SITC PATHdata Study
Immunotherapeutic agents are approved for use in more than a dozen tumor types, with early- and late-stage indications. In the neoadjuvant setting, pathologic response is the endpoint of many clinical trials and can become a surrogate endpoint for overall survival when long-term patient outcomes are available. However, robust datasets to support clinical utility often require meta-analyses of multiple individual studies. The ability to make meaningful comparisons across trials is currently limited by the parallel development and use of different pathologic response scoring criteria and data reporting systems in individual IO clinical trials, both within and across tumor types.
To address these issues, SITC held a PATHdata study to validate the reproducibility of a pan-tumor approach for pathologic response assessment in tissue specimens from patients treated with neoadjuvant IO. This was accomplished using immune-related pathologic response criteria (irPRC) and standardized data reporting. Updated guidelines for neoadjuvant scoring of pathologic response, the results of the study, and subsequent training materials are detailed in the manuscripts linked below.
Updated pan-tumor guidelines for neoadjuvant scoring of pathologic response: A joint SITC and INMC effort (link manuscript)
Pan-tumor Harmonization of Pathologic Response Assessment for Standardized Data Collection in Neoadjuvant/Periadjuvant Trials (PATHdata) (link manuscript)
Multiplex immunohistochemistry (IHC) and immunofluorescence (IF) Best Practices
To ensure standardization of multiplex IHC/IF adoption in research and clinical settings, the manuscripts below define best practices for multiplex IHC/IF sample handling (staining and validation), image analysis, and data sharing.
The Society for Immunotherapy of Cancer statement on best practices for multiplex immunohistochemistry (IHC) and immunofluorescence (IF) staining and validation
Society for Immunotherapy of Cancer: updates and best practices for multiplex immunohistochemistry (IHC) and immunofluorescence (IF) image analysis and data sharing
SITC MxIF-SIG Initiative
Pathology and specific multiplex imaging, which allows for simultaneous characterization of multiple markers, has been more readily investigated and is envisioned to be critical for the selection of novel therapeutics in the future. Clinical adoption of these technologies, however, remains limited due to various challenges including standardized data reporting methods.
To address this barrier in the field, the SITC Pathology Committee developed the Multiplex Immunofluorescence – Special Interest Group (MxIF-SIG) Initiative, with the primary goal of developing a consensus checklist for multiplex IF and immune histochemistry (IHC) data validation and reporting. The subsequent checklist is detailed in the manuscript linked below.
Manuscript link here