Updated pan-tumor guidelines for neoadjuvant scoring of pathologic response: a joint SITC and INMC effort

J S Deutsch¹, R A Scolyer², E Burton³, K J Busam⁴, K Y Chen⁵, A Cimino-Mathews⁶, T R Cottrell⁷, C E de Andrea⁸, P O Fiset⁹, G V Long¹⁰, J Messina¹¹, R V Rawson¹², R Salgado¹³, C M Schürch¹⁴, R R Seethala¹⁵, L M Sholl¹⁶, S Signoretti¹⁶, S L Topalian¹⁷, B A van de Wiel¹⁸, X Xu¹⁹, J E Gershenwald²⁰, M T Tetzlaff²¹, J M Taube²²

Affiliations

¹ Departments of Dermatology, Pathology, and Oncology, and The Bloomberg∼Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University SOM, Baltimore, USA.
² Melanoma Institute Australia, The University of Sydney, Sydney, Australia; Faculty of Medicine and Health, The University of Sydney, Sydney, Australia; Royal Prince Alfred Hospital and NSW Health Pathology, The University of Sydney, Sydney, Australia; Charles Perkins Centre, The University of Sydney, Sydney, Australia.
³ The University of Texas MD Anderson Cancer Center, Houston, USA.
⁴ Department of Pathology and Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, USA.
⁵ Departments of Dermatology, Johns Hopkins University SOM, Baltimore, USA.
⁶ Pathology, Johns Hopkins University SOM, Baltimore, USA.
⁷ Queen's University Sinclair Cancer Research Institute, Kingston, Canada.
⁸ Pathology, University of Navarra, Pamplona, Spain.
⁹ Department of Pathology, McGill University Health Centre, Montréal, Canada.
¹⁰ Melanoma Institute Australia, The University of Sydney, Sydney, Australia; Faculty of Medicine and Health, The University of Sydney, Mater and Royal North Shore Hospitals, Sydney, Australia.
¹¹ Department of Cutaneous Oncology, Moffitt Cancer Center, Tampa, USA.
¹² Melanoma Institute Australia, The University of Sydney, Sydney, Australia; Faculty of Medicine and Health, The University of Sydney, Sydney, Australia; Royal Prince Alfred Hospital and NSW Health Pathology, The University of Sydney, Sydney, Australia.
¹³ Department of Pathology, ZAS Hospitals, Antwerp, Belgium; Division of Research, Peter MacCallum Cancer Centre, Melbourne, Australia.
¹⁴ Department of Pathology and Neuropathology, University Hospital and Comprehensive Cancer Center Tübingen, Tübingen, Germany; Cluster of Excellence iFIT (EXC 2180) "Image-Guided and Functionally Instructed Tumor Therapies", University of Tübingen, Tübingen, Germany.
¹⁵ University of Pittsburgh Medical Center, Department of Pathology, Pittsburgh, USA.
¹⁶ Department of Pathology, Brigham and Women's Hospital, Boston, USA.
¹⁷ Department of Surgery, Johns Hopkins University SOM, Baltimore, USA; Bloomberg-Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University SOM, Baltimore, USA; Johns Hopkins Kimmel Cancer Center, Baltimore, USA.
¹⁸ Department of Pathology, Netherlands Cancer Institute, Amsterdam, The Netherlands.
¹⁹ Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA.
²⁰ Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, USA.
²¹ Departments of Pathology and Dermatology, Dermatopathology and Oral Pathology Unit, University of California San Francisco, San Francisco, USA.
²² Bloomberg-Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University SOM, Baltimore, USA; Departments of Dermatology, Pathology, and Oncology, The Mark Foundation Center for Advanced Imaging and Genomics, Baltimore, USA. Electronic address: jtaube1@jhmi.edu.

PMID: 41469296
DOI: 10.1016/j.annonc.2025.10.018

Review

Updated pan-tumor guidelines for neoadjuvant scoring of pathologic response: a joint SITC and INMC effort

J S Deutsch et al. Ann Oncol. 2026 Feb.

. 2026 Feb;37(2):141-154.

doi: 10.1016/j.annonc.2025.10.018. Epub 2025 Nov 4.

Authors

Affiliations

¹ Departments of Dermatology, Pathology, and Oncology, and The Bloomberg∼Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University SOM, Baltimore, USA.
² Melanoma Institute Australia, The University of Sydney, Sydney, Australia; Faculty of Medicine and Health, The University of Sydney, Sydney, Australia; Royal Prince Alfred Hospital and NSW Health Pathology, The University of Sydney, Sydney, Australia; Charles Perkins Centre, The University of Sydney, Sydney, Australia.
³ The University of Texas MD Anderson Cancer Center, Houston, USA.
⁴ Department of Pathology and Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, USA.
⁵ Departments of Dermatology, Johns Hopkins University SOM, Baltimore, USA.
⁶ Pathology, Johns Hopkins University SOM, Baltimore, USA.
⁷ Queen's University Sinclair Cancer Research Institute, Kingston, Canada.
⁸ Pathology, University of Navarra, Pamplona, Spain.
⁹ Department of Pathology, McGill University Health Centre, Montréal, Canada.
¹⁰ Melanoma Institute Australia, The University of Sydney, Sydney, Australia; Faculty of Medicine and Health, The University of Sydney, Mater and Royal North Shore Hospitals, Sydney, Australia.
¹¹ Department of Cutaneous Oncology, Moffitt Cancer Center, Tampa, USA.
¹² Melanoma Institute Australia, The University of Sydney, Sydney, Australia; Faculty of Medicine and Health, The University of Sydney, Sydney, Australia; Royal Prince Alfred Hospital and NSW Health Pathology, The University of Sydney, Sydney, Australia.
¹³ Department of Pathology, ZAS Hospitals, Antwerp, Belgium; Division of Research, Peter MacCallum Cancer Centre, Melbourne, Australia.
¹⁴ Department of Pathology and Neuropathology, University Hospital and Comprehensive Cancer Center Tübingen, Tübingen, Germany; Cluster of Excellence iFIT (EXC 2180) "Image-Guided and Functionally Instructed Tumor Therapies", University of Tübingen, Tübingen, Germany.
¹⁵ University of Pittsburgh Medical Center, Department of Pathology, Pittsburgh, USA.
¹⁶ Department of Pathology, Brigham and Women's Hospital, Boston, USA.
¹⁷ Department of Surgery, Johns Hopkins University SOM, Baltimore, USA; Bloomberg-Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University SOM, Baltimore, USA; Johns Hopkins Kimmel Cancer Center, Baltimore, USA.
¹⁸ Department of Pathology, Netherlands Cancer Institute, Amsterdam, The Netherlands.
¹⁹ Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA.
²⁰ Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, USA.
²¹ Departments of Pathology and Dermatology, Dermatopathology and Oral Pathology Unit, University of California San Francisco, San Francisco, USA.
²² Bloomberg-Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University SOM, Baltimore, USA; Departments of Dermatology, Pathology, and Oncology, The Mark Foundation Center for Advanced Imaging and Genomics, Baltimore, USA. Electronic address: jtaube1@jhmi.edu.

PMID: 41469296
DOI: 10.1016/j.annonc.2025.10.018

Abstract

Background: Practice-changing clinical trials for novel therapeutic regimens administered in the neoadjuvant setting have been reported for multiple cancer types, bringing this treatment strategy to the forefront for patients with high-risk surgically resectable disease. Previously, tumor-type- or therapy-type-specific scoring systems were used for pathologic response assessment. The goal of this effort is to update, harmonize, and standardize the emerging system(s) for pathologic response assessment and data capture.

Materials and methods: Leaders in pathology, oncology, and surgery, including those from the Society for Immunotherapy of Cancer's Pan-tumor Harmonization of Pathologic Response Assessment (PATHdata) efforts and the International Neoadjuvant Melanoma Consortium (INMC), convened to develop updated consensus guidelines for pathologic response assessment, including specimen handling and tissue submission, scoring, and reporting. This paper builds upon previous recommendations, which are updated based on histologic features associated with patient outcomes. Specific attention was paid to commonalities across tumor types, as well as tumor-type-specific considerations.

Results: A revised and standardized approach to tissue submission is recommended, including total submission of tumors ≤3 cm in size for histologic analysis. Additional guidance is provided for larger tumors. Pathologic response is quantified through assessments of percentage of residual viable tumor (%RVT), necrosis, and regression. Descriptions of histologic features to be scored are provided together with a standardized reporting template. Recommendations regarding collecting additional key datapoints are also made, to allow continued, extended validation of this pan-tumor approach.

Conclusions: As pathologic response emerges as a surrogate endpoint for long-term clinical outcomes and to help inform adaptive adjuvant therapy decisions in routine clinical care, standardization is critical to facilitate consistent and reliable application. This pan-tumor approach to scoring and reporting supports robust stratification of patient outcomes, facilitates comparisons across clinical trials and tumor types, enhances data collection, and establishes a foundation for identifying additional, clinically meaningful %RVT cut points.

Keywords: %RVT; guidelines; melanoma; neoadjuvant; pan-tumor; pathologic response.

PubMed Disclaimer

Publication types

Actions
Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions

LinkOut - more resources

Full Text Sources
- Elsevier Science
Medical
- MedlinePlus Health Information
Research Materials
- NCI CPTC Antibody Characterization Program

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

Updated pan-tumor guidelines for neoadjuvant scoring of pathologic response: a joint SITC and INMC effort

Affiliations

Updated pan-tumor guidelines for neoadjuvant scoring of pathologic response: a joint SITC and INMC effort

Authors

Affiliations

Abstract

Publication types

MeSH terms

LinkOut - more resources

Full Text Sources

Medical

Research Materials