Northampton General Hospital. Breast Multi-Disciplinary Team. Management and Clinical Guidelines

Transcription

1 Northampton General Hospital Breast Multi-Disciplinary Team Management and Clinical Guidelines The management of breast cancer will be the same regardless of whether the diagnosis is made is a screening or symptomatic setting. Management of breast cancer will be organised and performed to National Standards laid out in current Professional and Governmental Guidelines. These are laid out in Documents produced by Royal Colleges of Surgery (Association of Breast Surgeons at BASO), the National Institute of Clinical Excellence, and the Royal Colleges of Pathology and Radiology. These Guidelines are supported by Cancer Network (E Midlands) and Trust produced documents that outline local and regional variations in practice and are appropriate to individual staff groups and infrastructure differences in individual localities. Quality Assurance will be outlined and measured by a Programme of Local, Regional and National Audit processes. The Administration of the Breast Multi- Disciplinary Team is described in a separate Document The Local Breast Cancer Multi-Disciplinary Meeting Operational Policy. MULTIDISCIPLINARY CARE The breast multidisciplinary team (MDT) It is now widely accepted that breast care should be provided by breast specialists in each discipline and that multidisciplinary teams form the basis for best practice. The constituent members of the Breast Team are conveniently divided into two separate but inter-dependent groups. _ Diagnostic Team _ Cancer Treatment Team

2 Breast Diagnostic Team As most patients do not have breast malignancy, the role of the breast clinic is both to diagnose breast cancer and to treat and reassure patients with benign breast disorders. The key component members of this group are: _ Breast Specialist Lead Consultant Surgeon Mr J Harisha Breast Specialist Consultant Surgeon Mr JW Dawson Surgical Trainee Registrars Dedicated MDT Co-ordinator Mrs P Jones Breast Out - Patient Clinic Staff _ Specialist Breast Radiologist Lead Clinician Dr FLS Moss Specialist Breast Radiologist Imaging Plead Dr CR Pal Associate Specialist Breast Physician Dr J Wise Lead Radiographer - Mrs G Baxter Breast Screening Office Manager - Mrs D McNee _ Consultant Lead Breast Pathologist Dr J Nottingham Consultant Pathologist Dr A Molyneux _ Breast Care Nurses - Ms Sharon Ireson, Lead Breast Care Nurse. Ms Clare Tite, Lead Breast Care Nurse Ms Annie Jasper, Breast Care Nurse Ms Marion Hansell, Breast Care Nurse Breast Treatment Team. _ Consultant Clinical Oncologist - Mr Leon Houghton, Consultant Oncologist _ Consultant Clinical Oncologist - Dr Craig Macmillan, Consultant Oncologist Staff Grade Clinical Oncologist Dr J Inchley _ Plastic and Reconstructive Surgeon Mr N Vaingankar _ Medical Geneticist Mrs D (Oxford Ratcliff Trust) _ Data Manager _ Research Nurse - Mrs Tee _ Lymphoedema specialist - _ Medical Prosthetist _ Clinical Psychologist _ Palliative Care Team

3 Multidisciplinary team meetings Consultants and other team members within the breast unit must have contractual time for attendance at the multidisciplinary team meeting. The MDT meeting is by definition a fixed clinical commitment. For medical staff, this is counted as one half session or Programmed Activity (PA) (Target 1 PA). This reflects the time involved in preparation, the meeting itself and post-meeting administration. It is essential for trainees within breast surgery and its related disciplines to attend the MDT meeting. A record of attendance should be kept, and trainees should record attendance in their logbook. The conclusions of patient discussion should be recorded in the case notes. One Multi Disciplinary Meeting is held each week. Patients are discussed at up to 3 Stages in the management of care. a) Diagnostic This is where new cases are discussed. Discussion is considered for all cases where a needle biopsy has been carried out and the diagnosis is not clearly benign. The imaging and pathology (core biopsy / fine needle aspiration) results should be available. The correlation of results of triple assessment should be reviewed. All patients diagnosed with breast cancer should be discussed prior to instigation of therapy whether surgery, neo-adjuvant or primary medical therapy. Results of all required prognostic and predictive factors (including ER status and ideally HER2 status) should be available for this discussion. b) Treatment planning This is also known as the post-operative results MDT, whereby the pathology results of definitive treatment (usually surgery) are discussed and appropriate adjuvant treatment options decided. Results of all required prognostic and predictive Factors (ER, HER2) must be available for this discussion. c) Re-presentation This is where a previously treated patient re-presents with symptoms. A common instance of this might be the re-presentation of a patient with suspicious symptoms and a diagnosis of metastatic disease.

4 Diagnosis Wherever possible, a non-operative breast cancer diagnosis should be achieved by triple assessment, (clinical and radiological assessment followed by core biopsy and/or fine needle aspiration). Whilst core biopsy is preferable due to the additional information it can provide, there may be circumstances where only a fine needle aspiration is possible. A non-operative diagnosis should be possible in the vast majority of invasive breast cancers, with a minimum standard of achieving this in at least 90% of cases and a target of more than 95%. The majority of non-invasive breast cancers will be screen-detected and impalpable, making a non-operative diagnosis potentially more difficult. The minimum standard for non-operative diagnosis is at least 85% of cases for non-invasive cancers with a target of more than 90%. Diagnostic excisions Diagnostic excision biopsy is now relatively unusual, with the advent of triple assessment and also the increasing use of vacuum assisted biopsy for difficult cases. However, some breast lesions may still require diagnostic excision, if the core biopsy or FNA is not benign. Hence lesions graded as B3/4 or C3/4 may still need to be removed for definitive histology. Such lesions are more likely to emanate from the NHSBSP than the symptomatic clinic. To minimize patient anxiety, an operation for diagnostic purposes should be within two weeks of the decision to operate. For patients having surgical removal of a pathologically proven benign lesion the 18 week target waiting time will apply. All diagnostic biopsy specimens should be weighed. More than 90% of diagnostic biopsies for impalpable lesions, which subsequently prove to be benign should weigh less than 20 g in line with the current Quality Assurance Guidelines for Surgeons in Breast Cancer Screening. Any benign diagnostic resection specimen weighing more than 40 g will be discussed at the post operative MDT Meeting and any mitigating reasons recorded, and if a screening case, also discussed at the next Quality Assurance visit to that unit.

5 Treatment Planning and Communication These guidelines for the treatment of breast cancer have been formulated and agreed by the breast multidisciplinary team. The treatment of patients will usually follow these guidelines, although it is accepted that there may be reasonable exceptions. The reasons for not following guidelines will be discussed at the MDT meeting and documented. Following confirmation of a breast cancer diagnosis and appropriate MDT discussion to plan management, the results will be discussed with the patient. Patients will be encouraged to bring a partner or friend with them when the results are being discussed. The person conducting the consultation will be a member of the Breast MDT and the breast care nurse will usually be present. Consultations take place in an appropriate environment with adequate privacy. Follow up arrangements are made clear and the patient is given access to the breast care nurse and other relevant components of their care plan. Patients will be given adequate time, information and support in order to make a fully informed decision concerning their treatment. This will include discussion of suitable treatment options with the surgeon in liaison with the breast care nurse. The treatment options offered will have been agreed at a MDT meeting and the decisions agreed with the patient will be recorded. In the event of a patient refusing the recommended treatment options this will be recorded. Close communication will be maintained between surgeon and oncologist to plan primary treatment and to facilitate subsequent adjuvant therapy. A care plan for each patient will be drawn up and will take account of factors predictive of survival and of local or regional recurrence, the age and general health of the patient, the social circumstances and patient preferences. Treatment planning will allow adequate time for discussion of oncoplastic/reconstructive surgical options for those women who wish to consider it. Breast cancer at diagnosis is classified broadly into three clinical categories: (A) Operable Primary Breast Cancer The majority of breast cancer cases, presenting symptomatically or diagnosed through breast screening, will fall into this category. Surgery will usually be the first treatment. Neo - adjuvant endocrine treatment may be appropriate in some instances to downstage bulky disease to facilitate breast conserving surgery in post menopausal women with ER positive breast cancers. There is currently no consensus regarding the use of neo adjuvant chemotherapy in this circumstance. However the available data from randomised trials shows that breast conserving surgery after neo - adjuvant therapy is associated with a significantly increased risk of local recurrence. Where neo - adjuvant therapy is being considered the increased risk of local recurrence will be discussed. (The Oxford overview shows that the avoidance of local recurrence in the conserved breast prevents about one breast cancer death for every four such recurrences avoided).

6 (B) Locally advanced Primary Breast Cancer The management of locally advanced primary breast cancer will be multidisciplinary and will initially require a core biopsy and staging investigations. In some patients medical treatment, (hormonal/chemotherapy) and/or radiation therapy may be the most appropriate initial treatment. (C) Metastatic breast cancer Following the symptomatic presentation of distant metastases, average life expectancy is approximately 2 years, with virtually all patients eventually dying from breast cancer. The aim of treatment is to palliate symptoms and to maintain the highest possible quality of life. The management of patients with metastatic breast cancer should be multidisciplinary. Although the majority of patient care is likely to be delivered by oncologists and the palliative care team some surgeons with established experience in this field may continue to be involved in the multidisciplinary team. In addition all breast surgeons need to be involved with the local control of the disease. (D) Recurrent breast cancer A multidisciplinary approach is needed in the management of patients with recurrent breast cancer. All patients presenting with recurrent breast cancer will be restaged prior to definitive management. A significant proportion of patients presenting with local recurrence will have systemic relapse as well. Those patients with widespread disease should be managed by systemic therapy if possible. The management of recurrent breast cancer will be discussed further in these guidelines in the Oncological Sections.

7 Organisation of Breast Cancer Surgical Services Personnel Surgical treatment of patients with breast cancer will be carried out by surgeons with a special interest and training in breast disease. Each surgeon is involved in the NHS BSP and will maintain a surgical caseload of at least 10 screen-detected cancers per year, averaged over a three year period. Each surgeon can demonstrate an annual surgical workload of at least 30 treated breast cancers. Breast surgeons work in breast teams, which have the necessary expertise and facilities for a multidisciplinary approach. Waiting times for surgical treatment: When a decision has been reached to offer surgical treatment, patients will be offered a date for operation rather than be placed on a waiting list. Reconstruction procedures will require logistical planning but should not lead to unnecessary delay. All diagnostic and therapeutic operations are urgent. The NHS Cancer Plan states that patients should have a maximum wait of 31 days from decision to treat to first treatment. In 2002, this standard was extended to a maximum 62 days wait from urgent GP referral to first treatment. A similar 62 days wait target now applies to screen detected breast cancers, from December 2008, following publication of the Cancer Reform Strategy. Staffing levels must be appropriate to achieve this. The decision to treat is taken as the date on which the patient is informed by the treating clinician that they require treatment. As previously stated, an operation for diagnostic purposes should be carried out within two weeks of the decision to operate. By end - December 2009, all breast referrals will be seen within 2 weeks from GP referral. Cases will be managed, by routine, in a one-stop Clinic style with imaging and tissue sampling performed on the same day. Pre-operative investigations A pre-operative search for occult metastases by bone scan and liver ultrasound does not yield useful information in patients with operable primary breast cancer. These investigations will not normally be carried out unless the patient is symptomatic, taking part in a clinical trial or is recommended for neo-adjuvant therapy. A pre-operative chest x-ray is of limited value. The patient will have a full blood count, liver function tests and routine biochemistry and any abnormalities will be investigated appropriately.

8 Surgery for Invasive Breast Cancer Treat patients with early invasive breast cancer, irrespective of age, with surgery and appropriate systemic therapy, rather than endocrine therapy alone, unless significant co - morbidity precludes surgery (NICE CG80) Type of breast surgical procedure Long term follow up of randomised clinical trials have reported similar survival rates for women treated by mastectomy or breast conservation surgery.14e16 However all of these studies had selection criteria and indeed the vast majority of patients in these studies presented with tumours <2.5 cms. Accurate pre-operative assessment of the size and extent of the tumour is essential for deciding whether breast conservation surgery is an alternative option to mastectomy. Routine methods for assessing the extent of disease in the breast are clinical examination, mammography and ultrasound. In a significant number of cases the true extent of disease is underestimated, particularly with invasive lobular cancer. Selective use of magnetic resonance imaging (MRI) may be useful in planning surgical treatment and in particular if: there is a discrepancy between the clinical and radiological estimated extent of disease; if there is a dense breast pattern on mammography; or the diagnostic core biopsy suggests an invasive lobular cancer. (NICE CG 80) The decision to offer MRI will be discussed at the MDT meeting. Whilst many women may be suitable for breast conservation surgery, various factors (e g biological, patient choice) may lead to some women being advised or choosing to have a mastectomy for their disease. Wherever possible, patients should be offered an informed choice between breast conservation surgery and mastectomy. Patients choosing or advised to have mastectomy for invasive breast cancer should have the opportunity to discuss whether breast reconstruction is appropriate and feasible. The reasons for not offering choice and/or breast reconstruction to a patient should be documented in the patient s case notes.

9 Margins of excision Patients undergoing breast conservation surgery should routinely have malignant tumours excised with microscopically clear radial margins. Close margins at the chest wall (deep margin) or near the skin may be less important. Where breast tissue is to be moved at the time of surgery (e g oncoplastic techniques) particular consideration must be given to ensuring that further excision of involved margins can be easily carried out without a patient per se being committed to a mastectomy. There are no data to support a specific margin of excision. There are no randomised trials of margins of excision. While further occult foci of disease can be found more than 2 cm from the supposed margin in up to 43% of patients, the wider the margin the less occult foci are found. Whilst NICE have previously recommended a minimum margin of 2 mm, there are no data to substantiate this. Local Guidance in Northampton is to achieve a 2mm margin for invasive disease and a 5 mm margin for in situ disease Individual cases should be discussed at the treatment MDT meeting. If, after MDT meeting discussion, the margin of excision is deemed to be inadequate then further surgery to obtain clear margins should be recommended. Screen detected abnormalities Intra-operative specimen radiography is mandatory for impalpable lesions requiring radiological localization, and should be for all wide local excision procedures. Dedicated equipment (e g, digital specimen radiography cabinet) should be available so that a radiograph can be taken of the specimen and reported to or by the surgeon within 20 minutes. Interpretation of specimen radiographs must be clearly recorded. If this is done by the operating surgeon, the result must be confirmed by the radiologist at the subsequent multidisciplinary team meeting. If the radiologist reports the film at once, no more than 20 minutes should elapse before the reported film is received by the operating surgeon. If a specimen radiograph is performed, this should be available to the reporting pathologist. The surgeon should orientate and mark the specimen prior to delivery to the pathologist. The breast unit has a clear protocol for specimen orientation and the handling of pathological specimens. Histologically involved margins lead to an excessively high risk of local recurrence, even if adjuvant radiotherapy is given. Approximately one in four patients with later local recurrence will succumb to their disease, who otherwise would not have died of breast cancer if they had not developed a local recurrence.

10 Surgical Cavities Consistent and accurate localisation of the tumour resection bed after breast conservation is important if the full benefits of Intensity modulated radiotherapy (IMRT) and further radiotherapy advances are to be obtained. The marking of the tumour bed is especially important when oncoplastic techniques are used to improve the cosmetic outcome. The insertion of markers, such as surgical clips or gold seeds, in the tumour bed by the operating surgeon provides a way of visualising the tumour bed. Surgical clips will be placed at the margins of the tumour bed after breast conserving surgery. Patients will be entered in clinical trials, when possible, to allow assessment of new radiotherapy techniques (e g IMPORT LOW). Audit of local recurrence rates will be measured Target: Maximum of 5% at 5 years and a target of <3% at 5 years

11 Axillary Node Management in Invasive Breast Cancer The presence of axillary node metastases is the most powerful prognostic determinant in primary operable breast cancer and its assessment requires histological examination of excised axillary lymph nodes. Appropriate management of the axilla is also important in the prevention of uncontrolled axillary relapse. Axillary relapse is defined as relapse in the axilla itself. Some patients with invasive breast cancer may be diagnosed with axillary disease prior to definitive surgery. The use of pre-operative axillary assessment with ultrasound and appropriate fine needle aspiration (or core biopsy if feasible) can yield a diagnosis of involved nodes in some cases. Pre- treatment ultrasound evaluation of the axilla should be performed for all patients being investigated for early invasive breast cancer and, if morphologically abnormal lymph nodes are identified, ultrasound-guided needle sampling should be offered. (NICE CG80) If a positive non-operative diagnosis of axillary nodal metastasis is made in a patient with early breast cancer, that patient will normally proceed to an axillary clearance. In the last few years, sentinel node biopsy (SLNB) has become a standard approach for axillary staging. This technique provides accurate assessment of the axilla, with few false negatives and a significant reduction in surgical morbidity, especially lymphoedema. Breast surgeons have adopted the SLNB technique and taken part in the NEW START training programmes. The combined technique (blue dye and radio-isotope) is the recommended method used. Surgeons should be able to achieve minimum standards with a >90% sentinel node identification rates and <10% false negative rates over a minimum 30 case audit series. Minimal surgery, rather than lymph node clearance, should be performed to stage the axilla for patients with early invasive breast cancer and no evidence of lymph node involvement on ultrasound or a negative ultrasound-guided needle biopsy. SLNB is the preferred technique. (NICE CG 80) Where the sentinel node is positive (macrometastasis or micrometastasis), further axillary treatment (axillary dissection or radiotherapy) as well as adjuvant systemic therapy is recommended. However, the management of patients with positive sentinel nodes is currently under investigation. The EORTC-AMAROS trial compares axillary clearance versus radiotherapy. The ACOS-OG Z0011 trial compares axillary clearance versus observation only. These studies will not report for some time. The decision to carry out a completion (full) axillary clearance or to give axillary radiotherapy if the sentinel node is positive will be discussed at the MDT meeting and with the patient, be according to local guidelines, and be documented in the patient s case notes. The significance of isolated tumour cells in axillary lymph nodes is currently uncertain and these will be regarded as lymph node negative and routine axillary treatment will not be given.

12 ARTICLE IN PRESS The local standard procedures for assessment of the axilla are as follows. When mastectomy is chosen for excision of primary invasive malignancy, a Level 2 Clearance is performed. When mastectomy is performed for non-invasive disease, but high suspicion remains of invasive malignancy, 4 node sampling or similar dissection is performed. When breast conserving surgery for a pre-operatively node negative axilla is chosen, Sentinel Lymph Node Biopsy is performed. The technique used is to be that described in the New Start Program. When breast conserving surgery with a pre-operatively node positive axilla (clinically suspected or pathologically proven) is chosen, Level 2 clearance will be performed. Audit of pre-operative assessment of the axilla will be performed Standard: All patients selected for breast conserving surgery will have a pre-operative ultrasound scan. Audit of results of Sentinel Lymph Node biopsy will be performed to assess the preoperative false negative rate from ultrasound scan and FNA. Minimum standard >50% of node positive disease identified pre- operatively Audit of adequacy of axillary surgery will be performed. 1) Patients treated surgically for early invasive breast cancer should have an axillary staging procedure carried out if metastatic nodal metastasis is not confirmed non-operatively Minimum standard >90% Target 100% 2) When axillary node clearance is carried out, the level of anatomical dissection should be specified, and at least 10 nodes should be retrieved. Minimum standard >90% Target 100% 3) When axillary node sampling is carried out at least 4 nodes should be retrieved Minimum standard >90% Target 100% Audit of axillary recurrence rate will be performed. Minimum standard <5% axillary recurrence at 5 years Target <3% axillary recurrence at 5 years

13 Surgical management of ductal carcinoma in situ (DCIS) Ductal carcinoma in situ (DCIS) is a malignant precursor of invasive breast cancer. The aim of surgery is to achieve complete excision of the in situ tumour and to minimise local recurrence. The grade of the tumour and clear resection margins are important factors in the management of DCIS. Tumour multifocality is not uncommon and can lead to high local failure rates. Approximately 50% of local relapses after treatment for DCIS are invasive and not in situ. The indications for mastectomy are uncertain but extensive micro calcification on the pre-operative mammogram is a risk factor for local recurrence after conservation surgery. High recurrence rates occur with larger tumours (>40mm diameter) and mastectomy should be considered for such cases. While mammographic findings do not always correspond to pathological size the mammographic size is more commonly an underestimate of the final histological size. If mastectomy is being considered for the treatment of DCIS on the basis of multifocality, then, ideally, at least two areas of the breast should be biopsied to confirm this. There have been randomised trials of adjuvant radiotherapy after breast conservation for DCIS. In the EORTC study clear margins (>1 mm) were associated with a local recurrence rate of 15% at 5 years compared to 36% in patients with close or involved margins (<1 mm or frankly involved), regardless of the use of radiotherapy. Likewise, low grade DCIS is associated with a low risk of recurrence. Patients undergoing breast conserving surgery should routinely have the DCIS excised with microscopically clear radial margins. Close margins at the chest wall or near the skin may be less important. Intra-operative specimen radiography will be carried out for all cases of DCIS treated by breast conservation surgery, the vast majority of which will be impalpable lesions requiring radiological localization. Dedicated equipment (digital specimen radiography cabinet) will be available so that a radiograph can be taken of the specimen and reported to or by the surgeon within 20 minutes. Interpretation of specimen radiographs must be clearly recorded. If this is done by the operating surgeon, the result must be confirmed by the radiologist at the subsequent multidisciplinary team meeting. If the radiologist reports the film at once, no more than 20 minutes should elapse before the reported film is received by the operating surgeon. If a specimen radiograph is performed, this will be made available to the reporting pathologist. The surgeon will orientate and mark the specimen prior to delivery to the pathologist.

14 The local protocol for specimen orientation is to place the resected specimen on a Perspex plate with grid. The lead marker is placed in the top left hand corner as shown on the specimen radiograph. There are no data to support a specific margin of excision. Local guideline regarding acceptable margin width is a clear margin of 5mm. Individual cases will be discussed at the treatment MDT meeting. If, after MDT meeting discussion, the margin of excision is deemed to be inadequate then further surgery to obtain clear margins should be recommended. The local protocol for management of the axilla in cases of non-invasive disease. Lymph node staging is not normally required for patients with a non-operative diagnosis of DCIS alone. However, some patients may be at high risk of an occult invasive carcinoma being found at subsequent pathological examination. These would include patients undergoing surgery for an extensive area of microcalcification, a palpable mass, high grade disease or where micro-invasion or frank invasion is suspected on the non-operative biopsies. In such cases SNB or four node sampling may be considered. Axillary clearance is contra-indicated in the treatment of patients with a non-operative diagnosis of DCIS alone. The decision to carry out an axillary staging procedure will be discussed at the MDT meeting and with the patient, according to local guidelines, and will be documented in the patient s case notes. The management of screen detected non-invasive breast cancer (and atypical hyperplasias) is the subject of a national audit, the Sloane Project. The Northampton breast screening unit participates in this. Surgery for lobular in situ neoplasia Lobular in situ neoplasia, LISN, (formerly known as lobular carcinoma in situ or LCIS) is often an incidental finding and is usually occult. LISN may not be a local malignant precursor lesion, but it does confer an increased future risk, approximately seven-fold, of invasive breast cancer in both breasts. The risk of developing breast cancer is approximately 1% per year. It is suggested that breast lesions containing LISN should be excised for definitive diagnosis, as some patients may have a co-existing invasive malignancy. The limited data available on LISN suggests that clear resection margins are not required following surgery for LISN alone. A policy of close surveillance after excision biopsy is appropriate. The management of screen detected LISN is included in a national audit, the Sloane Project. The Northampton breast screening unit participates in this.

15 Breast Reconstruction All patients, in whom mastectomy is a treatment option, will have the opportunity to receive advice on breast reconstructive surgery. Not all patients will be physically fit for or wish to consider reconstruction. The breast unit has limited capacity for timely access to simple reconstruction procedures. Timely access for patients considering reconstruction is essential in order that they are not discouraged by the process. When local capacity is unavailable or expertise in complex reconstruction is limited, a recognised line of referral, to United Hospitals Leicester and City Hospital Nottingham, where there is particular expertise in breast reconstruction, is available. The Northampton Unit continues to audit local rates of breast reconstructive surgery And to pursue opportunities to improve Trust access to both simple and more complicated breast reconstruction procedures. Discuss immediate breast reconstruction with all patients who are being advised to have a mastectomy, and offer it except where significant co- morbidity or (the need for) adjuvant therapy may preclude this option. All appropriate breast reconstruction options should be offered and discussed with patients, irrespective of whether they are all available locally. (NICE CG80)

16 Peri and post operative care Peri-operative and follow up care Patients will be supported by a breast care nurse, who is a member of the breast team. They have established links with outpatient, ward and community nurses to assist in continuity of care. Following mastectomy (without immediate breast reconstruction), the fitting and supply of breast prostheses will be explained to patients. Patients will be informed about the range of services available to them and be provided with literature to include details of follow up treatment and local self help support groups. Communication with General Practitioners The breast team ensure that primary care practitioners (GPs) receive communications that give them a clear and rapid understanding of the diagnosis, care plan, and toxicity profile of any proposed treatment. It is the responsibility of clinical trialists to ensure that GPs are fully briefed about any trial for which the patient is entered and the potential side effects. Treatment multidisciplinary team meeting All patients with breast cancer have their cases discussed after definitive surgery in the post-operative results section of the MDT meeting. The post-operative pathology results include all required predictive and prognostic markers (ER, HER2) and must be available to allow adequate discussion. Decisions about the need for further surgical treatment and/or adjuvant treatments should be discussed and the decisions recorded in the patient s case notes. An Oncologist will be present for this section of the meeting.

17 Adjuvant Treatments Separate Local Protocols are available (Appendices) a) Radiotherapy Breast radiotherapy for invasive breast cancer Chest wall radiotherapy post mastectomy for invasive breast cancer Axillary radiotherapy for invasive breast cancer Breast irradiation for patients with ductal carcinoma in situ (DCIS) Axillary radiotherapy for patients with ductal carcinoma in situ (DCIS) b) Endocrine therapy All patients with ER positive invasive breast carcinoma can potentially benefit from hormonal therapy. Hormonal therapy reduces the hazard ratio of death from breast cancer by approximately 30%. This effect is independent of progesterone receptor status, patient age and concomitant chemotherapy use. A decision whether or not to use endocrine therapy should be based on an assessment of the absolute benefit and the risks or side effects of treatment. Treatment regimes are described in a local E Midlands Network protocol. Postmenopausal women with ER-positive early invasive breast cancer who are not considered to be at low risk should be offered an aromatase inhibitor, either anastrozole or letrozole, as their initial adjuvant therapy. Offer tamoxifen if an aromatase inhibitor is not tolerated or contraindicated. (NICE CG80) Current options for endocrine treatment include tamoxifen, aromatase inhibitors (anastrazole, exemestane, letrozole), progestogens, luteinising hormone releasing hormone (LHRH) analogues and oophorectomy by radiotherapy, laparoscopy or open surgery. The Early Breast Cancer Trialists Collaborative Group (EBCTCG) Oxford Overview shows that women with ER negative invasive tumours derive no benefit from hormonal therapy (Level 1 evidence). Endocrine treatment should not normally commence until the oestrogen receptor status has been determined.pr Bone monitoring, by dual energy x-ray absorptiometry (DEXA) scanning, is available for patients taking aromatase inhibitors, and offered according to national/local guidelines. (National Osteoporosis Society). Treatment for drug induced bone loss, such as calcium supplementation and bisphosphonates where necessary, is available. Patients with early invasive breast cancer should have a baseline dual energy X- ray absorptiometry (DEXA) scan to assess bone mineral density if they: are starting adjuvant aromatase inhibitor treatment have treatment-induced menopause are starting ovarian ablation/suppression therapy (NICE CG80)

18 c) Chemotherapy Adjuvant chemotherapy prolongs disease-free and overall survival in patients with early breast cancer, especially in premenopausal women with ER negative tumours. The efficacy of chemotherapy is greater in younger patients. Efficacy of chemotherapy is seen in both ER positive and negative breast cancer. However in ER positive disease treated by endocrine therapy the additional absolute benefit of chemotherapy will be calculated (Adjuvant online). This is particularly the case where the risk of recurrence is low, ER expression is high &/or the patient is of older age where they are competing causes of mortality. The newly documented adverse prognostic significance of HER2 positive disease will be taken into account when assessing the benefit of chemotherapy followed by traztuzumab therapy. d) Targeted therapy Traztuzumab (herceptin) is a monoclonal antibody to the HER2 receptor protein. In HER2 positive women, adjuvant traztuzumab (when combined with chemotherapy) approximately halves the risk of disease recurrence and death. HER2 testing is available for all new patients with invasive breast cancer; the test results must be available for discussion at the post operative results MDT meeting. Traztuzumab should be offered to all suitable patients according to NICE guidance Cardiac monitoring, both pre-treatment and during treatment should be available, as traztuzumab can lead to cardiac toxicity. ESS NICE Guidance CG80 states that early breast cancer patients having these treatments should start adjuvant chemotherapy or radiotherapy as soon as clinically possible within 31 days of completion of surgery. These activity targets will be audited and monitored.

19 Complications of Local Treatment and Menopausal Symptoms Lymphoedema All patients with early breast cancer are informed about the risk of developing lymphoedema and given relevant written information before treatment with surgery and radiotherapy. Advice is given on how to prevent infection or trauma that may cause or exacerbate lymphoedema to patients treated for early breast cancer. Patients with early breast cancer who develop lymphoedema have rapid access to a specialist lymphoedema service. Arm mobility The breast units should has written local guidelines agreed with the physiotherapy department for postoperative physiotherapy regimens. Breast cancer patients with pre-existing shoulder conditions are identified preoperatively as this may inform further decisions on treatment. Instructions are given, on functional exercises, which should start the day after surgery, to all breast cancer patients undergoing axillary surgery. This will include relevant written information from a member of the breast or physiotherapy team. Referrals to the physiotherapy department are made if patients report a persistent reduction in arm and shoulder mobility after breast cancer treatment. Menopausal symptoms Hormone replacement therapy (HRT) is discontinued in women who are diagnosed with breast cancer. HRT (including oestrogen/progestogen combination) is not offered routinely to women with menopausal symptoms and a history of breast cancer. HRT may, in exceptional cases, be offered to women with severe menopausal symptoms and with whom the associated risks have been discussed.

20 Clinical Follow Up Patients on continuing active treatment should be followed up until such treatment has been completed. Patients treated for breast cancer have an agreed, written care plan; Recorded by a named healthcare professional (or professionals), A copy sent to the GP A personal copy given to the patient. This plan should includes designated named healthcare professionals dates for review of any adjuvant therapy details of surveillance mammography signs and symptoms to look for and seek advice on. contact details for immediate referral to specialist care contact details for support services, for example support for patients with lymphoedema Patients with ER positive disease may need to be seen at planned intervals to discuss changes in therapy, the so called switch or extended therapy situations. Follow up should be stratified according to disease risk. Patients should be given information regarding their personal follow up programme (clinical and imaging). High risk patients may be followed up more closely with joint care by surgeons and oncologists according to agreed local protocols. Data about long-term follow up is essential in monitoring clinical outcomes locally, regionally and nationally. Data collection must be reliable and functioning. Nationally and locally, data collection in Breast Units is problematic. The Northampton Breast Unit relies on Manual and HES data for activity, quality assurance and audit in the symptomatic setting E Midlands Cancer Network has prioritised this area for improvement in care and development of robust quality assured service. The Northampton breast unit participates in ongoing national audits: The NHSBSP/ABS at BASO audits, the BCCOM audit and the Sloane Project. The nominated surgeon who is responsible for the accuracy of the data collected by the breast unit is Mr Since most recurrences occur in the first 5 years and the most commonly used benchmarks for outcome in breast cancer are the 5 year recurrence or survival rate, The Association of Breast Surgeons recommends that patients should be followed up for 5 years. In Northampton, clinical follow up continues for 2 years after surgery, in low risk cases and for 2 years after the completion of chemotherapy in higher risk disease. Patients in clinical trials continue to be followed up according to the trial protocol.

21 The ideal frequency for mammographic follow up is not established and current practice is variable. Current UK guidelines from the Royal College of Radiologists suggest routine mammography every 1 to 2 years for up to 10 years after diagnosis. Annual mammography should be performed for DCIS and Invasive disease until the patient commences NHS Breast Screening and for 5 years as a minimum when the patient has reached the age of eligibility for NHS breast screening. (NICE Guidance CG80) Mammography of the ipsi-lateral soft tissues IS NOT OFFERED after mastectomy Ultrasound and MRI are NOT OFFERED for routine post-treatment surveillance in patients who have been treated for early invasive breast cancer or DCIS. Mammographic follow up is arranged and administered through the Forrest Centre NHS Breast Screening Unit. If a GP detects a possible recurrence, the patient should be referred back to the breast unit. Mechanisms to facilitate this are made known to both GPs and patients. Patients diagnosed and treated for breast cancer will have ongoing requirements to meet their psychosocial needs, surveillance of ongoing treatment effects, monitoring of primary treatment morbidity and monitoring of recurrence rates.

22 Appendix 1 Local Rules Diagnostic Algorthms Women presenting with a Breast swelling Clinical examination and classification according to clinical suspicion (P value 1-5) 1 No pathology 2 Benign 3 Uncertain 4 Suspicious of malignancy 5 Clinically diagnostic of malignancy Mammography, ultrasound and histology results are also classified 1 5. Any clinical, radiological or histo- pathological value greater than 2 requires discussion at the breast MDM with a view to pursuing investigation until either a cancer is defined or an uncertain or suspicious finding is clearly explained and a malignant diagnosis refuted. (Responsibility: Relevant Specialist; Other Specialist, A/C Staff) Preferred method to obtain a histological diagnosis is Wide Bore Needle Biopsy (WBNB). Results are processed urgently and are available within three working days. Women over the age of 35 undergo mammography except when classified as P1 and without other symptoms. Women <35 undergo mammography following a histological diagnosis of malignancy. This provides a means of assessing the size of the tumour and assessing the contra-lateral breast. Women with no symptoms or signs of breast disease are not necessarily offered mammography. Women with other symptoms such as mastalgia, discharge, inflammatory changes and bleeding from the nipple will be offered mammography. Patients should be given an information leaflet on common benign breast conditions and access to a Breast Care Nurse if necessary.

23 CLINICO-RADIOLOGICAL INVESTIGATION PATHWAYS Women < 35 years of age Presentation Image Investigation Clinic/Imaging Investigation Clinic Follow up Pain (P1) Nil Nil Nil Lump (P1) Nil Nil Nil Resolved lump (P1) Nil Nil Nil Lump (P2) Ultrasound WBNB Results clinic Lump (P2) discrete Ultrasound Aspirate Cyst /core Results clinic Asymmetrical Ultrasound As per USS As per USS nodularity (P3) Lump (P3) Ultrasound WBNB Results Clinic Lump (P4) Mammogram WBNB Results Clinic Lump (P5) Mammogram WBNB Results Clinic Women > 35 years of age Presentation Image Investigation Clinic Investigation Clinic Follow up Lump (P1) Nil Nil Nil Pain (P1) Mammogram Nil Nil Lump (P2) discrete Mammogram Cyst asp/wbnb Results clinic Asymmetrical Mammogram& USS +/- WBNB Results clinic nodularity (P3) Lump (P3) Mammogram WBNB Results clinic Lump (P4) Mammogram WBNB Results clinic Lump (P5) Mammogram WBNB Results clinic Core biopsies should be performed AFTER mammography or ultrasound. Ultrasound scanning is performed as an adjunct to mammography when uncertainty remains about the presence or nature of a mass following mammography. This includes possible masses that may lie outside the field of view of a mammogram. In cases where the area of interest is of fatty density on mammography, NO further imaging is required. (Responsibility: Radiologist) Mammography is not performed within one year of a previous examination unless a clinical abnormality is present that is classified as R4/5. (Responsibility: Clinician, radiographer, A/C Staff)

24 To harmonize our classification of clinical and radiological data, the following annotation is used to describe diagnostic features: Clinical P1 Normal/blood stained discharge P2 Mobile mass with well-defined edge Nodularity (asymmetric) Thickening/glandular (asymmetric) P3 Mass with poorly defined edge P4 Irregular/Fixed P5 Malignant Radiological RI Fatty breast or mixed fatty and glandular density. R2 Glandular breast (dense) Mass with complete Well Defined margin Benign microcalcification R3 Mass with partly ill defined margin Lobulated mass Microcalcification of uncertain aetiology by appearance within mass Microcalcification which requires further imaging Possible PD Asymmetric density of uncertain cause. R4 Suspicious mass/mc Requires excision R5 Malignant mass or other feature. Requires excision Ultrasound U1 Normal breast U2 Normal breast/fibroadenosis causing diffuse changes in glandular tissue WD mass, smooth, homogeneous Simple cyst U3 WD mass, lobulated. Microcalcification. Focal acoustic shadowing, mixed echogenic mass. Complex cyst U4 Irregular edge/suspicious solid mass Complex cyst U5 Malignant mass or other feature

25 Protocol for management of benign swellings in women < 35 years (P2, P3)

26 Protocol for management of benign swellings women > 35 years (P2, P3)

27 Protocol for management of suspicious breast swellings (P4, P5)

28 Investigation of specific conditions Mastalgia Mammography is performed in the >35 age group. It is not offered to women <35. Discharge Discharge is checked to confirm that it does not contain blood. Mammography is performed in the >35 age group. It is not offered to women <35. Profuse or embarrassing discharge may require surgery. Consider hyperprolactinaemia. Discharge in male patients is a serious symptom, which requires further investigation. Cysts Aspirate, assess breast clinically and manage according to P value. Mammograms are performed in women >35. Rapidly recurrent cysts may require repeated aspiration and occasionally excision. Bleeding from the nipple Mammography is performed in the >35 age group. It is not offered to women <35. Uniduct discharge is treated with a microdochectomy, or subareolar resection if site of bleeding is not apparent at operation. Paget s disease of the nipple Diagnosis is made by incision biopsy of the lesion. Mammography is performed in >35. If normal, proceed to MRI to exclude occult lesion. MRI is investigation of choice in <35. Gynaecomastia Examination of testes. Serum Prolactin, HCG. Consider biopsy/mammogram if clinical diagnosis is uncertain.

29 Treatment Definitive cancer surgery is not undertaken without a definite histological diagnosis. Mastectomy is not performed on cytology alone but requires a core biopsy to confirm malignancy before surgery. All cases of proven malignancy are discussed preoperatively. SURGERY FOR OPERABLE BREAST CANCER Indications for Breast Conservation Surgery Solitary clinical and mammographic lesion (including lobular carcinoma). Tumour <40mm diameter Appropriate tumour/breast ratio considering site of tumour Central Wide excision may be appropriate for suitably sized centrally placed lesions Quadrantectomy may be appropriate if multifocality is clearly restricted to one quadrant Lobular carcinoma, when confirmed to be unifocal by MRI, if < 4cm in size Relative Indications for Mastectomy Patient choice Tumour diameter > 40mm Multifocality throughout the breast Relative size/site of tumour to make wide excision incompatible with clearance or satisfactory cosmetic result Centrally placed tumour. (Selected cases) Multifocal tumour of same histological type in more than one quadrant, or multifocality of more than one histological type Recurrent disease after conservation surgery Radiotherapy contraindicated (e.g. post Hodgkin s lymphoma, Pregnancy). Locally advanced breast cancer Locally advanced disease of the breast is characterized clinically by features suggesting infiltration of the skin or chest wall by tumour or extensively involved axillary nodes. Large operable breast cancers and tumours fixed to muscle should not be considered as locally advanced. Patients with locally advanced disease require:- Histological diagnosis ER status on core biopsy. Consideration of primary systemic therapy, which should be administered as part of a planned program of combined systemic and local treatment (i.e. radiotherapy +/- surgery).

30 Factors affecting choice of systemic treatment for locally advanced breast cancer Hormonal Treatment Slow growing or indolent disease Oestrogen receptor positive cancer Elderly or unfit patients Primary Medical Therapy for Operable Breast Cancer (see Neo - adjuvant Hormonal/Chemotherapy in guidelines for non-surgical treatment of breast cancer). Surgery for Operable Breast Cancer Symptomatic Disease - conservation surgery Primary tumour should be excised as a 'cylinder' of breast tissue from skin to deep fascia with macroscopic clearance of tumour. If this is in doubt macroscopically, a bed biopsy or excision of the margin in doubt should be taken. Specimens are marked with dye at the time of operation by the surgeon. The tradition used is that the following borders are marked thus: Green Blue Red Black Yellow deep superficial medial lateral inferior/special interest e.g. close to nipple or bed biopsy Symptomatic Disease mastectomy A modified radical mastectomy is performed with en bloc dissection of the axilla (level II clearance). Pectoralis muscles are preserved. The possibility of reconstructive surgery is discussed with all patients. Paget s disease In the absence of other pathology identified in the breast, patients are offered a central wide excision. Follow-up is for breast cancer. Male Breast cancer Treatment is similar to female breast cancer, though in practice this is likely to mastectomy and Axillary dissection. Tamoxifen for ER +ve tumours and adjuvant chemo/radiotherapy as per protocol.

31 Follow-up of Breast cancer patients We offer clinical follow-up for two years following cessation of treatment. This is combined with the oncologist if they have been involved with the patients care. Mammography is annually for breast conservation patients and for mastectomy patients, until they reach screening age and for a minimum of five years. All patients should be advised of their follow up plan and receive a written information leaflet at their 2 week post operative Results Clinic visit. Following treatment of the primary tumour patients should have easy access to the Breast Team and should be given written instructions on how to arrange interval clinic appointments, e.g. via Breast Care Nurse, Breast Service Coordinator, GP. Patients will be discharged from clinical follow up at 2 years following cessation of treatment but will continue to be automatically recalled for surveillance mammography. Those following more complex adjuvant treatment regimes may be followed up for a longer period as will those taking part in clinical trials Clinical examination of asymptomatic follow up patients will be restricted to breasts/chest wall and nodal fields. Investigations, other than mammography, done on a symptomatic basis only. Patients with suspected/confirmed local recurrence should be discussed at the next MDM and seen in the next surgical clinic. Patients with suspected/confirmed metastatic disease should be discussed at the next MDM and will be referred to the oncology clinic Summary of Clinical Follow-up SURGERY only CLINIC 2 weeks (post -op) Results clinic 6 months Breast clinic 12 months Breast clinic 24 months Breast clinic (Discharge) SURGERY & ONCOLOGY CLINIC 2 weeks (post -op) Results clinic 6 months Oncology 12 months Breast clinic 18 months Oncology 24 months Breast clinic 36 months Breast clinic (Discharge)

32 Appendix 2 Northamptonshire Centre for Oncology Treatment guidelines for non-surgical management of breast cancer Staging Investigations Full blood count and liver function tests. Further investigations e.g. Chest X-ray, bone scan and liver ultrasound at the discretion of the Oncologist once the patient has been assessed. Others e.g. CT Scan when required on the basis of symptoms, prognostic factors of treatment planning. Surgery The treatment of the primary tumour will be at the discretion of the Surgeon in consultation withthe patient. The precise mode of surgery will have been considered in the Breast Multidisciplinary Meeting and consideration may also have been given, for example to neo - adjuvant chemotherapy. The treatment of the axilla should be clearly defined in the operation note. Sentinel Lymph node biopsy, axillary clearance or axillary sampling may have been performed. Clearance should yield at least 10 nodes and sampling should include at least four lymph nodes. Pathology Pathological details of the tumour will include a Minimum Data set and include tumour size and grading, completeness of excision and indicate any particular adverse feature, e.g. vascular and lymphatic invasion. Specific types of tumour will be identified (e g lobular carcinoma). Hormone receptor status should be available on all patients. Oestrogen receptor status only is required. HER2 neu receptors status should be measured on all patients at the time of primary tumour diagnosis. Nottingham Prognostic Index will also be included Relapsed patients who are candidates for Trastuzimab will require measurement of HER2 neu status when this has not previously been assessed.

33 Systemic Treatment Adjuvant Chemotherapy Patients can be divided according to age and risk factors. The benefit of adjuvant chemotherapyin post-menopausal patients is increasingly appreciated making the traditional classification ofpatients pre-menopausal or post-menopausal less crucial. The benefit of adjuvant chemotherapydecreases with increasing age and this will be taken into account. It is anticipated that adjuvantchemotherapy would not normally be offered to patients over the age of 70. Where possible, patients should be offered participation in clinical trials. Risk Factors requiring consideration of the need To Offer Chemotherapy 1. Positive lymph nodes 2. Grade 2 and 3 histology 3. Tumour size greater than or equal to 2 cm 4. HER 2 positivity It is recognized that for those patients with tumours of between 1 and 2 cm size and the Primary tumours less than 1 cm size, which are not grade 3, benefit from chemotherapy is marginal. These patients would not normally be treated with chemotherapy. The standard chemotherapy will be four cycles of Epirubicin followed by four cycles of classic CMF chemotherapy. Neoadjuvant Chemotherapy These patients will be normally under the age of 65 years, but selected patients over this age should be considered at the discretion of patient and Oncologist. Normally they will have been discussed prior to seeing the Oncologist in the Breast Multidisciplinary Meeting. The aims of treatment are: 1. To downstage a tumour currently unsuitable for conservative treatment to one that is suitable for conservative treatment. 2. To downstage disease inoperable at presentation to disease that can be considered for surgery, patients in this category would normally require mastectomy. Staging investigations as mentioned before. If a clinical study is available patients should be offered participation in this. Otherwise they will receive four cycles of Epirubicin followed by four cycles of CMF. Definitive local treatment will be considered following Epirubicin and will consist of surgery, radiotherapy or both. In patients with hormone receptor positive disease, an alternative would be hormone manipulation, if the disease is felt not to be rapidly progressive.

34 Adjuvant Radiotherapy For patients treated with breast conservation surgery, radiotherapy to the breast would normally include the lower axilla in the tangential glancing fields. Radiation therapy to the supraclavicular fossa should be considered in patients with heavy axillary lymph node involvement, e.g. four or more involved nodes, involvement of the apical node or extranodal spread of tumour. For patients treated with mastectomy Post operative adjuvant radiotherapy to the chest wall is recommended to those patients with anyof the following five characteristics:- 1. Lymph node involvement 2. Primary tumour greater than or equal to 3 cm size 3. Narrow deep margin of excision (less than 0.5 cm) 4. Evidence of vascular spread 5. Grade 3 histology Radiation therapy to the supraclavicular fossa should be considered in patients with heavy axillary lymph node infestation, e.g. four or more nodes involved, involvement of the apical node, or extranodal spread of tumour. Ductal Carcinoma-In-Situ Radiotherapy should be considered for those patients with high grade, completely excised ductal carcinoma-in-situ who have had conservative surgery. Patients With Advanced Disease And Those Relapsing With Advanced Disease The age of the patient, their performance status and any prior treatment will be taken into account in recommendations.

35 Northamptonshire Centre For Oncology 2009 PROTOCOL FOR THE NON-SURGICAL MANAGEMENT OF BREAST CANCER 1) Staging Investigations Full blood count and liver function tests will be performed on all patients. Abnormalities will be further investigated. Chest X Ray is of limited value and its value will be assessed on a n individual patient basis. Further investigations e.g. bone scan and liver ultrasound at the discretion of the Oncologist once the patient has been assessed, for which patient factors such as unexplained symptoms, prognostic factors and proposed treatment will be taken into consideration. 2) SURGERY The treatment of the primary tumour will be at the discretion of the Surgeon in consultation with the patient. The precise mode of surgery will have been considered in the Breast Multidisciplinary Meeting and consideration may also have been given, for example to neo - adjuvant chemotherapy. The treatment of the axilla should be clearly defined in the operation note and axillary sampling should include at least six lymph nodes. It is highly desirable that clips are placed in the intact breast by the surgeon to mark the tumour bed margins, and also the upper limit of axilla dissection. These markers will aid radiotherapy planning and boost marking.

36 Appendix 3 NOTTINGHAM BREAST PROGNOSTIC INDEX This is: Grade + stage + (0.2 x size of tumour in cms). (Grade = 1-3) Stage N0-1 = axilla negative N1-2 = axilla low N2-3 = axilla high Prognostic Groups: a) Very good prognostic group T1 G1 N0 Score less than 2.4 b) Good prognostic group T1 G2 N0 Score c) Intermediate prognostic group T2 N0 G2 Score T2 N2 G1 d) Poor prognostic group Score e) Very poor prognostic group Score greater than 5.4 T2 N2 G1 T2 N1 G2 T1 N1 G3 T2 N1 G3

37 ADJUVANT SYSTEMIC TREATMENT SUMMARY OF BENEFITS Breast Cancer 10 year Survival

38 Appendix 4 Screening Assessment Management of Breast Screening Cases The Guidelines for Assessment produced by the NHS Breast Screening Programme should be followed. Clinical examination of the breasts is required for all women on whom tissue sampling is to be performed. Women assessed for micro-calcification should be imaged using magnification views performed in lateral and cranio-caudal projection. Ultrasound examination should be performed in those cases where there is a higher likelihood of an invasive component being present. This includes those with comedotype morphology and those with a larger number of calcifications present (>40). Guided biopsy of any mass identified in the area of micro-calcification is advisable. Digital Stereotactic biopsy is performed by screening radiographers trained in the technique to the level of Advanced Practitioner. Regular Audit of the rate of positive diagnosis of in situ and invasive malignancy is performed. Vacuum-assisted (Mammotome) biopsy offers an opportunity for accurate diagnosis of DCIS and, particularly, for the pre-operative detection of areas of invasive disease associated with it. Specimen radiographs are be performed and the presence of micro-calcification confirmed before adequacy of sampling is verified. Multi-focal calcification requires a particularly vigilant approach. The need for tissue sampling from several sites may be necessary before accurate pre-operative management decisions can be made.

39 Multi-Disciplinary Meetings Treatment Planning All cases of DCIS must be discussed at both the pre and post operative stages of management. Surgical management represents the prime treatment option and should be planned so as to ensure accurate identification of disease and promote excision with an adequate margin of normal tissue. Pre-operative Planning. Wide local excision and mastectomy are equally valid surgical procedures depending on the site and extent of disease, the presence or absence of associated invasive carcinoma, the size of the breast and on patient preference. Stereotactic Wire Localisation procedures should be discussed and planned when wide local excision is the likely preferred option for treatment. The number of wires to be introduced should be considered in terms of unifocality or multifocal disease and the diameter of the area of radiographic abnormality present. The need for further tissue sampling should be considered when a decision is made to recommend mastectomy, considering the possibility that benign and malignant microcalcification may co-exist. Examples include the presence of micro-calcification is non-contiguous quadrants, in multi-focal disease and in cases where differing morphology of micro-calcification is present in the same breast. Post-operative review This should include assessment of extent of disease, grade of DCIS, the presence of an invasive component, and adequacy of margins of excision. Correlation of radiographic findings with the extent of disease present pathologically is mandatory. The diameter considered as indicative of an adequate excision margin is controversial. Pathologically, measurement of disease free margin is an imprecise science, requiring a 2 Dimensional approach to a 3 Dimensional entity. Flexibility in the value chosen by different Units is acceptable in the range from 2 to 5 mm. Re-excision or mastectomy is required below these levels. Histopathology Reports should include the extent of disease present, the grade and details of disease free margins. The presence or absence of calcification should be stated. Reports should include the oestrogen status of DCIS

40 Radiotherapy Radiotherapy reduces the rate of recurrence from DCIS in some cases. Where Histology shows high-grade morphology radiotherapy should be offered routinely. Where disease is extensive, there may also be a benefit making it appropriate for Radiotherapy to be offered as an optional adjunct to surgery. Hormonal Therapy The place for hormonal therapy in treatment remains uncertain. Conflicting conclusions have resulted from recent Trials and consensus has not yet been achieved. The entry of patients into Trials is recommended (e.g. IBIS 2 DCIS arm) rather than there being variation between Units in the use of hormone therapy NICE CG80 DOES NOT recommend the use of hormonal therapy in DCIS. Surgical Management Units performing wide local excision for DCIS should be undertaking these operations on a regular basis throughout the year. Localisation and wide local excision Staff involved in the NHS-Breast Screening Programme must perform localisation procedures. Reports on these procedures must be available to the surgeon at the time of the operation. Surgical specimens must be imaged during the operative procedure to confirm the removal of relevant tissue containing microcalcification. It is desirable for digital imaging facilities to be available. This offers improved diagnostic quality images and facilitates transmission of images to the Operating Suite. This will reduce operating times, improve the accuracy of surgery, reducing the numbers of cases showing incomplete excision leading to repeated surgical procedures. Reports on specimen radiographs should be available. Screening staff should provide these or surgeons should have the expertise to assess the adequacy of excision from review of specimen radiographs. Axillary Lymph node sampling is not required as a routine feature of the surgical management of DCIS alone Mastectomy Mastectomy may be performed for extensive DCIS, for multi-focal disease or in cases where women have chosen this option after informed consent. Axillary Lymph node sampling is not required routinely but may be considered prudent in cases thought likely to contain an invasive focus that has not diagnosed pre-operatively.

41 Follow-up Cases of DCIS require careful follow-up because of the incidence of local recurrence of both in situ and invasive disease and because of the higher risk of development of contra-lateral disease. Clinical Examination is required for a limited period of 2 to 3 years only. Annual mammography using 2 views should be performed for a minimum of 5 years for patients treated by wide local excision. Annual mammography should be performed of the contra-lateral breast following mastectomy. In each case imaging follow up should continue until the woman reaches the age for automatic invitation to the NHS Breast Screening Programme. Audit The management of microcalcification and of DCIS is subject to change, as new information becomes available. Regular audit of a range of process and outcome measures is required to provide information upon which to assess critically the quality of care provided. FLS MOSS Lead Clinician May 2009

42 Appendix 5 HORMONE REPLACEMENT THERAPY (HRT) AND BREAST CANCER BENEFITS of HRT In the UK, HRT preparations are licensed to help relieve some of the symptoms of the menopause (whether natural or as a result of removal of the ovaries) including: Hot flushes Night Sweats Vaginal dryness/irritation Difficulty sleeping Depression Mood swings Tiredness Poor concentration Some HRT preparations are licensed for longer-term use to help prevent osteoporosis (thinning of the bones) which can be associated with an increased risk of fractures. HRT also appears to reduce the risks of colorectal cancer (cancer of the lower part of the bowel) RISKS of HRT While many women suffer no side effects from taking HRT, some may experience nausea, breast tenderness, weight gain and fluid retention. Some of the more serious side effects are considered below. These should be kept in perspective since the risk of these conditions is probably smaller than for smoking or being very overweight. HRT and Breast Cancer The increased risk of breast cancer may be apparent within 1-2 years of starting HRT. This risk will start to decline after stopping HRT and has disappeared after 5 years, leaving the level of risk of breast cancer the same as if HRT had never been taken. Oestrogen-only HRT preparations Women taking this type of HRT have a small increased risk of breast cancer. In a population of women aged 50 years, who do not take HRT, by the age of 65, thirtytwo women per 1000 will develop a breast cancer. In a similar population of women aged 50 who take oestrogen-only HRT for 5 years, 1-2 additional cancers will develop(33-34 cancers per 1000), and by 10 years 5 extra cancers will develop (37 per 1000).

43 Combined HRT preparations (oestrogen and a progestogen) Combined HRT includes preparations where the progestogen is taken every day (continuous) or for days each month (sequential). These women have approximately 4x the risk of developing breast cancer compared to oestrogen-only preparations. After 5 years of HRT in a population of women over 50, six extra cancers will develop per 1000 (38 cancers per 1000) and by 10 years, 19 extra cancer will develop (51 cancers per 1000). Tibilone (Livial) There is an increased breast cancer risk, greater than for oestrogen-only but lower than that for combined HRT preparations. HRT and Ovarian Cancer Evidence exists that if women with intact ovaries take oestrogen-only HRT for more than 5 years there is a increased risk of developing ovarian cancer. This risk increases the longer the duration of taking HRT, especially over 10 years. Combined HRT short-term use does not increase the risk, however the risk for longterm use remains unclear. Uterine Cancer and HRT Endometrial cancer or cancer of the lining of the uterus (womb) is known to occur in women, with an intact uterus, who take oestrogen-only HRT, which stimulates abnormal growth of the endometrium. This risk is significantly reduced by the addition of a progestogen (combined HRT). HRT and Coronary Heart Disease (CHD) HRT has been shown, in some studies, to have a favourable effect on the levels of fats (lipids) in the blood. HRT has not been show to prevent CHD. Some preparations of combined HRT (conjugated oestrogens &/medroxprogesterone) may slightly increase the risk of CHD, especially in the first year of treatment. HRT should not be taken to try to prevent CHD. HRT and Stroke For women in their 50s, the normal risk of developing a stroke is 3 per 1000 in any 5 year period. For those taking HRT for 5 years, the risk increase to 4 per 1000 (1 extra stroke). After the age of 60 the risk without HRT rises to 11 per 1000, but with 5 years of HRT, 15 per 1000 women will develop a stroke (4 extra strokes). HRT and Blood Clots (Venous Thromboembolism or VTE) The risk of VTE is increased with the use of HRT. Three per 1000 women in their 50s, not taking HRT, in any 5 year period, will develop VTE. In a similar period 7 per 1000 women on HRT will develop VTE. In their 60s, for a similar period, not taking HRT the risk is 8 per 1000, and with HRT rises to 17 per

44 HRT in Women with Breast Cancer or who have previously had Breast Cancer Present advice for women in this category is that they should not take HRT. (NICE CG80 February 2009) Many women with breast cancer experience a worsening of menopausal symptoms as a result of the effects of some treatments, e.g. Tamoxifen or Chemotherapy. If you are experiencing such problems your GP may be able to advise you on alternatives to HRT. Trials in patients with a diagnosis of breast cancer are ongoing; if you would like to be considered for such a trial please ask one of the breast team. Should women take HRT or not? The ultimate decision whether or not to take HRT is an individual one between yourself and your GP. Short-term use of HRT, perhaps for 3-6 months, to relieve menopausal symptoms may be acceptable, so long as you have weighed-up the benefits and risks. Longer usage of oestrogen-only preparations (in women without a uterus)carries a small increase risk of breast cancer. Current evidence now suggests that combined HRT taken for more than a short period may substantially increase a woman s chances of developing breast cancer. References: Risks and benefits of oestrogen in healthy postmenopausal women. JAMA 2002; 288: Menopausal Replacement Therapy and Risk of Ovarian Cancer. JAMA 2002; 288: Breast Cancer and Hormone Replacement Therapy in the Million Women Study. Lancet 2003; 362: Hormone Replacement Therapy: Latest Update (7 th August 2003). Medicines and Healthcare products & Committee on Safety of Medicines.

45 Appendix 6 Breast Cancer Imaging Policy Breast Conservation Annual Mammography in years 1 5. Annual Mammography in years 6-9 and subsequently until the age of 50 years. Automatic Invitation to NHS Breast Screening at the age of years or at the completion of symptomatic mammographic follow up. Self referral to NHS BSP for women over 73 years when symptomatic mammographic follow up completed. Mastectomy Contra lateral breast mammography in years 1-5 Contra lateral breast mammography in years 6-8 and subsequently until the age of 50 years. Automatic invitation to NHS Breast Screening at the age of years or at the completion of symptomatic mammographic follow up. Self referral to NHS BSP for women over 73 years when symptomatic mammographic follow up completed. Surveillance is administered by the Forrest Centre Breast Screening Unit. Administration The clinician performing clinical follow up completes a surveillance form details the date of diagnosis, features of the tumour, type of surgery performed together with radiotherapy. Recall is arranged and imaging read by a Consultant Radiologist involved in the NHS Breast Screening Programme. Reports are typed on the Radiology Department Information System (CRIS) A copy is posted to the appropriate surgical Secretary. A letter is sent to the patient detailing the result and any further investigations required.

46 The Organisation of Imaging Follow-Up for Breast Cancer Surveillance. The Breast Screening Office will arrange SYMPTOMATIC FOLLOW-UP upon receipt of a completed pro-forma from Breast Symptomatic Service Surgical Clinicians. The pro-forma allows annotation of the details of disease and the treatment given. On the reverse, a matrix is provided to allow records of imaging events to be made. The study is recorded using RIS dataset including the name, D of B, PAS Number, Event and Accession number together with the date and type of examination. The Reporting Radiologist will annotate the matrix after each event reported. This will detail any additional examinations required and the date of the next routine follow-up examination to be performed. When follow-up is completed, The Radiologist/Associate Specialist will record that surveillance has been completed. FLS MOSS Revision May 2009

47 Appendix 7 The Royal College of Radiologist Guidance on Screening and Symptomatic Breast Imaging (Second Edition) Imaging in the Management of Breast Disease The management of symptomatic breast disease requires a combination of clinical and diagnostic examinations called triple assessment. 1) Specialist clinical examination of the Breast 2) Imaging this will necessitate either mammography, ultrasound or combined examination depending on the clinical classification of the abnormality on palpation and the age of the patient 3) Tissue Sampling usually core biopsy is used for diagnosis, but aspiration may be provided for cysts and small or difficult lesions. The use of mammography alone as a diagnostic tool, outside the field of screening is not recommended. : Organisation of Breast Imaging Services 1. Symptomatic breast imaging services Diagnosis of breast disease should occur in a multidisciplinary setting using the principles of triple assessment (clinical assessment, imaging and needle cytology/histology) This is best achieved in designated specialist breast clinics in which both radiologists and surgeons work closely together Direct access from GPs for breast imaging alone is not recommended. The background to this recommendation is the Guideline on case-mix appropriate for management in General Practice: 1.1 Background The majority of women presenting with symptomatic breast disease first consult with their general practitioner (GP). Most of these women can be managed, at least initially, by their GP and guidelines regarding those patients who should be referred for specialist opinion have been published by the National Health Service Breast Screening Programme (NHSBSP) and The Royal College of Radiologists (RCR).1,2 The resultant guidelines, which are briefly summarised below, are not intended to be a definitive statement on how breast disorders should be managed in primary care. They are intended to aid discussions when drawing up locally produced guidelines. It is essential that GPs are involved in this process.

48 1.1.1 Women who can be managed at least initially by their GP: young women with tender, lumpy breasts and older women with symmetrical nodularity provided that they have no localised abnormality; women with minor and moderate degrees of breast pain who do not have a discrete palpable lesion; women under the age of 50 years who have nipple discharge that is from more than one duct or is intermittent and is neither bloodstained nor troublesome Guidelines It is important that Specialist Clinical Services should be provided in a timely way and that access should be optimised for likely sinister diagnoses. This requires appropriate referrals in urgent and non-urgent groups and provision of adequate capacity for symptomatic services. Patients with symptomatic breast disease who have conditions that require referral, who may or may not require imaging, should be referred to a multidisciplinary Specialist Breast Clinic. Imaging of symptomatic disease, which requires specialist referral, should only be performed as a part of triple assessment (clinical examination, imaging and needle biopsy [fine needle or core biopsy]). Mammography is the initial imaging modality of choice in symptomatic patients over 35 years of age. Ultrasound is the imaging modality of choice in symptomatic patients under 35 years of age. Mammography is NOT recommended unless there is a high clinical or ultrasound suspicion of breast cancer. Asymptomatic women of 50 years of age or over should participate in the NHSBSP. Asymptomatic women under 50 years of age at high risk of developing breast cancers (e.g. with a strong family history) should have their risks determined in a Specialist Breast Clinic before either annual or biennial mammographic screening is performed following agreed protocols. Asymptomatic women under 50 years of age receiving hormone replacement therapy (HRT) for more than five years have only a small increased risk of breast cancer and routine mammographic screening is not recommended for this reason alone. Base-line mammography prior to commencing HRT is not recommended. Radiologists involved in breast imaging (both NHS screening and symptomatic) should have agreed professional standards and training. Equipment used in breast imaging should satisfy the technical and quality requirements laid down by the NHSBSP. Grade of recommendation C B B B A C B C C C FLS MOSS Lead Clinician for Breast Cancer Northampton General Hospital. February 2005 (Reviewed May 2009)

49 Appendix 8 East Midlands Cancer Network Guideline Adjuvant Endocrine Therapy for Early Invasive Breast Cancer Post surgery adjuvant endocrine therapy should be considered for and discussed with all patients with ER positive early invasive breast cancer. These East Midlands Cancer Network Guidelines are based on the recommendations of NICE Clinical Guideline 80 Early and locally advanced breast cancer: diagnosis and treatment. Decisions should be based on the assessment of prognostic and predictive factors, the potential benefits and side effects of the treatment. Decisions to offer endocrine therapy should be discussed at the Multidisciplinary Meeting and recorded, prior to discussion of these factors with the patient. Low-risk patients can be identified using the Nottingham Prognostic Index (excellent or good prognostic groups, NPI <3.4), but additional prognostic factors, such as HER2 status and vascular invasion, may be taken into account at MDT discussion. Initial treatment for ER positive patients by risk group and menopausal status Pre-menopausal Low risk: Higher risk: Post-menopausal Low risk: Higher risk: Consider tamoxifen 20mg od for 5 years Tamoxifen 20mg od for 5 years Women offered chemotherapy, but who have chosen not to have it should be offered ovarian ablation / suppression in addition to tamoxifen. This should not routinely be offered to those treated with chemotherapy. Consider tamoxifen 20mg od for 5 years Aromatase inhibitor for 5 years (either anastrazole or letrozole) Patients at higher risk who have initially been treated with tamoxifen for 2-3 years, should be offered to switch to an aromatase inhibitor (either exemestane or anastrazole) for a total of 5 years endocrine therapy Patients at higher risk who have been treated with tamoxifen for 5 years should be offered additional treatment with an aromatase inhibitor (letrozole) for 2-3 years Aromatase inhibitors (anastrozole, exemestane, letrozole) should be prescribed according to their licensed indications; the relevant drugs are listed according to their current licensed indications in these guidelines.

50 Evaluation, monitoring and treatment of bone loss in early breast cancer in relation to aromatase inhibitor treatment in post menopausal women Patients with early invasive breast cancer should have a baseline dual energy X-ray absorptiometry (DXA) to assess bone mineral density (BMD) if they are starting 5 years of adjuvant aromatase inhibitor treatment. BMD assessments should be done at the lumbar spine and at one or both hip sites. There is no requirement to obtain a DXA before starting treatment, but a baseline assessment should be obtained within 3 months of commencing an aromatase inhibitor. Monitoring and treatment thereafter depends on: Baseline BMD age the presence of major clinical risk factors for osteoporotic fracture Clinical risk factors for osteoporotic fracture: Previous fragility fracture above age of 50 years; parental history of fracture; a body mass index of < 22; alcohol consumption of 4 or more units per day; diseases known to increase fracture risk such as premature menopause, rheumatoid arthritis, ankylosing spondylitis, immobility and Crohn s disease; prior corticosteroid use for more than 6 months. Subsequent management of women, including bisphosphonate treatment where indicated, should be according to the algorithms taken from Guidance for the management of breast cancer treatment-induced bone loss: A consensus position statement from a UK expert group (2008) that are reproduced as Appendix 2 in NICE Clinical Guideline 80. For women over the age of 75 years with one or more major risk factors, bone protection therapy with a bisphosphonate is recommended irrespective of baseline BMD. Mr Mark Sibbering (Derby Burton) Prof John Robertson (Mid-Trent) Dr Leigh Moss (Leicestershire, Northamptonshire & Rutland)

51 Appendix 9 Near Patient Testing Protocol Ultrasound Scanning Symptomatic Breast Unit Northampton General Hospital Introduction Triple Assessment is the accepted best method for the confirmation and exclusion of malignancy in breast disease. Radiologists have performed the Imaging component of the assessment, traditionally. Modern Practice accents the need to make accessible to other staff groups the ability to contribute to diagnostic testing. This should be based on competence, not professional background. Skill mix initiatives have led to the use of Ultrasound scanning by surgeons and radiographers. This should be encouraged, whilst ensuring that quality standards are maintained. This Document addresses the issues surrounding competence and audit in this setting. Quality Measures The issues to be addressed, when providing methods of quality assurance of Ultrasound of the Breast are described. 1) Training The imager should undertake a Royal College or University approved Course of training. The Unit should approve this. It should include an appropriate list of competences that should be learned. Success in achieving Competence should be reflected in a Final Document made available to the Unit. Clinical services should be supervised in the period prior to attainment of the Final Qualification. 2) Protocol for Use of Ultrasound in the Unit setting. This should be agreed between the members of the Diagnostic Team and reflect the Competences learned during the skill mix training process. This Document addresses these issues. 3) Quality of Equipment. The ability of the test to provide results with appropriate specificity and sensitivity depends on the specification of the equipment used as well as the skill of the operator. National Breast Screening Standards indicate the need to use modern high specification equipment that is serviced regularly when assessing the presence or absence of malignancy. The probe range should be of high frequency > 10 MHZ. Frequency ranges below this are appropriate for the diagnosis of cysts and for image guided cyst aspiration only.

52 A programme of Servicing or agreed date of obsolescence should be agreed by the Unit. The Equipment should be included in the Capital Equipment Log for the Unit. 4) Results recording Formal records of individual patient results should be created and be available in the patient record. In the Northampton Unit, it is acceptable for this to be appended to the CRIS (Radiology Information System) as part of the report provided for other examinations forming part of the Imaging Assessment. The name of the operator should be included in this record. When no other Imaging has been performed, the result should be recorded separately in the patient record. This should include a classification of the findings (U1 5) and the name of the Imager. 5) Audit Regular Audit should be performed to ensure that standards are maintained at Unit level. This should be presented to The Breast MDT Meeting at agreed intervals. This should include monitoring of success rates for cyst aspiration and biopsy/excisions Scope of Examinations 1) Confirmation of Cystic Nature of Breast Masses. 2) Identification of masses in preparation for and in the process of performing Ultrasound Guided Biopsies and excisions. (Vacuum-assisted) 3) Specifically Excluded are the following: a) Exclusion of the presence of malignancy. This requires top-of-the range equipment as described in RCR Documentation. b) Pre- treatment assessment of malignant masses including size, multifocality and axillary involvement. Conclusion Ultrasound of the breast is employed, with increased frequency, in diagnosis and treatment of breast disease. The Unit will ensure that this is made available widely and appropriately in a variety of patient settings. Measures are described to ensure the maintenance of high standards of diagnosis and treatment. DOCUMENT CREATED BY Dr FLS MOSS Lead Clinician for Breast Cancer Northampton General Hospital NHS Trust. Approved July 2007 Reviewed May 2009

53 Appendix 10 PROTOCOL FOR RADIOGRAPHER PERFORMED WIRE STEREOTACTIC LOCALISATION OF BREAST Forrest Centre Breast Screening Unit Northampton General Hospital 1. INTRODUCTION Traditionally radiologists have performed Breast Localisation examinations with the assistance of radiographers. More recently it has become acceptable to delegate some of this work to appropriately trained radiographers. This protocol outlines the scheme of delegation for the Northampton NHS Trust. 2. DEFINITION OF APPROPRIATELY TRAINED RADIOGRAPHER Before commencing training the individual must: - A. Hold current full accreditation for mammography and be a qualified advanced practitioner in stereo tactic core biopsies of the breast. B. Be a senior mammography radiographer with a minimum of five years experience in mammography C. Hold membership of College or Radiographers or other professional body offering professional liability cover D. Be currently employed within an appropriate unit, offering a full breast imaging service E. Show a degree of enthusiasm, desire and aptitude to acquire this additional skill. 3. THE REQUEST There must be valid written request from a member of the Breast Unit (surgeon or radiologist). The written request MUST include accurate clinical information, including the quadrant containing the abnormality to be localised. A request for ultrasound guided localisation may only altered to stereo tactic localisation after discussion with a Breast Consultant Radiologist or Associate Specialist. Prior to any localisation appointment being scheduled in the Breast Screening Unit, availability of the consultant radiologist in charge must be confirmed. 4. PLANNING THE PROCEDURE All stereo tactic localisation procedures require planning and approval by a Consultant Breast Radiologist or Associate Specialist.

54 Planning includes: - 1. Confirmation that a stereo tactic procedure is more appropriate than ultrasound guidance. 2. Confirmation of the site of the lesion (quadrant and side) 3. Confirmation of the site of previous biopsy 4. Review of screening assessment films to ensure that no other uncertain/suspicious lesions are present 5. Removal of china graph arrow markers of confirmed benign and biopsied lesion from screening films. 6. Decisions about the need to have a Radiologist/Associate Specialist present during the procedure. Examples include awkwardly placed lesions, barely visible lesions, and lesions in patients who may find it difficult to co-operate during the examination. 7. A decision on the radiographic approach to be used (oblique or cc projections) 8. A decision on the number and position of wires to be introduced. 5. THE EXAMINATION Localisation procedures may be required for both screen detected and symptomatic new and follow up referrals. The Breast Surgical Team obtains procedure in advance, in compliance with the Trust s consent policy. Verbal consent is obtained by the Consultant Radiologist/Associate Specialist or radiographer prior to the procedure and documented. A consultant breast radiologist, or Associate Specialist, in Breast Unit will be available for indirect supervision when radiographers are performing localisations. Exceptionally a breast surgeon should be available close to the Breast Unit. A consultant breast radiologist should be present during difficult or complex localisations. The Breast Screening records clinical review and symptomatic documentation will be available. The Breast Screening referral letter with pictorial representation of the lesion will also be available for review. 6. THE REPORT A report is completed after the procedure. Any resultant report is the interpretation of observations from the examination. This will be made by the named supervising radiologist/or qualified advanced Practitioner. Details to be included are: 1. The quadrant containing the abnormality 2. The type of abnormality (mass, parenchymal deformity micro calcification) 3. The size of the abnormality. For micro calcification, two diameters should be given the largest diameter in mm, and the longest diameter in mm at 90 degrees to this (this provides an area of abnormality) 4. The distance of the lesion from the tip of the wire 5. The length of wire lying within the breast 6. The pre-operative diagnosis and classification (B value).

55 The radiographer should create the descriptive element. But the supervising radiologist/associate specialist who will assess and approve the final report must provide the conclusion or provisional diagnosis. 7. RISK MANAGEMENT AND ACCOUNTABILITY Radiographers should be aware that in all circumstances they would be legally Accountable for their professional actions. Accountability means being answerable for decisions about work and being professionally responsible for the standard or practice (Derrick 1989). The Code of Professional Conduct issued by The College of Radiographers in 1994 gives advice and guidance to all practising members on:- 1. The responsibilities with, and responsibilities to patients 2. Professional integrity 3. Professional relationship and responsibilities 4. Professional standards. 8. PROFESSIONAL STANDARDS The Code of Conduct states: Radiographers should develop their professional role. This may be done provided that they have been properly trained for the role development. There is an agreed scheme of work and the Northampton NHS Trust has been informed in writing and assured of radiographers competence. 9. MEDICO LEGAL ISSUES A radiographer should not directly supervise or undertake breast localisation examinations unless this constitutes part of a scheme of work agreed by medical staff, radiographers and the Northampton NHS Trust. The relevant points are: 1. The person to whom the task is delegated must be properly trained, and the task must be within that person s experience, skill and competence. 2. A protocol method of work must be established, for the guidance of the delegate. 3. The delegate must no accept tasks that are outside of the protocol and method of work 4. The radiologist should provide direct or indirect supervision 5. In the event of a mishap, and where there is proper delegation, medicolegal responsibility may be with the delegate, though the person delegation may not be immune. 6. If improper delegation has occurred, the Northampton NHS Trust may be subject to a claim of medical negligence. 7. The delegate must declare to the person delegating if they think that a task is beyond their competence. 8. A record must be kept of those staff trained to undertake breast localisation examinations.

56 10. VICARIOUS LIABILITY Northampton NHS Trust must approve officially of any role extensions (DHSS 1977). In the NHS, Northampton NHS Trust will accept responsibility for their employees, for example, radiographers, who are working in accordance with the policies agreed between the two parties, and that are officially recorded (Derrick 1989). Unauthorised procedures, that are not agreed, must not be carried out. 11. AUDIT It is the responsibility of the clinical director of the breast unit/supervising consultant radiologists to review the departmental procedure under which these staff work and to update those procedures when necessary using the guidelines which are relevant to their practice. It is recommended that audit of examination quality is performed. Subject for Audit should include: 1. The distance from the tip of the wire to the lesion 2. Confirmed identification of pre-operative abnormalities within excision specimens 3. Adequacy of excision of localisation specimens 4. The presence or absence of specimen radiographs after localisation procedures. 12. COMPLAINTS Northampton NHS Trust complaints procedure is to be followed. It is understood that this section along with all of the above apply only to patients in the NHS sector. PERFORMING BREAST LOCALISATION EXAMINATIONS Before performing breast core biopsy examinations, the selected radiographers must complete the necessary theoretical and practical training, and be assessed as to their competence by the nominated consultant radiologist. The Theoretical and Practical Training will consist:- 1a Basic training in: Sterile technique Intradermal introduction of local anaesthesia 1b Training in: Performance of guide wire apparatus Use of guide wire placement Method of haemostasis Recognition of possible complications 1c The radiographer will observe a minimum of TEN localisations of the breast undertaken by a consultant radiologist. 2. Under close supervision from the supervising radiologist, the radiographer will perform localisations using phantom or other model. (Level 1d competency)

57 3. The supervising radiologist must assess that the radiographer has achieved Level 1 (a, b, c, d) competency before the radiographer may proceed to undertake any localisations on patients. This level 1 (full) competency radiologists. 4. Once assessed to have reached level 1 (full) competency the radiographer will perform at least TEN localisations on patients, under close supervision of the Consultant radiologists. (Level 2 competency) 5. The supervising radiologists must assess that the radiographer has achieved the Level 2 competency before the radiographer may proceed to undertake any less supervised localisations on patients. This level 2 competency must be recorded. 6. Once assessed to have reached level 2 competency the radiographer will perform at least TEN localisations on patients, unaided, but the consultant radiologist close at hand to assist if necessary. (Level 3 competency) 7. The supervising radiologist must assess that the radiographer has achieved the level 3 competency. Once level 3 competency has been achieved, the radiographer will be deemed to have reached a satisfactory level of expertise to allow them to perform localisation of the breast unaided. This level 3 competency must be recorded. 8. Level 3 competency must be signed off by the clinical director of the breast unit. Radiographers may only progress to the next level of training after assessment of their clinical capabilities by the supervising radiologist.

58 1b Performance of Guide wire apparatus Supervising Consultant Radiologist 1b Use of guide wire Supervising Consultant Radiologist 1b 1b 1c 1d Methods of Homeostasis Recognition of Complications Observation of TEN Localisations Localisations using Phantom 2 Localisation under close supervision 3 Localisation unaided Supervising Consultant Radiologist Supervising Consultant Radiologist Supervising Consultant Radiologist Supervising Consultant Radiologist Supervising Consultant Radiologist Supervising Consultant Radiologist Observation Practical training Log Book Observation Practical training Log Book Observation Practical training Log Book Observation Practical training Log Book Observation Practical training Log Book Observation Practical training Log Book Observation Practical training Log Book Observation Practical training Log Book Supervising Consultant Radiologist Supervising Consultant Radiologist Supervising Consultant Radiologist Supervising Consultant Radiologist Supervising Consultant Radiologist Supervising Consultant Radiologist Supervising Consultant Radiologist Supervising Consultant Radiologist DATED: Authors: Mrs G Baxter Dr CR Pal Dr FLS Moss Approved: Lead Clinician. Reviewed May 2009

59 Appendix 11 Ultrasound of the Axilla as part of the Pre-operative Staging of Breast Malignancy The use of Sentinel Lymph Node Biopsy has been adopted as standard practice for the assessment of the axilla in cases planned for Wide Local Excision of the Primary Tumour. This method is appropriate to the Majority of cases of Screen detected Breast cancer as well as a proportion of symptomatic presentations of breast cancer. The process of pre-operative assessment and surgical excision should be carried out by a method that ensures that the number of node positive SLNBs is minimised to avoid the need for repeat surgery to the axilla. Ultrasound assessment of the axilla has been adopted as the chosen method for confirmation of node positivity prior to Sentinel Node Scintigraphy. Fine Needle Aspiration has been selected as the method of tissue sampling. Protocol for Assessment The scan is to be performed using high quality equipment as described by the NHS Breast Screening Programme. Operators should be experienced in the use of Ultrasound as part of the NHS Breast Screening Programme. Lymph node size and morphology is assessed. Criteria for assessment leading to Guided FNA are as follows: Size Cortical width - >3 mm Cortical Outline - Asymmetry or focal thickening. Palpable clinically suspicious lymph nodes suspicious of malignant involvement. Clinical FNA without image guidance may be performed Cytological analysis to be requested. Management Cases of cytological malignancy, as assessed by guided FNA and positive cytology should be scheduled for Axillary Clearance. Audit Annual review of false negative assessment rates after Wide Local Excision will be performed Target > 50% Dr FLS MOSS Lead Clinician for Breast Disease June 2007 Revision Date May 2009

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