The College of American Pathologists (CAP) has updated 14 Cancer Protocols, including changes to breast cancer biomarker reporting and molecular testing for gastrointestinal stromal tumors.
Released September 16, the third-quarter revisions align standardized pathology reporting with updates to World Health Organization classifications, American Joint Committee on Cancer guidance, and developments in precision oncology. The protocols provide structured reporting elements for pathology findings used in cancer diagnosis, staging, and treatment planning.
“Cancer Protocols ensure that cancer information is collected and reported consistently and accurately,” said M. E. de Baca, Chair of the CAP Council on Informatics and Pathology Innovation. “Such standardization is imperative for the promise of Personalized Health Care to become a reality.”
The revised Breast Biomarker Protocol updates scoring and reporting criteria for estrogen receptor, progesterone receptor, and HER2. These biomarkers help classify breast cancers and identify patients who may benefit from endocrine or HER2-directed therapies. Consistent reporting can support interpretation of results and communication between pathology laboratories and treating clinicians.
The update also introduces a new accreditation requirement for malignant phyllodes tumors, a rare group of fibroepithelial breast neoplasms. Laboratories must now use the CAP Breast Phyllodes Tumor protocol when reporting these tumors. The revised protocol incorporates changes from the sixth edition of the WHO classification and updates reporting elements related to staging and surgical margins.
CAP also expanded the molecular testing and reporting options in its gastrointestinal stromal tumor (GIST) protocols. The revisions add reporting options for NTRK fusion gene analysis and enhance the documentation of KIT and PDGFRA biomarker testing.
Most GISTs contain activating variants in KIT or PDGFRA, while tumors without these alterations may require further molecular investigation. Structured reporting of NTRK fusions provides a standardized way to document another potentially actionable molecular finding.
The protocols can now be used to report GISTs arising at all anatomic sites. Although these tumors most commonly develop in the stomach or small intestine, they may occur elsewhere in the gastrointestinal tract and, less frequently, outside it.
The revisions may require changes to report templates, laboratory information systems, and local workflows. Laboratories should review biomarker fields, terminology, and accreditation requirements to ensure their reports incorporate the latest protocol elements.
Updates to biomarker reporting should be integrated with established assay validation, quality control, and proficiency testing procedures. Molecular reports should also clearly describe the specimen, testing method, findings, and any limitations affecting interpretation.
CAP updates its Cancer Protocols quarterly to incorporate changes in cancer classification, staging, and biomarker testing. A full summary of the latest revisions is available through the organization’s cancer reporting resources.
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