One-sentence summary:
The College of American Pathologists (CAP) has released new protocols for endocrine tumors and updated breast cancer guidelines to improve diagnostic precision and align with the latest scientific and clinical advancements.

Three brief takeaways:

  1. New endocrine tumor protocols standardize reporting for rare tumors like PPGLs and PitNETs, improving diagnostic accuracy and treatment decisions.
  2. Updated breast cancer protocols enhance biomarker and HER2 status reporting to match patients with emerging targeted therapies.
  3. Standardized terminology and comments in reports aim to improve clarity and align pathology with current clinical trial and FDA treatment criteria.

New protocols for endocrine tumors and updated existing protocols for breast cancer diagnoses are now available from the College of American Pathologists (CAP). These and other updates to protocols reflect the latest scientific advancements, ensuring that pathology reports provide oncologists with precise information to guide cancer diagnosis and treatment decisions.

CAP Issues New Endocrine Tumor Protocols

New standardized reporting protocols for rare and complex endocrine tumors will improve diagnostic clarity for:

  • Paraganglioma and Pheochromocytoma (PPGL): These protocols address the high rate of germline predisposition and unique biomarkers of PPGLs, offering a standardized reporting framework that aligns with the 2022 WHO classification. They help ensure consistent evaluation and reporting of clinically relevant parameters, and also by providing guidance in the distinction of multifocal primary tumors from metastatic disease in patients with hereditary syndromes.
  • Pituitary Neuroendocrine Tumors (PitNET): As the first-ever CAP protocol for PitNETs, this guidance supports accurate tumor subtyping and characterization, informed by the latest WHO/IARC classification. The protocol aids in recognizing developmental transcription factors and tumor subtypes, helping to guide appropriate clinical management and improve diagnostic precision.

“Accurate, standardized and detailed pathology reporting protocols better support integrated clinical care for patients with PPGLs and PitNETs,” said lead author of the CAP endocrine cancer protocols, Ozgur Mete, MD, who is a member of the CAP Cancer Committee.

CAP’s Updated Breast Cancer Protocols

Updates in breast cancer biomarker reporting were made to ensure identification of patients potentially eligible for new treatments:

  • Updated biomarker reporting for expanded treatment indications : Recent clinical trials and Food and Drug Administration (FDA) approvals have driven updates to ensure metastatic breast cancer patients are accurately matched with the latest targeted therapies.
  • Refined HER2 reporting: Enhanced reporting for HER2 status helps guide appropriate scoring and reporting to ensure accurate treatment options.
  • Standardized report comments to emphasize clinical relevance: Optional, standardized comments clarify key terms such as HER2 “low” and “ultralow,” improving understanding of clinical trial criteria and treatment relevance.

“For metastatic breast cancer, more detailed HER2 reporting was needed to keep up with the latest treatment approvals,” says Kimberly Allison, MD, FCAP, co-author of the CAP breast cancer protocol update. “These updates are critical for determining if cancer patients are eligible for rapidly evolving treatment options.”

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