Quality assurance in pathology in colorectal cancer screening and diagnosis—European recommendations

Phil Quirke 0 1 2 4 Mauro Risio 0 1 2 4 Ren Lambert 0 1 2 4 Lawrence von Karsa 0 1 2 4 Michael Vieth 0 1 2 4 0 R. Lambert Screening Group, Early Detection and Prevention Section, International Agency for Research on Cancer , Lyon, France 1 M. Risio Pathology Department, Institute for Cancer Research and Treatment , Turin, Italy 2 P. Quirke Pathology and Tumour Biology, Leeds Institute of Molecular Medicine, University of Leeds , Leeds, UK 3 ) Institute of Pathology , Klinikum Bayreuth, Preuschwitzerstr. 101, 95445 Bayreuth, Germany 4 L. von Karsa Quality Assurance Group, Early Detection and Prevention Section, International Agency for Research on Cancer , Lyon, France In Europe, colorectal cancer is the most common newly diagnosed cancer and the second most common cause of cancer deaths, accounting for approximately 436,000 incident cases and 212,000 deaths in 2008. The potential of high-quality screening to improve control of the disease has been recognized by the Council of the European Union who issued a recommendation on cancer screening in 2003. Multidisciplinary, evidence-based European Guidelines for quality assurance in colorectal cancer screening and diagnosis have recently been developed by experts in a pan-European project coordinated by the International Agency for Research on Cancer. The full guideline document consists of ten chapters and an extensive evidence base. The content of the chapter dealing with pathology in colorectal cancer screening and diagnosis is presented here in order to promote international discussion and collaboration leading to improvements in colorectal cancer screening and diagnosis by making the principles and standards recommended in the new EU Guidelines known to a wider scientific community. - Colorectal cancer is a significant health problem, the importance of which will increase substantially in the coming years [1]. In Europe, colorectal cancer is the most common newly diagnosed cancer and the second most common cause of cancer deaths, accounting for approximately 436,000 incident cases and 212,000 deaths in 2008 [2]. Randomized trials have shown that systematic screening of a target population of suitable age can reduce colorectal cancer (CRC) by detecting asymptomatic lesions [35]. Early treatment is more effective and has a lower morbidity and mortality. Moreover, the endoscopic removal of adenomas reduces the incidence of CRC by stopping the progression of precursor lesions to cancer. The potential of high-quality screening to improve control of CRC has been recognized by the Council of the European Union who issued a recommendation on cancer screening in 2003 [6]. The recommendation encourages the EU Member States to implement population-based screening programmes using evidencebased tests for breast, cervical and colorectal cancer, according to European Quality Assurance Guidelines where they exist. Comprehensive European Guidelines for quality assurance of breast and cervical cancer screening have been prepared by experts and published by the European Commission [7, 8]. Multidisciplinary, evidence-based European Guidelines for quality assurance in colorectal cancer screening and diagnosis have recently been developed by experts in a pan-European project coordinated by the International Agency for Research on Cancer. The comprehensive guidelines cover the entire screening process including clinical aspects, public health, organization and communication. The full guideline document consists of ten chapters and an extensive evidence base [9]. The content of the chapter dealing with pathology in colorectal cancer screening and diagnosis [10] is presented here in a slightly modified format in order to promote international collaboration in improvement of colorectal cancer screening and diagnosis by making the principles and standards recommended in the new EU Guidelines known to a wider scientific community. This area is rapidly developing and future evidence-based revisions will be required. The pathology service plays a very important role in colorectal cancer screening since the management of participants in the programme depends on the quality and accuracy of the diagnosis. Pathology affects the decision to undergo further local and/or a major resection as well as surveillance after screening. The adoption of formal screening programmes leads to improvement not only in the management of early but also advanced disease by the introduction of guidelines, quality standards, external quality assurance and audit. In screening programmes, the performance of individuals and programmes must be assessed and it is advantageous if common diagnostic standards are developed to ensure quality, recognise areas where sufficient evidence is still lacking, and initiate highquality studies to answer these questions. The present chapter suggests practical guidelines for pathology within a colorectal screening programme. We have concentrated on the areas of clinical importance in the hope of standardising these across the European Union. In the associated annex [11], we deal with some of the more difficult areas and suggest topics for future research. We have included guidelines for the reporting and management of resected specimens in an attempt to move towards agreed minimum European standards of pathology in these areas as well. This is the first edition of what will be a continuing process of revision as new data emerge on the pathology, screening and management of colorectal cancer. We hope to set minimum standards that will be followed in all programmes and to encourage the development of higher standards amongst the pathology community and screening programmes. Many lesions are found within a screening programme some of which are of little or no relevance to the aim of lowering the burden of colorectal cancer in the population. The range of pathology differs between the different approaches, with faecal occult blood programmes yielding later, more advanced disease than flexible sigmoidoscopy and colonoscopy screening. Programme activities must focus on the identification and appropriate management of invasive colorectal cancer and its precursors. The management of pre-invasive lesions involves surveillance to allow the prevention of future disease, whereas management of adenocarcinoma focuses on immediate treatment and decisions on local removal, or radical surgery with the potential for operative mortality. Overuse of radical surgery must be avoided and recommendations for its use must be balanced with the risks to the patient. There are a number of lesions, especially in the serrated pathway leading from hyperplastic polyps to other serrated lesions and in some cases to adenocarcinoma, that may be difficult to diagnose and for which knowledge of their natural history and clinical implications is limited [12]. Further work is required in this area, but until we understand these lesions better it is recommended that all serr (...truncated)