It’s crucial for laboratory professionals to stay aligned with the latest standards in oncology and patient care, and that these standards are reviewed regularly to ensure patient safety. The College of American Pathologists (CAP) recently released updates to 23 cancer protocols, reflecting the latest guidance from the American Joint Committee on Cancer and the World Health Organization (WHO).
Here, Lara Rabih Harik, Chair of the CAP Cancer Committee, and M. E. (Doc) de Baca, Chair of the Council on Informatics and Pathology Innovation, explain what these updates mean for diagnostic precision.
What are the most clinically significant diagnostic updates in the latest cancer protocol revisions, and how do they reflect evolving standards in oncology care?
Members of the CAP Cancer Committee are committed to regularly updating the CAP Cancer Protocols – also known as synoptic worksheets – to reflect current standards in cancer reporting and oncology care. A key responsibility of the committee’s subject matter experts is to ensure these protocols align with global guidelines from organizations such as the WHO (for tumor classification and grading) and the American Joint Committee on Cancer (for staging and prognostic criteria). Updates are released quarterly as needed.
The Q2 2025 update includes revisions to 23 protocols – aiming to improve reporting of complex cases, including documenting pathologic response after neoadjuvant therapy and managing multifocal tumors. The committee also reviews questions submitted by pathologists and issues clarifications when appropriate.
Biomarker reporting continues to evolve rapidly, and pathologists play a vital role in this area. In this release, the breast biomarker protocol was refined to improve how test methods are captured for conditional reporting. These changes support ongoing efforts to enhance accuracy, consistency, and clarity in cancer diagnostics.
Were there any changes that explicitly address emerging technologies such as digital pathology, AI-based image analysis, or molecular diagnostics?
Biomarker reporting is a critical part of modern cancer treatment planning and is evolving quickly. To support this, the CAP Cancer Committee develops biomarker-specific protocols to help pathologists report in line with the latest guidelines.
The committee also leads the Biomarker Project Team – a collaborative group that brings together experts from across multiple CAP councils. This team works to coordinate biomarker messaging, improve efficiency, and reduce duplication across efforts.
We regularly review and update both short- and long-term strategies. As digital pathology and AI become more integrated into clinical workflows, we are exploring ways to adapt cancer protocols to support these emerging technologies.
How do these updates aim to improve diagnostic precision, particularly in challenging cases like multifocal invasive carcinoma or pleural mesothelioma?
Synoptic reporting was developed to improve consistency in cancer reporting across institutions and among pathologists. It ensures that key clinical data are recorded in a standardized, structured format. Recent updates support more precise documentation of multiple tumors and improve grading accuracy for pleural mesothelioma.
In addition, the CAP Cancer Committee, in collaboration with the CAP Pathology Electronic Reporting Committee, has launched an initiative to optimize the cancer protocols. As cancer reporting becomes more complex, the goal is to present essential data elements clearly and concisely – without compromising clinical value or the ability to capture structured data.
In the gastrointestinal protocol updates, what prompted the addition of new questions around treatment effect and histologic types – and how might this impact pathology reporting?
The American Joint Committee on Cancer (AJCC) has launched a multidisciplinary initiative focused on tumors treated with neoadjuvant therapy, led by Jeffrey Gershenwald, chair of the AJCC executive committee. The CAP Cancer Committee is working in collaboration with AJCC to improve pathology reporting in this evolving area.
While breast and colorectal cancers have been at the forefront of neoadjuvant treatment, clinical trial data now support its use across a wider range of tumor types. As more specialties adopt this approach, the need for standardized reporting of pathologic treatment response is growing. Clear documentation of treatment effect is essential for evaluating therapy success and guiding ongoing patient care. The CAP Cancer Committee continues to refine these reporting elements as new evidence becomes available.
Regarding histologic subtype updates, one of the Committee’s key responsibilities is ensuring pathologists use the most current classifications, as defined by the WHO. Pathologists in community and general practice settings rely on CAP for up-to-date guidance on tumor classification and histologic subtypes.
How is CAP working to ensure that labs – especially smaller or resource-limited ones – can quickly and accurately adopt these updates into their laboratory information system or reporting templates?
The CAP Cancer Protocols are freely available for pathologists to access and use at any time. These versions include explanatory notes following each synoptic data element, which provide helpful guidance on how to complete each section accurately, along with relevant references.
The electronic Cancer Protocols are regularly updated and distributed to licensed laboratory information system vendors for integration. CAP works closely with these vendors to ensure updates are implemented accurately and on time.
For pathologists without access to integrated electronic protocols, CAP is also developing new resources to support their reporting needs.
Looking ahead, are there plans to expand or revise protocols related to novel immunotherapies or targeted treatments that are increasingly relevant to cancer diagnostics?
Absolutely. While much of the CAP Cancer Committee’s work focuses on current clinical practice, we’re also committed to preparing for the future. Two key areas of focus are biomarkers and artificial intelligence, where we aim to provide forward-looking guidance for pathologists worldwide.
Projects like the biomarker initiative and the neoadjuvant therapy initiative are designed to give us the flexibility to update cancer protocols in real time as these fields evolve. For example, recent clinical trial data and FDA approvals for new therapies and companion diagnostics have led to updates in biomarker reporting. Our experts have promptly revised the breast and gynecologic biomarker templates to ensure pathologists are using the most current guidelines and recommendations.
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