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Clinical Guidelines for Breast Cancer Control and Management

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Clinical Guidelines for Breast Cancer Control and Management CLINICAL GUIDELINES FOR BREAST CANCER CONTROL AND MANAGEMENT 1 National Department of Health Switchboard: 012 395 8000 Physical Address: Civitas Building Corner of Thabo Sehume and Struben Streets Pretoria Postal address: Private Bag X828 Pretoria 0001 Published by the Department of Health, Private Bag X828, Pretoria, 0001, South Africa Copyright: © Department of Health, Republic of South Africa April 2018 www.doh.gov.za 2 Table of Contents Foreword ...................................................................................................................................................... 4 Acknowledgements ...................................................................................................................................... 5 Abbreviations and Acronyms ........................................................................................................................ 6 Definition of terms ......................................................................................................................................... 8 List of tables ............................................................................................................................................... 10 List of figures .............................................................................................................................................. 10 1. Introduction.......................................................................................................................................... 12 2. Key area 1: Prevention and early detection, screening and genetic assessment ........................ 14 3. Key area 2: Timely access to care .................................................................................................... 24 4. Key area 3: Assessment, diagnosis and staging ............................................................................ 39 5. Key Area 4: Treatment of breast cancer .......................................................................................... 49 6. Key area 5: Palliative care in breast cancer ..................................................................................... 60 7. Key area 6: Follow-up and surveillance in breast cancer ............................................................... 66 8. Key Area 7: Data, monitoring and research ..................................................................................... 73 9. Key area 8: Community outreach and engagement ........................................................................ 75 Annexures .................................................................................................................................................. 77 3 Foreword Breast cancer, along with cervical cancer, has been identified as a national priority in South Africa. Breast cancer is the most prevalent cancer and a leading cause of death among South African women. The increasing incidence of breast cancer is a major health concern. 19.4 million women aged 15 years old and older live at-risk of contracting the disease. Per the National Cancer Registry in 2012, 8 203 new cases of breast were observed. Given the recent advances in medicine and technology, however, we have a tremendous opportunity to attack breast cancer energetically and effectively with a revised national programme. The Breast Cancer Clinical Guidelines is an important document aimed at providing detailed information regarding the standards laid out in the Breast Cancer Prevention and Control Policy – its companion document. These standards include awareness, prevention, and treatment and care in the South African context. It provides clinicians with the step-by-step guidance from the initial contact with the patient to the discharge back into the community. The implementation of these clinical guidelines will reduce the breast cancer related mortalities. The clinical guidelines will also provide an opportunity to respond to the health system priorities related to cancers. It provides guidelines on the required minimum standard to establish Regional Breast Units (RBUs), including list of essential equipment, essential medicines, and personnel required. It further provides guidance on collaboration with civil society and private partners in fighting the battle against cancer. Dr Aaron Motsoaledi Minister of Health 4 Acknowledgements The National Department of Health would like to acknowledge the irreplaceable contribution of the writing group of breast cancer clinicians responsible for the clinical guidelines. The authors of this document would like to make clear however, that any conclusions in this document and standards derived from this evidence are not necessarily the opinion of this writing group and should not be taken as such. The contributors consisted of breast surgeons, plastic and reconstructive surgeons, oncologists, radiologists, nuclear physicians, pathologists, and geneticists. In addition, experts in the various fields, including civil society organisations and other interest groups, were also contacted when necessary for further input. The clinical guidelines provide additional context based on information that may not be available in the Breast Cancer Prevention and Control Policy. It is aligned to the health care situation in South Africa and the needs envisaged by the people of this country. NDoH leads: Dr M Makua and Dr Y Pillay Project Manager and Editorial lead: Mr J Tillus and Clinton Health Access Initiative Clinical experts: Dr A Sherriff, Dr A Hoosen, Dr D Shamley, Dr T Thebe, Dr E Panieri, Dr G Demetriou, Dr J Smilg, Dr J Edge, Dr L Cairncross, Dr P Ruff, Dr S Nietz, Dr S Rayne, Dr S Cacala, Dr L Stopforth, Ms T Wainstein, Dr Z Mohamed, Dr Z Jafta, Dr R Krause, Dr I Buccimazza and Dr H Cubasch National Department of Health contributors: Mr G Steel, Ms J Riddin, Ms D Chweneyagae and Ms S Singh Partners and CSOs: Ms S Meyer (Cancer Alliance) and Ms L Turner (Breast Health Foundation) Other contributors: Ministerial Advisory Committee for Cancers (MACC) representatives, Affordable Medicines representatives, Provincial Heads of Breast units, Medical Oncology units and Radiation Oncology units, Breastcare, Bettercare Books, BIGOSA and The Breast Course for Nurses 5 Abbreviations and Acronyms ADH Atypical ductal hyperplasia ALH Atypical lobular hyperplasia ALND Axillary lymph node dissection ASR Age standardised rate AUS Axillary ultrasonography BCCCP Breast Cancer Comprehensive Control Policy BCN Breast care nurse BCS Breast conserving surgery BI-RADS Breast imaging-reporting and data system BMI Body mass index BPM Bilateral prophylactic mastectomy BPSO Bilateral prophylactic salpingo-oophorectomy BRCA Breast cancer gene mutation BRCA1 Breast cancer gene 1 BRCA2 Breast cancer gene 2 BCRL Breast cancer related lymphoedema BSE Breast self-examination CBC Contralateral breast cancer CBE Clinical breast examination CI Confidence interval CISH Chromogenic in-situ hybridization CMF Cyclophoshamide, methrotrexate and fluorouracil CNB Core needle biopsy CPM Contralateral prophylactic mastectomy CT Computerized tomography DCIS Ductal carcinoma in situ DFS Disease free survival DH District Hospital DOH Department of Health EDA Emotional distress assessment ER/PR Estrogen-receptor/progesterone receptor ESMO European Society for Medical Oncology FDG-PET Fluorodeoxyglucose-positron emission tomography FEC 5-fluorouracil, Epirubicin, and cyclophosphamide FISH Fluorescent in-situ hybridization FNAC Fine needle aspiration cytology H&E Haematoxylin and eosin HER-2 Human epidermal growth factor receptor 2 HERA Herceptin Adjuvant HR Hazard ratio IDC Invasive ductal carcinoma IHC Immunohistochemistry ILC Invasive lobular carcinoma LABC Locally advanced breast cancer LCIS Lobular carcinoma in situ LHRH Luteinizing-hormone-releasing hormone LN Lobular neoplasia LTR Lifetime risk MDT Multi-disciplinary team MMG Mammogram MRI Magnetic resonance imaging NCCN National Comprehensive Cancer Network NDoH National Department of Health 6 NICE National Institute for Health and Care Excellence OS Overall survival PCHCT Palliative and hospice care team Pcr Pathological complete response PCR Polymerase Chain reaction PET/CT Positron emission tomography/computerized tomography PHC Primary Health Care PISCBE Provider Initiated Screening Clinical Breast Examination PPV Positive predictive value QoL Quality of life RBu Regional breast unit RCT Randomized control trial RR Relative Risk RRSO Risk reducing salpingo-oophorectomy SBA Specialist breast assessment SBU Specialized breast unit SISH Silver-enhanced in-situ hybridization SLNB Sentinel lymph node biopsy SR Systematic review TRAM Transverse rectus abdominismyocutaneous WHO/IARC World Health Organization/International Agency for Research on Cancer 7 Definition of terms Term Definition Adjuvant systemic therapy Chemotherapy, monoclonal antibodies, radiotherapy and hormonal blockade given after surgery to help decrease the risk of the cancer recurring. Benign disease Condition, tumour, or growth that is not cancerous. This means that it does not spread to other parts of the body. It does not invade nearby tissue Breast care nurse Nurse who specialises in breast care. Breast care nurses improve the continuity of care for women, and provide important information, support and referral for a wide range of needs experienced by women Breast conserving surgery An operation to remove the cancer and some normal tissue around it, but not the breast itself. It is also called breast-sparing
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