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New protocols on deck as pathology helps reshape cancer staging

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Anne Paxton

December 2016—It’s a familiar campus lament. New editions of textbooks in some academic fields have become notorious for providing little more than a few extra paragraphs of text or a few more references and altered pagination—mainly, students suspect, to serve as a damper on the textbook resale market. What is happening with a key text in the field of cancer care, however, is in marked contrast. The changes contained in the 8th edition of the AJCC Cancer Staging Manual of the American Joint Committee on Cancer, slated to take effect Jan. 1, 2018, are the opposite of cosmetic.

This first revision of the staging manual in seven years presents a major expansion and reconfiguring of cancer staging classifications, a transformational shift of approach to accommodate molecular advancements, and detailed added discussion of prognostic factors. The 8th edition not only sets a high-water mark for international cooperation but also represents a milestone for pathology. This is the first time that a pathologist, rather than a surgical oncologist, has been selected as editor-in-chief to lead the revisions, and at least one pathologist was assigned to assist on each chapter.

Dr. Baker

Dr. Baker

The 8th edition is one of the most significant sets of changes in the staging manual’s history, says Thomas P. Baker, MD, chair of the CAP Cancer Committee. “It’s a pretty comprehensive overhaul that affects every single tumor that is staged.” Mary K. Washington, MD, PhD, a past CAP Cancer Committee chair who served on the AJCC editorial board for the 8th edition, agrees the new edition is very different from the 7th. “Many more of the non-anatomic factors are incorporated into the prognostic staging systems, staging definitions are changed or new for many sites, and there’s finally a systematic attempt to go beyond the tumor-node-metastasis system to make it more relevant to personalized medicine.”

Since cancer staging is at the core of the CAP’s cancer protocols, the new staging manual will mean changing every CAP cancer protocol as well, Dr. Baker adds. “We have 66 protocols that we’re currently updating and they will be available on paper, but they also need to be converted into electronic form for the electronic checklist. Then the vendors who use the electronic checklist need to put the changes into their LISs.”

The protocols as well as the inspection process will be adapted to match the changes. Revised protocols will be released in the second quarter of 2017, well in advance of their effective date. This will give all stakeholders time to make the adjustment to the new staging and new protocols. Although the 8th edition was initially announced and distributed in September 2016 for a Jan. 1, 2017 effective date, by mid-November the AJCC decided to defer the effective date to Jan. 1, 2018—largely to allow software vendors and laboratories time to adapt their LIS worksheets and cancer reporting systems to the modifications.

“The time extension will allow all partners to develop and update protocols and guidelines and for software vendors to develop, test, and deploy their products in time for the data collection and implementation of the 8th edition in 2018,” the AJCC executive committee announced. The decision to delay was made in collaboration with the CAP; the National Cancer Database; the Centers for Disease Control and Prevention; the National Comprehensive Cancer Network; the National Cancer Institute’s Surveillance, Epidemiology, and End Results program; and the American College of Surgeons’ Commission on Cancer.

Many questions surround the implementation process, and it may appear that clinicians and pathologists will need bifocals to grapple with the transition year, because the clinical side of cancer patient care is going to be operating on a somewhat different track than the data reporting side. But that split is often a familiar state of affairs anyway in cancer care, as practice guidelines, electronic data management, and data collection are never in perfect synchrony, according to CAP officials who have been involved in the cancer staging and protocols efforts.

Michael A. Berman, MD, chair of the CAP Pathology Electronic Reporting Committee, suggests that this transition period is not different from those in the past. “The issue we are all facing is in dealing with cancer patients and staging systems, cell types, personalized medicine, and companion diagnostics: This is a really fast-moving target.” The challenge, he says, is getting the most up-to-date information into the hands of the treating physicians and tumor registries to improve patient outcome. “All stakeholders need to work together to make the transition as seamless and efficient as possible,” he adds.

In terms of the impact the new staging manual will have on pathology practice, the most important facts are as follows:

    • The AJCC 8th edition staging manual has been published, but clinicians and pathologists will continue to use the 7th edition to stage all new cancer patients and to produce pathology reports throughout 2017.
    • For patient care, clinicians can use the scientific content of the 8th edition immediately. Pathologists can immediately rely on the new scientific content in reporting on whatever they see in their specimens.
    • In the second quarter of 2017, new CAP cancer protocols will be released, with a note that the implementation date will be Jan. 1, 2018.
    • Laboratories will not be surveyed for patient reports using the AJCC 8th edition until after Jan. 1, 2018, the official release of the revised CAP cancer protocols.

Staging is the nomenclature and the global common language of cancer, says Mahul Amin, MD, former chair of the CAP Cancer Committee and the AJCC editor-in-chief who led the development of the 8th edition. “It’s a fundamental language, and with each new edition of the staging manual, it is becoming the standard of classifying cancer across the globe.”

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