effective treatment strategies are required to improve patient survival. 4. To evaluate real world effectiveness outcomes of patients with newly diagnosed While less severe (termed early stage) cancers are treated with surgery or radiotherapy, locally advanced cancers require various combinations and rounds of surgery, radiotherapy and or chemotherapy. This mixed approach to treatment can make evaluating the effectiveness of different treatment strategies difficult. Many clinical trials have shown that different treatment strategies and drugs can improve the control of locally advanced head and neck cancer, but very few studies have investigated this outside the clinical trial setting, in the real world. LA HNSCC including event-free survival (EFS) and overall survival (OS). This study will therefore evaluate how patients in England are being treated for locally advanced squamous cell head and neck cancer by providing a comprehensive overview of the types of patients prescribed each treatment, their outcomes, and the healthcare use and associated costs related to this, to understand which patients types may benefit from improvements in treatment. 2.2 Exploratory Objective(s) & Hypothesis(es) The Data will be used to provide services to Merck Sharp & Dohme (UK) Limited (Medical Affairs UK) only. Merck act as joint data controller and funder under this application. 1. To estimate the prevalence of LA HNSCC and describe changes in the epidemiology over time. The Data will be used to provide the following services only: 2. To evaluate disease progression following a diagnosis of LA HNSCC, including time to locoregional progression (LR/P) and time to recurrent/distant metastases (R/DM). • improvement of health and social care planning. 3. To describe the treatment landscape, including pharmacological and other interventional (i.e. surgery, radiotherapy) treatments by stage of HNSCC progression (LR/P and R/DM). The following NHS England Data will be accessed: 4. To describe the all-cause and HNSCC-related HCRU and direct medical costs by stage of HNSCC progression (LR/P and R/DM). • NDRS Cancer Registrations • NDRS Systemic Anti-Cancer Therapy Dataset (SACT) • NDRS National Radiotherapy Dataset (RTDS) • NDRS Linked HES APC • NDRS Linked HES Outpatient • NDRS Linked HES AE • NDRS Linked Cancer Waiting Times (Treatments only) • NDRS Linked DIDs • NDRS Cancer Pathway All data is necessary to describe the characteristics of patients newly diagnosed with Locally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC) in England, including treatment patterns, clinical outcomes and healthcare resource utilization (HCRU). The level of the Data will be: • Pseudonymised The Data will be minimised as follows: • Limited to a study cohort identified by NHS England (previously PHE) as –Adults (≥18 years old) in England with a first diagnosis of head and neck cancer within the indexing period. Patients who are diagnosed with early stage disease and progress to the locally advanced stage are of interest as well as newly diagnosed patients at the locally advanced stage. • Patients diagnosed with head and neck cancer between 01/01/2015 and 31/12/2018 • Limited to conditions relevant to the study identified by specific ICD codes (ICD-10 C00x-C14x, C30x-C32x, with ICD-02/O3 - 805x-808x, 8094, 8560, 8570, 9312) • Limited to the following geographic areas: England Adelphi Group Limited (AGL); otherwise known as Adelphi Real World (ARW); is the controller. Merck act as joint data controller and funder under this application. Merck has commissioned Adelphi Group Ltd to undertake this work and has determined the purpose of processing but will not process the data nor direct Adelphi Group Limited in the processing of these data. The lawful basis for processing personal data under the UK GDPR is: Article 6(1)(f) - processing is necessary for the purposes of the legitimate interests pursued by the controller or by a third party. Adelphi Group Limited has determined the processing is necessary for its legitimate interests in being able to describe the current treatment patterns and outcomes for the patient group to increase general understanding and increase awareness for multiple scientific and public groups including clinicians, researchers, the patient community, and the public. The lawful basis for processing special category data under the UK GDPR is: Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject. This processing is in the public interest because it adheres to the UK Policy Framework for Health and Social Care Research, which protects and promotes the interests of patients, service users and the public, and aims to produce generalisable and publicly available information to inform future decisions over patients’ treatments or care. The funding is provided by Merck Sharp & Dohme (UK) Limited (Medical Affairs UK). The funding is specifically for the project described. Funding to continue the work described will be sought on an ongoing basis. The funder will have no ability to suppress or otherwise limit the publication of findings. Box.com is a processor acting under the instructions of Adelphi Group Ltd. Box.com provides cloud storage services to Adelphi Group Ltd and will store the Data as contracted by Adelphi Group Ltd.

Processing activities

The population of interest for this study will be adults (≥18 years old) in England with a first diagnosis of LA HNSCC within the indexing period. Patients who are diagnosed with early stage disease and progress to the locally advanced stage are of interest as well as newly diagnosed patients at the locally advanced stage. Specific eligibility criteria are detailed in the subsequent section. Public Health England (PHE) dissolved in October 2021 the National Disease Registration Service (NDRS) migrated to NHS England. Inclusion Criteria 1. No data will flow to NHS England for the purposes of this Data Sharing Agreement (DSA). Patient has a diagnosis of primary head and neck cancer (ICD-10 codes C00-C14, C32) recorded within the Cancer Registry at any time. PHE provided the relevant records from the Cancer Registry, Systemic Anti-Cancer Therapy Dataset (SACT), National Radiotherapy Dataset (RTDS), HES Admitted Care, HES Outpatient, HES Accident and Emergency, Cancer Waiting Times (CWT), Diagnostic Imaging Dataset (DIDs) and the Cancer Pathway datasets to Adelphi Group Ltd. 2.Patient has a confirmed histology of squamous cell carcinoma of the primary head and neck tumour(ICD-02 code). The Data held contains no direct identifying data items. The Data will be pseudonymised and individuals cannot be reidentified through linkage with other data in the possession of the recipient. 3.Patient has a record of locally advanced disease of the primary head and neck tumour within the indexing period (Stage derived from imaging: III, IVa or IVb; or TNM stage T3 and above, N0 and above and M0). Adelphi Group Ltd will extract a subset of the Data comprised of aggregated data and make this available to Merck. 4.Patient is aged ≥18 years on the date of the first record of locally advanced HNSCC. Adelphi Group Ltd stores Data on the Cloud provided by Box.com. 5.Patient has data linkage to HES datasets (for all objectives except that of prevalence estimation). The Data will not leave the UK at any time. Exclusion Criteria The core dataset will only be accessed by employees or agents of Adelphi Group Ltd. They will produce subsets of the Data that will be accessed by Merck. 1.Patient is diagnosed with and/or receiving treatment for other primary malignancies registered within the Cancer Registry prior to, including or during the index and/or follow up period. All personnel accessing the Data have been appropriately trained in data protection and confidentiality. 2.Patient has a record of newly diagnosed primary head and neck tumor at the metastatic stage (Stage: IVc; TNM: M stage of M1). Data linkage was conducted by NHS England’s predecessor (PHE). 3.Patient has a confirmed histology of non-squamous cell carcinoma of the primary head and neck tumour (ICD-02 code). There will be no requirement and no attempt to reidentify individuals when using the Data. 4.Patient is enrolled in a clinical trial for any line of systemic anti-cancer therapy treatment relating to their HNSCC diagnosis, identified by the clinical trial indicator in SACT (or any other of the NCRAS datasets). Analysts from Adelphi Group Ltd will analyse the Data for the purposes described above. 3.5 Stratification / Subgroup analyses Where possible and if sample size allows, all analyses will be stratified according to the following factors: 1)Socio-demographics: age, gender, ethnicity 2)Stage at diagnosis: Stage I, Stage II, Stage III, Stage IVa & Stage IVb; Newly diagnosed LA HNSCC vs progression from early HNSCC disease 3)Location of primary tumour: Lip, Oral cavity, Oropharynx, Salivary glands, Larynx, Hypopharynx Middle ear, Nasal cavity, Other; Tumours within Oropharynx, Larynx, Hypopharynx and Oral cavity vs other locations 4)Resectability: Resectable / unresectable at initial HNSCC diagnosis 5)Treatment: Systemic anti-cancer received vs surgery/radiotherapy treated only Data Sources NCRAS is the population-based cancer registry for England. It is responsible for collecting, quality assuring and analysing data on all patients who have been diagnosed with a primary tumour (ICD 10 C00-97, D00-48) in England. NCRAS employs an event-based registration model, with data on each primary tumour being sent from multiple sources to NCRAS, and either registered as a new cancer or linked to an existing cancer registration as a new event. Finalised cancer registrations are processed within an environment called the Cancer Analysis System (CAS). CAS is comprised of a number of relational datasets, outlined in the sections below. NCRAS data sets are maintained and managed by Public Health England (PHE) and NHS England. The individual data sets are linked by pseudonymized Patient ID numbers to ensure patient anonymity. A single data application, currently via PHE, is required to provide access to the linked data sets with no limitation on the number of linkages that can be requested. The suggested data sets for use in this study are detailed below. Cancer Registry The Cancer Registry is a population-based registry which collects data on cancer patients in England, including diagnosis information, tumour information and treatment events. Patients are entered into the registry on their first cancer diagnosis (multiple primary cancers are recorded). Various validation and quality control steps are applied to each registry input, ensuring the collection and release of consistent and fully processed data. The registry has complete national coverage of cancer patients in England, receiving data from all NHS providers (~98-99% of hospital activity). Data is received from a variety of sources, including: ‘ multidisciplinary team meetings, pathology reports, molecular testing results, treatment records, hospital activity records, hospital Patient Administration Systems, and operational standards such as cancer waiting times’[32]. Tumour site and morphology is coded using the ICD-O2 classification and ICD-10 coding. Patients diagnosed with registerable tumours in the calendar years 1995 to 2018 are currently available within the dataset. Patient data collected includes socio-demographics including age and ethnicity. Comorbidities via the Charlson Comorbidity Index (CCI) is captured using data from HES. Vital status information. Limited Access date and cause) is reported using data from the Office for National Statistics (ONS). Cancer/tumour specific details captured include: diagnosis date, cancer site, morphology, stage at diagnosis (TNM), hormone receptor status for specific tumour types, and cancer treatment data (procedure codes) [32]. Registry records can be deterministically linked to the SACT data set which provides additional comprehensive chemotherapy-specific treatment data. All data received from the Cancer Registry is structured data and does not include any verbatim records lifted directly from patient records. Systemic Anti-Cancer Therapy (SACT) Data Set The SACT data set collects data on both adult and paediatric patients receiving chemotherapy for cancer, in or funded by the NHS. This includes inpatient, outpatient, day case and community delivered chemotherapy occurrences, as well as chemotherapy provided in clinical trials. The SACT data set contains granular and comprehensive data for all anti-cancer chemotherapy occurrences allowing for a detailed assessment of the treatment landscape, including regimen specifics (e.g. start date and decision to treat date); cycle details (e.g. start date and cycle number); drug details (e.g. regimen, drug types and dosages) and outcomes (e.g. regimen modifications and overall outcome summary). Basic patient demographics are also captured, along with tumour information such as primary diagnosis, morphology and TNM stage at the start of each treatment regimen [33]. Like the cancer registry, the ICD-10 coding system is used for diagnoses. Tumour information is coded using ICD-O2 (histology) and ICD-10 (topography) coding systems. Some treatment procedure information is coded using the UK Office of Population, Census and Surveys (OPCS) Classification of Interventions and Proceduressystem [33]. Data is available to the last available quarter before the request date, which is approximately 6 months behind the current date. The same time periods for data availability also applies to the RTDS Radiotherapy Data Set (RTDS). PHE applies restrictions on data related to treatment using drugs funded through the Cancer Drug Fund (CDF). As a result, data on patients receiving such treatments may not be available. Limitations. It is anticipated that this limitation will have minimal impact on the study since there are no therapies recommended for use within the CDF for LA HNSCC and the number of therapies available via the CDF for metastatic disease is limited (only TA490 at exit stage with an anticipated final recommendation due by NICE in August 2021)[35]. 3.6.1.3 Radiotherapy Data Set (RTDS) The RTDS captures clinical information on patients treated with radiotherapy in or funded by the NHS in England. Detailed radiotherapy information is collected including comprehensive treatment dates, regimen details, exposure details and dosages. Diagnoses (ICD-10) are also captured. RTDS data will allow radiotherapy-related interventions to be observed for the study. Hospital Episode Statistics (HES) secondary care data The PHE data sets will be linked to the HES Admitted Care (AC), Outpatient (OP) and Accident & Emergency (A&E) datasets. HES contains details on all inpatient admissions (AC), outpatient appointments (OP) and A&E attendances (A&E) to an NHS funded centre in England and was established to monitor hospital activity. HES linkage will enable an extensive assessment of HCRU in relation to HNSCC patients and allow for derivation and identification of key events in the patient pathway. HES data is available up to 4-7 months prior to the current date/date of data request and can be linked up to 12-months prior to patient registration in the cancer registry, enabling baseline data to be gathered. HES AC data includes basic patient demographics, date and method of hospital admission (elective/non-elective) and discharge, diagnoses (including primary diagnosis), specialists seen, and procedures undertaken. Data is coded using the ICD-10 coding frame as well as procedure information being coded using the OPCS version 4.6 Classification of Interventions and Procedures system. HES OP contains records of outpatient appointments in England including dates, specialty, clinical diagnoses and procedures. The HES A&E dataset consists of individual records of patient attendances in A&E in England, including diagnoses and investigations and attendance outcomes. A Healthcare Resource Group (HRG) can be derived for each inpatient admission and outpatient attendance, whereby HRGs are standard groupings of clinically similar treatments / events which use common levels of healthcare resource. The HRG4+ Local Payment Grouper can be used to derive HRGs and was developed to be used in line with the National Reimbursement System as produced by NHS England and NHS Improvement [36]. The derivation of HRGs in the inpatient setting incorporates patient demographics, source / method of admission, destination / method of discharge, durations of episodes, specialties treated under, diagnoses and procedures undertaken. Derivation of HRGs in the outpatient setting incorporates only patient demographics, specialties treated under, sequence of attendances and procedures undertaken. Unit cost data. The following elements of HCRU can be transformed into direct healthcare costs using appropriate unit cost data: Systemic anti-cancer therapy, For branded systemic anticancer therapies, the following sources may be used to estimate costs associated with each treatment: Monthly Index of Medical Specialities British National formulary (BNF) aka Medicines Complete. For chemotherapies the drugs and pharmaceutical electronic market information tool (eMIT) may be used to estimate costs associate with each treatment. Systemic anti-cancer treatment cost calculations will take into account the duration of treatment and drug doses administered. HRGs derived for secondary care activity. The HRG4+ Local Payment Grouper will be used to derive HRGs for care provided in the inpatient, outpatient and A&E settings. The monetary amount a provider is reimbursed for a particular HRG code will be taken from the national prices and national tariff workbook compiled and provided by NHS Improvement and NHS England. The workbook outlines national prices for each HRG code, which are dependent upon the care setting (inpatient or outpatient), method of admission (elective, non-elective, day case etc.) and length of stay. For all sources of unit cost data, the most recent source document available at the time of analysis will be used with the version noted and detailed in the final study report. If the most current documentation is one or more years outdated at the time of analysis, inflation adjustments for costs will be applied with full details to be documented in a separate study Statistical Analysis Plan (SAP). Previous unit cost data may be used if data from recent source documents lacks costing information for specific HRG costs. Diagnostic Imaging Data set (DID)The DID collects detailed diagnostic imaging data for NHS patients, which is extracted from radiology information systems. The DID captures information about referrals for diagnostic imaging (e.g. the source), imaging details (type and body site), dates of imaging (including request dates and reporting dates). It also captures patient demographics. National Interim Clinical Imaging Procedure (NICIP) codes and Systematized Nomenclature of Medicine Clinical Terms (SNOMED-CT) codes are used to inform on test modality and body site of tests. Due to limitations in data availability (data only available to end of 2018) DID data for the baseline clinical characteristics only will be assessed using this dataset. 3.6.2.3 Cancer Pathway Data set. The cancer pathway data set describes significant clinical or administrative patient events occurring in the process between diagnosis to treatment and into follow up. Such events are summarized using data from the Cancer Registry, SACT, RTDS, HES, DID and CWT. Events may include, CWT referrals, diagnoses, A&E attendances, major surgery or various treatment events, each of which are recorded as a single event. Disease progression may be inferred using patient pathway events. National Cancer Waiting Times (CWT) The National CWT Monitoring Data Set supports the continued management and monitoring of English NHS cancer waiting times standards. Data is available for all cancer treatments recorded in the CWT database that are linked to a registerable tumour from the cancer registry data. Approximately 80% of tumours (ICD-10 C00-C97, D05 exc. C44) are linked to at least one treatment record in the National CWT database. The CWT captures information about the patient’s referral process, diagnosis including tumour characteristics as well as treatment events

Expected output

A final study report is in development, describing the methods, results, and interpretation of results. A manuscript will be developed and submitted to a relevant peer-reviewed journal (such as the Journal of Clinical Oncology, Frontiers in Oncology or Annals of Oncology (to be decided) as well as an abstract and poster to be submitted to an appropriate congress (American Society of Clinical Oncology [ASCO] – others to be decided. One abstract was submitted and accepted for presentation at ESMO 2022. Manuscript development, submission and review is planned to be completed by the end of 2023. These outputs will enable both the scientific community and general public to be informed of and benefit from the results of this study, with the aim of encouraging discussion between academics and clinicians on potential areas for improvement within the patient treatment pathway. The outputs will only be aggregated data with small number suppression applied where necessary (both primary and secondary suppression). The study is not looking at specific treatments and direct outcomes and no safety data will be generated as a result of this study. The expected outputs of the processing will be: Results to the public domain in the form of abstracts, posters, presentations and/or manuscripts for submission to scientific congresses and journals will be aggregated outputs of the results only, with both primary and secondary small number suppression where required. Additionally, published findings of this study will be disseminated to the public and patient community to improve patient information / understanding and patient engagement. • Submissions to peer reviewed journals (such as the Journal of Clinical Oncology, Frontiers in Oncology or Annals of Oncology) • Presentations to an appropriate congress (American Society of Clinical Oncology [ASCO] • Presentation at ESMO 2022. The outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived. The outputs will be communicated to relevant recipients through the following dissemination channels: • Journals • Press/media engagement • Public promotion of the research • Reports aimed at the public and patient community The DSA extension is required to complete analyses for the purpose of manuscript publication, to characterise the treatment pathway and outcomes of the Locally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC) population in England. As the final publication is not complete, we would benefit from having the dataset available, in case feedback from journals require further minor amendments to analyses conducted.

Expected measurable benefits

Worldwide, there were 890,100 new cases of head and neck squamous cell carcinoma (HNSCC) and 450,000 deaths in 2018. The incidence of HNSCC is predicted to rise to 1.08 million new cases annually by 2030, with around 60% of patients being diagnosed with locally advanced (LA) HNSCC (stage III to IVb). Survival rates have only modestly improved over the past 30 years. Patients surviving HNSCC also have the second highest suicide rates (63.4 per 100,000 individuals) compared with survivors of other cancers. As a result, there is a clear psychological and clinical burden on patients with HNSCC, where better treatments and outcomes are required. These statistics highlight that the study results could help highlight gaps in the care of LA HNSCC patients, improve the lives of these patients. The findings of this research study are expected to enable both the scientific community and general public to be informed of and benefit from the results of this study, with the aim of encouraging discussion between academics and clinicians on potential areas for improvement within the patient treatment pathway. Additionally, to improve patient information, understanding and patient engagement. [1 paragraph unchanged] - A better understanding of the clinical characteristics of patients with LA HNSCC Locally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC) - Treatment patterns and observed pathways for patients diagnosed with LA HNSCC Locally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC) - An understanding of gaps in the treatment of LA HNSCC, Locally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC), and highlight where the introduction of immunotherapy and other medical strategies may benefit patient outcomes and improve survival rates - An understanding of the burden of LA HNSCC Locally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC) on both patients and the NHS by assessing the real-world effectiveness outcomes [5 words unchanged] as well as healthcare resource use and costs incurred to the NHS The dissemination strategy will provide evidence to support clinicians in the treatment of LA HNSCC, Locally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC), inform ongoing standard of care improvement strategies in the use of new [9 words unchanged] clinical trials in line with the overall aim to improve patient outcomes. This study is not in support of a PhD/post-graduate research study. Data will not be used for sales and marketing purposes.

Benefits reported

N/A The results from this study have been presented as a poster at ESMO 2022 and in an online abstract for ASCO 2023. They demonstrated the real-word treatment patterns and clinical outcomes of Locally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC). Locally advanced head and neck squamous cell carcinoma (stage III-IVb) is a potentially curable disease. However, many patients experience recurrence and metastasis, resulting in poorer prognoses. The multimodal approach to treating locally advanced head and neck squamous cell carcinoma makes the evaluation of treatment regimens difficult. This study aimed to describe the clinical characteristics and real-world treatment patterns of locally advanced head and neck squamous cell carcinoma patients in England. In this retrospective cohort study, we used data from the National Cancer Registration and Analysis Service databases (Cancer Registry, Systemic Anti-Cancer Therapy, Hospital Episode Statistics, National Radiotherapy Dataset). Adults with a first record of primary locally advanced head and neck squamous cell carcinoma between 01/01/2015 and 31/12/2018 were indexed. We investigated standard treatment patterns and clinical characteristics during a maximum of 5-years follow-up period extending to December 2020. A total of 12,790 patients met the inclusion criteria, 73.0% male. The mean age at diagnosis was 62.4 years (SD 11.5). 75.9% of patients were diagnosed with stage 4 head and neck squamous cell carcinoma at index (65.4% stage 4a) and 40.3% were deemed resectable. The mean time from index to primary surgery was 57.2 days (SD 139.2). 47.0% were treated with surgery and/or radiotherapy alone. Of the 6665 patients who received chemotherapy as part of their combination treatment (which may have included surgery and/or radiotherapy +/- concurrent chemotherapy), 3.1% (204/6665) received neoadjuvant (induction) chemotherapy, 31.3% (2087/6665) received chemotherapy after surgery and 65.6% (4374/6665) received chemotherapy in the absence of surgery. The majority of chemotherapy regimens used were platinum-based. This is one of the first real world studies using the UK NCRAS dataset to characterise the UK locally advanced head and neck squamous cell carcinoma population and their treatment patterns. The majority of patients were diagnosed at an advanced stage, highlighting the need for earlier identification and detection of these patients to improve their clinical outcomes.