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Review
. 2025 Oct;26(10):e536-e546.
doi: 10.1016/S1470-2045(25)00345-6.

Assessing pathological response to neoadjuvant therapy in renal cell carcinoma: a systematic review and guidelines for sampling and reporting standards from the International Neoadjuvant Kidney Cancer Consortium

Collaborators, Affiliations
Review

Assessing pathological response to neoadjuvant therapy in renal cell carcinoma: a systematic review and guidelines for sampling and reporting standards from the International Neoadjuvant Kidney Cancer Consortium

James P Blackmur et al. Lancet Oncol. 2025 Oct.

Abstract

Pathological response is a surrogate marker of efficacy of neoadjuvant therapy in various tumour types, but there is no consensus on reporting pathological response for renal cell carcinoma. We aimed to assess the status of pathological response reporting in renal cell carcinoma and develop a recommendation on tissue preparation and response reporting for neoadjuvant treatment. We conducted a systematic review of publications on the PubMed and Web of Science databases to identify manuscripts reporting response to pre-surgical therapy in renal cell carcinoma. 119 eligible papers were identified. Only five (4%) studies included details of how pathological response had been assessed. Qualitative statements on residual tumour were common (55 [46%] studies), but only eight (7%) studies used a quantitative assessment of pathological response. Guidelines for tissue preparation and pathological response reporting were reviewed at an international workshop held at the Netherlands Cancer Institute in October, 2024, and further developed through expert discussions. To assess neoadjuvant pathological response, nephrectomy specimens should be sampled with the use of a standardised baseline approach with consideration for more extensive sampling. Microscopic assessment should quantify the residual viable tumour in 10% intervals and greatest linear extent. Clinical details, including the neoadjuvant therapy received, should accompany the pathological assessment. In this systematic review, we describe a standardised method for assessment and reporting pathological response, initially intended for use in clinical trials or research settings. These guidelines will help investigators to assess whether the degree of pathological response is linked to survival outcomes and will inform future standard reporting practices.

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Conflict of interest statement

Declaration of interests JPB has received travel expenses from the Kidney Cancer Association. JOJ has received salary funding from Cancer Research UK; declares project funding from AstraZeneca; and reports speaker fees from Advanced Therapies and consultancy fees from Evinova. JCKvdM has received institutional research funding from Bayer; consultancy fees from Merck, MSD, and AstraZeneca; travel funding from Ipsen; and speaker funding from Novartis. LB has received speaker funding from British Association of Urological Pathology (BAUP), British Division of the International Academy of Pathology (BDIAP) and travel funding from International Neoadjuvant Kidney Cancer Consortium (INKCC); is a trustee for the BDIAP and BAUP charities; and is a topic advisor for the National Institutes for Health (NIH) a committee member for the National Institute for Health and Care Excellence (NICE) Kidney Cancer Guideline, a reference group member for the National Kidney Cancer Audit, and a member of the Renal Genomics England Clinical Interpretation Partnership. PK has received NIH funding (Kidney Cancer SPORE), and endowment funding from the Jan and Bob Pickens Distinguished Professorship and Brock Fund for Medical Sciences. SS has received grant funding and consultancy fees from Bristol Myers Squibb, AstraZeneca, Merck; grant funding from Exelixis, Merck, NiKang Therapeutics, and Arsenal Bioscience; consultancy fees from CRISPR Therapeutics, American Association for Cancer Research, National Cancer Institute, and NextPoint Therapeutics; and received royalties from Biogenex. AB has received educational grants from Pfizer; is an advisory board member for Telix; is on steering committees for Roche/Genentech and BMS; and has received speaker funding from Ipsen. GDS has received educational grants from AstraZeneca; consultancy fees from Evinova; compensation for travel expenses from MSD; is Clinical lead (urology) National Kidney Cancer Audit and topic advisor for the NICE Kidney Cancer Guideline; and is an associate editor of British Journal of Urology International and Chair of the Kidney Cancer Pathway of Getting it Right First Time. All other authors declare no competing interests.

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