MALIGNANT SALIVARY GLAND NEOPLASMS STRUCTURED REPORTING PROTOCOL (1 st Edition 2013)

Transcription

1 MALIGNANT SALIVARY GLAND NEOPLASMS STRUCTURED REPORTING PROTOCOL (1 st Edition 2013) Core Document versions: AJCC Cancer Staging Manual 7 th edition (including errata corrected with 5th reprint 10 th Aug 2010). World Health Organization Classification of Tumours Pathology and Genetics: Head and Neck Tumours.2005 i

2 ISBN: Publications number (SHPN) (CI): Online copyright RCPA 2013 This work (Protocol) is copyright. You may download, display, print and reproduce the Protocol for your personal, non-commercial use or use within your organisation subject to the following terms and conditions: 1. The Protocol may not be copied, reproduced, communicated or displayed, in whole or in part, for profit or commercial gain. 2. Any copy, reproduction or communication must include this RCPA copyright notice in full. 3. With the exception of Chapter 6 - the checklist, no changes may be made to the wording of the Protocol including any Standards, Guidelines, commentary, tables or diagrams. Excerpts from the Protocol may be used in support of the checklist. References and acknowledgments must be maintained in any reproduction or copy in full or part of the Protocol. 4. In regard to Chapter 6 of the Protocol - the checklist: o o o o o o The wording of the Standards may not be altered in any way and must be included as part of the checklist. Guidelines are optional and those which are deemed not applicable may be removed. Numbering of Standards and Guidelines must be retained in the checklist, but can be reduced in size, moved to the end of the checklist item or greyed out or other means to minimise the visual impact. Additional items for local use may be added but must not be numbered as a Standard or Guideline, in order to avoid confusion with the RCPA checklist items. Formatting changes in regard to font, spacing, tabulation and sequencing may be made. Commentary from the Protocol may be added or hyperlinked to the relevant checklist item. Apart from any use as permitted under the Copyright Act 1968 or as set out above, all other rights are reserved. Requests and inquiries concerning reproduction and rights should be addressed to RCPA, 207 Albion St, Surry Hills, NSW 2010, Australia. First published: November 2013, 1st Edition (Version 1.0) ii

3 Disclaimer The Royal College of Pathologists of Australasia ("College") has developed these protocols as an educational tool to assist pathologists in reporting of relevant information for specific cancers. While each protocol includes standards and guidelines which are indicators of minimum requirements and recommendations, the protocols are a first edition and have not been through a full cycle of use, review and refinement. Therefore, in this edition, the inclusion of standards and guidelines in each document are provided as an indication of the opinion of the relevant expert authoring group, but should not be regarded as definitive or as widely accepted peer professional opinion. The use of these standards and guidelines is subject to the clinician s judgement in each individual case. The College makes all reasonable efforts to ensure the quality and accuracy of the protocols and to update the protocols regularly. However subject to any warranties, terms or conditions which may be implied by law and which cannot be excluded, the protocols are provided on an "as is" basis. The College does not warrant or represent that the protocols are complete, accurate, error-free, or up to date. The protocols do not constitute medical or professional advice. Users should obtain appropriate medical or professional advice, or where appropriately qualified, exercise their own professional judgement relevant to their own particular circumstances. Users are responsible for evaluating the suitability, accuracy, currency, completeness and fitness for purpose of the protocols. Except as set out in this paragraph, the College excludes: (i) all warranties, terms and conditions relating in any way to; and (ii) all liability (including for negligence) in respect of any loss or damage (including direct, special, indirect or consequential loss or damage, loss of revenue, loss of expectation, unavailability of systems, loss of data, personal injury or property damage) arising in any way from or in connection with; the protocols or any use thereof. Where any statute implies any term, condition or warranty in connection with the provision or use of the protocols, and that statute prohibits the exclusion of that term, condition or warranty, then such term, condition or warranty is not excluded. To the extent permitted by law, the College's liability under or for breach of any such term, condition or warranty is limited to the resupply or replacement of services or goods. iii

4 Contents Scope... v Abbreviations... vi Definitions... vii Introduction... 1 Authority and development Pre-analytical Specimen handling and macroscopic findings Microscopic findings Ancillary studies findings Synthesis and overview Structured checklist Formatting of pathology reports Appendix 1 Pathology request information and surgical handling procedures Appendix 2 Guidelines for formatting of a pathology report Appendix 3 Example of a pathology report Appendix 4 Appendix 5 WHO histological classification of tumours of the salivary glands Examples of grading of mucoepidermoid carcinoma References iv

5 Scope This protocol contains standards and guidelines for the preparation of a structured report for malignant neoplasms of the salivary glands, specifically epithelial and myoepithelial tumours. Standards and guidelines for preparation of structure protocols for other soft tissue neoplasms and lymphomas affecting salivary glands follow different protocols published separately. Structured reporting aims to improve the completeness and usability of pathology reports for clinicians, and improve decision support for cancer treatment. The protocol provides the framework for the reporting of any salivary gland neoplasms, whether as a minimum data set or fully comprehensive report. v

6 Abbreviations AFIP AJCC IHC IHI LIS MRN NHI PBS RCPA TNM UHI UICC WHO Armed Forces Institute of Pathology American Joint Committee on Cancer Immunohistochemistry Individual health identifier Laboratory Information System Medical Record Number National Health Index number (NZ) Pharmaceutical Benefits Scheme Royal College of Pathologists of Australasia tumour-node-metastasis Unique Health Identifier International Union Against Cancer World Health Organization vi

7 Definitions The table below provides definitions for general or technical terms used in this protocol. Readers should take particular note of the definitions for standard, guideline and commentary, because these form the basis of the protocol. Ancillary study Clinical information Commentary An ancillary study is any pathology investigation that may form part of a cancer pathology report but is not part of routine histological assessment. Patient information required to inform pathological assessment, usually provided with the specimen request form, also referred to as pre-test information. Commentary is text, diagrams or photographs that clarify the standards (see below) and guidelines (see below), provide examples and help with interpretation, where necessary (not every standard or guideline has commentary). Commentary is used to: define the way an item should be reported, to foster reproducibility explain why an item is included (e.g. how does the item assist with clinical management or prognosis of the specific cancer). cite published evidence in support of the standard or guideline state any exceptions to a standard or guideline. In this document, commentary is prefixed with CS (for commentary on a standard) or CG (for commentary on a guideline), numbered to be consistent with the relevant standard or guideline, and with sequential alphabetic lettering within each set of commentaries (e.g. CS1.01a, CG2.05b). General commentary General commentary is text that is not associated with a specific standard or guideline. It is used: to provide a brief introduction to a chapter, if necessary for items that are not standards or guidelines but are included in the protocol as items of potential importance, for which there is currently insufficient evidence to recommend their inclusion. (Note: in future reviews of protocols, such items may be reclassified as either standards or guidelines, in line with diagnostic and prognostic advances, following evidentiary review). vii

8 Guideline Guidelines are recommendations; they are not mandatory, as indicated by the use of the word should. Guidelines cover items that are not essential for clinical management, staging or prognosis of a cancer, but are recommended. Guidelines include key observational and interpretative findings that are fundamental to the diagnosis and conclusion. Such findings are essential from a clinical governance perspective, because they provide a clear, evidentiary decision-making trail. Guidelines are not used for research items. In this document, guidelines are prefixed with G and numbered consecutively within each chapter (e.g. G1.10). Macroscopic findings Microscopic findings Predictive factor Prognostic factor Standard Measurements, or assessment of a biopsy specimen made by the unaided eye. In this document, the term microscopic findings refers to histomorphological assessment. A predictive factor is a measurement that is associated with response or lack of response to a particular therapy. A prognostic factor is a measurement that is associated with clinical outcome in the absence of therapy or with the application of a standard therapy. It can be thought of as a measure of the natural history of the disease. Standards are mandatory, as indicated by the use of the term must. Their use is reserved for core items essential for the clinical management, staging or prognosis of the cancer and key information (including observations and interpretation) that is fundamental to the diagnosis and conclusion. These elements must be recorded and at the discretion of the pathologist included in the pathology report according to the needs of the recipient of the report. The summation of all standards represents the minimum dataset for the cancer. In this document, standards are prefixed with S and numbered consecutively within each chapter (e.g. S1.02). Structured report Synoptic report A report format which utilises standard headings, definitions and nomenclature with required information. A structured report in condensed form (as a synopsis or precis). viii

9 Synthesis Synthesis is the process in which two or more pre-existing elements are combined, resulting in the formation of something new. The Oxford dictionary defines synthesis as the combination of components or elements to form a connected whole. In the context of structured pathology reporting, synthesis represents the integration and interpretation of information from two or more modalities to derive new information. ix

10 Introduction Salivary gland neoplasms Malignant salivary gland neoplasms are derived from the gland parenchyma and are generally uncommon lesions. 1-2 When they do occur there is wide variation in their histological features and also in their clinical behaviour. 3 The frequency of salivary gland malignancies ranges from 0.4 to 13.5 cases per population. 1 They account for between 5-6% of head and neck cancers and 0.3-1% of malignancies of all body sites. 1-2 They can arise in the major salivary glands, minor glands or rarely ectopic sites. Malignant neoplasms arising in minor salivary glands are classified using the same staging principle as for other primary mucosal malignancies and include predictive factors associated with the specific histological type. 3 Surgical removal of salivary gland neoplasms usually involves partial excision of the gland including the tumour mass or, alternatively by complete excision of the entire gland. Benefits of structured reporting Structured pathology reports with standardised definitions for each component have been shown to significantly enhance the completeness and quality of data provided to clinicians, and have been recommended both in North America and the United Kingdom. 4-7 The College of American Pathologists and the Royal College of Pathologists (UK) have recently published useful protocols for the reporting of head and neck cancer. 8-9 These have been widely used in recent years in Australia and New Zealand, usually in modified formats to suit local requirements and preferences. A protocol endorsed by the Royal College of Pathologists of Australasia and other local organisations involved in the management of salivary gland neoplasms is therefore needed. The authors have not attempted to re-invent the wheel but have borrowed freely from pre-existing publications. The intention is to provide pathologists with a dataset that is comprehensive, easy to use, and in keeping with local capacities and practice. Importance of histopathological reporting Information from pathology reports has a key role in the rational planning of patient management, which is used to guide clinical decision making. It is vital that head and neck pathology reports contain all of the information required to determine correct tumour staging. This will allow clinicians to make appropriate adjuvant therapy recommendations and provide accurate information regarding prognosis. 10 1

11 Design of this protocol This structured reporting protocol provides a complete framework for the assessment and documentation of all the pathological features of malignant salivary gland neoplasms. Mandatory elements (standards) are differentiated from those that are not mandatory but represent best practice (guidelines). Consistency and speed of reporting is improved by the use of discrete data elements recorded from the checklist. However, the pathologist is encouraged to include free text or narrative to document any other relevant issues, to give reasons for coming to a particular opinion and to explain any points of uncertainty. The structure provided by the following chapters, headings and subheadings describes the elements of information and their groupings, but does not necessarily represent the format of either a pathology report (Chapter 7) or checklist (Chapter 6). These, and the structured pathology request form (Appendix 1) are templates that represent information from this protocol, organised and formatted differently to suit different purposes. Key documentation Guidelines for Authors of Structured Cancer Pathology Reporting Protocols, Royal College of Pathologists of Australasia, The Pathology Request Test Report Cycle Guidelines for Requesters and Pathology Providers, Royal College of Pathologists of Australasia, AJCC Cancer Staging Manual, 7th edition, American Joint Committee on Cancer, Pathology and Genetics: Head and Neck Tumours. World Health Organization Classification of Tumours, IARC Press, Lyon, Changes since the last edition Not applicable 2

12 Authority and development This section provides details of the committee involved in developing this protocol and the process by which it was developed. Protocol developers This protocol was developed by an expert committee, with assistance from relevant stakeholders. Expert committee Professor Richard M. Logan (Lead author), Oral and Maxillofacial Pathologist Professor Jane Dahlstrom (Chair), Pathologist Dr Sophie Otto, Pathologist Dr Brandon Nguyen, Radiation Oncologist Associate Professor Hedley G. Coleman, Oral and Maxillofacial Pathologist Professor Guan Chong, Surgeon Acknowledgements The salivary gland neoplasms expert committee wish to thank all the pathologists and clinicians who contributed to the discussion around this document. Stakeholders Anatomical Pathology Advisory Committee (APAC) Australian Cancer Network Australian and New Zealand Head and Neck Cancer Society Cancer Australia Cancer Council ACT Cancer Council NSW Cancer Council Queensland Cancer Council SA Cancer Council Tasmania Cancer Council Victoria Cancer Council Western Australia Cancer Institute NSW Cancer Services Advisory Committee (CanSAC) Cancer specific expert groups engaged in the development of the protocols Faculty of Oral and Maxillofacial Pathology, The Royal College of Pathologists of Australasia (FOMP) National Round Table Working Party for Structured Pathology Reporting of Cancer NSW Head and Neck Group The Royal Australasian College of Surgeons (RACS) 3

13 The Royal Australian and New Zealand College of Radiologists (RANZCR) The Royal College of Pathologists of Australasia (RCPA) Other Reviewers ACT Health Australian Association of Pathology Practices Inc (AAPP) Australian Commission on Safety and Quality in Health Care Cancer Voices Clinical Oncology Society of Australia (COSA) Department of Health and Ageing Grampians Integrated Cancer Services (GICS) Health Informatics Society of Australia (HISA) Independent Review Group of Pathologists Medical Software Industry Association (MSIA) National Coalition of Public Pathology (NCOPP) National E-Health Transition Authority (NEHTA) National Pathology Accreditation Advisory Council (NPAAC) New Zealand Guidelines Group (NZGG) NSW Department of Health Peter MacCallum Cancer Institute Queensland Cooperative Oncology Group (QCOG) Representatives from laboratories specialising in anatomical pathology across Australia Royal Australasian College of Physicians (RACP) Southern Cancer Network, Christchurch, New Zealand Southern Melbourne Integrated Cancer Service (SMICS) Standards Australia The Medical Oncology Group of Australia The Royal Australian College of General Practitioners (RACGP) Victorian Cooperative Oncology Group (VCOG) Western Australia Clinical Oncology Group (WACOG) Secretariat Meagan Judge, Royal College of Pathologists of Australasia Development process This protocol has been developed following the nine-step process set out in Guidelines for Authors of Structured Cancer Pathology Reporting Protocols. 11 Where no reference is provided, the authority is the consensus of the expert group. 4

14 1 Pre-analytical This chapter relates to information that should be recorded on receipt of the specimen in the laboratory. The pathologist is reliant on the quality of information received from the clinicians or requestor. Some of this information may be received in generic pathology request forms, however, the additional information required by the pathologist specifically for the reporting of salivary gland neoplasms is outlined in Appendix 1. Appendix 1 also includes a standardised request information sheet that may be useful in obtaining all relevant information from the requestor. Surgical handling procedures affect the quality of the specimen and recommendations for appropriate surgical handling are included in Appendix 1. S1.01 All demographic information provided on the request form and with the specimen must be recorded. CS1.01a CS1.01b CS1.01c The Royal College of Pathologists of Australasia (RCPA) The Pathology Request-Test-Report Cycle Guidelines for Requesters and Pathology Providers must be adhered to. 14 This document specifies the minimum information to be provided by the requesting clinician for any pathology test. The patient s ethnicity must be recorded, if known. In particular whether the patient is of aboriginal or Torres Strait islander origin. This is in support of a government initiative to monitor the health of indigenous Australians particularly in relation to cancer. The patient s health identifiers may include the patient s Medical Record Number as well as a national health number such as a patient s Medicare number (Australia), Individual Healthcare Identifier (IHI) (Australia) or the National Healthcare Identifier (New Zealand). S1.02 All clinical information as documented on the request form must be recorded verbatim. CS1.02a The request information may be recorded as a single text (narrative) field or it may be recorded discretely. S1.03 The pathology accession number of the specimen must be recorded. S1.04 The principal clinician involved in the patient s care and responsible for investigating the patient must be recorded. CS1.04a Knowledge of the clinical presentation is an essential part of the WHO classification yet it may not be available for a number of reasons: The clinical assessment and staging may be incomplete at the time of biopsy. 5

15 The pathology request is often authored by the clinician performing the biopsy rather than the clinician who is investigating and managing the patient. The identity of this clinician is often not indicated on the pathology request form In practice therefore, it is important in such cases that the reporting pathologist should be able to communicate with the managing clinician for clarification. G1.01 Any clinical information received in other communications from the requestor or other clinician should be recorded together with the source of that information. 6

16 2 Specimen handling and macroscopic findings This chapter relates to the procedures required after the information has been handed over from the requesting clinician and the specimen has been received in the laboratory. Specimen handling Pathologists may be requested to provide tissue samples from fresh specimens for tissue banking or research purposes. The decision to provide tissue should only be made when the pathologist is confident that doing so will not compromise the diagnostic process and interfere with the assessment of important parameters that may influence patient prognosis and management such as the measurement of tumour size or distance of surgical margins. As a safeguard, research use of the specimen may be postponed until the diagnostic process is complete. Complications may arise however if suitability for research requires a fresh specimen to be kept frozen and in such instances the diagnostic process takes precedence and the tissue will be fixed for routine processing. Images (such as macroscopic photographs and / or specimen radiography) of the gross specimen showing the overall conformation of the neoplasm and, especially in the case of complicated resections, images showing the relation of the neoplasm to the resection margins, are desirable, and useful for multidisciplinary meetings. Placement of arrows and labels indicating important anatomical structures is desirable, and images should always include a scale. The specimen must be handled in a systematic and thorough fashion to ensure completeness and accuracy of pathological data. The pathological findings from examination of resection specimens are important in guiding the patient s subsequent clinical management; for example, in predicting a patient s prognosis, or in deciding whether adjuvant therapy is indicated. Hence, these specimens must be handled in a systematic and thorough fashion to ensure the completeness and accuracy of the pathological data. Specimens are best received fresh and without delay if tissue banking is part of the standard protocol. The subsequent fixation, macroscopic assessment and sampling for histology are crucial. Despite the pressure on the pathologist for rapid turnaround, adequate fixation and processing of biopsies as well as resection specimens is vital for high quality pathology. Full fixation facilitates obtaining thin transverse slices through the neoplasm and it has also been shown to increase lymph node yield. The specimen needs to be thoroughly examined before sectioning. 7

17 Complex specimens should be examined and orientated together with the responsible surgeon, if possible. Alternatively the surgeon should orientate the specimen with the use of ties or pin the specimen out and label the corkboard. The application of paints/indelible inks to the specimen is crucial in assessing the surgical margins on histological slides. In most cases, a single colour ink will suffice. Multiple colours may be necessary to accurately identify specific margins of the resection. It is important that the ink is dry before sectioning to prevent ink tracking and seepage from creating a false margin. 15 Macroscopic findings S2.01 The labelling of the specimen must be recorded. S2.02 The specimen type must be recorded. CS2.02a Options include: incisional biopsy excisional biopsy of minor gland resection of submandibular gland extended resection of submandibular gland (surgeon to indicate extent of anatomical resection) resection of sublingual gland superficial parotidectomy +/- facial nerve sacrifice total parotidectomy facial nerve preservation facial nerve sacrifice extended radical total parotidectomy (includes resection of parotid gland, facial nerve, masseter muscle, zygoma and mandible) neck dissection (nodal levels included in the dissection should be listed): o o o o selective modified radical radical extended radical 8

18 other (specify) G2.01 The integrity of the specimen should be recorded as intact or fragmented. S2.03 Record if the specimen is received fresh or in formalin. S2.04 The specimen should be measured in 3 dimensions. S2.05 The size, site (including laterality) and appearance of the tumour (lesion) must be recorded. CS2.05a Tumour size is an important prognostic factor in neoplasms of the salivary gland. 16 The maximum dimension relates to T stage and prognosis. The prognosis of stage III or IV neoplasms is poor regardless of histological grade. The benefit of adjuvant radiotherapy is also dependent on the size of the neoplasm with little benefit shown in terms of survival advantage in neoplasms that are less than 4cm. 16 S2.06 Macroscopic evidence of extraparenchymal extension of the tumour must be recorded. CS2.06a In the AJCC staging system, extraparenchymal extension qualifies for a T3 tumour. This does not include extension into the skin, mandible, ear canal, facial nerve, base of skull, pterygoid plates or encasement of the carotid artery, which are classified as T4 tumours. S2.07 Neck dissection (if present) must be described and measured. CS2.07a Record the laterality and type of neck dissection. S2.08 The number of lymph nodes in each level and size of the largest node per level must be recorded if available. CS2.08a This should include the following lymph node groups: submental (level IA), submandibular (level IB), upper jugular (level IIA and IIB), middle jugular (level III), lower jugular (level IV), posterior triangle (level VA and VB). 13 Use of a template board or transparency diagram may assist the pathologist in localising the different levels of the neck dissection. The onus however rests with the surgeon to orientate and label the nodal groups with the use of sutures, ties or by pinning the neck dissection specimen out and labelling the corkboard. Anatomical lymph node groups may also be submitted in separate specimen containers. All lymph node tissue should be submitted for histological examination, where possible. CS2.08b Lymph nodes measuring up to 6mm or less in maximum dimension are embedded whole

19 Nodes measuring 6-15mm around the equator are bisected longitudinally through the hilum and embedded in total in one casette Nodes larger than 15mm around the equator are bisected and one half resliced at 90 degrees to the original plane of bisection. 13,17-18 Enlarged nodal masses and the largest lymph node should 13, 17 be measured in millimetres. For enlarged nodes, greater than 10mm and for macroscopically involved nodes with or without apparent fixation to the surrounding tissue, the surrounding surgical margin should also be sampled. 17 All enlarged nodes, specifically those larger than 10 mm and any with apparent fixation to surrounding tissue should be examined for the presence of extracapsular extension and/or invasion of adjacent muscles, blood vessels, nerves must be documented. 13,19 G2.02 A descriptive or narrative field should be provided to record any other macroscopic information that may not be recorded in the above standards and guidelines, and that would normally form part of the macroscopic description. CG2.02a CG2.02b CG2.02c CG2.02d The traditional macroscopic narrative recorded at the time of specimen dissection is often reported separately from the cancer dataset. Although this remains an option, it is recommended that macroscopic information be recorded within the overall structure of this protocol. Much of the information recorded in a traditional macroscopic narrative is covered in the standards and guidelines above and in many cases, no further description is required. Evidence of macroscopically visible tumour or extracapsular spread should be noted. If photographs and radiological images are taken or diagrams are drawn this should be recorded in the macroscopic narrative. S2.09 The nature and sites of all blocks must be recorded. 10

20 3 Microscopic findings Microscopic findings relates to purely histological (morphological) assessment. Information derived from multiple investigational modalities, or from two or more chapters, is described in Chapter 5. S3.01 The histological tumour type and subtype must be recorded. CS3.01a The histological type of salivary gland neoplasm is an important predictor of biological behaviour and should be recorded according to the WHO classification 3 (see Appendix 4). S3.02 Histological grade must be recorded (where relevant). CS3.02a Specific grading systems have not been developed for all salivary gland neoplasms. In many instances, specific tumours characteristically demonstrate either high or low grade behaviour (e.g. salivary duct carcinoma compared with polymorphous low grade adenocarcinoma) 16 (See Table 1 below)., Alternatively a histologic subtype of a specific tumour may be associated with high-grade behaviour (e.g. solid type adenoid cystic carcinoma) and in these instances the histological description and diagnosis will be sufficient to indicate behaviour. 20 If there are histological features indicating low or high-grade behaviour that is not typical for the tumour, these can be indicated in the report. 20 In the case of mucoepidermoid carcinoma, specific grading systems have been developed (WHO classification of tumours 3 ) (Appendix 5). Table 1: Prognostic factors in salivary adenocarcinoma Salivary adenocarcinomas Polymorphous low grade adenocarcinoma Low grade + High grade Acinic cell carcinoma + + Basal cell adenocarcinoma + Cribriform adenocarcinoma + Mammary analogue secretory carcinoma + + Myoepithelial carcinoma + + Cystadenocarcinoma + Epithelial-Myoepithelial carcinoma + 11

21 Mucoepidermoid carcinoma + + Adenoid cystic carcinoma + + Adenocarcinoma, not otherwise specified + + Squamous cell carcinoma + + Carcinoma ex-pleomorphic adenoma + Salivary duct carcinoma + Oncocytic carcinoma + Undifferentiated carcinoma + Reprinted from Speight PM and Barrett AW (2009). Prognostic factors in malignant tumours of the salivary glands. British Journal of Oral and Maxillofacial Surgery 47: with permission from Elsevier. CS3.02b Mucoepidermoid carcinoma Grading of mucoepidermoid carcinoma previously involved making an assessment of the number of mucous cells in the neoplasm. An increased number of mucous cells and higher volume of mucus production are associated with less aggressive neoplasms that are less likely to metastasise. Neoplasms that are predominantly epidermoid in nature are deemed higher risk for metastasis. 16 The development of more objective grading systems for mucoepidermoid carcinoma have been contentious, but the use of such systems may remove some subjectivity from the assessment. The modified AFIP grading system for example, scores specific histopathological features and can be used to provide an objective grading of neoplasms 3 (refer to Appendix 5). If a specific grading system is applied, it should be specified in the report. Generally, mucoepidermoid carcinoma arising within the submandibular gland generally has a poorer prognosis. 2 Mucoepidermoid carcinoma with MECT1-MAML2 translocation is reported to have a better prognosis than those tumours without the translocation (see CS4.02b). 21 CS3.02c Acinic cell carcinoma Histological grading systems for acinic cell carcinoma are inconsistent. Factors such as increased mitoses, necrosis, neural invasion, pleomorphism and stromal hyalinisation have been associated with increased neoplasm aggressiveness. The cell proliferation marker Ki-67 has been suggested to indicate a neoplasms behaviour with increased aggressiveness in neoplasms with >5% of cells staining. 3 12

22 The location of acinic cell carcinomas is important, with submandibular gland tumours demonstrating more aggressive behaviour than parotid tumours. 3 Furthermore, acinic cell carcinomas arising in minor salivary glands are less aggressive than those that arise in major glands. 3 CS3.02d Mammary analogue secretory carcinoma Mammary analogue secretory carcinoma (MASC) is a recently described tumour that has features similar to acinic cell carcinoma. 22 These neoplasms have variable growth patterns including solid areas, papillary cystic and microcystic spaces which contain PAS positive material They are characterised by the ETV6-MTRK3 translocation It has been suggested that although slightly more aggressive than acinic cell carcinoma, the clinical outcome is similar. 24 CS3.02e Adenoid cystic carcinoma Various histological patterns are associated with adenoid cystic carcinomas. Tubular and cribriform patterns are considered to be less aggressive compared to solid forms. 3,26 It has been suggested that neoplasms that have more than 30% solid component should be considered as high-grade neoplasms. 20 CS3.02f Carcinoma ex pleomorphic adenoma Non-invasive carcinoma ex pleomorphic adenoma generally behave in a similar fashion to benign pleomorphic adenoma and are associated with a good prognosis. 3 Invasive carcinoma ex pleomorphic adenomas are considered aggressive neoplasms. Minimally invasive carcinoma (<1.5mm of invasion) are considered low-grade variants. 3,20 CS3.02g Polymorphous low-grade adenocarcinoma Although these neoplasms are classified as low-grade according to their name, up to a third recur locally or metastasise to regional lymph nodes. 16 Some studies have demonstrated a link between lymph node metastases and papillary cystic growth pattern. 27 Cribriform adenocarcinoma of the tongue is a subtype of polymorphous low-grade adenocarcinoma and is associated with increased lymph node metastases. 28 CS3.02h Salivary duct carcinoma Salivary duct carcinoma, although uncommon, is a high-grade aggressive adenocarcinoma with poor prognosis 3 Histologically the neoplasm has features similar to intraductal and infiltrating mammary duct carcinoma. The ductal component is demonstrates a cribriform growth pattern of epithelioid cells whilst the infiltrating component may have solid or papillary areas with psammoma bodies. 3 Cytologically 13

23 the neoplastic cells have pleomorphic nuclei with prominent nucleoli; prominent mitotic activity is also observed. 3 Spindle cell or sarcomatoid variants have also been described. 3 CS3.02i Minor salivary gland tumours Malignant neoplasms arising in minor salivary glands are classified using the same staging principle as for other primary mucosal malignancies and include predictive factors associated with the specific histological type. 3 S3.03 Tumour size must be recorded. CS3.03a Neoplasm size is an important factor relating to the outcome of salivary gland neoplastic disease. 16 The prognosis of stage III or IV neoplasms is poor regardless of histological grade. Lesions that are less than 4cm in size generally have a better prognosis. 16 S3.04 The involvement of adjacent structures must be recorded. CS3.04a Involvement of skin, mandible, ear canal or facial nerve confers a T4a classification while encasement of the carotid artery or invasion of the skull base and pterygoid plates indicates T4b disease. S3.05 The presence of perineural involvement must be recorded. CS3.05a Evidence of perineural involvement may be diagnostically useful for some neoplasms such as adenoid cystic carcinoma and polymorphous low-grade adenocarcinoma. 16 The prognostic significance of perineural involvement varies between studies. From a radiation oncology perspective, it is important to specify if this involves a named nerve, the size or diameter of the involved nerve and the length of involvement. This provides useful information for risk assessment in determining whether to include the nerve back to the base of skull in the radiation target volume. S3.06 The presence or absence of lymphovascular invasion must be recorded. CS3.06a There is a need to distinguish between retraction artefact and intravascular embolisation. Vascular invasion usually occurs in thin walled vessels and involvement of muscular vessels is rare. Identify vascular invasion only when tumour emboli are within clear spaces that are completely lined by endothelial cells. 19 The detection of vascular invasion implies the increased likelihood of successful metastatic spread by the tumour. 9,29-31 S3.07 The status of the surgical resection margins must be recorded. CS3.07a This includes both the surface mucosa at the edge of excision as well as the submucosal and deeper soft tissues around the 14

24 neoplasm. CS3.07b CS3.07c In routine examination and assessment the tissue shrinkage as a result of fixation is not taken into account. This may result in 30-47% reduction in the margin width when compared to the in-situ clinical width. The measurement from the closest surgical margin(s) must be documented. The UK guidelines for recording the status of the mucosal and deep margins designate margins of >5mm as clear, 1-5mm as close and < 1mm or with histological cut-through as involved. 9 It is recommended that these be adopted. 9 Involved margin(s) are associated with an increased risk of local recurrence and this should be recorded. 32 Specifically this should include location and extent of involvement (measurement of linear extend of marginal involvement). If multiple margins are involved these features should be specified for each margin. S3.08 The cervical lymph node status must be recorded. CS3.08a CS3.08b CS3.08c If lymph nodes have been received, for each anatomical level record the total number of nodes identified and the number of nodes involved. Measure and document the size of the largest metastatic deposit. This is an important criteria in determining the nodal stage in the AJCC TNM staging system. 13 The number of positive nodes may be uncertain due to matting of the nodes and in such circumstances an estimate of the number of nodes is required as well as maximum dimension and level(s) of nodes involved. This confers (at least) a pn2b status for the patient. 13 If the maximum dimension were greater than 6cm, a status of N3 would be recorded. CS3.08d The prognostic significance of isolated tumour cells (ITC - collections of cells totalling < 0.2mm) and micro metastases (<2mm in diameter) is uncertain and should be recorded and included in the total number of involved lymph nodes. 19 CS3.08e The presence or absence of extracapsular spread should be recorded. Studies suggest that extracapsular spread in salivary gland neoplasms specifically mucoepidermoid carcinoma and adenoid cystic carcinoma is associated with poor prognosis. 2,33 Whilst generally the evidence for the importance of extracapsular spread specifically in salivary gland neoplasms is limited 2,33 it is suggested that this should be recorded for the purposes of further study into its significance. If present, describe the microscopic extracapsular spread as being present or absent and include the measurement of the extent (in mm) from the original nodal capsule. 18,19 Describe the number of nodes with extracapsular spread; if only one node is affected count the number of foci of extracapsular 15

25 spread in that node. Describe any structures that may be involved by the extranodal tumour. Permeation of perinodal lymphatics should also be documented, however this does not constitute extra-capsular spread. 19 Measure the distance from perinodal surgical margins. If it is uncertain whether there is extracapsular spread, additional serial sections should be examined and if there is still ambiguity it should be recorded as present. 9 G3.01 Any additional relevant comments should be recorded. Sentinel node biopsy This has been suggested as a technique which may potentially avoid the need and morbidity associated with neck dissections, but at present it is not part of standard patient care and remains an experimental procedure in head and neck cancer. 9 Likewise there is limited evidence for its use in salivary gland malignancies

26 4 Ancillary studies findings Ancillary studies may be used to determine lineage, clonality or disease classification or subclassification; as prognostic biomarkers; or to indicate the likelihood of patient response to specific biologic therapies. Research continues into various prognostic biomarkers, however at the present time there are no specific molecular markers that are used in routine clinical practice to assist clinicians in predicting the neoplasms behaviour or response to therapy for salivary gland neoplasms. The few ancillary tests that may be required in certain situations will be listed by technique. No ancillary tests are currently used on a routine basis for the diagnosis of salivary gland neoplasms. Immunohistochemistry (IHC) staining S4.01 The results of any immunohistochemistry, if performed, must be incorporated into the pathology report. CS4.01a CS4.01b CS4.01c CS4.01d CS4.01e CS4.01f In general the use of IHC is non-specific for differentiating many salivary gland neoplasms. 3 For example, labelling for CD117 (c-kit) has been used to differentiate between adenoid cystic carcinoma and polymorphous low-grade adenocarcinoma. 36 There is variability between studies. IHC studies may assist in the resolution of differential diagnosis problems. Myoepithelial markers and cytokeratins may assist in the differentiation of clear cell carcinoma and clear cell variants of myoepithelioma or epithelialmyoepithelial carcinoma. 3 Labelling of high molecular weight cytokeratins may be useful in the diagnosis of mucoepidermoid carcinoma where the epidermoid component is sparse. 3 The use of Ki-67 labelling index has been suggested by some authors to differentiate higher-grade neoplasms (e.g. high grade acinic cell carcinomas). The prognostic implications for this have not been established. 3,37 Salivary duct carcinomas show strong reactivity for androgen receptors and positive membrane staining for HER-2 protein. Overexpression of HER-2 has been shown to correlate with high grade malignancy and poor prognosis. 38 Immunohistochemical studies are indicated initially and if there is strong positive staining, the results can be followed up with CISH (see CS4.02d). S100 and Mammaglobin may be useful in distinguishing acinic cell carcinoma from mammary analogue secretory carcinoma. However it should be noted that these markers have been demonstrated in other salivary gland carcinomas (polymorphous low-grade adenocarcinoma and adenoid cystic carcinoma 39 and therefore appreciation of the histological features is important as well as demonstration 17

27 of the ETV6 translocation in the case of mammary analogue secretory carcinoma (see CS4.02e). In-situ Hybridisation S4.02 The results of any in-situ hybridisation, if performed, must be incorporated into the pathology report. CS4.02a CS4.02b CS4.02c CS4.02d CS4.02e At the present time in-situ hybridisation is not routinely performed for salivary gland neoplasms. There is some evidence that it may be useful in the diagnosis and as prognostic markers for some salivary gland neoplasms. If requested the results should be incorporated into the pathology report. Mucoepidermoid carcinoma with MECT1-MAML2 translocation is reported to have a better prognosis than those tumours without the translocation. 21 However despite this, the translocation has been reported in some histologically high-grade and clinically aggressive tumours and therefore it is important not to overlook traditional clinical and histological parameters when assessing these lesions. 21 EWSR1-ATF1 fusion is consistently found in hyalinising clear cell carcinomas HER-2 expression in salivary duct carcinoma can be demonstrated by CISH. 42 Demonstration of ETV6 translocation is useful in the diagnosis of mammary analogue secretory carcinoma. 25,43 and differentiating from acinic cell carcinoma and other salivary gland tumours that demonstrate S100 and Mammaglobin immunohistochemical staining. 25 Cytogenetics S4.03 The results of any cytogenetics, if performed, must be incorporated into the pathology report. CS4.03a At the present time cytogenetic investigations are not routinely performed for salivary gland neoplasms. 18

28 5 Synthesis and overview Information that is synthesised from multiple modalities and therefore cannot reside solely in any one of the preceding chapters is described here. For example, tumour stage is synthesised from multiple classes of information clinical, macroscopic and microscopic. By definition, synthetic elements are inferential rather than observational, often representing high-level information that is likely to form part of the report Summary or Diagnosis section in the final formatted report. Overarching case comment is synthesis in narrative format. Although it may not necessarily be required in any given report, the provision of the facility for overarching commentary in a cancer report is essential. S5.01 The tumour stage and stage grouping based on the TNM staging system of the AJCC Cancer Staging Manual (7th Edition) 13 must be recorded. (See Tables S5.01a and b below.) Table S5.01a TNM staging # T classification TX T0 T1 T2 T3 T4a T4b N classification NX N0 N1 N2 Primary tumour Primary tumour cannot be assessed No evidence of primary tumour Tumour 2 cm or less in greatest dimension without extraparenchymal extension* Tumour more than 2 cm but not more than 4 cm in greatest dimension without extraparenchymal extension* Tumour more than 4 cm and/or tumour having extraparenchymal extension* Moderately advanced disease Tumour invades skin, mandible, ear canal, and/or facial nerve Very advanced disease Tumour invades skull base and/or pterygoid plates and/or encases carotid artery Regional lymph nodes Regional lymph nodes cannot be assessed No regional lymph node metastasis Metastasis in a single ipsilateral lymph node, 3 cm or less in greatest dimension Metastasis in a single ipsilateral lymph node, more than 3 cm 19

29 N2a N2b N2c N3 M classification M0 M1 but not more than 6 cm in greatest dimension, or in multiple ipsilateral lymph nodes, none more than 6 cm in greatest dimension, or in bilateral or contralateral lymph nodes, none more than 6 cm in greatest dimension Metastasis in a single ipsilateral lymph node, more than 3 cm but not more than 6 cm in greatest dimension Metastasis in multiple ipsilateral lymph nodes, none more than 6 cm in greatest dimension Metastasis in bilateral or contralateral lymph nodes, none more than 6 cm in greatest dimension Metastasis in a lymph node, more than 6 cm in greatest dimension Distant metastasis No distant metatasis Distant metastasis *Note: Extraparenchymal extension is clinical or macroscopic evidence of invasion of soft tissues. Microscopic evidence alone does not constitute extraparenchymal extension for classification purposes. #Used with the permission of the American Joint Committee on Cancer (AJCC), Chicago, Illinois. The original source for this material is the AJCC Cancer Staging Manual, Seventh Edition (2010) published by Springer Science and Business Media LLC, Table S5.01b Pathological stage grouping #. Stage T N M I T1 N0 M0 II T2 N0 M0 III T3 N0 M0 T1 N1 M0 T2 N1 M0 T3 N1 M0 IVA T4a N0 M0 T4a N1 M0 T1 N2 M0 T2 N2 M0 T3 N2 M0 T4a N2 M0 IVB T4b Any N M0 Any T N3 M0 IVC Any T Any N M1 #Used with the permission of the American Joint Committee on Cancer (AJCC), Chicago, Illinois. The original source for this material is the AJCC Cancer Staging Manual, Seventh Edition (2010) published by Springer Science and Business Media LLC, S5.02 The year of publication and edition of the cancer staging system must be included in the report. 20

30 G5.01 The Diagnostic summary section of the final formatted report should include: a) Type of operation (S1.02) b) Anatomical site / laterality (S1.02) c) Tumour type (S.01) d) Histological grade (S3.02) e) Tumour dimensions (S3.03) f) Extraglandular extension of tumour (S3.08) g) Lymphovascular invasion (S3.06) h) Perineural invasion (S3.05) i) Involved or close margins with measurements (S3.07) j) Type of neck dissection (if present) (S2.07) k) Presence or absence of metastatic tumour in lymph nodes and level of involved nodes (S3.08) l) Presence or absence of extra-capsular spread of tumour (S3.08) m) Ki-67 index (S4.01) n) Tumour stage (S5.01) G5.02 A field for free text or narrative in which the reporting pathologist can give overarching case comment should be provided. CG5.02a This field may be used, for example, to: list any relevant ancillary tests document any noteworthy adverse gross and/or histological features express any diagnostic subtlety or nuance that is beyond synoptic reporting document further consultation or results still pending. CG5.02b Use of this field is at the discretion of the reporting pathologist. 21

31 6 Structured checklist The following checklist includes the standards and guidelines for this protocol which must be considered when reporting, in the simplest possible form. The summation of all Standards is equivalent to the Minimum Data Set for neoplasms of the salivary glands. For emphasis, standards (mandatory elements) are formatted in bold font. S6.01 The structured checklist provided below may be modified as required but with the following restrictions: a. All standards and their respective naming conventions, definitions and value lists must be adhered to. b. Guidelines are not mandatory but are recommendations and where used, must follow the naming conventions, definitions and value lists given in the protocol. G6.01 The order of information and design of the checklist may be varied according to the laboratory information system (LIS) capabilities and as described in Functional Requirements for Structured Pathology Reporting of Cancer Protocols. 44 CG6.01a CG6.01b Where the LIS allows dissociation between data entry and report format, the structured checklist is usually best formatted to follow pathologist workflow. In this situation, the elements of synthesis or conclusions are necessarily at the end. The report format is then optimised independently by the LIS. Where the LIS does not allow dissociation between data entry and report format, (for example where only a single text field is provided for the report), pathologists may elect to create a checklist in the format of the final report. In this situation, communication with the clinician takes precedence and the checklist design is according to principles given in Chapter 7. G6.02 Where the checklist is used as a report template (see G6.01), the principles in Chapter 7 and Appendix 2 apply. CG6.02a All extraneous information, tick boxes and unused values should be deleted. G6.03 Additional comment may be added to an individual response where necessary to describe any uncertainty or nuance in the selection of a prescribed response in the checklist. Additional comment is not required where the prescribed response is adequate. 22

32 Values in italics are conditional on previous responses. Values in all caps are headings with sub values. S/G Item description Response type Conditional Pre-analytical S1.01 Demographic information provided S1.02 Clinical information provided on request form Type of operation Text OR Structured entry as below: Multi select value list (select all that apply): incisional biopsy excisional biopsy of minor gland resection of submandibular gland extended resection of submandibular gland resection of sublingual gland +/- facial nerve sacrifice superficial parotidectomy total parotidectomy o o o facial nerve preservation facial nerve sacrifice extended radical total If selective neck dissection, modified radical neck dissection, radical neck dissection, or extended radical neck dissection is selected record the laterality and nodal levels included. If extended resection of submandibular gland record the extent of anatomical resection 23

33 S/G Item description Response type Conditional Extent of anatomical resection Laterality of neck dissection Nodal levels included Text neck dissection o o o o parotidectomy (includes resection of parotid gland, facial nerve, masseter muscle, zygoma and mandible) selective modified radical radical other (specify) extended radical Single select value list: left right bilateral Multi select value list (select all that apply): submental (level IA) submandibular (level IB) upper jugular (level IIA) upper jugular (level IIB) middle jugular (level III) lower jugular (level IV) If other, record the other nodal tissue submitted 24

34 S/G Item description Response type Conditional Other nodal tissue submitted Text Anatomical site of neoplasm Site Text posterior triangle (level VA) posterior triangle (level VB) other (specify) Note: if a bilateral neck dissection is performed, record for each laterality Multi select value list (choose all that apply: Parotid gland - whole Parotid gland - superficial lobe Parotid gland - deep lobe Submandibular gland Sublingual gland Minor salivary gland Other If minor salivary gland record the site If other, describe the other anatomical site Other anatomical site Text Laterality of the lesion Clinical history Single selection value list: Left Right Text 25

35 S/G Item description Response type Conditional Clinical TNM stage Clinical diagnosis or differential diagnosis New primary cancer or recurrence Pre-operative or prior radiotherapy administered Any involvement of adjacent structures Text Text Details Text Details Text Single selection value list: New primary Recurrence regional (local) Recurrence distant metastasis Single selection value list: Text None administered Yes If recurrence distant metastasis is selected record details If yes, provide details S1.03 Pathology accession number Alpha-numeric S1.04 Principal clinician caring for the patient G1.01 Other clinical information received Text Text Macroscopic findings S2.01 Specimen labelled as Text 26

36 S/G Item description Response type Conditional S2.02 Specimen type Multi select value list (choose all that apply): If minor salivary gland is selected, record the site(s) Parotid gland - whole Parotid gland - superficial lobe Parotid gland - deep lobe Submandibular gland Sublingual gland Minor salivary gland Neck dissection Biopsy incisional Biopsy excisional Biopsy resection Other (specify) Site(s) Text G2.01 Specimen integrity Single selection value list: Intact Fragmented S2.03 Specimen received Single selection value list: Fresh Formalin 27

37 S/G Item description Response type Conditional S2.04 Specimen measurements Numeric: x x mm S2.05 DESCRIPTION AND MEASUREMENTS OF LESION Size Numeric: x x mm Notes: length x width x thickness Site Text Notes: Appearance Text S2.06 Macroscopic evidence of extraparenchymal extension Site should include laterality Single selection value list: Absent Present S2.07 Neck dissection Single selection value list: Absent Present If present, record the type, description (eg any anatomical structures), laterality and dimensions Type Single selection value list: selective neck dissection modified radical neck dissection 28

38 S/G Item description Response type Conditional radical neck dissection extended radical neck dissection Laterality of neck dissection Single selection value list: Left Right Bilateral Dimensions Numeric: x x mm Notes: Description Text S2.08 MACROSCOPIC LYMPH NODE STATUS length x width x thickness Notes: Include for example any anatomical structures Single selection value list: Not received Received If received, record the specific lymph nodes levels received. If bilateral is recorded in S2.07 record the levels for EACH laterality. submental (level IA) Numeric: Lymph nodes and Numeric: with largest node mm Notes: Specify the number of lymph nodes and size of 29

39 S/G Item description Response type Conditional largest node eg 3 Lymph nodes with largest node 5mm If bilateral neck dissection, record the level for each laterality. submandibular (level IB) Numeric: Lymph nodes and Numeric: with largest node mm Notes: Specify the number of lymph nodes and size of largest node eg 3 Lymph nodes with largest node 5mm If bilateral neck dissection, record the level for each laterality. upper jugular (level IIA) Numeric: Lymph nodes and Numeric: with largest node mm Notes: Specify the number of lymph nodes and size of largest node eg 3 Lymph nodes with largest node 5mm If bilateral neck dissection, record the level for each laterality. 30

40 S/G Item description Response type Conditional upper jugular (level IIB) Numeric: Lymph nodes and Numeric: with largest node mm Notes: Specify the number of lymph nodes and size of largest node eg 3 Lymph nodes with largest node 5mm If bilateral neck dissection, record the level for each laterality. middle jugular (level III) Numeric: Lymph nodes and Numeric: with largest node mm Notes: Specify the number of lymph nodes and size of largest node eg 3 Lymph nodes with largest node 5mm If bilateral neck dissection, record the level for each laterality. lower jugular (level IV) Numeric: Lymph nodes and Numeric: with largest node mm 31

41 S/G Item description Response type Conditional Notes: Specify the number of lymph nodes and size of largest node eg 3 Lymph nodes with largest node 5mm If bilateral neck dissection, record the level for each laterality. posterior triangle (level VA) Numeric: Lymph nodes and Numeric: with largest node mm Notes: Specify the number of lymph nodes and size of largest node eg 3 Lymph nodes with largest node 5mm If bilateral neck dissection, record the level for each laterality. posterior triangle (level VB) Numeric: Lymph nodes and Numeric: with largest node mm Notes: Specify the number of lymph nodes and size of largest node eg 3 Lymph nodes with largest node 5mm If bilateral neck dissection, record the level for 32

42 S/G Item description Response type Conditional G2.02 Other macroscopic comment Text S2.09 Block identification key Text Microscopic findings each laterality. S3.01 Histological tumour type Single selection value list from WHO Classification of Tumours. Pathology and Genetics: Head and Neck Tumours.(2005) S3.02 HISTOLOGICAL GRADE Grading system Text Grade/score Text S3.03 Tumour size Numeric: x x mm S3.04 Involvement of adjacent structures Single selection value list: Not applicable Absent Present Site(s) Multi select value list (select all that apply): Skin Mandible If present, record all the sites which apply. 33

43 S/G Item description Response type Conditional Ear canal Facial nerve Base of skull Pterygoid plates Carotid artery encasement Other (specify) S3.05 Perineural involvement Single selection value list: Not identified Present S3.06 Lymphovascular invasion Single selection value list: Not identified Present S3.07 SURGICAL MARGIN STATUS Margin Text (specify margin) If not involved, specify the distance to tumour. AND Single selection value list: Not involved Involved 34

44 S/G Item description Response type Conditional Notes: Distance to tumour Numeric: mm Note that the margin and whether it is positive or negative must be repeated for each surgical margin. S3.08 CERVICAL LYMPH NODE STATUS submental (level IA) Total number of nodes: Numeric AND Number of involved (positive) nodes: Numeric submandibular (level IB) Total number of nodes: Numeric AND Number of involved (positive) nodes: Numeric upper jugular (level IIA) Total number of nodes: Numeric AND Number of involved (positive) nodes: Numeric The lymph node status will be conditional on specific nodal levels received in S2.08 if any. NOTE: If bilateral is recorded in S2.07 record the levels for EACH laterality. The number of nodes per level recorded in S2.08 should be presented to the pathologist for review at this point. 35

45 S/G Item description Response type Conditional upper jugular (level IIB) Total number of nodes: Numeric AND Number of involved (positive) nodes: Numeric middle jugular (level III) Total number of nodes: Numeric AND Number of involved (positive) nodes: Numeric lower jugular (level IV) Total number of nodes: Numeric AND Number of involved (positive) nodes: Numeric posterior triangle (level VA) Total number of nodes: Numeric AND Number of involved (positive) nodes: Numeric posterior triangle (level VB) Total number of nodes: Numeric LARGEST METASTATIC DEPOSIT AND Number of involved (positive) nodes: Numeric 36

46 S/G Item description Response type Conditional Location Text Dimensions Numeric: x x mm Notes: length x width x thickness Extracapsular spread Extent of invasion from nodal capsule Number of nodes with extracapsular spread Number foci /tongues of extracapsular spread Structures involved in extracapsular spread Distance from closest perinodal surgical margins Single selection value list: Absent Present Numeric: mm Numeric: Numeric: Text Numeric: mm If present, record the extent of invasion from nodal capsule, the number of nodes with extracapsular spread, the structures involved in extracapsular spread, and the distance from closest perinodal surgical margins If only 1 node record the number foci /tongues of extracapsular spread 37

47 S/G Item description Response type Conditional Permeation of perinodal lymphatics G3.01 Other microscopic comment Text Ancillary test findings Single selection value list: Absent Present S4.01 IMMUNOHISTOCHEMICAL STAINS Performed Single selection value list: No Yes Pending Antibodies List (as applicable): Positive antibodies Negative antibodies Equivocal antibodies Interpretation Text If yes, record antibodies, interpretation and clinical significance. Clinical significance Text S4.02 IN-SITU HYBRIDISATION Performed Single selection value list: No If yes, record performing lab, results, conclusions and person 38

48 S/G Item description Response type Conditional Performing laboratory Text Yes Pending responsible for reporting. Result Text Conclusion Text Person responsible for reporting Text S4.03 CYTOGENETICS Performed Single selection value list: No Yes Pending Performing laboratory Text If yes, record performing lab, results, conclusions and person responsible for reporting. Result Text Conclusion Text Person responsible for reporting Text Synthesis and overview S5.01 PATHOLOGICAL AJCC 39

49 S/G Item description Response type Conditional TUMOUR STAGING Primary Tumour (pt) Single selection value list: TX Primary tumour cannot be assessed T0 T1 T2 T3 T4a T4b No evidence of primary tumour Tumour 2 cm or less in greatest dimension without extraparenchymal extension* Tumour more than 2 cm but not more than 4 cm in greatest dimension without extraparenchymal extension* Tumour more than 4 cm and/or tumour having extraparenchymal extension* Moderately advanced disease. Tumour invades skin, mandible, ear canal, and/or facial nerve Very advanced disease. Tumour invades skull base and/or pterygoid plates and/or encases carotid artery Notes: * Extraparenchymal extension is clinical or macroscopic evidence of invasion of soft tissues. Microscopic evidence alone does not constitute extraparenchymal extension for classification purposes. 40

50 S/G Item description Response type Conditional Regional Lymph Nodes (pn) Single selection value list: NX N0 N1 N2 Regional lymph nodes cannot be assessed No regional lymph node metastasis Metastasis in a single ipsilateral lymph node, 3 cm or less in greatest dimension Metastasis in a single ipsilateral lymph node, more than 3 cm but not more than 6 cm in greatest dimension, or in multiple ipsilateral lymph nodes, none more than 6 cm in greatest dimension, or in bilateral or contralateral lymph nodes, none more than 6 cm in greatest dimension N2a Metastasis in a single ipsilateral lymph node, more than 3 cm but not more than 6 cm in greatest dimension N2b Metastasis in multiple ipsilateral lymph nodes, none more than 6 cm in greatest dimension N2c Metastasis in bilateral or contralateral lymph nodes, none more than 6 cm in greatest dimension N3 Metastasis in a lymph node, more than 6 cm in greatest dimension Distant Metastasis (pm) Anatomic Stage/Prognostic Group Single selection value list: M0 No distant metastasis M1 Distant metastasis Single selection value list: Stage T N M 41

51 S/G Item description Response type Conditional I T1 N0 M0 II T2 N0 M0 III T3 N0 M0 T1 N1 M0 T2 N1 M0 T3 N1 M0 IVA T4a N0 M0 T4a N1 M0 T1 N2 M0 T2 N2 M0 T3 N2 M0 T4a N2 M0 IVB T4b Any N M0 Any T N3 M0 IVC Any T Any N M1 S5.02 Year of publication and edition of cancer staging system G5.01 Diagnostic summary Include: a) Type of operation (S1.02) b) Anatomical site / laterality (S1.02) c) Tumour type (S.01) d) Histological grade (S3.02) e) Tumour dimensions (S3.03) Numeric: year AND Text: Edition eg 1 st, 2 nd etc Text 42

52 S/G Item description Response type Conditional f) Extraglandular extension of tumour (S3.08) g) Lymphovascular invasion (S3.06) h) Perineural invasion (S3.05) i) Involved or close margins with measurements (S3.07) j) Type of neck dissection (if present) (S2.07) k) Presence or absence of metastatic tumour in lymph nodes and level of involved nodes (S3.08) l) Presence or absence of extra-capsular spread of tumour (S3.08) m) Ki-67 index (S4.01) n) Tumour stage (S5.01) G5.02 Overarching comment Text 43

53 7 Formatting of pathology reports Good formatting of the pathology report is essential for optimising communication with the clinician, and will be an important contributor to the success of cancer reporting protocols. The report should be formatted to provide information clearly and unambiguously to the treating doctors, and should be organised with their interpretation of the report in mind. In this sense, the report differs from the structured checklist, which is organised with the pathologists workflow as a priority. Uniformity in the format as well as in the data items of cancer reports between laboratories makes it easier for treating doctors to understand the reports; it is therefore seen as an important element of the systematic reporting of cancer. For guidance on formatting pathology reports, please refer to Appendix 2. 44

54 Appendix 1 Pathology request information and surgical handling procedures This appendix describes the information that should be collected before the pathology test. Some of this information can be provided on generic pathology request forms; any additional information required specifically for the reporting of salivary gland neoplasms may be provided by the clinician on a separate request information sheet. An example request information sheet is included below. Elements which are in bold text are those which pathologists consider to be required information. Those in non-bold text are recommended. Also included in this appendix are the procedures that are recommended before handover of specimens to the laboratory. Patient information Adequate demographic and request information should be provided with the specimen. Items relevant to cancer reporting protocols include: patient name date of birth sex identification and contact details of requesting doctor date of request The patient s ethnicity should be recorded, if known. In particular whether the patient is of aboriginal or Torres Strait islander origin. This is in support of a government initiative to monitor the health of indigenous Australians particularly in relation to cancer. The patient s health identifiers should be provided. The patient s health identifiers may include the patient s Medical Record Number as well as a national health number such as a patient s Medicare number (Australia), Individual Healthcare Identifier (IHI) (Australia) or the National Healthcare Identifier (New Zealand). Clinical Information The type of operation performed must be recorded. It is important to state the nature of the surgical procedure for example: incisional biopsy 45

55 excisional biopsy of minor gland resection of submandibular gland extended resection of submandibular gland (surgeon to indicate extent of anatomical resection) resection of sublingual gland superficial parotidectomy +/- facial nerve sacrifice total parotidectomy facial nerve preservation facial nerve sacrifice extended radical total parotidectomy (includes resection of parotid gland, facial nerve, masseter muscle, zygoma and mandible) neck dissection (the laterality and nodal levels included in the dissection should be listed): o o o o selective modified radical radical extended radical other (specify) The type of operation performed will influence the subsequent handling of the specimen in the laboratory. The anatomical site of the neoplasm should be recorded. This may include: Parotid gland - whole Parotid gland - superficial lobe Parotid gland - deep lobe Submandibular gland Sublingual gland Minor salivary gland (specify site) Other (specify) Site is an important identifier especially when multiple biopsies are performed. For carcinomas that may involve more than one 46

56 site it is recommended that the clinician identify all sites involved and that if possible the principal site of involvement be recorded. Sufficient information is required to localise the lesion for subsequent therapy. A diagram or photograph can facilitate this. Prognostic significance the association between anatomical site and survival may be explained by the tumour site s influence on metastasis to cervical lymph nodes. 29,45 The laterality of the lesion should be recorded. Laterality information is needed for identification purposes. Clinical history should be recorded. The clinical TNM stage should be recorded. The clinical diagnosis or differential diagnosis should be recorded. Providing the provisional clinical diagnosis or differential diagnosis improves clinico-pathological correlation and improves diagnostic accuracy. Record if this is a new primary cancer or a recurrence of a previous cancer, if known. The term recurrence defines the return, reappearance or metastasis of cancer (of the same histology) after a disease free period. Recurrence should be classified as distant metastases or regional (local) recurrence. Regional (local) recurrence refers to the recurrence of cancer cells at the same site as the original (primary) tumour or the regional lymph nodes. Distant metastasis refers to the spread of cancer of the same histologic type as the original (primary) neoplasm to distant organs or distant lymph nodes. The reporting of metastatic deposits, either resected or not resected, is required for assessment of the metastatic (M) stage of the neoplasm. 13 The presence of involved non-regional lymph nodes stages the neoplasm as M1. 13 This information will provide an opportunity for previous reports to be reviewed during the reporting process, which may provide valuable information to the pathologist. This information also has implications for recording cancer incidence and evidence-based research. 47

57 If pre-operative or prior radiotherapy has been administered, this should be recorded. Pre-operative radiotherapy significantly alters the gross and microscopic appearance of the neoplasm. This information would prompt a comment on the extent of any response to the treatment. Any involvement of adjacent structures should be recorded. With regard to extension of disease into areas that either have or have not been resected, it is the responsibility of the surgeon to report these deposits and, if indicated, mark these areas with a suture or other marker. Surgical handling The specimen must be handled in a systematic and thorough fashion by the surgeon and theatre staff. The pathological findings from examination of a surgical specimen are important in guiding the patient s subsequent management. Hence the surgeon should handle the specimen in a systematic and thorough fashion to ensure accuracy of pathological data, resection margin status and pathological stage. The specimen should be correctly labelled, orientated or be capable of orientation. The status of specific surgical margins is critical in determining the need for, or extent of, further surgery or other adjuvant therapies. 46 Where there are no anatomical landmarks, specimen orientation should be indicated with marking sutures or other techniques. If a specimen is orientated, the orientation should be indicated on the specimen request form (this may be facilitated by the use of a diagram). 48

58 Example Request Information Sheet The above Request Information Sheet is published to the RCPA website. 49

59 Appendix 2 Guidelines for formatting of a pathology report Layout Headings and spaces should be used to indicate subsections of the report, and heading hierarchies should be used where the Laboratory Information System (LIS) allows it. Heading hierarchies may be defined by a combination of case, font size, style and, if necessary, indentation. Grouping like data elements under headings and using white space assists in rapid transfer of information. 47 Descriptive titles and headings should be consistent across the protocol, checklist and report. When reporting on different neoplasm types, similar layout of headings and blocks of data should be used, and this layout should be maintained over time. Consistent positioning speeds data transfer and, over time, may reduce the need for field descriptions or headings, thus reducing unnecessary information or clutter. Within any given subsection, information density should be optimised to assist in data assimilation and recall. Configuring reports in such a way that they group data elements into a single unit will help to improve recall for the clinician. 47 Clutter should be reduced to a minimum. 47 Thus, information that is not part of the protocol (e.g. billing information, Snomed codes, etc) should not appear on the reports or should be minimized. Injudicious use of formatting elements (e.g. too much bold, underlining or use of footnotes) constitutes clutter and may distract the reader from the key information. Where a structured report checklist is used as a template for the actual report, any values provided in the checklist but not applying to the case in question must be deleted from the formatted report. Reports should be formatted with an understanding of the potential for the information to mutate or be degraded as the report is transferred from the LIS to other health information systems. As a report is transferred between systems: text characteristics such as font type, size, bold, italics and colour are often lost tables are likely to be corrupted as vertical alignment of text is lost when fixed font widths of the LIS are rendered as proportional fonts on screen or in print spaces, tabs and blank lines may be stripped from the report, disrupting the formatting supplementary reports may merge into the initial report. 50

60 Appendix 3 report Example of a pathology 51