Document Type
Article
Publication Date
7-1-2026
Abstract
The management of locally-advanced, resectable head and neck squamous cell carcinoma (HNSCC) is undergoing a major shift driven by the integration of neoadjuvant immunotherapy (nIO). The rationale for nIO lies in its administration within an immunologically active, treatment-naïve microenvironment that enhances immune priming and anti-tumor response. Despite encouraging clinical data, including the pivotal KEYNOTE-689 trial and multiple phase II studies, methodological heterogeneity in trial design, endpoint definitions, and response criteria currently hampers data comparability and the establishment of new standards of care. This expert narrative review proposes a structured framework for standardizing clinical, pathologic, imaging, and translational endpoints in HNSCC nIO trials, highlighting harmonized definitions of pathologic response, practical reporting templates, and methods to evaluate immune priming. Standardization of response evaluation, biomarker integration, and trial methodology is essential to accelerate the translation of neoadjuvant immunotherapy into routine clinical practice for HNSCC.
Recommended Citation
Resteghini, Carlo; Argiris, Athanassios; Blanchard, Pierre; Braña, Irene; Camarda, Anna Maria; Chan, Anthony T. C.; Ferris, Robert; Gregoire, Vincent; Harrington, Kevin J.; Tinhofer, Ingeborg; Koljenović, Senada; Lee, Nancy Y.; Leemans, C. René; Machiels, Jean-Pascal; Mehanna, Hisham; Metcalf, Robert; O'Sullivan, Brian; Oosting, Sjoukje; Orlandi, Ester; Paleri, Vinidh; Psyrri, Amanda; Saba, Nabil F F.; Schmitz, Sandra; Simon, Christian; Tahara, Makoto; Poorten, Vincent Vander; Vošmik, Milan; and Bossi, Paolo, "Standardization of Objectives and Response Criteria for Neoadjuvant Immunotherapy in Resectable Squamous Cell Carcinoma of the Head and Neck" (2026). Department of Medical Oncology Faculty Papers. Paper 343.
https://jdc.jefferson.edu/medoncfp/343
Creative Commons License

This work is licensed under a Creative Commons Attribution-Noncommercial-No Derivative Works 4.0 License.
PubMed ID
42365828
Language
English

Comments
This article is the author's final published version in Cancer Treatment Reviews, Volume 148, 2026, Article Number 103175.
The published version is available at https://doi.org/10.1016/j.ctrv.2026.103175. Copyright © The Authors.