{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T04:57:27Z","timestamp":1790744247476,"version":"4.1.0"},"reference-count":71,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T00:00:00Z","timestamp":1790640000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T00:00:00Z","timestamp":1790640000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["pathsocjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Journal of Pathology CR"],"published-print":{"date-parts":[[2026,11]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Head and neck cancer (HNC) trials have demonstrated pathological complete response (pCR) in patients receiving neoadjuvant treatment prior to surgery; however, systematic reviews have reported marked variation in pCR rates. This scoping review was designed to determine the definition, criteria, and assessment methodologies for pCR in interventional neoadjuvant HNC clinical trials. The review was conducted in accordance with the\n                    <jats:italic>JBI Manual for Evidence Synthesis<\/jats:italic>\n                    and the protocol prospectively registered. Medical databases, trial registries, and grey literature were systematically searched, and eligibility criteria applied. Study characteristics and pCR assessment methodologies were extracted and described. A total of 4,931 sources were identified, and screening identified 114 trials. Only 22 studies had publicly accessible protocols for assessment. Trials were initiated between 1989 and 2025, and the majority were phase II investigating chemotherapy + immunotherapy regimens (51%). pCR was most frequently classified as a secondary endpoint (55%), and reported pCR rates ranged from 0% to 100%. There was heterogeneity and incomplete documentation in both specimen preparation and pCR assessment. Where specified, most included assessment at both primary tumour and lymph nodes (50 of 69; 72%), and quantitative assessment calculating percentage residual viable tumour was common. While no formal guidelines for pCR assessment in HNC were identified, one trial outlined an immune\u2010related pathological response criteria for oral squamous cell carcinoma, and another included a detailed \u2018pathological response assessment\u2019 proforma. Citation of methodologies used in other cancers, for example, lung and breast cancer, was a recurring theme. Based on these findings, we propose pragmatic definitions, assessment considerations, and a structured reporting proforma to support increased transparency and reproducibility in pCR reporting. While these proposed elements are not consensus based, they provide a foundation for harmonisation efforts and highlight priorities for development of international consensus guidelines to enable meaningful comparison of interventions and determine the validity of pCR as a surrogate endpoint in HNC.\n                  <\/jats:p>","DOI":"10.1002\/2056-4538.70114","type":"journal-article","created":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T04:16:27Z","timestamp":1790741787000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Assessment methods of pathological complete response in neoadjuvant head and neck cancer clinical trials: a scoping review"],"prefix":"10.1002","volume":"12","author":[{"ORCID":"https:\/\/orcid.org\/0009-0003-6194-2237","authenticated-orcid":false,"given":"Peter","family":"Robinson","sequence":"first","affiliation":[{"name":"Faculty of Medical Sciences Newcastle University  Newcastle upon Tyne UK"},{"name":"Department of Cellular Pathology The Newcastle upon Tyne Hospitals NHS Foundation Trust  Newcastle upon Tyne UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charlotte Catrina","family":"Currie","sequence":"additional","affiliation":[{"name":"Faculty of Medical Sciences Newcastle University  Newcastle upon Tyne UK"},{"name":"Department of Cellular Pathology The Newcastle upon Tyne Hospitals NHS Foundation Trust  Newcastle upon Tyne UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hisham","family":"Mehanna","sequence":"additional","affiliation":[{"name":"The Institute for Head and Neck Studies and Education (InHANSE) University of Birmingham  Birmingham UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Muhammad Shahid","family":"Iqbal","sequence":"additional","affiliation":[{"name":"Northern Centre for Cancer Care The Newcastle upon Tyne Hospitals NHS Foundation Trust  Newcastle upon Tyne UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James","family":"O'Hara","sequence":"additional","affiliation":[{"name":"Faculty of Medical Sciences Newcastle University  Newcastle upon Tyne UK"},{"name":"Department of Otolaryngology \u2010 Head and Neck Surgery The Newcastle upon Tyne Hospitals NHS Foundation Trust  Newcastle upon Tyne UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elsa","family":"Camp\u00f4a","sequence":"additional","affiliation":[{"name":"Department of Oncology Unidade Local de Sa\u00fade do Algarve  Portim\u00e3o Portugal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Myrto","family":"Moutafi","sequence":"additional","affiliation":[{"name":"Department of Oncology Attikon University Hospital  Athens Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4491-6865","authenticated-orcid":false,"given":"Max","family":"Robinson","sequence":"additional","affiliation":[{"name":"Department of Cellular Pathology The Newcastle upon Tyne Hospitals NHS Foundation Trust  Newcastle upon Tyne UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,9,29]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"crossref","first-page":"923","DOI":"10.1001\/jamaoncol.2024.1530","article-title":"Neoadjuvant nivolumab plus chemotherapy followed by response\u2010adaptive therapy for HPV+ oropharyngeal cancer: OPTIMA II phase 2 open\u2010label nonrandomized clinical trial","volume":"10","author":"Rosenberg AJ","year":"2024","journal-title":"JAMA Oncol"},{"key":"e_1_2_8_3_1","doi-asserted-by":"crossref","first-page":"37","DOI":"10.1056\/NEJMoa2415434","article-title":"Neoadjuvant and adjuvant pembrolizumab in locally advanced head and neck cancer","volume":"393","author":"Uppaluri R","year":"2025","journal-title":"N Engl J Med"},{"key":"e_1_2_8_4_1","volume-title":"Pembrolizumab for Neoadjuvant and Adjuvant Treatment of Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma TA1145","author":"National Institute for Health and Care Excellence","year":"2026"},{"key":"e_1_2_8_5_1","unstructured":"National Comprehensive Cancer Network.NCCN Clinical Practice Guidelines in Oncology Head and Neck Cancers. 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