VULVA CANCER
STRUCTURED REPORTING
PROTOCOL
(1st Edition 2013)
Core Document versions:
•
World Health Organization Classification of Tumours Pathology and Genetics of
Tumours of the Breast and Female Genital Organs (2003).
ISBN: 978-1-74187-708-3
Publications number (SHPN): (CI) 110256
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o
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o
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First published: February 2013, 1st Edition (version 1.0)
2
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
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3
Contents
Scope ................................................................................................................. 5
Abbreviations ..................................................................................................... 6
Definitions.......................................................................................................... 7
Introduction ..................................................................................................... 10
Authority and development .............................................................................. 13
1
Pre-analytical ......................................................................................... 16
2
Specimen handling and macroscopic findings ........................................ 18
3
Microscopic findings .............................................................................. 24
4
Ancillary studies findings ....................................................................... 30
5
Synthesis and overview ......................................................................... 31
6
Structured checklist ............................................................................... 32
7
Formatting of pathology reports ............................................................ 53
Appendix 1
Pathology request information and surgical handling
procedures………………………………………………………………… 54
Appendix 2
Guidelines for formatting of a pathology report ................. 60
Appendix 3
Example pathology report for vulva cancer ........................ 61
Appendix 4
WHO Classification of Tumours .......................................... 65
Appendix 5
Figures ............................................................................... 67
Appendix 6
TNM and FIGO Staging ....................................................... 71
References ....................................................................................................... 74
4
Scope
Structured reporting aims to improve the completeness and usability of pathology
reports for clinicians, and improve decision support for cancer treatment. This protocol
provides the standards and guidelines for the reporting of any vulva carcinoma, whether
as a minimum data set or a comprehensive report.
This protocol covers resections of all types of vulva carcinomas. Readers are referred to
general protocols in this series for melanomas, sarcomas and lymphomas.
5
Abbreviations
AJCC
American Joint Committee on Cancer
EMPD
extramammary Paget’s disease
FIGO
Federation Internationale de Gynecologie et d’Obstetrique
(International Federation of Obstetricians and Gynecologists)
RCPA
Royal College of Pathologists of Australasia
TNM
Tumour–node–metastasis (a staging system)
SCC
Squamous cell carcinoma
UICC
Union Internationale Contre le Cancer (International Union Against
Cancer)
VIN
Vulva Intraepithelial Neoplasia
WHO
World Health Organization
LIS
Laboratory information system
6
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
An ancillary study is any pathology investigation that may
form part of a cancer pathology report but is not part of
routine histological assessment.
Clinical information
Patient information required to inform pathological
assessment, usually provided with the specimen request
form. Also referred to as ‘pretest information’.
Commentary
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 (eg how does the item
assist with clinical management or prognosis of the
specific cancer).
•
cite published evidence in support of the standard or
guideline
•
clearly 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 (eg 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).
7
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 (eg G1.10).
Macroscopic findings
Measurements, or assessment of a biopsy specimen made by
the unaided eye.
Microscopic findings
In this document, the term ‘microscopic findings’ refers to
histo-morphological assessment.
Predictive factor
A predictive factor is a measurement that is associated with
response or lack of response to a particular therapy.
Prognostic factor
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.
Standard
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)
which 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 (eg S1.02).
8
Structured report
A report format which utilizes standard headings, definitions
and nomenclature with required information.
Synoptic report
A structured report in condensed form (as a synopsis or
precis).
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.
9
Introduction
Vulva carcinoma
Vulva cancer accounts for approximately 4% of gynaecological cancers. Over 85% of
vulva cancers are squamous cell carcinomas. Vulva melanomas, adenocarcinomas, basal
cell carcinomas, lymphomas, sarcomas and miscellaneous rare tumours account for the
remainder. Vulva cancer is disproportionately important compared to its low incidence
because of morbidity and mortality due to its frequent late diagnosis, involvement of
distal urinary and alimentary tracts and psychosexual effects of the disease and
treatment. This protocol on reporting vulva cancers is confined to carcinomas,
particularly squamous cell carcinomas. For other cancers, eg melanoma or lymphoma,
the reader is referred to generic (non-site specific) protocols in this series.
This vulva carcinoma protocol is largely unreferenced, apart from where a different view
point to standard references is offered. The reader is referred to the the vulva chapter in
Berek and Hacker's "Gynecologic Oncology", 5th edition, for clinical information1 and to
the WHO “bluebook”2 and standard gynaecological pathology textbooks for pathology.3-5
As clinicians manage women with vulva cancer according to FIGO stage6, it is particularly
important that pathologists have a thorough understanding of FIGO stage. In 2009, FIGO
produced a revised staging system for vulva cancer. The 2009 system is a mixture of
clinical and pathological parameters. Stage 1 and 3 are mainly pathologically-defined
stages, although all stages require some clinical input. Stage 1 is tumour confined to the
vulva and Stage 3 metastases to the inguinofemoral lymph nodes. Stage 1 is subdivided
depending on whether depth of invasion is equal to or <1mm (stage 1a) or >1mm (stage
1b). Stage 1a only refers to a lesion equal to or less than 2 cm in diameter. However,
othodox opinion is that carcinomas arise from one cell and grow centrifugally. If this
hypothesis is correct, it is difficult to see how a larger lesion can have a depth of invasion
of 1mm or less. Inguinofemoral lymph node metastases (Stage 3) are stratified according
to the pathological data of how many nodes are involved, how many of the involved
nodes have metastases equal to or >5mm and whether there is any extracapsular
invasion present. By contrast, Stage 2 (early spread to vagina, urethra or anus) and
Stage 4 (advanced local disease, ulcerated or fixed inguinofemoral lymph node
metastases or distant metastases) are mainly, but not entirely, determined clinically.
Two types of specimen may contain vulva cancers, macroscopic tumour and VIN excision
specimens. These are handled slightly differently. Macroscopic tumours need to be
confirmed that they are carcinomas rather than some mimic such as keratoacanthoma,
pseudoepitheliomatous hyperplasia or prurigenous nodule. Then prognostic parameters
are assessed. Microscopic cancers occur in VIN excision specimens in about 20%. Early
invasion arising in VIN has a different differential diagnosis than that of macroscopic
tumours, including unusual growth patterns of VIN of appendageal involvement and noninvasive budding into the dermis. Once invasion has been identified, measuring depth of
invasion correctly is crucial as this is the single best predictor of groin lymph node
metastases and will largely determine whether lymph nodes are excised.
The grossing protocol (chapter 2) is that developed at Hunter Area Pathology Service
from first principles over a period of years. Other departments have their own protocols,
the important point is that there is a protocol, particularly when the person doing the
grossing is not the person reporting the microscopy.
The microscopic diagnosis of vulva squamous cell carcinomas (chapter 3) is usually
straight forward, although occasionally, there is difficulty distinguishing squamous cell
10
carcinoma from unusual benign simulants such as pseudoepitheliomatous hyperplasia.
An in depth discussion of the differential diagnosis of squamous cell carcinoma is beyond
the scope of this protocol. Once the diagnosis of invasive squamous cell carcinoma has
been made, the pathologist must turn their attention to measuring depth of
invasion/tumour thickness. We stress that depth of invasion/tumour thickness are
surrogates for tumour volume and, consequently, different tumour growth patterns
require different ways of measuring. Depth of invasion/tumour thickness is crucial as it is
the single biggest factor in determining whether groin lymph nodes are resected. As
groin lymph node resection carries a substantial risk of permanent lower limb
lymphoedema, nodes are only investigated if there is an appreciable risk of metastases,
as occurs with a depth of invasion of >1mm. Sentinel lymphadenectomy is being
evaluated in vulva cancer to reduce morbidity associated with groin dissection.
Ancillary studies (chapter 4) such as immunohistochemistry play a small, but
occasionally important, role in the reporting vulva carcinomas.
In the synthesis and overview (chapter 5), we do not advocate pathologists staging
vulva carcinomas. Staging is clinicopathological and is best assessed by the lead
clinician.
Importance of histopathological reporting
Pathological assessment of tissue is a critical aspect in the multidisciplinary management
of vulva carcinoma patients. Such assessment establishes a definite diagnosis in most
cases and provides information that, to a major extent, influences patient prognosis and
directs the next stages of management.
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 Kingdom710
.
The College of American Pathologists and the Royal College of Pathologists (UK) have
recently published useful protocols for the reporting of vulva cancer11-12. A protocol for
the management of vulva cancer and endorsed by the Royal College of Pathologists of
Australasia and other Australasian organisations is timely.
Design of this protocol
This structured reporting protocol provides a complete framework for the assessment
and documentation of all the pathological features of vulva carcinoma.
Mandatory elements (standards) are differentiated from those that are not mandatory
but are recommended (guidelines). Consistency and speed of reporting is improved by
the use of discrete data elements recorded from the checklist. However, the pathologist
11
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 documents
•
Guidelines for Authors of Structured Cancer Pathology Reporting Protocol, Royal
College of Pathologists of Australasia, 200913
•
Tumours of the Breast and Female Genital Organs. Pathology and Genetics, World
Health Organization Classification of Tumours, eds Tavassoli FA, Devilee P. 2003.
IARC Press, Lyon, France2
•
Hacker NF Vulvar cancer in Berek and Hacker’s Gynecologic Oncology, 5th edition.
Berek JS, Hacker NF. Walters Kluwer/Lippincott Williams & Wilkins. 2010 536-5751
•
Pecorelli S. FIGO Committee on Gynecologic Oncology Revised FIGO staging for
carcinoma of the vulva, cervix and endometrium. Int J Gynecol Obstet 105 (2009)
103-4.6
Updates since last edition
Not applicable
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 group
Protocol development committee for Vulva Cancer
Conjoint Associate Professor James Scurry, pathologist (Lead Author)
Associate Professor Peter Grant, gynaecologist oncologist
Professor Neville Hacker, gynaecologist oncologist
Dr Colin Stewart, pathologist
General expert committee for all gynaecological cancers
Prof Janes Armes, pathologist (Chair)
Associate Professor David Allen, gynaecologist oncologist
Associate Professor Kailash Narayan, radiation oncologist
Dr Colin Stewart, pathologist
Professor Neville Hacker, gynaecologist oncologist
Professor Peter Russell, pathologist
Conjoint Associate Professor James Scurry, pathologist
Associate Professor Peter Grant, gynaecologist oncologist
Dr Marsali Newman, pathologist
Dr Kerryn Ireland-Jenkin, pathologist
Dr Linda Mileshkin, medical oncologist
Associate Professor David Ellis, pathologist (RCPA representative)
International Liaison
Dr. Christopher Otis, Chair of the Gynecologic Tumors Cancer Committee, College of
American Pathologists
Acknowledgements
The gynaecological cancer expert committee wishes to thank all the pathologists and
clinicians who contributed to the discussion around this document.
13
Stakeholders
ACT Health
Anatomical Pathology Advisory Committee (APAC)
Australian Association of Pathology Practices Inc (AAPP)
Australian Cancer Network
Australian Commission on Safety and Quality in Health Care
Australian Society of Clinical Oncologists (ASCO)
Australian Society of Colposcopy and Cervical pathology (ASCCP)
Australian Society of Cytology (ASC)
Australian Society of Gynaecologic Oncologists (ASGO)
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 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
International Federation of Obstetricians and Gynecologists (FIGO)
International Gynecological Cancer Society (IGCS)
Medical Software Industry Association (MSIA)
National Breast and Ovarian Cancer Centre (NBOCC)
National Coalition of Public Pathology (NCOPP)
National E-Health Transition Authority (NEHTA)
National Pathology Accreditation Advisory Council (NPAAC)
National Round Table Working Party for Structured Pathology Reporting of Cancer.
New Zealand Guidelines Group (NZGG)
NSW Department of Health
Peter MacCallum Cancer Institute
Queensland Cooperative Oncology Group (QCOG)
14
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 Australasian College of Surgeons (RACS)
The Royal Australian and New Zealand College of Obstetricians & Gynaecologists (RANZCOG)
The Royal Australian and New Zealand College of Radiologists (RANZCR)
The Royal Australian College of General Practitioners (RACGP)
The Royal College of Pathologists of Australasia (RCPA)
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 seven-step process set out in Guidelines
for Authors of Structured Cancer Pathology Reporting Protocols.13
Where no reference is provided, the authority is the consensus of the expert group.
15
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 vulva cancer 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
S1.02
All demographic information provided on the request form and
with the specimen must be recorded.
CS1.01a
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.
CS1.01b
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).
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 atomically.
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
16
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 procedure.
•
The pathology request is often authored by the
clinician performing the procedure 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
•
G1.01
In practice therefore, it is important in such cases
that the reporting pathologist should be able to
communicate with the managing clinician for
clarification.
Any clinical information received in other communications from the
requestor or other clinician should be recorded together with the
source of that information.
17
2
Specimen handling and macroscopic
findings
This chapter describes procedures required after the information has been handed
over from the requesting clinician and the specimen has been received in the
laboratory. The key is to follow a protocol. While it may appear time consuming,
adherence to a protocol will help avoid irretrievable errors and save a lot of time
later by greatly facilitating microscopic reporting and review. Recording the time
and date the specimen is picked up from the operating theatre and the time the
specimen arrives in the laboratory assists specimen tracking and assessment of
components of turn-around-time. Scanning the pathology request form on arrival
in laboratory enables easy access on the LIS for the pathologist reporting the
case.
Specimen handling

Pathologists should consider providing tissue samples from fresh
specimens for tissue banking or research purposes.
•


All specimens must be pinned out and placed in 10% buffered
formalin and fully fixed before slicing.
•
Specimens that are fixed in formalin without being pinned out
are subject to distortion because of uncontrolled retraction
leading to difficulty in description and blocking. Specimens that
are sliced and blocked before fully fixed are likely to buckle
because of uncontrolled retraction leading to incomplete faces of
the histological sections.
•
Fixation, except for the smallest specimens, requires overnight
immersion in formalin. Even after overnight immersion, the deep
surface of a thick, tightly pinned-out specimen may not be fixed.
Gentle loosening or removing some of the pins so that formalin
can freely flow onto the deep part of the specimen may be
required for these specimens.
Photographing the external aspect of the specimen is recommended.
•
18
The decision to provide tissue should only be made when the
pathologist is sure that the diagnostic process will not be
compromised. As a safeguard, research use of the specimen
may be put on hold until the diagnostic process is complete.
A specimen photograph is particularly useful if the person
performing the cut up is not the pathologist reporting the
specimen. Specimen photographs are helpful in communication
with the surgeon, at tumour board and for case presentations
and reports. If the LIS allows, it may be issued with the report.
The photograph is taken with the specimen pinned out with the
surgeon’s orientation sutures and/or markings intact.

The specimen must be inked.
•

Drawing a diagram of the external surface is recommended.
•

Inking is essential to accurately assess the margins. The entire
peripheral margin and deep surface of the specimen should be
inked. Two colour inking facilitates identification of margins.
The diagram is a useful tool to show how the specimen has been
sliced and, see below, from where blocks have been selected, fig
1a and fig 2a (Appendix 5). Diagrams allow easy understanding
of the sites and orientations of the blocks. The diagram is
orientated (eg 12 o’clock) and is composed of the outlines of
the specimen and tumour. It is stored in the Pathology
Department and is not issued with the report. A printed image
(photograph, scan or photocopy) on which the slices can be
drawn may be used as alternative to a diagram.
The specimen must be sliced according to a protocol.
•
Specimen slicing must only commence when the specimen is
fully fixed in formalin.
Slicing is performed in a systematic way. It is helpful to first
mark the level of the mid-point of the tumour, then parallel
horizontal slicing from 12 to 6 o’clock is performed. The
pathologist should adjust the width of the slices so that a slice
through the centre of tumour is performed as this slice will
frequently show the point of deepest invasion. Failure to cut a
central slice will result in underestimation of the depth of
invasion. The distance between the slices depends on the size of
the specimen. Small specimens may be sliced at block thickness
(2-3mm). This saves thinning the slices to fit cassettes. Thin
slicing is particularly suitable for VIN/extramammary Paget’s
disease excision specimens. The first (12 o’clock) and last (6
o’clock) may be wider than the other slices to allow radial blocks
of the 12 and 6 o’clock margins.

Photographing the cut slices and a close up of the slice with the
maximum tumour (usually the central slice) may be useful.
•

Drawing a diagram of the cut sections is recommended, fig 1b and fig
2b (Appendix 5).
•

Photographs of the cut slices are taken as a permanent record to
complement the macroscopic description and to facilitate
correlation with the block code diagram.
The diagram of the cut sections allows the block code to be
drawn on the cut sections so that the reporting pathologist can
see at a glance where the blocks have come from. The diagram
is stored in the Pathology Department and is not issued with the
report.
Blocks must be systematically selected to allow microscopic
assessment of the deepest point of invasion and margins.
19
•
The choice of blocks is guided by the size of the gross specimen.
For small specimens, the entire specimen may be blocked. For
larger specimens with a small tumour, the entire tumour should
be blocked. For large specimens with large lesions, there should
be generous sampling of all lesions, but the entire specimen
does not need to be blocked. Different appearing areas of the
main tumour should be sampled, eg raised, ulcerated and, most
importantly, the junction between the tumour and adjacent skin.
The junction is the best place to confirm that the tumour is
arising from the epidermis by showing a connection to the
epidermis and to show adjacent VIN. The slice in which there
appears to be greatest depth of invasion and closest margins
(often, but not always central) should be blocked in its entirety,
fig 2a (Appendix 5). For specimens without an obvious tumour,
but with a suture or mark to indicate the site of a previous
narrow excision or biopsy, this area should be all blocked if the
scar is not too long. Long scars, however, may be sampled
rather than all submitted.
If the tissue is too large in the superficial-deep dimension to fit
in a cassette, eg there is a thick layer of fat on the deep surface
or an exophytic tumour, then the block is divided parallel to the
surface and 2 blocks are made, one superficial and the other
deep tissue (“composite blocks”), fig 1b (Appendix 5).
•

Once the blocks have been taken, the remaining slices and portions of
slices should be stored in a way that does not disturb their orientation.
•

If the slices have been placed on paper or fabric, the material on
which the slices lie can be rolled up. If further blocks are
needed, the material can be unrolled carefully and the slices
should be in their original positions.
Labelling the sites of the blocks on the diagram of the slices is
recommended, figs 1b and 2b (Appendix 5).
•
20
For excision specimens of VIN, pathologists should attempt to
block the entire specimen so as to not miss any microscopic
invasion. If the specimen is too large so that it is not practical to
be blocked entirely, there should be very generous sampling of
the abnormality, particularly in the most raised areas, fig 2b
(Appendix 5). In most cases, such blocking will have already
supplied ample blocks for the assessment of all margins.
The pathologist reporting the case can see at a glance from
where the blocks have originated.
Macroscopic findings
S2.01
The specimen must be orientated.
CS2.01a
G2.01
Surface anatomical structures should be described.
CG2.01a
S2.02
Tumours are measured in 3 dimensions. The maximum
horizontal measurement is termed “size” by FIGO. Size
<20mm is a staging criterion for Stage 1a and the
absolute value is a prognostic factor for Stage 1b tumours.
Tumour margins must be assessed and measured.
CS2.06a
S2.07
SCCs are usually fungating or ulcerated. The surface of a
fungating SCC is usually hyperkeratotic. Ulcerated
tumours usually have a raised border.
The size of each tumour must be measured.
CS2.05a
S2.06
Multiple macroscopic tumours occur in 5% of vulva
cancers.
The macroscopic appearance of the tumour must be
described.
CS2.04a
S2.05
Measurements are in 3 dimensions and in mm.
The number of macroscopic visible tumours must be recorded.
CS2.03a
S2.04
The clitoris and urethral and vaginal orifices should be
described if they are present. The type of surface should
be described as hair-bearing skin (usually stubble as the
vulva is shaved in preparation for surgery) and/or hairless
skin/squamous mucosa. Hairless skin and mucosa are
usually not distinguishable in the fixed specimen. Labial
folds should be described if they are present, but they are
not usually apparent in pinned out specimens from postmenopausal women.
The specimen must be measured.
CS2.02a
S2.03
Vulvectomy specimens are pieces of skin or mucosa of
different shapes and sizes. Radical excisions include a
thick layer of fat and/or stroma. Superficial vulvectomies
include little or no fat or stroma. The specimen is
orientated according to anatomical features and clinical
markers. All the clinical orientating markers are to be
included in the description.
All involved margins need to be listed and the distance to
the deep margin and closest peripheral margin measured.
Any adjacent abnormality of the skin must be described.
CS2.07a
VIN is commonly seen next to a tumour. VIN appears as a
sharply demarcated area, usually as a elevated plaque,
and may be a range of colours from white, pigmented, red
21
to skin coloured. Lichen sclerosus appears as whitened
skin, and is usually thickened and hyperkeratotic adjacent
to carcinomas. Lichenified lichen sclerosus is not
macroscopically distinguishable from differentiated VIN.
S2.08
The depth of invasion must be assessed.
CS2.08a
S2.09
Tumour invasion is clearly seen if it occurs in a part of the
vulva with subcutaneous fat. Where this occurs a
macroscopic measurement of depth of invasion is
performed. Medially where there is underlying stroma,
then a macroscopic assessment of the depth of invasion
and margins is usually not possible because stroma is not
distinguishable from tumour.
Lymph node specimens must be handled according to a
protocol.
CS2.09a
Inguinofemoral lymph nodes. The overall dimensions
of the fatty tissue may be measured. Lymph nodes are
dissected from the fat taking care not to inadvertently
transect them. The number of lymph nodes is counted.
The largest and smallest are measured in their greatest
dimension. The number of lymph nodes with visible
metastases is counted. The greatest diameter of the
largest metastasis in each involved node is measured.
Macroscopically benign lymph nodes are sliced at right
angles to the long axis at 2-3mm intervals and all the
nodal tissue embedded. Lymph nodes with macroscopic
metastases are not required to be completely blocked,
however should be sampled generously so that
extracapsular invasion will not be missed. Large
macroscopically benign lymph nodes may require 2 or
even 3 blocks to be all embedded.
Some pathologists embed all the fatty tissue of a lymph
node dissection on the grounds that the lymph node count
is frequently increased. Others do not as they feel that this
technique distorts the node count and does not increase
the yield of metastases.
CS2.09b
S2.10
The block code must be described.
CS2.10a
22
Sentinel lymph nodes. As there is no agreed protocol for
vulva carcinoma sentinel nodes, these are treated as for
those in other cancers (eg breast, melanoma) according
to each Laboratory’s protocol. An acceptable protocol
involves measuring the nodes, slicing them at right angles
to the long axis at 2-3 mm intervals and embedding all the
lymph node tissue in one or more blocks.
The described block code provides a permanent record of
where the blocks from the main specimen have come
from. It is essential when the case is reviewed.
CS2.10b
The block code needs to clearly identify how many lymph
nodes are in each cassette and which blocks hold the
macroscopically involved nodes. For small nodes, it is not
necessary to submit only one node per cassette.
23
3
Microscopic findings
Microscopic findings relates to purely histological (morphological) assessment.
Information derived from multiple investigational modalities, or from two or more
chapters, are described in Chapter 5.
Depending on whether the specimen is an excision of a macroscopic tumour or
excision of VIN which incidentally contains a microscopic focus of invasion, the
emphasis is different. With macroscopic tumours, the pathologist must first
confirm the diagnosis of malignancy, then evaluate a list of prognostic features.
With VIN excisions, the emphasis is to identify and measure microscopic foci of
invasion correctly, so that the clinician can determine whether further therapy
such as a lymph node resection and/or a wider excision is warranted.
S3.01
The number of primary tumours must be recorded.
CS3.01a
5% of vulva carcinomas are synchronous primaries.
Each carcinoma must be described separately.
G3.01
A microscopic description may be given.
CG3.01a
S3.02
The tumour type(s) must be recorded.
CS3.02a
S3.03
24
Microscopic findings relate purely to histological
assessment. A description of the microscopic findings is
important for clinical governance and to indicate the
process of diagnostic decision making and any areas of
uncertainty. The description is particularly important in
complex or unusual cases, but even apparently
straightforward cases show sufficient peculiarities so that
most pathologists will still wish to include a microscopic
description as free text.
The WHO classification is recommended.2 Refer to
Appendix 4.
The depth of invasion must be recorded.
CS3.03a
Depth of invasion is the single most important risk factor
for groin lymph node metastases. Groin dissection carries
a risk of subsequent lower limb lymphoedema, but
recurrence of vulva SCC as a metastasis in the groin
nodes in an undissected groin following primary
treatment carries a mortality of about 90%.1 A depth of
invasion <1mm has practically no risk of metastases for
lesions up to 20mm in diameter. Those with a depth of
invasion >1mm have a significant risk of groin lymph
node metastases and the risk increases with increasing
depth.
CS3.03b
With depth measurement, the goal is to measure
exposure to lymphatics, which depends on the volume of
the invasive tumour.
Biology dictates that the true depth is measured from
where the tumour is arising, ie, the overlying interface
from which the tumour arises to the deepest point of
invasion. This is most accurately performed with tumours
with early stromal invasion (eg those found incidentally
arising from VIN) and flat tumours.
However, there are circumstances where an alternative to
the source of invasion is needed because a) the source of
invasion cannot be seen, b) the overlying surface is not
present (ulcerated) and c) exophytic tumours.
a) Where the source of invasion cannot be seen, the
FIGO/WHO method is recommended. The FIGO
method is the length of a vertical line drawn from
the top of an adjacent dermal papilla (usually the
second or third papilla away from the carcinoma)
to a horizontal line drawn from the deepest
invasive squamous cell. While the dermal papilla
used for the measurement is not in the carcinoma,
it is usually in an area of abnormal skin such as
VIN or hyperplasia and only occasionally is it in
normal skin.
b) In ulcerated tumours, the tumour that is now
“missing” because it has ulcerated was originally
there and exposed to lymphatics. The risk of
lymphatic invasion persists because of the prior
exposure. Again, the adjacent most superficial
papillae (FIGO/WHO method)is recommended as it
gives an indication of where the surface used to
be, fig 3c (Appendix 5).
c) The pivotal question with exophytic tumours is
whether the tumour stroma confers the same risk
of lymphatic space invasion as the native dermis.
Since purely exophytic tumours metastasise, the
risk must be assumed to be the same and the
depth measured from the stromal-epithelial
interface OVERLYING the tumour to the point of
deepest invasion, fig 3d (Appendix 5). Using the
adjacent dermal papilla as the superficial reference
point will underestimate the volume and therefore
the malignant potential as the exophytic portion of
the tumour is not counted. This is an important
consideration as most SCCs develop an exophytic
component after reaching a width of only a few
millimeters.
CS3.03c
The presence of invasive adenocarcinoma arising from
extramammary Paget’s disease (EMPD) must be
recorded. Such invasion is nearly always microscopic. The
depth of invasion must be measured analogously to
invasive squamous cell carcinoma arising from VIN.
25
CS3.03d
Tumour within lymphvascular spaces is not counted in the
measurement of depth of invasion.
The measurement of tumour thickness is not
recommended as an alternative to depth of invasion.
Tumour thickness is the measurement from the most
viable cell of the overlying epithelium to the deepest
invasive cell. To include overlying epithelium overstates
the measurement as this component is technically still in
situ and not exposed to lymphatics. This is particularly
relevant given the variation in epithelial thickness
(especially given that VIN can be very thick).
G3.02
It is strongly recommended that the method of measurement is
defined in the report.
S3.04
The size of microscopic tumours must be measured.
S3.05
S3.06
S3.07
CS3.04a
The width of microscopic tumours represents the
maximum horizontal separation of invasive malignant
cells.
CS3.04b
Microscopic width is measured in the plane of section as a
single dimension. A second measurement of width
estimated by adding block thicknesses will help prevent
underestimation of size in asymmetric tumours.
Lymphvascular space invasion (LVSI) must be reported.
CS3.05a
LVSI is diagnosed when tumour is seen in an endotheliallined space. LVSI is most commonly seen just beyond the
advancing edge of invasive tumour, often near arteries.
Tumour thrombi are rounded collections of tumour cells
and must be distinguished from translocation artifact
when jagged clumps of tumour cells are artificially carried
into vascular spaces during cut-up or when retraction
artifact causes a clear space around a clump of tumour
cells. Both these artefacts are seen more commonly when
tissue has not been adequately fixed.
CS3.05b
LVSI in vulva carcinoma is associated with an increased
risk of local recurrence, lymph node metastases and
poorer survival.
Perineural invasion must be reported.
CS3.06a
Perineural invasion is diagnosed when tightly juxtaposed
tumour nests and nerves are seen beyond the advancing
edge of the tumour.
CS3.06b
Perineural invasion has an increased risk of local
recurrence.15
Closest peripheral and deep margins must be recorded.
CS3.07a
26
Involved and close margins are associated with an
increased risk of local recurrence. Because of surgical
considerations, the closest margins will usually be the
medial (vaginal), urethral, anal, clitoral or deep. Close
lateral margins are defined as <8mm on formalin fixed
tissue (this equates to a surgical margin of about 10mm
on the patient).
There is no clear guideline as to what constitutes a close
deep margin. Most gynaecological oncologists will accept
a clear deep margin as sufficient and are aware that
measurement of deep fatty margins is problematic.
S3.08
S3.09
S3.10
The presence and type of Intraepithelial Neoplasia must be
reported.
CS3.08a
Vulva SCC often show adjacent VIN. The presence and
type of adjacent VIN, that is, whether the usual type or
differentiated VIN must be recorded. Differentiated VIN is
believed to more rapidly transform into carcinoma than
the usual type.
CS3.08b
The microscopic reporting of EMPD should follow that of
VIN.
The presence of Intraepithelial Neoplasia at the margin must
be reported.
CS3.09a
If the margin is involved with VIN then this must be
recorded. VIN at the margin is associated with an
increased risk of what has been loosely termed
“recurrence” in the literature. If arising from VIN and
showing a wedge-shaped invasion into the dermis, such
“recurrences” are likely to be “re-occurrences” (new
primary carcinomas).
CS3.09b
If the margin is involved with EMPD, then this must be
recorded. Involved margins are associated with an
increased risk of recurrence of EMPD. The margins of
EMPD are often poorly defined and well beyond the
clinical limits of the lesion.
For each lymph node site received, record the total number of
lymph nodes and the number of positive nodes.
CS3.10a
S3.11
The number of lymph nodes examined must be reported
so that it can be determined whether sufficient lymph
nodes were examined to provide the necessary staging
information. The number of lymph nodes has also been
used as a rough quality control measure for both the
surgeon and pathologist, although there are obvious
limitations to this practice. At least 6 lymph nodes are
expected in each groin dissection.
The measurement of size of metastatic lymph node deposits
must be recorded.
CS3.11a
The new FIGO 2009 grading system has been validated
by clearly demonstrating distinct groups with different
27
survivals. It uses pathologic information of lymph node
involvement for the designation of all of stage III
categories (Stage IIIA, B and C) and is one criterion for
Stage IVB. Stage IIIA is defined as either “1
inguinofemoral lymph node metastasis > 5mm diameter
or 1-2 lymph nodes with metastasis (es) <5mm” . (We
interpret the FIGO document as meaning 2 nodes with
metastases <5mm). Stage IIIB is defined as 2 or more
lymph nodes with metastases > 5mm or 3 or more lymph
nodes with metastases <5mm. Stage IIIC is positive
lymph node(s) with extracapsular spread. Stage IVB is
defined as any distant metastases including pelvic lymph
nodes. The size of the metastasis is that of the largest
deposit within a lymph node.
S3.12
The presence or absence of extracapsular extension must be
recorded.
CS3.12a
G3.03
Extracapsular invasion is defined as tumour invading
through the full thickness of the capsule, but not
necessarily into adjacent fatty tissue. It needs to be
distinguished from afferent or efferent lymphatic
involvement in the hilus, deposits in a very fatty lymph
node where the capsule is incomplete and an inflamed
desmoplastic reaction to tumour still within the capsule.
Other diagnoses should be recorded.
CG3.03a
Documentation of histopathological features in clinically
suspicious areas will allow clinicopathological correlation.
Documentation of lichen sclerosus is helpful as patients
with lichen sclerosus have an increased risk of developing
further primary carcinomas even with margins clear of
differentiated VIN.
The progression of lichen sclerosus to squamous cell
carcinoma is a gradual process. It is artificially divided
into 4 stages: lichen sclerosus, lichen sclerosus with
lichen simplex chronicus (lichen sclerosus with
hyperplasia), lichen sclerosus with differentiated VIN and
lichen sclerosus with squamous cell carcinoma. In later
stages, dermal homogenisation may be lost and the
diagnosis of lichen sclerosus may be difficult.
G3.04
28
Any additional relevant microscopic comments should be recorded.
CG3.04a
Tumour grade and histological growth pattern may be
recorded as part of this additional commentary.
CG3.04b
Grading has traditionally followed an empirical system
used in SCC of any site and is based on a summation of
amount of extra- and intracellular keratinisation, degree
of nuclear atypia and mitotic count. While empirical
grading is commonly performed, it is of disputed value as
a prognostic indicator. One problem is that keratin
production is used as a grading criterion despite there
being little prognostic difference between keratin-rich
(keratinising) and keratin-poor (basaloid) carcinoma.
While grading may work in an experimental setting, it is
of little use in routine reporting. The WHO does not grade
vulva SCC.2
CG3.04c
Two types of histological growth pattern have been
described. A pushing margin is where the invasive tumour
nodules are large and the tumour-stromal interface at the
advancing edge of the tumour is smooth. A spray
(infiltrative) pattern of growth is when the tumour
nodules are small and the tumour-stromal interface is
irregular. Spray pattern carcinomas have a higher risk of
local recurrence and lymph node metastasis than the
pushing pattern. If distinct, the growth pattern should be
recorded, particularly if clearly a spray pattern, however,
routine reporting of growth pattern has limited usefulness
as most cases are intermediate.
29
4
Ancillary studies findings
S4.01
The investigation of sentinel nodes must include
immunohistochemistry (IHC).
CS4.01a
G4.01
The results of all ancillary studies should be included.
CG3.03a
G4.02
IHC has been found to increase the sensitivity of sentinel
node biopsies by identifying very small deposits of tumour
that may be overlooked in routine stains.
Recording the results of ancillary studies improves the
transparency of the diagnostic process and prevents reordering of the same studies when the case is reviewed.
IHC is recommended in certain instances in vulva neoplasia.
CG4.02a
IHC may be used to confirm an epithelial cell lineage of a
carcinoma and help with the measurement of depth of
invasion and lymphvascular space and perineural
invasion.
CG4.02b
IHC may be used to define the extent of a spray pattern
of dermal invasion with single spindle-shaped squamous
cells disappearing off amongst fibroblasts. The
microscopic measurement of such tumours is more
reliable with IHC.
CG4.02c
IHC maybe useful in identifying and typing VIN.
Differentiated VIN is often a difficult diagnosis and IHC
may be used. However, to avoid overdiagnosis of
differentiated VIN, the IHC needs to be carefully
correlated with the morphological appearances. In a
controversial area of pathology, the consensus view,
which we follow, is to make a diagnosis of differentiated
VIN only when basal nuclear atypia is present.
The IHC demonstration of HPV-associated nuclear
changes in VIN facilitates the differentiation of the usual
type of VIN from differentiated VIN in difficult cases.
30
CG4.02d
IHC is useful in separating primary EMPD originating on
the vulva from secondary forms originating in the lower
urinary or alimentary tracts.
CG4.02e
IHC is useful determining the margins of EMPD and the
presence and depth of small foci of invasion.
5
Synthesis and overview
In some cancers, pathological staging is included in the pathology report. While
pathologists reporting vulva cancers must be familiar with the FIGO staging
system and provide accurate pathological information to enable FIGO staging, the
responsibility for staging the patient must be the lead clinician’s as pathologists
can never be sure whether all the clinical information has been provided. Unlike
some other cancers, even a pT stage can be misleading as the pathologist may
not be able to determine whether the vagina is involved or not. To avoid errors,
putting the FIGO stage in the pathology report is not recommended.
Adding the TNM stage to the pathology report of vulva cancers is also not
recommended. No gynaecological oncology unit in Australasia uses TNM for vulva
carcinoma. Furthermore, like FIGO, TNM uses categories that can best or only be
determined clinically. For cancer statistics, the FIGO 2009 and the 7th edition of
TNM use identical definitions, so any interested party can translate FIGO into TNM
(See Appendix 6).
G5.01
G5.02
The ‘diagnostic summary’ section of the final formatted report should
include:
a.
operative procedure (S1.02)
b.
tumour type (S3.02)
c.
tumour size (S3.04)
d.
depth of invasion (S3.03)
e.
lymphvascular space invasion status (S3.05)
f.
status of margins (S3.07)
g.
lymph node status (S3.10 – S3.12)
An overarching comment is recommended in appropriate
circumstances.
CG5.02
Appropriate circumstances for an overarching comment
include:
•
When there are difficulties with any aspect of the
report.
•
When the results of any test are pending, eg
molecular.
•
When a second opinion is being sought.
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 vulva
tumours. 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
G6.02
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.16
CG6.01a
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.
CG6.01b
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.
Where the checklist is used as a report template (see G6.01), the
principles in Chapter 7 and Appendix 2 apply.
CG6.02a
G6.03
32
All extraneous information, tick boxes and unused values
should be deleted.
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.
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
Text
OR
Structured entry as below:
Clinical diagnosis
Text
Note: record diagnosis and include whether
confirmed via biopsy.
New primary, recurrence,
precancer (VIN) or other
previous cancer
Single selection value list:
•
New primary cancer
•
Precancer (VIN)
•
Local recurrence (vulva)
•
Regional recurrence (groin)
•
Distant metastasis
•
Other previous cancer diagnosis
If recurrence, record the
diagnosis and method of
treatment
33
S/G
Item description
Response type
Diagnosis
Text
Method of treatment
Text
Operative specimen
Single selection value list:
Part
Part of vulva radically
resected
Describe
34
•
Local excision
•
Part of vulva, radically resected
•
Total radical vulvectomy
Conditional
If local excision, select which
part
If part of vulva radically
resected, select which part of
vulva radically rsected
Text
Multi select value list (select all that apply):
•
Right
•
Left
•
Anterior
•
Posterior
•
Other
Text
If other, describe
S/G
Item description
Response type
Lymph nodes
Select
•
Conditional
None received
OR
Multi select value list (select all that apply):
S1.03
•
Right inguinal
•
Left inguinal
•
Right femoral
•
Left femoral
•
Right pelvic
•
Left pelvic
•
Right sentinel
•
Left sentinel
Any accompanying
specimens
Text
Specimen site
Text
Number of tumours
Numeric: ___
Surgical orientation markers
Text
Pathology accession number
Alpha-numeric
35
S/G
Item description
Response type
S1.04
Principal clinician caring for
the patient
Text
G1.01
Other clinical information
received
Text
Macroscopic findings
S2.01
G2.01
S2.02
Specimen orientation
markers
Text
Surface anatomical structures
(eg clitoris, urethral/vaginal
orifice etc)
Text
Type of surface
Single selection value list:
Specimen measurements
•
Hair bearing skin
•
Hairless skin/mucosa
•
Both hair bearing and hairless
skin/mucosa
•
Cannot determine
Numeric: __x__x__mm
Notes:
(length x width x thickness)
S2.03
36
Number of macroscopically
visible tumour(s)
Numeric: ____
Conditional
S/G
Item description
Response type
S2.04
MACR OS COP I C AP P E AR AN CE
OF TUMOUR ( S )
Note: that the macroscopic apperance will need
to be repeated for each primary tumour
identified.
Type of growth
Single selection value list:
Details
S2.05
•
Fungating
•
Ulcerative
•
Other
Conditional
If other, describe.
Text
Other features (shape, colour,
demarcation)
Text
Tumour dimensions
Numeric: __x__x__mm
Notes:
(length x width x thickness)
The dimensions will need to be repeated for each
primary tumour identified.
S2.06
Margins
Single selection value list:
•
Not assessable
•
Clear
•
Involved
If clear, record distance to
closest peripheral and closest
deep margin.
If involved, record site of
involved margin(s)
37
S/G
Item description
Distance to closest
peripheral margin
Numeric: ___mm
Distance to closest deep
margin
Numeric: ___mm
Site(s) of involved
margin(s)
S2.07
Adjacent skin abnormality
Describe (eg white, thickened,
elevated etc)
S2.08
Response type
Macroscopic depth of
invasion
Conditional
Text
Single selection value list:
•
No
•
Yes
If yes, describe
Text
Numeric:___mm
OR
Not assessable
S2.09
LYMPH NODES
RIGHT INGUINAL LYMPH
NODES
38
Single selection value list:
•
Received
•
Not received
If received, record the
description, number of nodes,
range of dimension, number of
LN with visible metastases and
greatest diameter of metastasis.
S/G
Item description
Description
Total number of nodes
Size range
Response type
Conditional
Text
Numeric: ___
Numeric: __ to __mm
Notes: Smallest node (longest dimension) to
largest node (longest dimension)
Number of LN with visible
metastases
Greatest diameter of
metastasis
LEFT INGUINAL LYMPH
NODES
Description
Total number of nodes
Numeric: ___
If >0, record the longest
diameter of the largest
metastases for each involved
node
Numeric: ___mm
Note: This is the longest diameter of the largest
metastasis for each involved node recorded
above.
Single selection value list:
•
Received
•
Not received
If received, record the
description, number of nodes
range of dimension, number of
LN with visible metastases and
greatest diameter of metastasis.
Text
Numeric: ___
39
S/G
Item description
Size range
Response type
Conditional
Numeric: __ to __mm
Notes: Smallest node (longest dimension ) to
largest node (longest dimension)
Number of LN with visible
metastases
Greatest diameter of
metastasis
RIGHT FEMORAL LYMPH
NODES
Description
Total number of nodes
Size range
Numeric: ___
Numeric: ___mm
Note: This is the longest diameter of the largest
metastasis for each involved node recorded
above.
Single selection value list:
•
Received
•
Not received
Text
Numeric: ___
Numeric: __ to __mm
Notes: Smallest node (longest dimension ) to
40
If >0, record the longest
diameter of the largest
metastases for each involved
node
If received, record the
description, number of nodes
range of dimension, number of
LN with visible metastases and
greatest diameter of metastasis.
S/G
Item description
Response type
Conditional
largest node (longest dimension)
Number of LN with visible
metastases
Greatest diameter of
metastasis
LEFT FEMORAL LYMPH
NODES
Description
Total number of nodes
Size range
Numeric: ___
If >0, record the longest
diameter of the largest
metastases for each involved
node
Numeric: ___mm
Note: This is the longest diameter of the largest
metastasis for each involved node recorded
above.
Single selection value list:
•
Received
•
Not received
If received, record the
description, number of nodes
range of dimension, number of
LN with visible metastases and
greatest diameter of metastasis.
Text
Numeric: ___
Numeric: __ to __mm
Notes: Smallest node (longest dimension ) to
largest node (longest dimension)
Number of LN with visible
Numeric: ___
If >0, record the longest
diameter of the largest
41
S/G
Item description
Response type
metastases
Greatest diameter of
metastasis
RIGHT PELVIC LYMPH NODES
Description
Total number of nodes
Size range
Conditional
metastases for each involved
node
Numeric: ___mm
Note: This is the longest diameter of the largest
metastasis for each involved node recorded
above.
Single selection value list:
•
Received
•
Not received
If received, record the
description, number of nodes
range of dimension, number of
LN with visible metastases and
greatest diameter of metastasis.
Text
Numeric: ___
Numeric: __ to __mm
Notes: Smallest node (longest dimension ) to
largest node (longest dimension)
Number of LN with visible
metastases
42
Numeric: ___
If >0, record the longest
diameter of the largest
metastases for each involved
node
S/G
Item description
Greatest diameter of
metastasis
LEFT PELVIC LYMPH NODES
Description
Total number of nodes
Size range
Response type
Conditional
Numeric: ___mm
Note: This is the longest diameter of the largest
metastasis for each involved node recorded
above.
Single selection value list:
•
Received
•
Not received
If received, record the
description, number of nodes
range of dimension, number of
LN with visible metastases and
greatest diameter of metastasis.
Text
Numeric: ___
Numeric: __ to __mm
Notes: Smallest node (longest dimension ) to
largest node (longest dimension)
Number of LN with visible
metastases
Greatest diameter of
metastasis
Numeric: ___
If >0, record the longest
diameter of the largest
metastases for each involved
node
Numeric: ___mm
Note: This is the longest diameter of the largest
metastasis for each involved node recorded
43
S/G
Item description
Response type
Conditional
above.
RIGHT SENTINEL
INGUINOFEMORAL LYMPH
NODES
Description
Total number of nodes
Size range
Single selection value list:
•
Received
•
Not received
If received, record the
description, number of nodes
range of dimension, number of
LN with visible metastases and
greatest diameter of metastasis.
Text
Numeric: ___
Numeric: __ to __mm
Notes: Smallest node (longest dimension ) to
largest node (longest dimension)
Number of LN with visible
metastases
Greatest diameter of
metastasis
LEFT SENTINEL
INGUINOFEMORAL LYMPH
44
Numeric: ___
If >0, record the longest
diameter of the largest
metastases for each involved
node
Numeric: ___mm
Note: This is the longest diameter of the largest
metastasis for each involved node recorded
above.
Single selection value list:
If received, record the
description, number of nodes
S/G
Item description
NODES
Description
Total number of nodes
Size range
Response type
•
Received
•
Not received
Conditional
range of dimension, number of
LN with visible metastases and
greatest diameter of metastasis.
Text
Numeric: ___
Numeric: __ to __mm
Notes: Smallest node (longest dimension ) to
largest node (longest dimension)
Number of LN with visible
metastases
Greatest diameter of
metastasis
S2.10
Block code
Numeric: ___
If >0, record the longest
diameter of the largest
metastases for each involved
node
Numeric: ___mm
Note: This is the longest diameter of the largest
metastasis for each involved node recorded
above.
Text
Microscopic findings
45
S/G
Item description
Response type
S3.01
Number of primary tumours
Numeric: ___
G3.01
Microscopic description
Text
S3.02
Tumour type (of primary
tumour(s))
Single selection value list:
•
Squamous cell carcinoma
•
Other tumour type
Note that S3.02 tumour type will need to be
repeated for each primary tumour identified in
S3.01.
Type
S3.03
Depth of invasion
Text
Numeric: ___mm
Note that S3.03 will need to be repeated for each
primary tumour identified in S3.01.
G3.02
Superficial reference point for
depth of invasion measurement
Single selection value list:
•
From point of origin
•
From most superficial epithelial-stromal
interface (exophytic tumours only)
•
From top of adjacent dermal papilla (for
ulcerated tumours and where the point of
origin is not known)
Note that this question should be considered for
46
Conditional
If other tumour type is selected,
specify the type.
S/G
Item description
Response type
Conditional
each response to S3.03.
S3.04
S3.05
Size of microscopic
tumour(s)
Numeric: __mm
Lymphvascular space
invasion
Single selection value list:
Note: this should be repeated for each
microscopic tumour identified that has not been
identified previously in the macroscopic.
•
Absent
•
Present
Conditional on microscopic
tumours being identified. If only
previously identified
macroscopic tumours are
identified – do not include.
Note that the questions in S3.05 will need to be
repeated for each primary tumour identified in
S3.01.
S3.06
Perineural invasion
Single selection value list:
•
Absent
•
Present
Note that the questions in S3.06 will need to be
repeated for each primary tumour identified in
S3.01.
S3.07
Margin status (invasive
tumour)
Single selection value list:
•
Clear
•
Involved
If clear, record distance to
closest peripheral margin and
closest deep margin.
47
S/G
Item description
Response type
Note that the questions in S3.07 will need to be
repeated for each primary tumour identified in
S3.01.
Distance to closest
peripheral resection margin
Numeric: ___mm
Distance to closest deep
margin
Numeric: ___mm
Involved margin(s)
Other involved margin
S3.08
48
Intraepithelial Neoplasia eg
VIN, EMPD
Multi select value list (select all that apply):
•
medial (vaginal)
•
urethral
•
anal
•
clitoral
•
deep margin
•
other
Conditional
If involved, record involved
margin(s)
If other is selected, specify other
involved margin(s)
Text
Single selection value list:
•
Absent
•
Present
If present, record type
S/G
Item description
Response type
Type
S3.09
Margin status (VIN/EMPD)
Involved margin(s)
Other involved margin
Conditional
Multi select value list (select all that apply):
•
VIN - Differentiated
•
VIN - Warty-basaloid (usual, HPVassociated)
•
EMPD
Single selection value list:
•
Clear
•
Involved
•
Uncertain
Multi select value list (select all that apply):
•
medial (vaginal)
•
urethral
•
anal
•
clitoral
•
deep margin
•
other
If involved record involved
margin(s)
If other is selected, specify other
involved margin(s)
Text
49
S/G
Item description
Response type
Conditional
S3.10
Number of nodes involved by
tumour
Numeric: ___/____
Conditonal on the sites received
in S2.09
Note: number of nodes involved by tumour over
the total number of nodes from this site.
Note the total number of nodes resected from
this site has been recorded in S2.09.
To be recorded for each lymph node site
recorded as received in S2.09
S3.11
S3.12
Max. diameter(s) of largest
metastases in each involved
node
Extracapsular spread
Numeric: __mm
Note: this will need to be repeated for each
involved node recorded in S3.10.
Single selection value list:
•
Absent
•
Present
Note: this will need to be repeated for each site
received in S2.09.
G3.03
50
OTHER DIAGNOSES
Histopathological features of
lesions other than cancers
Text
Lichen sclerosus
Single selection value list:
•
Absent
•
Present
Conditonal on involved sites
recorded in S3.10
Conditonal on the sites received
in S2.09
S/G
Item description
Response type
G3.04
Other relevant microscopic
comments
Text
Conditional
Ancillary test findings
S4.01
IMMUNOHISTOCHEMICAL
STAINS – SENTINEL NODES
Antibodies
G4.01
Conditional on sentinel nodes
being recieved in S2.09
List (as applicable):
•
Positive antibodies
•
Negative antibodies
•
Equivocal antibodies
Interpretation
Text
Other Ancillary Tests
Single selection value list:
•
Not performed
•
Performed
Test result type eg FISH,
cytogenetics etc
Text
Result
Text
If performed, record the test
result type(s), result(s) and
interpretive comment(s).
Note: Test result type, result and interpretive
comment will need to repeat for each other
ancillary test performed.
Note: Test result type, result and interpretive
51
S/G
Item description
Response type
comment will need to repeat for each other
ancillary test performed.
Interpretive comment
Text
Note: Test result type, result and interpretive
comment will need to repeat for each other
ancillary test performed.
Synthesis and overview
G5.01
Diagnostic summary
Text
Include:
a. Operative procedure (S1.02)
G5.02
52
b.
Tumour type (S3.02)
c.
Tumour size (S3.04)
d.
Depth of invasion (S3.03)
h.
Lymphvascular space
invasion status (S3.05)
e.
Status of margins (S3.07)
f.
Lymph node status (S3.10 –
S3.12)
Overarching comment
Text
Conditional
7
Formatting of pathology reports
Good formatting of the pathology report is essential to optimise 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 use 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.
Please see Appendix 2 for further guidance.
53
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
vulva cancer 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:
i
ii
patient name
date of birth
iii sex
iv identification and contact details of requesting doctor
v
•

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 clinical diagnosis should be recorded.
•

54
Large excisions are usually not performed on the vulva without a
biopsy diagnosis. The surgeon must give the diagnosis.
Record if this is a new primary cancer or recurrence. If a
recurrence then previous diagnosis and method of treatment
must be recorded.
•
The term recurrence defines the return, reappearance or
metastasis of cancer after a disease free period. Vulva cancers are
apt to recur, often on multiple occasions.
Recurrence is classified as local (vulva), regional (groin) and
distant metastases. Recently, local recurrence has been subdivided
into primary site and remote site (eg. recurrences on the
contralateral side).17 Distant metastasis refers to the spread of
cancer to distant organs or distant lymph nodes.

•
Previous surgical therapies produce anatomical distortion which
may confuse the pathologist.
•
Previous radiation therapy may cause dermal sclerosis which may
be confused with lichen sclerosus.
The nature of the operative specimen and any accompanying
specimens should be recorded.
•

Standard therapy for a macroscopic vulva cancer is a radical
(deep) excision (that is, to the depth of Colles’ fascia) of part of
the vulva with skin margins of at least 1cm and inguinofemoral
lymphadenectomy. For large or multifocal tumours, a radical
(total) vulvectomy may be perfomed.
The site of the specimen should be recorded.
•
Occasionally, there may be two or more synchronous primary
vulva carcinomas requiring two separate excisions. Site is a
particularly important identifier when multiple excisions are
performed.
•
Sufficient information is required to localise the lesion for
subsequent therapy. A diagram or photograph can facilitate this.
(Refer to Figure A1)
•
The siting of the carcinoma on the vulva influences the extent and
type of surgery performed. The surgeon in consultation with the
patient aims to strike a balance between the need to save life and
morbidity. There may be narrower margins of critical structures,
eg urethra, anus or clitoris, than the carcinoma alone would
dictate. The margins of these critical structures require extra
attention from the pathologist as they are often the closest. Siting
also strongly influences the decisions about performing
inguinofemoral (groin) lymphadenectomy. Anterior and posterior
tumours are more likely to involve bilateral lymph nodes and
therefore bilateral lymphadenectomy or bilateral sentinel node
procedures are usually performed. Lateral tumours tend to only
involve ipsilateral lymph nodes and generally are treated by
ipsilateral lymphadenectomy or sentinel node biopsy. A lesion is
considered lateral when it is entirely contained between parallel
lines drawn from right to left at the levels of the urethra and
posterior fourchette. For those tumours in the vestibule between
the urethra and anterior vagina and between posterior vagina and
fourchette, an alternative definition of lateral of >1cm from the
55
midline may be used.

The number of tumours identified should be recorded.

The specimen must be capable of orientation and orientation
markers should be recorded.
•
Orientation of the specimen is essential to identify specific surgical
margins. The status of specific margins is critical in determining
the need for, or extent of, further treatment. The minimum
requirement for orientation is a suture placed by the surgeon at
12 o’clock or “anterior”. It is helpful if the site of the vaginal
orifice is marked on the board to which the specimen is pinned.
Marking the site of other structures, such as the anus, clitoris or
urethra, in a simple diagram on the board is also helpful in
relevant cases. The orientation should be indicated on the
specimen request form (this may be facilitated by the use of a
diagram – see Figure A1). Where the surgeon is aware of any
tearing or splitting that has occurred during the procedure, this
should be clearly marked on the specimen as this may affect the
measured tumour free margin.
Surgical handling


The vulvectomy specimen must either be pinned out and placed
in formalin or transported immediately to the laboratory
•
It is important that the specimen is flat and not folded, stretched
or compressed. Due to different tissue constituents, specimens
distort and buckle with formalin fixation if not properly pinned out.
A distorted specimen is more difficult to describe and, if it is not
flat, it may not be possible to obtain optimal blocks. Wellorientated perpendicular blocks with a complete
epidermal/mucosal surface are essential to obtain accurate
histological measurement of depth of invasion.
•
The measurement of the margins is altered if the specimen is
stretched or compressed. Surgeons aim for a clinical margin of
10mm, which equates to a histological margin of 8mm after
reduction due to natural elasticity and formalin fixation.
If there has been a previously narrowly excised or biopsied tumour and a
tumour or wound is no longer visible, the site of the original tumour
should be marked by the surgeon with a stitch or ink.
•
56
Difficulty in the identification of the tumour site may lead to suboptimal sampling and/or histological examination.
Figure A1
Vulva diseases diagram
57
Example Request Information Sheet
The above Request Information Sheet is published to the RCPA website.
58
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 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 information18.
Descriptive titles and headings should be consistent across the protocol, checklist
and report.
When reporting on different tumour 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 ‘chunk’ data elements into a single
unit will help to improve recall for the clinician18.
•
‘Clutter’ should be reduced to a minimum18. Thus, information that is not part of
the protocol (eg billing information, Snomed codes, etc) should not appear on
the reports or should be minimised.
•
Injudicious use of formatting elements (eg too much bold, underlining or use of
footnotes) also increases 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.
60
Appendix 3
Example pathology report for
vulva cancer
61
62
63
64
Appendix 4
WHO Classification of Tumours
Epithelial tumours
Squamous and related tumours and precursors
Squamous cell carcinoma, not otherwise specified
Keratinizing
Non- keratinizing
Basaloid
Warty
Verrucous
Keratoacanthoma-like
Variant with tumour giant cells
Others
Basal cell carcinoma
Squamous intraepithelial neoplasia
Vulva intraepithelial neoplasia (VIN)
Squamous cell carcinoma in situ
Benign squamous lesions
Condyloma acuminatum
Vestibular papilloma (micropapillomatosis)
Fibroepithelial polyp
Seborrheic and inverted follicular keratosis
Keratoacanthoma
8070/3
8071/3
8072/3
8083/3
8051/3
8051/3
8090/3
8077/2
8070/2
8052/0
Glandular tumours
Paget disease
8542/3
Bartholin gland tumours
Adenocarcinoma
8140/3
Squamous cell carcinoma
8070/3
Adenoid cystic carcinoma
8200/3
Adenosquamous carcinoma
8560/3
Transitional cell carcinoma
8120/3
Small cell carcinoma
8041/3
Adenoma
8140/0
Adenomyoma
8932/0
Others
Tumours arising from specialised anogenital mammary-like glands
Adenocarcinoma of mammary gland type
8500/3
Papillary hidradenoma
8405/0
Others
Adenocarcinoma of Skene gland origin
8140/3
Adenocarcinomas of other types
8140/3
Adenoma of minor vestibular glands
8140/0
Mixed tumour of the vulva
8940/0
Tumours of skin appendage origin
Malignant sweat gland tumours
Sebaceous carcinoma
Syringoma
Nodular hidradenoma
Trichoepithelioma
Others
8400/3
8410/3
8407/0
8402/0
8100/0
65
Soft Tissue tumours
Sarcoma botryoides
Leiomyosarcoma
Proximal epithelioid sarcoma
Alveolar soft part sarcoma
Liposarcoma
Dermatofibrosarcoma protuberans
Deep angiomyxoma
Superficial angiomyxoma
Angiomyofibroblastoma
Cellular angiofibroma
Leiomyoma
Granular cell tumour
Others
Melanocytic tumours
Malignant melanoma
Congenital melanocytic naevus
Acquired melanocytic naevus
Blue naevus
Atypical melanocytic naevus of the genital type
Dysplastic melanocytic naevus
Miscellaneous tumours
Yolk sac tumour
Merkel cell tumour
Peripheral primitive neuroectodermal tumour/
Ewing tumour
8910/3
8890/3
8804/3
9581/3
8850/3
8832/3
8841/1
8841/0
8826/0
9160/0
8890/0
9580/0
8720/3
8761/0
8720/0
8780/0
8720/0
8727/0
9071/3
8247/3
9364/3
9260/3
Secondary tumours
Morphology code of the International Classification of Diseases for Oncology (ICD-O)
and the Systematized Nomenclature of Medicine (http://snomed.org). Behaviour is
coded /0 for benign tumours, /2 for in situ carcinomas and grade 3 intraepithelial
neoplasia, /3 for malignant tumours, and /1 for borderline or uncertain behaviour.
Intraepithelial neoplasia does not have a generic code in ICD-O. ICD-O codes are
only available for lesions categorized as squamous intraepithelial neoplasia grade 3
(eg intraepithelial neoplasia /VIN grade 3) = 8077/2; squamous cell carcinoma in
situ 8070/2.
©World Health Organisation. Reproduced with permission
66
Appendix 5
Figures
Fig 1a
Cancer excision specimen, see example report. Drawing of outline of
specimen, tumour and slices, shows at a glance how the specimen has
been sliced.
Fig 1b
Cancer excision specimen. Drawing of slices and block code shows at a
glance where the blocks have come from.
67
Fig 2a
VIN excision specimen. Drawing of outline of specimen, lesion and slices
shows at a glance how the specimen has been sliced.
Fig 2b
VIN excision specimen. Drawing of slices and block code shows at a glance
where the blocks have come from.
68
In the diagrams 3A-D, there are 2 methods of measurement depth
of invasion in each diagram: A is always the correct
measurement.
Fig 3a
VIN excision specimen with microscopic invasive squamous cell carcinoma
where the point of origin is known. SCC usually arises from the tip of an
elongated rete ridge (or sometimes an appendage) involved with VIN. The
depth of invasion is measured from the point of origin (A = 0.1mm).
Measurement from the adjacent dermal papilla (B = 1.2mm)
overestimates the volume and, therefore, metastatic potential of the
cancer and might lead to an unnecessary inguinofemoral lymph node
dissection.
Fig 3b
VIN excision specimen with microscopic invasive carcinoma where the
point of origin of the SCC is not known. In these cases, the depth is
measured from the top of an adjacent dermal papilla (A = 1.6mm). By
contrast with fig 3a, measurement from the closest rete ridge involved
with VIN (B = 0.6mm) would underestimate the volume of the cancer and
might lead the clinician into not performing an inguinofemoral lymph node
procedure when there is a chance that a node will be involved.
69
Fig 3c
In an ulcerated tumour, the depth of invasion is measured from the top of
an adjacent dermal papilla (A). To measure from within the ulcerated area
will underestimate the tumour volume.
Fig 3d
In a tumour with an exophytic component, the depth of invasion is
measured from the top of the epithelial-stromal junction within the
tumour (A). Measuring from the adjacent dermal papilla (B) will
underestimate tumour volume.
70
Appendix 6
TNM and FIGO Staginga
PRIMARY TUMOR (T)
TNM
CATEGORY
FIGO
STAGE
TX
Primary tumor cannot be assessed
T0
No evidence of primary tumor
Tis
*
Carcinoma in situ (preinvasive carcinoma)
T1a
IA
Lesions 2 cm or less in size, confined to the vulva or
perineum and with stromal invasion 1.0 mm or less**
T1b
IB
Lesions more than 2 cm in size or any size with
stromal invasion more than 1.0 mm, confined to the
vulva or perineum
T2***
II
Tumor of any size with extension to adjacent perineal
structures.(Lower/distal 1/3 urethra, lower/distal 1/3
vagina, anal involvement)
T3****
IVA
Tumor of any size with extension to any of the
following: upper/proximal 2/3 of urethra,
upper/proximal 2/3 vagina, bladder mucosa, rectal
mucosa, or fixed to pelvic bone.
*
**
***
****
FIGO staging no longer includes Stage 0 (Tis).
The depth of invasion is defined as the measurement of the tumor from the
epithelial-stromal junction of the adjacent most superficial dermal papilla to
the deepest point of invasion. This is at odds with recommendations for
cancers with known source of origin or exophytic tumours as per sections
described above. Perhaps this should be alluded to. Otherwise this is
conflicting.
FIGO uses the classification T2/T3. This is defined as T2 in TNM.
FIGO uses the classification T4. This is defined as T3 in TNM.
Note that, in the opinion of the protocol authors, the TNM/FIGO method of
measurement of depth of invasion is not applicable in small tumours where
the point of origin is known and in tumours with an exophytic tumour. For
these tumours, refer to Fig 3a and 3d.
a
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, www.springerlink.com.
71
REGIONAL LYMPH NODES (N)
TNM
CATEGORY
FIGO
STAGE
NX
Regional lymph nodes cannot be assessed
N0
No regional lymph node metastasis
N1
One or two regional lymph node with the following
features
N1a
IIIA
1 or 2 lymph node metastases each 5 mm or less
N1b
IIIA
One lymph node metastases 5 mm or greater
N2
IIIB
Regional lymph node metastasis with the following
features
N2a
IIIB
Three or more lymph node metastases each less than
5 mm
N2b
IIIB
Two or more lymph node metastases 5 mm or greater
N2c
IIIC
Lymph node metastasis with extracapsular spread
N3
IVA
Fixed or ulcerated regional lymph node metastasis
DISTANT METASTASIS (M)
TNM
CATEGORY
FIGO
STAGE
M0
M1
72
No distant metastasis
IVB
Distant metastasis (including pelvic lymph node
metastasis)
ANATOMIC STAGE • PROGNOSTIC GROUPS
GROUP
T
N
M
Stage 0*
Tis
N0
M0
Stage I
T1
N0
M0
Stage IA
T1a
N0
M0
Stage IB
T1b
N0
M0
Stage II
T2
N0
M0
Stage IIIA
T1, T2
N1a, N1b
M0
Stage IIIB
T1, T2
N2a, N2b
M0
Stage IIIC
T1, T2
N2c
M0
Stage IVA
T1, T2
N3
M0
T3
Any N
M0
Any T
Any N
M1
Stage IVB
*FIGO no longer includes Stage 0 (Tis).
73
References
1
Hacker N (2010). Vulvar Cancer. In Berek JS and Hacker NF Gynecologic
Oncology. Wolters Kluwer; Lippincott Williams & Wilkins
2
WHO (World Health Organization) (2003). World Health Organization
Classification of Tumours. Pathology and Genetics of Tumours of the Breast
and Female Genital Organs. Tavassoli FA and Devilee P. IARC Press, Lyon.
3
Clement PB and Young RH (2008). Pages 27-48 from Malignant tumors of
the vulva. In Atlas of gynaecological surgical pathology, 2nd edn. Saunders
Elsevier.
4
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