Introducing New College of American Pathologists Reporting Templates for Cancer Biomarkers

Abstract

The College of American Pathologists (CAP) has been developing guidelines on cancer data reporting for more than 25 years, with more than 80 regularly updated cancer case summaries now available for pathologists’ use. The protocols consist mostly of traditional data elements determined by gross and microscopic examination, but many of the case summaries within the protocols also include short sections on ‘‘ancillary testing.’’ As the frequency of biomarker testing and its importance in managing patients has grown, however, these results are no longer considered ancillary. The growing number of details related to this testing add to the length and complexity of the cancer resection report. Another problem with including biomarker testing in the cancer case summary is that the results are often not available at the time the primary cancer resection report is completed, either because they are still pending or because they are ordered later. In response to requests from pathologists to address these issues and streamline the CAP cancer protocol case summaries, a multidisciplinary group was assembled in 2012 to establish guidelines for reporting biomarker assays. The Cancer Biomarker Reporting Workgroup was composed of a steering committee and 3 initial site-specific expert panels charged with developing pilot biomarker reporting templates for breast, colorectal, and lung cancers. Panel members participated from a variety of organizations, including the CAP, the Association for Molecular Pathology, the American Society of Clinical Oncology, the Centers for Disease Control and Prevention, the American Joint Committee on Cancer, the North American Association of Central Cancer Registries, and other organizations. The workgroup goals were to establish reporting guidelines for commonly ordered biomarkers, create stand-alone reporting templates, and improve consistency and completeness of results reporting to assist tumor registrars and others involved in data collection, exchange, and surveillance. This issue of Archives of Pathology & Laboratory Medicine introduces new reporting templates for lung and colorectal cancer biomarkers (the template for breast cancer was harmonized with the recent update to the American Society of Clinical Oncology/CAP guideline for HER2 testing subsequent to the writing of this editorial and was completed in late 2013). These 3 templates incorporate standards based on existing guidelines as well as expert consensus where formal guidelines do not exist. These draft templates were reviewed by the CAP Cancer, Molecular Oncology, Immunohistochemistry, and Pathology Electronic Reporting Committees, followed by formal public comment and field-testing periods.