Key Issues in Reporting Common Cancer Specimen Findings Using the College of American Pathologists Cancer Protocols

The culmination of our entire professional assessment of a pathologic specimen resected for cancer is reflected in the statement made by the pathology report. Inherent in its content is the synopsis of the cornerstones of our evaluation—gross pathology, microscopic examination, and use of ancillary diagnostic studies such as immunohistochemistry. In the contemporary era of “disease management teams” and a “multidisciplinary site-specific approach” in the area of cancer, the pathology report is an integral component of and often the centerpiece required for determining optimal clinical care. The pathology report for resected cancer specimen findings forms the basis for evaluating the need for adjuvant therapy and for patient prognostication. Given its critical role in cancer care, there is increased attention to the timeliness and completeness of the pathology report.A little more than 15 years ago, members of the Cancer Committee of the College of American Pathologists (CAP) realized that there was great heterogeneity in the reporting of resected cancer specimen findings, with critical elements required for patient management often missing. Clinicians at referring institutions were sometimes faced with therapeutic dilemmas because of incomplete pathology reports. Data from the National Cancer Data Base in the late 1990s showed that up to one fourth of colon cancer pathology reports lacked information on lymph node status and as many as half the sarcomas were signed out without assignment of a grade. In an attempt to promote consistency in the reporting of resected cancer specimen findings, the Cancer Committee of the CAP developed a series of cancer protocols, beginning with the more common carcinomas such as colon, prostate, and breast. These protocols were published in the Archives of Pathology & Laboratory Medicine as guidelines and as a resource tool for pathologists, encouraging a synoptic pathology report for completeness and for consistency. A compendium of the initial protocol collection was published by the CAP in September 1998 (Reporting on Cancer Specimens). A conscious effort was made to develop the protocols as a resource tool and not as a form of marching orders.As more protocols were being developed during the last decade and with the growing complexity of information included in a pathology report, there was increased recognition within our community of the need to present relevant pathologic information in a synoptic style of reporting. Many institutions began developing synoptic reports or checklists, often using the CAP's protocols as a reference tool. The Association of Directors of Anatomic and Surgical Pathology also released their recommendations for common cancer pathology reporting and are also a valuable resource.Each published cancer protocol consisted of the protocol for reporting cancer or background documentation (a long form of a comprehensive list of elements to be reported, including demographics and clinical information, gross and microscopic findings, and ancillary studies), explanatory notes, and references, and a short form or checklist (a synoptic list of elements to be reported). The response to the protocols in the community ranged from the view that the protocols were an invaluable resource tool to the opinion that the protocols promoted excessively long documents and that any form of protocol implementation would be overly time-consuming in a climate of ever-increasing work volume and decreasing compensation. Despite this controversy and inconsistent use of the protocols, the benefits of synoptic reporting became steadily more recognized and accepted across the nation's pathology departments and laboratories.The American College of Surgeons (ACS) Commission on Cancer (COC) initially endorsed voluntary use of the cancer protocols but indicated a desire to implement mandatory protocols beginning in 2002, with expected compliance in 2003. Because of the complexity of mandating a large number of pathology departments to simultaneously incorporate a multitude of protocols into their practices (which often included the integration of laboratory information systems), the CAP convinced the ACS COC to extend the deadline for requiring its accredited cancer programs to use the CAP protocols until January 1, 2004. Standard 4.6 of the ACS COC requires that pathologists at COC-approved cancer programs include all scientifically validated or regularly used data elements of the CAP checklists in their pathology reports for each site and specimen. The required data elements on the synoptic checklists are those without asterisks, while the optional elements are marked with asterisks.Although the ACS COC mandate may seem to be an imposition on our specialty and may appear to curb the individual's expression of opinion, it is important that the developed standards are of the pathologists (the CAP protocol checklists), by the pathologists (the Cancer Committee of the CAP), and for the pathologists (rather than standards developed by a governmental organization that may not fully understand the practical issues relevant to our reporting). The ACS standard does not require the use of the CAP checklist and does not require a specific format of data or order for inclusion in pathology reports. Furthermore, the mandated elements are not exclusive of any other data but are the minimum requirement for inclusion in the pathology report. Additional information is available at the CAP Web site at http://www.cap.org/apps/docs/cancer_protocols/protocols_intro.html.The use of standardized reporting promotes our participation in multidisciplinary specialty care. The standardized reports ensure uniformity of reporting within a group or a department, promote consistency between institutions nationally, guarantee completeness and inclusion of therapeutically and prognostically relevant data, reduce ambiguity, facilitate data collection for research and data registries, serve as a quality assurance indicator of quality of care, and potentially save time with their list formats from which to select required reporting elements.The charge of the Cancer Committee of the CAP is “to advance the role of pathologists as leaders in oncology worldwide and to serve as a resource in cancer-related patient care, education and research.” Although the cancer protocols are inextricably tied to this central mission, education is also an important component. Toward this end, at the companion meeting of the CAP at the United States and Canadian Academy of Pathology 94th Annual Meeting, San Antonio, Tex, members of the Cancer Committee of the CAP presented a 3-hour symposium on “Key Issues on Reporting Common Cancer Specimens.” The didactic summaries of the presentations of the 4 symposium speakers comprise a special section in this issue of the Archives. The resultant articles highlight key prognostic and predictive parameters in breast, lung, prostate, and colon cancer from the CAP cancer protocols; outline criteria for the resolution of problems in their interpretation; and present the clinical utility and rationale for their inclusion in the protocols.The article “Changes and Problematic Areas in Interpretation of the AJCC Cancer Staging Manual, 6th Edition, for Breast Cancer” by Connolly focuses on a variety of practical problems that arise during the assessment of pathologic stage, including tumor size and assignment of an N status for lymph nodes with isolated tumor cells, micrometastases, and metastases. The second article, by Marchevsky, outlines the practical difficulties in distinguishing among stage pT1, stage pT2, and stage pT3 lesions based on their location and pleural involvement, as well as the problem of differentiating between multiple synchronous or metachronous primary lung tumors (stage pT1m) and intrapulmonary metastasis (stage pT4 or stage pM1). The article by Srigley focuses on key parameters in radical prostatectomy specimens that are relevant in determining prediction of adjuvant therapy and in patient prognostication after radical prostatectomy. Besides the critical analytic parameters, his article emphasizes the importance of the preanalytic phase (ie, the handling of the radical prostatectomy specimen), which is central to deriving meaningful information from the analytic parameters such as Gleason score, pathologic stage, and margin status. Finally, the article by Compton, “Key Issues in Reporting Common Cancer Specimens: Problems in Pathologic Staging of Colon Cancer,” not only emphasizes common problems but also provides useful insight into the contemporary problems in staging that are raised by neoadjuvant therapy. Understanding the concept and the evaluation of circumferential resection margins of colorectal cancer specimens continues to be a problem area for pathologists, and this issue has been thoroughly described from the practical and the prognostic viewpoints.These are 4 outstanding articles in this special section of the Archives. I believe that they provide a useful resource for the implementation of select key and problematic parameters from the respective CAP cancer protocols in routine clinical practice.

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