The 2009 Version of the Cancer Protocols of the College of American Pathologists: A Continuing Journey From “Guidelines for Pathologists” to “Standards for Multidisciplinary Comprehensive Cancer Care”

Abstract

In recent years, breathtaking advances in cancer have occurred at many levels such that the management of patients with cancer often emanates from complex therapeutic decisions that are made based on input from a multidisciplinary team of surgeons, oncologists, radiation oncologists, pathologists, and radiologists. The culmination of the professional assessment of a pathologic specimen resected for cancer is reflected in the form and content of the pathology report. Embodied within the report is a synopsis of the cornerstone of our evaluation—gross pathology, microscopic examination, and use of ancillary diagnostic modalities.1 The latter have evolved in recent years from being primarily diagnostic to having prognostic and predictive value such that they have become an integral component of the pathology report for some cancers. In the contemporary era of personalized molecular medicine, this list is only apt to grow exponentially. Given the increasing critical role of pathology reports in determining prognosis, adjuvant therapies, and overall management, there has been a greater emphasis on the accuracy, completeness, and timeliness of the pathology report.2A little less than 25 years ago, the Cancer Committee of the College of American Pathologists (CAP) recognized the great heterogeneity in the reporting of resected cancer specimen findings such that often critical elements required for patient management were incomplete or missing from the report. To address this issue the Cancer Committee of the CAP, in 1986, published the first set of protocols on breast cancer, bladder cancer, and Hodgkin disease. In the ensuing years, protocols for several major cancer sites were published in the Archives of Pathology & Laboratory Medicine primarily with the aim of being guidelines and a resource tool for pathologists.3–5 A compendium of several major protocols was first published as a single offering by the CAP in September 19986 (Table 1). In this offering, a conscious effort was made to develop the protocols as a resource tool for pathologists and not as form of marching orders. Reporting in a checklist or synoptic format was encouraged for completeness and consistency.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 their own synoptic reports, or checklists, often using CAP's protocols as a reference tool.7–9 The Association of Directors of Anatomic and Surgical Pathology also released its recommendations for common cancer pathology reporting and served as an additional valuable resource.10Each published cancer protocol consisted of a background documentation section (a long comprehensive list of elements to be reported including demographics and clinical information, gross and microscopic findings, and ancillary studies), explanatory notes, references, and a short form or checklist.4,5 The response to the protocols from the community ranged from the view that they were an outstanding resource tool to the opinion that protocols promoted excessively long documents and that any form of protocol implementation was overly time consuming in a climate of increasing work and decreasing compensation. Other potential drawbacks that were discussed include inhibition of thoughtful and systematic evaluation of a case that would also be detrimental to resident education, the end of the consultative expression of the “art of pathology” and the personalized nature of a pathologist's evaluation, making it more objective and uniform in appearance. There was fear that there would be increased need for sophisticated laboratory information systems, which would be expensive to implement, and potential increase in transcription errors. Despite the controversies and inconsistent use of protocols, the benefits of synoptic reporting became steadily recognized with increased acceptance.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 use of the CAP protocols beginning in 2002 with expected compliance in 2003 for ACS COC accreditation. Because of the complexity of requiring a large number of protocols to be simultaneously incorporated into practices, CAP worked closely with ACS COC to extend the deadline for requiring CAP protocols to January 1, 2004. Standard 4.6 of the ACS COC requires that pathologists at COC-approved cancer programs include all regularly used or scientifically validated data elements (SVDEs) of the CAP checklists in their pathology reports.11 The required data elements for ACS COC accreditation on the CAP synoptic checklists were those without an asterisk sign, while those that were optional were identified with an asterisk sign. A compendium of 42 protocols, which essentially represented the 3rd edition of Reporting on Cancer Specimens,12 was published in 2003.Since the implementation of these accreditation requirements, the use of the CAP cancer protocols has been widespread. Standardized reports ensure uniformity of reporting within a group or department, promote consistency between institutions nationally, guarantee completeness and inclusion of therapeutically and prognostically relevant data, reduce ambiguity, facilitate communication and data collection for research and data registries, and serve as a seal of quality assurance.Building on the material included in the 3rd edition of Reporting on Cancer Specimens, the Cancer Committee took the opportunity to take the protocols to a new level between 2005 and 2009. This body of work is reflected in the 2009 edition of Reporting on Cancer Specimens,13 which contains 55 revised protocols with the anticipation of 10 new protocols in 2010. This time around, in addition to updates, there is a massive reformatting of the protocols with addition of newer protocols (Table 2). The protocols are now substantially leaner due to the adoption of a more compact and user-friendly format, while the explanatory notes were expanded to include more straightforward staging directions and helpful images and schematic diagrams. The protocols are now systematically developed by multidisciplinary panels of experts and reviewed by a broad range of CAP resource committees. A significant step was that the Cancer Committee developed 12 disease-specific CAP cancer protocol review panels (CAP-CPRPs) (gastrointestinal system, genitourinary, hematolymphoid, dermatopathology, head and neck, bone and soft tissue, pulmonary and cardiovascular, central nervous system, ophthalmic, gynecologic, breast, and pediatric pathology). In contrast to the prior editions, which largely represented the work of the 10 to 15 members of the Cancer Committee with exhaustive multidisciplinary input, this version has more formal input from more than 150 pathologists and clinicians representing both the academic as well as the practicing community. Several CAP-CPRPs have international representation and the genitourinary protocols are endorsed by the International Society of Urologic Pathologists. Multidisciplinary organizations including the Association of Directors of Anatomic and Clinical Pathology, American College of Radiology, Cancer Care Ontario, Centers for Disease Control and Prevention, North American Association of Central Cancer Registries, National Cancer Registrars Association, National Accreditation Program for Breast Centers, National Cancer Institute, and Systematic Nomenclature of Medicine International have direct liaison relationships or involvement with the CAP Cancer Committee or CAP-CPRPs; the liaison members have had active input into the generation of these protocols (Figure). The protocols were developed simultaneously with the 7th edition of the American Joint Committee on Cancer Cancer Staging Manual and at least 1 member from each CAP-CPRP participated formally in the American Joint Committee on Cancer task force teams. Due to advances in our understanding of prognostic and predictive markers, as appropriate, many of the protocols now have molecularly analyzed elements included as mandatory or optional reporting elements. The 2009 edition, for the first time, also requires reporting of SVDEs in select biopsy settings and for premalignant disease. Recognizing that almost half the patients with prostate cancer in the United States may not be treated by radical prostatectomy and that the prostate biopsy represents the only documentation of the patient's cancer, the CAP protocol on prostate cancer requires reporting of SVDEs in prostate biopsies.14 Excisions for ductal carcinoma in situ of the breast require almost the same detailed and systematic documentation of SVDEs as invasive cancer, and, hence, a separate checklist for this preneoplastic condition is offered in this version.15 The Pathology Electronic Reporting Task Force, part of the CAP Diagnostic Intelligence Health Information Technology initiative and with representation from the Cancer Committee, was formed to create the specifications for both the data model and the graphic user interface; these specifications, when implemented, will be aligned with the checklists as designed by the Cancer Committee.Another development that supports the increasing relevance of the cancer protocols is the addition of 3 protocol-related questions to the CAP Laboratory Accreditation Program anatomic pathology checklist. First, a phase II question to determine whether SVDEs needed for grading, staging, and prognostication is included in the pathology reports. A new question in 2009 was added that asks, “For specimens with malignant diagnoses from definite cancer resections and specific biopsies as outlined in the CAP cancer protocols, are pathology reports audited at least annually to ensure that all scientifically validated data elements are included?” This checklist item requires laboratories to annually evaluate 30 consecutive reports from cancer resections and specific biopsies as outlined in the CAP protocols. If the 3-month total is less than 30, all reports must be evaluated. At least 90% of the reports should contain all the SVDEs from the appropriate cancer protocols, failing which the laboratory must implement appropriate corrective action. With recent studies showing the great value in synoptic reporting,16,17 another new question was included in 2009 asking “For specimens from definite cancer resections, are all SVDEs as outlined in the CAP protocols reported in a synoptic fashion?” The COC has also recognized the value of pathology reports in a synoptic fashion and offers a commendation for COC-accredited institutions that use synoptic formatting for the CAP SVDEs in their pathology reports.The recent release of the 55 revised protocols in October 2009 coincides with the release of the 7th edition of the American Joint Committee on Cancer Cancer Staging Manual.18 The SVDEs contained in the October 2009 revisions should be incorporated into pathology reports as soon as possible after January 1, 2010, and must be implemented and/or incorporated into laboratory reporting systems no later than August 1, 2010, to comply with CAP laboratory accreditation requirements. Information regarding the ACS COC accreditation program compliance will be available shortly.The journey from guidelines to standards is ongoing. The CAP created the new Pathology & Laboratory Quality Center in 2009 to assist CAP committees with the development and distribution of these types of documents that in this day of electronic medical records takes on a new value as the main communications structure of cancer diagnosis, treatment, and ongoing research. Future efforts in the committee would be to develop greater consensus worldwide such that all pathology reporting potentially has one voice. Recently, the Canadian Association of Pathology has endorsed the use of the CAP protocols for reporting cancer in Canada and there is interest from other similar international pathology organizations. As more molecular markers are incorporated into the paradigm of histopathologic evaluation, closer working relationships of the Cancer Committee with other CAP committees such as the Molecular Pathology Committee, Immunohistochemistry Committee, and the Personalized Healthcare Committee will be fostered. With the increasing importance of data formatting and portability, synergistic working relationship with the Diagnostic Intelligence Health Information Technology Committee is planned. Most importantly, the CAP cancer protocols will strive to be the uniform voice of multidisciplinary cancer care for pathologic characterization of oncologic specimens and close working ties with the American Society of Clinical Oncology and National Comprehensive Cancer Network are being developed as the cancer protocols evolve into the next phase.The generation of the CAP cancer protocols is a monumental task that requires active voluntary participation of a wide spectrum of members of the pathology and the oncology community. The new release is built on the strong foundation laid by former chairs of the Cancer Committee including Robert Hutter, MD; Elizabeth Hammond, MD; and Carolyn Compton, MD, PhD, whose leadership and passion have contributed to the high visibility and utility of the protocols. The Cancer Committee is grateful to the support it receives from the CAP membership and staff and especially would like to thank all the members of the CAP-CPRP and the current and future inbound multidisciplinary liaison organizations including the American Joint Committee on Cancer, ACS-COC, Association of Directors of Anatomic and Clinical Pathology, American College of Radiology, Cancer Care Ontario, Centers for Disease Control and Prevention, National Cancer Registrars Association, National Accreditation Program for Breast Centers, North American Association of Central Cancer Registries, and National Cancer Institute for their enthusiastic support of this process. It is hoped that this collective work in the 2009 edition of Reporting on Cancer Specimens, which is an update and refinement with the addition of a few new protocols, will continue to have high impact on cancer care worldwide.The author has no relevant financial interest in the products or companies described in this article.