The Sloane Project NHS - Cancer Screening Programmes

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                                                                                     NHS
                                                               Cancer Screening Programmes

                                                      The Sloane Project
                                         UK prospective audit of screen detected non-invasive
                                           carcinomas and atypical hyperplasias of the breast

                                                                        Annual Report
                                                                           2003/2004
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                                                                                                                         1
                                                                       Mr Hugh Bishop,
                                                                 Chair of Sloane Project
                                                                         Steering Group

          THE SLOANE
                           PROJECT

          A UK Prospective Audit of Screen-detected Non-invasive
          Carcinomas of the Breast

          INTRODUCTION                                           add your own comments on the design of the
          It is a pleasure to contribute to the 2003/04          form, or on particular aspects of the patients’ data.
          Annual Report on the Sloane Project. The               If we do not receive completed forms from you, it
          Sloane Project started on 1st April 2003. At that      is up to us on the Sloane Project Steering Group
          time, we stipulated that patients could only be        to find out why and to engineer an improvement.
          included if they had been invited for screening        So, don’t worry if all your boxes aren’t ticked, just
          after the 1st April 2003. I had failed to              send us all the details that you can.
          appreciate that this meant that the first patients
          that could be registered would only start to           Trials (e.g. New DCIS Trial, IBIS II, etc)
          emerge in July/August of that year. This did little    We positively encourage you to participate in
          to swell numbers in 2003/04. Since those early         all available DCIS trials. The Sloane Project is
          days, I am delighted to report that 67 breast          an audit; it does not and should not mean that
          screening units have agreed to participate and         a Sloane Project patient cannot be entered into
          that data have been received from nearly 50            an appropriate clinical trial.
          units. I am extremely grateful to all who have
          participated for their unstinting generosity. The      Other Non-invasive Lesions
          high standard of data completeness on the              (e.g. ADH, LISN etc)
          forms that you have returned to date is                We encourage you to register these patients
          particularly worthy of note. Surgeons are often        with difficult lesions within the Sloane Project.
          berated for their supposed inability to fill in
          forms, so I am particularly pleased to report that     Funding
          the treatment forms, submitted by surgeons             Until now, the Sloane Project has been
          (allegedly) are the most complete! I am                financed by a grant from the NHS Breast
          delighted to report that over one thousand             Screening Programme and we remain very
          patients have now been registered in the Sloane        grateful to Julietta Patnick for all her
          Project.                                               encouragement and support. Unfortunately, the
          May I draw your attention to the following:            budget for the NHS Cancer Screening
                                                                 Programmes has been cut considerably this
          Data Completeness                                      year. This decision has thrown the whole
          Please do not fret if you can’t complete every last    Sloane Project into jeopardy. I am therefore
          box. Just send us what you can. The West               very pleased to tell you that we have secured an
          Midlands Cancer Intelligence Unit is not quite as      unrestricted educational grant from Pfizer
          all knowing as the Inland Revenue, but it does         Pharmaceuticals for £75,000, over the next
          have considerable skills in pursuing data. We          three years, to help to cover the running costs of
          know that the pathology data form can be               the Sloane Project. We are extremely grateful to
          challenging and that pathologists are trained to be    Pfizer for their generous support.
          accurate and meticulous. Nevertheless, we
          would particularly ask pathologists to complete as     It only remains to say, how pleased I am that the
          many of the data fields as they can and not to         Sloane Project is making the progress that it is,
          ignore the form, simply because they can’t             and I continue to be very grateful for all
          complete all of the data fields. Please feel free to   voluntary contributions to its success.
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 2
                                                                        Professor John Sloane

                                                                                     Background and S
                                                                                                                             of t

                   There has been a marked increase in the              Oncology (ABS at BASO). The Sloane Project is
                   incidence of non-invasive breast cancers since       co-ordinated by Karen Clements, the Sloane
                   the introduction of the NHS Breast Screening         Project Officer.
                   Programme (NHSBSP). Ductal carcinoma in
                   situ (DCIS) now accounts for over 20% of all         As a prospective audit recording particular
                   breast cancers detected by the NHSBSP. The           characteristics in terms of radiological and
                   reason for the increase is that DCIS is relatively   pathological appearance and details of surgical
                   easy to detect on a mammogram due to the             and adjuvant treatment, the Sloane Project will
                   microcalcification that is frequently present.       compile a database of potentially 10,000 DCIS
                                                                        cases over five years. At the same time the
                   Currently over 2,500 new non-invasive breast         project will also look at the incidence of lobular
                   cancers are detected by the NHSBSP each year.        in situ neoplasia (LISN), atypical ductal
                   Unfortunately there are still uncertainties about    hyperplasia (ADH) and atypical lobular
                   the natural history, invasive potential and          hyperplasia (ALH).
                   optimal treatment for this condition. One of the
                   main aims of the Sloane Project, therefore, is to    Participation in the Sloane Project is invited
                   gain more knowledge regarding the diagnosis,         from all 98 UK breast screening units and, at
                   treatment and clinical outcomes of screen            present, 67 units have agreed to take part. A
                   detected in situ carcinoma and atypical              lead clinician needs to be identified to lead the
                   hyperplasia. This will assist in the construction    co-ordination of the Sloane Project in each unit
                   of proposals for the management of these non-        and to ensure complete and accurate data
                   invasive breast diseases.                            collection. As the Sloane Project is a multi-
                                                                        disciplinary project involving surgeons,
                   The Sloane Project is named after the late           pathologists, radiologists and oncologists,
                   Professor John Sloane, a prominent pathologist       communication and a team-based approach are
                   who worked at the Royal Liverpool Infirmary,         essential components to the success of the
                   who had a great interest in the pathology of         Sloane Project in each unit.
                   DCIS. The project is an NHSBSP audit, which is
                   being administered through the West Midlands         The data for the Sloane Project are being
                   Cancer Intelligence Unit (WMCIU) in                  collected by way of specifically designed data
                   collaboration with the Association of Breast         collection forms for each discipline, which will
                   Surgery at the British Association of Surgical       provide full and detailed information about the
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                                                                                                                     3
                                     Miss Karen Clements,
                                     Sloane Project Officer

d Summary
f the Sloane Project

           patient’s journey from diagnosis to treatment.       Eligibility Criteria
           The cases will be followed up and the
           incidence of local recurrence, contralateral         Patients are eligible if:
           breast cancer, metastases and deaths will be         They have ductal carcinoma in situ (DCIS),
           determined. The follow up information will be        lobular in situ neoplasia (LISN), atypical ductal
           collected on a simple spreadsheet with more          hyperplasia (ADH), or atypical lobular
           detailed recurrence information being collected      hyperplasia (ALH) and
           on a specially designed follow up form. There is     Their disease was screen-detected within the
           a specific pathology protocol to ensure the          NHS Breast Screening Programme and
           gathering of accurate pathology data, as well as     Their disease is non-invasive or micro-invasive
           radiology guidelines to assist in the completion
           of the radiology form.                               Patients are not eligible if:
                                                                They have invasive disease or
           Careful prospective collection of these data will    Their disease was not screen detected within
           enable the correlation of clinical outcomes with     the NHSBSP or
           treatment received. This information will allow      Their disease was symptomatically detected or
           the identification of prognostic indicators, the     They have recurrent breast cancer or
           examination of the role of margins and adjuvant      They have had a previous contralateral breast
           therapy on outcome, and the calculation of           cancer
           survival. As a result, the project will be able to
           suggest what might be the optimal treatment for      Consent and Ethics Committee Approval
           DCIS and other non-invasive breast cancers.          Ethics committee approval is not needed for the
                                                                Sloane Project as it is a prospective audit rather
                                                                than a trial and is covered under the NHSBSP’s
                                                                application to the Patient Information Advisory
                                                                Group (PIAG).

                                                                If you require any further information about any
                                                                aspect of the Sloane Project, please contact
                                                                Miss Karen Clements, Sloane Project Officer, by
                                                                e-mail at karen.clements@wmciu.nhs.uk
                                                                or on 0121 415 8190
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 4                                           Dr Sarah Pinder,
                                             Consultant Breast Pathologist

                                             PATHOLOGY

                                             DCIS now comprises a significant portion of the
                                             breast pathology workload; in many centres
                                             more than 20% of screen-detected cancers are
                                             in the form of DCIS. However, the handling of
                                             breast excision specimens for DCIS is fraught
                                             with difficulties, not least because the lesion is
                                             often not visible to the naked eye and the
                                             preparation of samples is thus often time
                                             consuming and complicated. Specific resources
                                             such as the facility for specimen X-ray are
                                             required, as X-ray of both the whole specimen
                                             and (very often) specimen slices is used to
                                             identify the areas of concern in the form of
                                             microcalcification. It is clear that thorough
                                             sampling to exclude the presence of foci of
                                             invasion and to assess completeness of excision
                                             is vital to the management of patients with
                                             DCIS, but no one method of specimen handling
                                             can be used in all cases. There are a variety of
                                             techniques which can be used and local
                                             laboratory idiosyncrasies are frequently found.

                                             The Sloane Project is an audit of the way DCIS
                                             is identified and treated in the UK, with the aim
                                             of collecting better DCIS data. The Sloane
                                             Project pathology protocol is not prescriptive
                                             and describes several possible methods of
                                             specimen dissection, and it should be noted
                                             that other methods can be used to provide the
                                             Sloane Project pathology data, as long as they
                                             are fully documented.

                                             Previous review of the cases entered into the
                                             first UKCCCR DCIS trial showed that central
                                             review of DCIS was almost impossible with
                                             respect to size of disease and distance of
                                             disease to relevant margins, at least in some
                                             cases. There is no agreement as to what
                                             constitutes an adequate margin of excision and
                                             this requires further evaluation in a large well-
                                             characterised series of cases. It is, however,

                                             Prof Ian Ellis, Prof Andrew Hanby,
                                             Dr Jim Macartney, Dr Jeremy Thomas
                                             Sloane Project Steering Group Pathologists
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                                                                                                                 5

          clear from literature review and previous           disease, rather the components are itemised
          experience that high quality pathology is           separately as (a) necrosis - present and (b) the
          essential for the evaluation of features of         architecture - solid, cribriform, micropapillary
          importance in the biology, diagnosis and            or papillary etc.
          management of patients with DCIS, including
          the two features of size and margin distance.       The NHSBSP pathology EQA scheme also
          Thus, any multicentre large trial, which does       shows that there are significant deficiencies in
          not include the highest quality pathological        the reproducibility of diagnosis of ADH and
          input at the time of assessment in the source       micro-invasive carcinoma. Yet these, albeit
          breast pathology laboratory, is significantly       rare, lesions are seen more often in breast
          flawed. The Sloane Project pathology data           screening practise than in symptomatic work.
          analysis will allow examination of features of      Recent evidence also suggests variances in the
          interest in a large body of cases of DCIS           behaviour of LISN, and information on “high
          diagnosed through the UK NHSBSP which have          risk” lesions will also be collected in order to
          undergone      high    quality    pathological      add to the body of knowledge of these diseases.
          assessment, with collection of a specified,         As no single institution will be able to collect
          targeted set of parameters which have               such data on these infrequent processes, a large
          previously been indicated to be of value.           national database is required, and the Sloane
                                                              Project will fulfil this need.
          The pathology protocol for the Sloane Project
          has been written in order to facilitate             A number of regional workshops for specimen
          completion of the pathology data form, which        handling and DCIS microscopy have been held
          has undergone some simplification since its         through the NHSBSP regional pathology co-
          inception. The pathology protocol outlines not      ordinators’ group. Others can be organised if
          only methods for handling, but also for             desired through the Sloane Project Team at the
          reporting of DCIS in the hope of improving          West Midlands Cancer Intelligence Unit. In
          consistency of pathological assessment. The         addition, a CD of DCIS microscopic images has
          NHSBSP pathology EQA scheme has                     been produced and distributed through the
          demonstrated that there is sub-optimal              NHSBSP National Pathology Update Course
          reproducibility in the assessment of grade of       (April 2004). It is intended to expand on this
          DCIS. This feature has nevertheless been shown      aide memoire in the near future and make this
          in several series to be of prognostic importance.   available through the NHSBSP pathology EQA
          Numerous other factors have been suggested to       scheme.
          be of importance in the prediction of behaviour
          of DCIS including the size of the lesion, the       Any additional suggestions and feedback
          presence or absence of necrosis, and the            regarding the histopathology of the Sloane
          architecture of the DCIS. The pathology             Project are welcome and can be directed
          protocol outlines the definitions of these          through Karen Clements to the pathologists on
          features in order to clarify completion of the      the Sloane Project Steering Group.
          form; for example, comedo DCIS is not
          considered to be an architectural type of the
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                                         Dr Anthony Maxwell,
                                         Consultant Radiologist

                                         RADIOLOGY

                   Most cancers of the breast exist in situ for at      minutes or so to complete it is hoped that the
                   least part of their natural history, and an          submission rate will improve. Efforts are
                   understanding of the behaviour of DCIS (the          continuing to encourage currently non-
                   commonest non-invasive breast cancer) is             participating units to start data collection - an
                   crucial to our understanding of breast cancer as     average sized unit with around 20 eligible cases
                   a whole. As DCIS is usually clinically occult,       annually would only need a couple of hours of
                   radiology plays an essential role in the             radiologist time to complete the forms each
                   diagnosis, assessment and follow up of the           year. Even if pathology and surgery forms are
                   disease. Treatment of DCIS is still largely          not currently being completed, it is still useful
                   empirical, the surgical procedure being              for radiology forms to be submitted. The more
                   determined mainly by comparison of                   cases that are entered into the Sloane Project,
                   mammographic estimates of disease extent and         the greater confidence we can have in the
                   proximity to the nipple with arbitrary standards.    results.

                   The radiology data, which are being collected        With the recent changes to the national breast
                   through the Sloane Project, will allow a number      screening computer system, the easiest way to
                   of aspects of diagnosis and management to be         identify the eligible cases is to run a KC62 (this
                   investigated. These include analysis of the          can be done at any time in the screening year)
                   radiological appearance, distribution and extent     and print a list of women in columns 27 & 28 of
                   of the disease, the size and density of the breast   Tables A - F2. Some minor amendments are
                   and the patients’ age and screening round.           being made to the guidance for completion of
                   These factors can then be correlated with the        the radiology forms, and updated versions of
                   surgical and pathological data, to suggest future    the document will be sent to the Sloane Project
                   improvements in radiological diagnosis and           contacts in participating breast screening units.
                   assessment of the disease. In the longer term,
                   correlation of preoperative radiology with local     Considerable thought has gone into deciding
                   recurrence rates will be possible.                   what information needs to be collected for
                                                                        Sloane Project patients under follow up.
                   Of the 784 cases from the 2003/04 screening          Mindful of the possibility of overburdening
                   year which have been registered at the time of       radiologists, it has been decided that a follow
                   writing, radiology forms have been received for      up form will only need to be filled in where
                   660 (84.2%). These forms have a good level of        there is proven recurrent or new malignancy (in
                   data completeness. This is an encouraging            either breast).
                   response, and it is anticipated that the
                   remaining radiology forms for many of these          Please keep the forms coming in, and please
                   women will be received in due course.                remember to include any cases of LISN, ADH
                   However, over 1,000 cases would be expected          and ALH (without associated invasive disease).
                   from the participating breast screening units. It    Our knowledge of the natural history of these
                   is recognised that many units are short of           less common conditions is very poor, and each
                   radiologists, but as each form only takes five       case registered makes a valuable contribution.
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                                                                 Dr David Dodwell,
                                                    Consultant in Clinical Oncology

          RADIOTHERAPY

          A number of randomised control trials have          there is a tendency for surgical treatment for
          now provided evidence for the benefits of           DCIS to comprise wide local excision rather
          radiotherapy in reducing the incidence of breast    than mastectomy, the need for radiotherapy will
          cancer recurrence of both invasive and in situ      increase and so it was felt important to collect
          disease type following initial wide local           information on current radiotherapy prescribing
          excision for DCIS. Despite this evidence,           patterns as part of the Sloane Project.
          radiotherapy following wide local excision for
          DCIS is not established as routine treatment in     It is hoped that the Sloane Project will answer a
          all countries including the UK. The decision to     number of crucial questions, providing an
          use radiotherapy may depend on pathological         understanding of how patients are selected for
          margin status, grade, size of DCIS, presence of     radiotherapy, the techniques and fractionation
          necrosis and oestrogen receptor status (and         regimens employed, the importance of the
          therefore possible confounding use of               management of screen detected DCIS on the
          concurrent endocrine therapy). There may be         utilisation of radiotherapy resources and the
          concerns regarding the morbidity of                 importance of radiotherapy in preventing future
          radiotherapy. Its availability within an            local recurrence. Happily the radiotherapy form
          acceptable time frame is also an issue given the    within the Sloane Project is simple and
          pressure on radiotherapy resources and the          although many returns are outstanding,
          waiting lists that have become apparent in          compliance with completion of this form has
          many UK centres recently. Nevertheless, as          generally been very good.
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                                             Dr Caroline Rubin,
 8
                                             Director of Breast Screening, Southampton & Salisbury

                                             UNIT PERSPECTIVE FROM
                                                  SOUTHAMPTON AND
                                               SALISBURY BREAST SCREENING UNIT

                   The Southampton and Salisbury Breast                  documentation and presentation provided to
                   Screening Unit serves a population of                 us, and local acceptance was ameliorated
                   approximately 58,000 women aged 50-64. The            because one of our pathologists had trained
                   Unit is staffed by 4 consultant radiologists          under John Sloane.
                   undertaking 10 funded sessions, 10
                   radiographers,     including     5    advanced        The Director of Breast Screening, who also
                   practitioners, 2 RDAs and 7 A&C staff. The Unit       completes the demographic details on the
                   has access to 4 breast care nurses, 2 consultant      surgical and pathology forms and forwards
                   breast surgeons and an associate specialist in        them to the appropriate consultant, completes
                   Southampton as well as 2 consultant breast            all the radiology data forms. The surgical and
                   surgeons in Salisbury. Breast reconstruction is       pathology forms are forwarded directly to the
                   provided in partnership with the plastic              clinician performing the surgery or the
                   surgeons based in Salisbury. 6 consultant             pathologist who reported on the operative
                   pathologists provide the cytopathology and            specimen. To date only one patient has had
                   histopathology service, two of whom report on         radiotherapy and the clinical oncologist
                   both histopathology and cytopathology                 responsible for her care completed the form.
                   specimens. 2 consultant medical oncologists           Reminders are sent if the forms are not returned
                   and 2 consultant clinical oncologists complete        in a timely fashion.
                   the team.
                                                                         Data Collection
                   The Unit has always had a high detection rate         The data are collected from the breast screening
                   of in situ disease. In 2003-2004 the rate was 2.3     unit packets, the case notes (surgery) and the
                   per 1,000 in the age group 50-64                      pathology reports/information system. The multi-
                   approximating to 28% of total cancers detected.       disciplinary meeting does not play a significant
                                                                         role in identifying cases. Primarily these arise
                   Sloane Project Participation                          from an internal review of all FNAs, core
                   We found out about the Sloane Project via             biopsies and operative histology undertaken by
                   national mammography meetings and regional            the Director of Breast Screening. Completion of
                   QA meetings but got involved after a direct           the demographic data on all the forms, filling in
                   approach from the Sloane Project Officer. We          the radiology form and managing a manual
                   decided to participate as we had observed the         tracking system takes between 15 and 30
                   natural progression of the disease in our own         minutes per case. We do not keep a local copy
                   unit, with patients who we thought had been           of the data but a paper log is maintained to track
                   adequately treated for local DCIS re-presenting       the paperwork and identify those cases that have
                   a variable number of years later with further in      been completed and forwarded. We are shortly
                   situ or invasive disease. The Sloane Project is       going to reconcile the cases to date with the
                   likely to provide information to assist clinicians    NBSS to identify any additional cases that have
                   in the management of these unpredictable non-         not been captured.
                   invasive conditions.
                                                                         I would like to acknowledge all my colleagues
                   The Director of Breast Screening undertakes the       who have kindly filled in the documentation
                   role of the Sloane Project contact and the co-        and who respond cheerfully to my nagging
                   ordinator for data collection as the local audit      despite their onerous clinical and other
                   department felt they were unable to contribute.       commitments and for whom this is yet another
                   The Sloane Project was introduced utilising the       unfunded burden.
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                                                                                                                                    9

          SCREENING OFFICE MANAGEMENT
                  PERSPECTIVE FROM
                      WIRRAL BREAST SCREENING SERVICE

                                                                                                                           Wirral
                                                                                                                           Breast
                                                                                                                           Team

          My name is Glen Penn and I am the screening                columns 27 and 28 and then knew I had them
          office manager for the Wirral Breast Screening             all! I then pulled all the film packets from file
          Service. We have a population of women aged 50-            and sent for the hospital case notes, filled out
          70 of 43,500 with approximately 15,000 screened            all the demographics on the specialist forms
          each year. Last year we diagnosed 105 cancers,             (usually 3 for each case, 4 in some instances)
          with 11 of them having non-invasive disease and            and clipped them to the front of the notes.
          therefore eligible for the Sloane Project. I first found   Then comes the difficult bit, getting the
          out about the Sloane Project at the national A&C           specialists to fill them in! I found that if I gave
          co-ordinators’ group meeting in London, when the           each specialist 3 or 4 at a time when they were
          Sloane Project Officer gave a presentation. I met up       in clinic and complete with the notes then
          with the Sloane Project Officer again when she             they got into the swing of them. Of course it
          came to repeat the presentation to a North West            takes a little while as each patient has 3 or 4
          QA Team meeting. I then gave the presentation to           specialist forms of different permutations and
          my own breast team at our monthly audit meeting.           so the case notes hung around in my office for
          I found the presentation pack provided was                 a number of weeks but overall it worked very
          excellent although by now I think I could repeat it        well and I hope to do the same again this year.
          in my sleep!
                                                                     Each completed form was photocopied and
          Our team consists of 3 surgeons, 3 radiologists,           put into the patient’s screening packet for
          3 pathologists, 2 oncologists as well as                   future reference and the front of the packet
          specialist nurses, radiographers, theatre and              marked to ensure no duplication. I realise that
          ward staff and admin and clerical staff, who all           if everyone decided to do it this way then the
          seemed very enthusiastic and keen to take part.            forms would all descend on the Sloane Project
          However, in the cold light of day and with all             office at similar times with a large void during
          the good will in the world, cases were not being           most of the year, although KC62’s can be run
          identified regularly and enthusiasm waned! I               at any time throughout the year. I know
          decided that if our unit was going to participate          everyone is very busy and although it might
          then I would have to co-ordinate it.                       seem an extra burden on screening office
                                                                     managers, our expertise and experience with
          Although the multi-disciplinary team meeting               filling in of forms for the screening programme
          seemed a good source of identifying the data,              make us ideal candidates to carry this out. It
          in reality some cases were picked up but I                 really did not take a huge amount of time and
          wasn’t convinced I had them all. So I ran the              it is very rewarding to know we are helping
          KC62, printed out women from tables A – F2                 with important research.
10
                                                                                                                                                                                                                                                                                                                                                                                                                                    Sloane Report

                                                 No. of Sloane Project cases entered (2003/2004)
                                                                                                                                                                                                                                                                                                                                                       Number of screening units
                                                                                                                                                                                                                                                                                                                                                                                                                                    30/4/05

                                             0
                                                    20
                                                             40
                                                                       60
                                                                                 80
                                                                                          100
                                                                                                   120
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                                                                                                                                                                                                                                                                                                                                               0
                                                                                                                                                                                                                                                                                                                                                   2
                                                                                                                                                                                                                                                                                                                                                         4
                                                                                                                                                                                                                                                                                                                                                               6
                                                                                                                                                                                                                                                                                                                                                                     8
                                                                                                                                                                                                                                                                                                                                                                           10
                                                                                                                                                                                                                                                                                                                                                                                     12
                                                                                                                                                                                                                                                                                                                                                                                                         14
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                                                                                                                                                                                                                                                                                                                                                                                                                                    Page 10

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                                                                                                                                                                                                                                                                                                                                                                                                                     RESULTS

                                                                                                                                                                                                                                                                                                                               st

                                                                                                                                                                                                                                                                Interest show n but participation not confirmed
                         Dudley & Wolves                                                                                                                                                                                                                                                                                              (W
                                                                                                                                                                                                                                                                                                                     So                 )
                                   Wirral                                                                                                                                                                                                                                                                              ut
                                                                                                                                                                                                                                                                                                                         h
                           Leicestershire                                                                                                                                                                                                                                                                                            W
                                                                                                                                                                                                                                                                                                                                      es
                                                                                                                                                                                                                                                                                                                                         t

                                                                                                                                                                                                  Participating and collecting data but not yet submitted any
                            South Essex

                            Peterborough                                                                                                                                                                                                                                                                                         W
                                                                                                                                                                                                                                                                                                                                  al
                                                                                                                                                                                                                                                                                                                                    es
                            East Sussex                                                                                                                                                                                                                                                                                  W
                                                                                                                                                                                                                                                                                                                          es
                              Portsmouth

Breast Screening Unit
                                                                                                                                                                                                                                                                                                                            tM
                                                                                                                                                                                                                                                                                                                              id
                           North Cumbria                                                                                                                                                                                                                                                                                        s
                            South Staffs
                        Hereford & Worcs
                                Wiltshire

                                                                                                         Cases entered to date for screening year 2003/2004
                             North Yorks
                                                                                                                                                                                                                                                                                                                                                                                                                     SO FAR

                                Sheffield
                             West Devon

                                                                                                                                                              Figure 2
                                                                                                                                                                                                                                                                                                                                                                                Figure 1

                                    Avon

                              Chelmsford
                              East Devon

                                                                                                                                                              screening unit
                                   Leeds
                                                                                                                                                                                                                                                                                                                                                                                screening region

                              Nottingham

                                   Bolton
                        South Derbyshire
Warks, Solihull & Cov

                                  Gloucs
                                                                                                                                                              Number of cases entered into

                            Southampton
                                                                                                                                                              the project in 2003/04 by each

                           West Scotland
                                                                                                                                                                                                                                                                                                                                                                                Participating units in each breast

                                   Jarvis
Sloane Report   30/4/05   6:32 pm   Page 11

                                                                                                                     11

          The majority of the data presented in the results    two years, following promotional activities and
          section are for those patients who were              letters, more units have agreed to take part,
          screened between 1st April 2003 and 31st             with recruitment to the project ongoing. This
          March 2004. However, Figure 1 shows the              has meant that some units have only recently
          current situation with regard to participation by    been recruited into the project and have just
          screening region up to and including March           started collecting data. Many units did not
          2005. As of the beginning of March 2005, 49 of       begin collecting data until the end of 2003,
          the 98 (50%) UK Breast Screening Units have          with some only beginning to collect data for
          sent in data. A further 18 units (18%) have          the screening year 2004/05. This is because the
          confirmed that they are collecting data and          Sloane Project is a prospective audit and
          have given the reasons for the delay (e.g. they      any retrospective data would have to be
          have only just begun to collect data or have         complete and very accurate, which many units
          previously been experiencing difficulties). 13       would find difficult. It is anticipated that a lot
          units (13%) have said that they wish to take part    more data will be received for the 2004/05
          but have not yet confirmed that they are             screening year, as more screening units will be
          collecting data. 18 units (18%) have either not      collecting a “full screening year’s worth” of
          replied or have said they do not wish to or are      data.
          unable to take part in the Sloane Project at this
          time. Breast screening units are still being         The beginning of the Sloane Project also
          recruited into the Sloane Project in an ongoing      coincided with the expansion of the NHSBSP,
          process, to which would we would encourage           placing additional pressure on the screening
          any of those units not participating at present to   units. Furthermore, changes in the National
          submit data in the future.                           Breast Screening Computer System meant that
                                                               lists of non-invasive cases could not be run until
          As of 21st March 2005, 784 cases had been            a Crystal Report was created. This has now
          entered into the Sloane Project for the              been completed and issued nationally, which
          screening year 2003/04. It was anticipated that      should assist units in collecting their full cohort
          more cases would be entered for that screening       of cases. In addition to this, manpower
          year, as 2,870 cases of non-invasive and             problems and lack of funding have also been
          micro-invasive cancer were detected by the           cited as barriers to participation.
          NHSBSP in the screening year 2003/04.
          However, there are a number of reasons for this      The Sloane Project Steering Group is therefore
          relatively low participation rate. One of these is   extremely grateful to all those who have
          a delay in recruiting breast screening units into    submitted data and would encourage
          the Sloane Project due to the difficulty in          everybody to continue collecting data for this
          disseminating the necessary information to           worthwhile audit. Finally, we would like to
          such a large group of people. There was an           encourage any units who have not submitted
          initial burst of interest following the launch of    data or have not started to participate to begin
          the Sloane Project, then gradually over the past     collecting data.
Sloane Report   30/4/05                            6:32 pm       Page 12

 12
                                                                                                                                                     Cases entered into the Sloane Project to date by screening
                                                                                                                                                                         region (2003/2004)
                                                                                                                                         160

                                                                                                                                         140

                                                                                                             Number of screening units
                                                                                                                                         120

                                                                                                                                         100

                                                                                                                                          80

                                                                                                                                          60

                                                                                                                                          40
                                                 Figure 3
                 Number of cases entered into the Sloane                                                                                  20

                   Project for each screening region (for                                                                                  0
                                 screening year 2003/04)

                                                                                                                                                                                   r
                                                                                                                                                           nd

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                                                                                                                                                                    Y
                                                                                                                                                                 E,
                                                                                                                                                                N
                                                                                                                                                                                                  Screening Region
                                                        Number of completed forms returned for each discipline
                                                                             (2003/2004)
                                                                 660                          676                                                      553
                                                                                                                                                                                       Figure 4
                                                 100%                                                                                                                                  Number of completed data collection
                                                 90%                                                                                                                                   forms returned for each discipline
                                                 80%
                    & completed forms returned

                                                 70%

                                                 60%

                                                 50%

                                                 40%

                                                 30%

                                                 20%

                                                 10%

                                                  0%
                                                               Radiology                Treatment                                                    Pathology

                                                                           Sloane Project data collection form

                                                                           % forms returned     % forms not returned

                   Data Quality and Completeness                                                                                                                 radiotherapy forms have been completed and
                                                                                                                                                                 returned.
                   An idea of data quality and completeness from
                   a national and regional perspective is provided                                                                                               Some difficulties have been encountered with
                   in the following summary which is based on                                                                                                    the submission of pathology forms. This is
                   data collected for the screening year 1st April                                                                                               partly due to the fact that the pathology
                   2003 and 31st March 2004 and entered onto                                                                                                     protocol is quite detailed and therefore that
                   the Sloane Project database up to the middle of                                                                                               some pathologists believe that this would
                   March 2005. The data are as up-to-date as                                                                                                     create a lot of extra work. However, as the cut
                   possible, but continually changing. Missing                                                                                                   up procedures recommended in the Sloane
                   data will be chased on a six-monthly basis at                                                                                                 Project pathology protocol are now part of the
                   the end of April and the end of October each                                                                                                  NHSBSP pathology guidelines and are
                   year, so data completeness will also improve for                                                                                              therefore a requirement for pathologists
                   the screening year 2003/04.                                                                                                                   working in the breast screening programme, it
                                                                                                                                                                 is hoped that more pathologists will be
                   Figure 3 shows that the number of cases entered                                                                                               following the protocol in their routine work. It
                   by region varies widely, with some regions not                                                                                                is also possible that at times the pathologist
                   submitting any data to the Sloane Project for the                                                                                             may not be notified that the pathology form
                   screening year 2003/04. Breast screening units                                                                                                needs to be completed. The Sloane Project
                   from Breast Test Wales have now started                                                                                                       Steering Group is trying to assist
                   submitting data for the screening year 2004/05.                                                                                               pathologists by creating a CD-ROM for
                                                                                                                                                                 assisting in classifying nuclear grade, as
                   Figure 4 shows that overall data collection is                                                                                                mentioned earlier. There are also plans to
                   good and the number of completed forms being                                                                                                  incorporate further training on a new CD-
                   returned for each patient is excellent for                                                                                                    ROM, which will include radiological images
                   radiology and treatment. 168 of 271 (62%)                                                                                                     as well.
Sloane Report   30/4/05          6:32 pm      Page 13

                                                                                                                                                                                         13
                             Number of surgical procedures carried out
                                                               No surgical
                                     Three operations
                                                               procedures
                                          2.81%
                                                                 1.48%

                Two operations
                   26.18%

                                                                                                             Figure 5
                                                                                                             Number of surgical procedures carried
                                                                                                             out on Sloane Project cases

                                                                              One operation
                                                                                69.53%

                                                                                                          Adjuvant therapy given to Sloane Project patients in screening year
                  No surgical procedures   One operation   Two operations    Three operations                                       2003/2004 (n=676)
                                                                                                                      Adjuvant therapy
                                                                                                                         unknown
                                                                                                                           5.62%
                                                              Figure 6
                                                                                                                                                                    Radiotherapy alone
                                             Adjuvant therapy given to                                                                                                   31.07%

                                                Sloane Project patients

                                                                                                No adjuvant therapy
                                                                                                       given
                                                                                                     44.23%

                                                                                                                                                                   Radiotherapy and
                                                                                                                                                                   Hormone Therapy
                                                                                                                                                                        8.73%

                                                                                                                                                     Hormone Therapy
                                                                                                                                                          alone
                                                                                                                                                         10.36%

          Preliminary Data                                                                      Adjuvant Therapy

                                                                                                Figure 6 shows the proportion of Sloane Project
          Surgical Procedures                                                                   patients receiving adjuvant therapy. 271 of 654
                                                                                                patients (41%) with known adjuvant treatment
          Figure 5 shows that the majority of Sloane                                            data were referred for radiotherapy. 383 of 654
          Project patients are just undergoing one                                              patients (59%) with known adjuvant treatment
          therapeutic operation, with a further 26%                                             data were not referred for radiotherapy. The
          having two operations. Just under 3% of                                               remaining radiotherapy data are to be chased to
          patients have three operations. 1.48% of                                              get a more complete and accurate picture.
          patients had no therapeutic operation. The                                            Approximately 20% of patients were given
          reasons for this included the patient having a                                        hormone therapy. Nearly half the patients with
          diagnosis of ADH and the patient choosing not                                         known treatment data received no adjuvant
          to have any further surgery following the initial                                     therapy.
          diagnosis.

          75% of final therapeutic operations (498 out of
          666 cases with known surgery) were                                                    Hormone Therapy and Oestrogen Receptor
          conservation surgery. A mastectomy was                                                Status
          undertaken as the final therapeutic operation in
          168 cases (25%). 29 (5.8%) patients who                                               Of the patients who were given hormone
          underwent conservation surgery also had                                               therapy and also had known pathology data,
          axillary surgery. 125 (74%) patients who had a                                        72 (77%) were oestrogen receptor positive, 4
          mastectomy also had nodal surgery. Overall,                                           (4.3%) were oestrogen receptor negative and
          23% of patients with known surgery had an                                             18 (19%) had unknown oestrogen receptor
          axillary procedure carried out.                                                       status.
Sloane Report   30/4/05   6:32 pm   Page 14

 14

                   SUMMARY                                               FUTURE PLANS

                   The Sloane Project has almost finished its            Future plans include setting up a Sloane Project
                   second year of data collection. Though it got off     website. It is intended that the website will help
                   to slow start at first, participation by the UK       participants with registration and explain the
                   breast screening units is now good. Some              data collection process. The website will also
                   interesting findings are coming through already.      contain general information on matters relating
                   Just from looking at the data that have been          to the Sloane Project and will hopefully be the
                   submitted to the Sloane Project so far, it is quite   first point of call for anybody seeking
                   clear that practise in the treatment of DCIS still    information about non-invasive breast disease,
                   varies greatly amongst surgeons and across            including recent publications, trial results and
                   hospitals and breast screening units. The Sloane      other educational material which could be used
                   Project has shown that the data that are being        as ongoing training. QA reference centres and
                   collected are going to be extremely useful for        breast screening units will be kept informed of
                   planning how patients diagnosed with screen           progress with the website.
                   detected non-invasive breast carcinomas and
                   atypical hyperplasias should be treated in the        Promotional work for the Sloane Project is
                   future.                                               ongoing. The Sloane Project Steering Group is
                                                                         still trying to recruit as many breast screening
                   The Sloane Project Steering Group is grateful to      units as possible and will continue to promote
                   all who have assisted us in the Sloane Project so     the project and provide updates at regional,
                   far and would like to encourage everyone to           national and international meetings and
                   continue their hard work.                             conferences. There will be a Sloane Project
                                                                         promotional stand at the ABS at BASO meeting
                                                                         on 11th May 2005. There will also be a Sloane
                                                                         Project and DCIS workshop at the Nottingham
                                                                         International Breast Cancer Conference on 15th
                                                                         September 2005.

                                                                         The Sloane Project Steering Group is conscious
                                                                         that efforts need to be concentrated on ensuring
                                                                         that those units who are submitting data already
                                                                         continue to do so. This will be done by
                                                                         providing feedback through presentations and
                                                                         reports such as this. A Sloane Project meeting
                                                                         will also be held in 2006 for all Sloane Project
                                                                         contacts who have assisted in co-ordinating the
                                                                         audit in their breast screening unit.
Sloane Report   30/4/05   6:32 pm   Page 15

                                                                                                         15

          Breast          Screening Units
                                              Submitting          Data

          Thank you to all staff who work in and with the following breast screening units

          Avon Breast Screening Service                  Nottingham Breast Screening Service
          Barking, Havering and Brentwood Breast         Peterborough Breast Screening Service
          Screening Service                              Portsmouth Breast Screening Service
          Bedfordshire and Hertfordshire Breast          Rotherham Breast Screening Service
          Screening Service                              Sheffield Breast Screening Service
          Bolton, Bury and Rochdale Breast Screening     Shropshire Breast Screening Service
          Service                                        South Derbyshire Breast Screening Service
          Cambridge and Huntingdon Breast Screening      South Devon Breast Screening Service
          Service                                        South Essex Breast Screening Service
          Chelmsford and Colchester Breast Screening     South Staffordshire Breast Screening Service
          Service                                        South West Scotland Breast Screening Service
          Chester Breast Screening Service               Southampton and Salisbury Breast Screening
          Cornwall Breast Screening Service              Service
          Doncaster Breast Screening Service             Surrey (Jarvis) Breast Screening Service
          Dudley and Wolverhampton Breast Screening      Walsall and Sandwell Breast Screening Service
          Service                                        Warwickshire, Solihull and Coventry Breast
          East Berkshire Breast Screening Service        Screening Service
          East Devon Breast Screening Service            West Berkshire Breast Screening Service
          East Sussex Breast Screening Service           West Devon Breast Screening Service
          Gloucestershire Breast Screening Service       West of Scotland Breast Screening Service
          Great Yarmouth Breast Screening Service        Wiltshire Breast Screening Service
          Hereford and Worcester Breast Screening        Wirral Breast Screening Service
          Service                                        Wycombe Breast Screening Service
          Isle of Wight Breast Screening Service
          Leeds and Wakefield Breast Screening Service
          Leicestershire Breast Screening Service
          Liverpool Breast Screening Service
          Maidstone Breast Screening Service
          Medway Maritime Breast Screening Service
          Milton Keynes Breast Screening Service
          North Cumbria Breast Screening Service
          North Nottingham Breast Screening Service
          North Wales Breast Screening Service
          North Yorkshire Breast Screening Service
          Northampton Breast Screening Service
Sloane Report   30/4/05    6:32 pm   Page 16

                   Publications and Presentations
                            (April 2003 to March 2004)

                   2003
                   April    Promotional Stand at ABS at BASO Study Day, Solihull
                            Presentation at North West QA Team meeting, Warrington

                   May      Presentation at London Regional Breast Screening Study Day, London
                            Presentation at South West QA Study Day
                            Presentations by group members at West Midlands DCIS Study Day, Birmingham
                            Presentation at QA Co-ordinators meeting, Sheffield

                   July     Presentation   at Brighton Breast Cancer Day, Brighton
                            Promotional    Leaflets given out at Cambridge Breast Cancer Conference
                            Presentation   at South West Screening Office Managers’ meeting, Bristol
                            Presentation   at MDT meeting, Royal Hallamshire Hospital, Sheffield

                   Sept     Poster at Nottingham International Breast Cancer Conference, Nottingham

                   Oct      Presentation at Consultant Meeting, Norwich
                            Poster at UK Association of Cancer Registries conference, Cardiff
                            Presentation at North Trent Breast Education Meeting, Sheffield University
                            Presentation at MDT Co-ordinator’s Study Day, Birmingham Women’s Hospital
                            Article in NHSBSP Network magazine

                   Nov      Presentation at Royal College of Radiologists Breast Group Annual Scientific meeting,
                            Cardiff
                            DCIS and Sloane Project pathology workshop, cut up demonstration and presentations,
                            Liverpool
                            Presentation at MDT Meeting, Rotherham
                            Article in ABS at BASO Newsletter

                            2004
                   Jan      Presentation at Breast Test Wales Annual Conference, Cardiff

                   Feb      Presentations and Pathology Cut-up demonstration at East of England DCIS & Sloane
                            Project
                            pathology meeting, Cambridge

                   March Poster at 4th European Breast Cancer Conference, Hamburg
Sloane Report   30/4/05   6:32 pm   Page 17

          Acknowledgements

          Sloane Project Steering Group

          Radiologists
          Dr Hilary Dobson            Consultant Radiologist, The West of Scotland Breast Screening
                                      Programme, Glasgow
          Dr Andy Evans               Consultant Radiologist, Nottingham Breast Institute, Nottingham
          Dr Anthony Maxwell          Consultant Radiologist, Royal Bolton Hospital, Bolton
          Dr Matthew Wallis           Consultant Radiologist, Coventry & Warwickshire Teaching Hospitals
                                      NHS Trust, Coventry

          Pathologists
          Professor Ian Ellis         Reader in Histopathology, Nottingham City Hospital, Nottingham
          Professor Andrew Hanby      Professor of Breast Pathology, St James’ University Hospital, Leeds
          Dr James Macartney          Consultant Pathologist, Walsgrave Hospital NHS Trust, Coventry
          Dr Sarah Pinder             Consultant Breast Pathologist, Addenbrooke’s Hospital, Cambridge
          Dr Jeremy Thomas            Consultant Pathologist, Western General Hospital, Edinburgh
          Professor Sunil Lakhani     Professor of Breast Cancer Pathology, The Breakthrough Tony Robins
                                      Breast Cancer Research Centre, London

          Surgeons
          Mr Hugh Bishop              Consultant Surgeon and Chair of Sloane Project Steering Group, Royal
                                      Bolton Hospital, Bolton
          Professor W D George        Regius Professor of Surgery, Western General Infirmary, Glasgow
          Mr Martin Lee               Consultant Surgeon, Coventry & Warwickshire Teaching Hospitals NHS
                                      Trust, Coventry

          Oncologists
          Dr John A Dewar             Consultant Radiotherapist & Oncologist, Nine Wells Hospital, Dundee
          Dr David Dodwell            Consultant in Clinical Oncology, Cookridge Hospital, Leeds
          Dr Gillian Ross             Honorary Consultant in Clinical Oncology, Royal Marsden Hospital,
                                      London

          Management
          Miss Karen Clements         Sloane Project Officer, West Midlands Cancer Intelligence Unit
          Dr Gill Lawrence            Regional Director of Breast Screening Quality Assurance,
                                      West Midlands Cancer Intelligence Unit, Birmingham
          Miss Olive Kearins          Deputy Director of Breast Screening Quality Assurance,
                                      West Midlands Cancer Intelligence Unit
          Mrs Margot Wheaton          Programme Manager
                                      Warwickshire, Solihull and Coventry Breast Screening Service
Sloane Report   30/4/05   6:32 pm   Page 18

 18

                   Special thanks to the following
                               Sloane Project contacts

                   Ms Claire Alexander           Mrs Annette Mainon
                   Dr Pam Alleyne                Ms Karen Makinson
                   Ms Jenny Andrews              Ms Joanne Mann
                   Dr Holly Archer               Ms Nina Margetts
                   Dr Geoff Athey                Mr Jamal Maroof
                   Dr Rob Bailey                 Mrs Patricia McCubbin
                   Dr Joanna Basten              Dr Sarah Moorhouse
                   Ms Sharon Bayles              Ms Debbie Nicholson
                   Dr Linda Bobrow               Dr Anna Parker
                   Dr Peter Britton              Dr Margaret Payne
                   Mrs Helen Brown               Ms Sophia Peart
                   Ms Adrienne Catcheside        Mrs Glen Penn
                   Mr Sankaran Chandrasekharan   Ms Christine Phillips
                   Ms Alison Chatten             Ms Marilyn Phillips
                   Miss Jane Clarke              Mr Joe Psaila
                   Ms Joanne Cooper              Dr Hugh Renny
                   Dr Eleanor Cornford           Ms Bethan Richardson
                   Mrs Ruth Croft                Mrs Sheila Roath
                   Ms Maggie Cutler              Mr Neil Rothnie
                   Dr Cathy Dale                 Dr Caroline Rubin
                   Dr Hilary Daintith            Dr Gary Rubin
                   Ms Anne-Marie Dare            Ms Vicky Sands
                   Ms Diane Davis                Dr Ali Sever
                   Mr Peter Donnelly             Mr Mark Sibbering
                   Mrs Christine Duff            Dr S Sivathasan
                   Miss Julie Dunn               Mrs Jean Smith
                   Mr Karl Fortes Mayer          Ms Karen Smith
                   Dr Roderick Grant             Ms Eleanor Spalding
                   Ms Jennifer Greatbatch        Ms Helen Stansby
                   Dr Marcia Hall                Dr Kerstin Stepp
                   Ms Freda Hammerton            Mr Guy Stevens
                   Mrs Claudia Harding-Mackean   Mrs Anne Stotter
                   Ms Julia Hayes                Dr Richard Suarez
                   Mrs Judith Hearne             Dr Caroline Taylor
                   Mrs Linda Heppenstall         Mrs Lynn Todd
                   Dr Luci Hobson                Ms Ruth Thorpe
                   Mr Chris Holcombe             Mr Tamoor Usman
                   Dr Sue Hotston                Dr Susan Varkey
                   Ms Sandra Hullock             Ms Lynda Wagstaff
                   Dr Christine Ingram           Dr Matthew Wallis
                   Dr Samar Jader                Mr Roger Watkins
                   Mrs Sharon Kirkham            Ms Maureen Wells
                   Dr Monica Lamont              Dr Jenny Wise
                   Dr Elsbeth Lindsay            Dr Suzanne Wright
                   Mrs Sarah Macdonald
Sloane Report   30/4/05   6:32 pm   Page iii
Sloane Report   30/4/05   6:32 pm   Page iv
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