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Innovation and clinical specialities: oncology Table 1: Early detection amd access to care LEVEL OF RESOURCE DETECTION METHOD (S) EVALUATION GOAL Basic Breast health awareness (education + self examination) Baseline assessment and repeated survey Clinical breast examination (clinical education) Limited Targeted outreach/education encouraging CBE for at-risk group Downstaging of eymptomatic disease Diagnostic ultrasound + diagnostic mammography Enhanced Diagnostic mammography Opportunities screening of asymptomatic patients Opportunitic mamographic screening Maximal Population-based mammographic screening Population-based screening of asymptomatic patient Other imaging technologies as appropriate: high-risk group, unique imaging challenge managed with more conservative and less locally ablative procedures such as lumpectomy. The past three decades has witnessed an enormous growth in the knowledge and understanding of the basic science of the disease especially the genetic and molecular basis of the disease. Anatomy of the breast The breast is a modified sweat gland and therefore ectodermal in origin. It is present in all mammals and becomes particularly prominent in females as the hallmark of pubertal development. It lies cushioned in adipose tissue between the subcutaneous fat layer and the superficial pectoral fascia. It extends from the clavicle above to the upper border of the rectus sheath below and from the midline to the posterior axillary line. It overlies the second to the sixth ribs, the pectoralis major, serratus anterior and the upper part of the rectus sheath. The area covered is wider than the visible protuberant breast. An axillary extension of the breast (axillary tail of Spence) always exists and its size is proportional to the total volume of the main breast mass. The innervation of the breast is derived from the anterior branches of the intercostal nerves 2 through 6 with the nipple receiving its innervation from the 4th intercostal nerve. The major blood supply, in order of importance, are the internal mammary branches, the lateral thoracic, and the thoracodorsal perforating vessels from the pectoral branch of the throacoacrominal branch of the axillary artery, and small intercostals branches. The venous and lymphatic drainage parallel the blood supply. The glandular tissue consists mainly of epithelium, fibrous stroma, and fat. The breast is organized into roughly 20 lobular units made up of terminal ducts surrounded by fat and fibrous tissues and efferent ductules. These terminal ducts coalesce and drain towards the areola forming the 15-20 ducts of the nipple areolar complex. The lymphatic drainage is primarily to the axillary nodes (75%), divided into three levels by the Pectoralis minor muscle (level I nodes lie lateral, level II nodes behind and level III nodes medial to the muscle). Usually, but with some exceptions, lymphatic drainage is progressive through these levels. Drainage also occurs to the internal mammary chain of lymph nodes which lie in the intercostal spaces, the supraclavicular nodes, the opposite breast and axilla, and to the liver via the rectus abdominis muscle. Epidemiologic risk factors/etiology The precise etiology of breast cancer is largely unknown, but several risk factors have been identified. Table 1 lists the known risk factors. 14 The risk factors include: ✚ Age: The incidence of breast cancer increases with age and is rare before the age of 20 years. The breast cancer incidence in Caucasians is highest at age 50-59, after menopause, dropping after age 70. In Africa and African-Americans the peak age incidence is about one decade less, so that the majority of the patients are pre- menopausal. While numerous theories have been proposed to explain this difference, including age at menarche, time of first delivery, parity, sociodemographic factors, body mass index, and underlying genetic difference, none are completely satisfactory and more research is needed in this area. 3-5;15-17 ✚ Sex: Breast Cancer is 100 times more common in women than in men with male breast cancer accounting for
Innovation and clinical specialities: oncology ✚ Previous breast disease: Individuals who have a prior history of invasive carcinoma or ductal carcinoma in situ have a 0.5%-1% per year risk of developing a new invasive breast carcinoma. Women with atypical ductal or lobular hyperplasia have a four to five times higher risk of developing breast cancer. Proliferative lesions without atypia, such as moderate hyperplasia and sclerosing adenosis, are associated with a slightly increased risk (1.5-2%). Other common nonproliferative changes such as palpable cysts, fibroadenomas and duct papillomas are not associated with a significantly increased risk. 34 ✚ Enviromental Exposures: Exposure to ionizing irradiation increases the risk of developing breast cancer. Excess breast cancer has been observed in patients given multiple fluoroscopies, radiotherapy for ankylosing spondylitis, Hodgkin’s disease, or enlargement of the thymus gland and in survivors of the atomic bombings, painters of radium watch faces and X-ray technicians 28 . Environmental exposures to organic chlorines and other environmental/synthetic estrogens like cosmetics and phytoestrogens found in food have also been postulated to increase the risk, but so far there are no conclusive evidence linking organic chlorines to breast cancer. 31;35;36 Lifestyle risks Anthropometric indices and physical activity: Height, obesity and high body mass index are risk factors especially in post menopausal women. In pre-menopausal women, obesity and high body mass index has an insignificant but inverse relationship to breast cancer risk that is reduced by physical activity. 37-39 Diet, alcohol and smoking: alcohol and diets rich in fat especially saturated fat raises the risk while smoking does not appear to affect the risk. 40-42 Family history and genetics A family history of breast cancer increases a woman's risk of developing the disease. A woman is considered to be at increased risk if the family member is a first degree relation with early age of onset (< age 50), if both breasts are involved, or if she has multiple primary cancers (such as breast and ovarian cancer). Women with one, two, and three or more first-degree affected relatives have an increased breast cancer risk when compared with women who do not have an affected relative (risk ratios 1.8, 2.9 and 3.9, respectively) 43 Such women are recommended to begin breast cancer screening at an age 10 years younger than the age at which the affected relative was diagnosed. Hereditary breast cancer caused by an underlying inherited gene mutation accounts for a small proportion (5-10%) of all breast cancers. The majority is accounted for by 2 germline mutations BRCA-1 (50%) and BRCA-2 (32%), which are inherited in an autosomal dominant fashion with varying penetrance. These tumor suppressor genes are important in the processing of DNA damage and preservation of genomic integrity. BRCA-1 is located on chromosome 17q while BRCA-2 is located on chromosome 13q. 44 They are most commonly found in the European Ashkenazi Jewish population and their descendants, accounting for their relatively high prevalence in the developed world. In Europe and North America, BRCA1 is found in 0.1% of the general population, compared with 20% in the Ashkenazi Jewish population and is found in 3% of the unselected breast cancer population and in 70% of women with inherited early-onset breast cancer. 9 Up to 50- 87% of women carrying a mutated BRCA1 gene develop breast cancer during their lifetime. Risks for ovarian and prostate cancers are also increased in carriers of this mutation. BRCA2 mutations are identified in 10-20% of families at high risk for breast and ovarian cancers and in only 2.7% of women with early-onset breast cancer. The lifetime risk of developing breast cancer in female carriers is 25-30%. BRCA2 is also a risk factor for male breast cancer; male carriers have a lifetime risk of 6% for developing the cancer. BRCA2 mutations are associated with other types of cancers, such as prostate, pancreatic, fallopian tube, bladder, non-Hodgkin lymphoma, and basal cell carcinoma. Risk management strategies for BRCA-1 and BRCA-2 carriers include: ✚ prophylactic mastectomy and reconstruction; ✚ prophylactic oophorectomy and hormone replacement therapy; ✚ intensive surveillance for breast and ovarian cancer; and ✚ chemoprevention using Tamoxifen or raloxifene (postmenopausal women) In contrast, less is known about genetic mutations as a cause of breast cancer in the non-Caucasian population. Studies that have been done of African-Americans, whose genetic history includes Caucasians, have identified BRCA-1 and -2 mutations but of a different pattern. 17,45,46 In native Africans, a wide range of BRCA-1 and BRCA-2 mutations and sequence variations have been found which are unique. This suggests that there may be significant differences in the genetics of hereditary breast cancer in Africa. A screening of 206 black South African women with breast cancer revealed 3 common BRCA1 mutations: 185delAG in exon 2, 4184del4 in exon 11, and 5382insC in exon 2022. A second study of the coding regions of BRCA1 and BRCA2 genes from 70 Nigerian patients diagnosed with breast cancer before the age of 40 years revealed 2 novel BRCA1 truncating mutations, Q1090X and 1742insG; four BRCA1 missense variations; one BRCA2 truncating mutation, 3034del4, previously unreported in anyone of African descent; and 20 nontruncating variants were detected in BRCA2.45 BRCA1 and BRCA2 mutations and sequence variations are potentially significant in cases of early-onset breast cancer within Africa. However, only a small portion of the mutations were protein truncating, fewer than those observed among white women 47 Other rare genetic changes that account for predisposition to breast cancer include Li Fraumeni syndrome (TP53 gene mutation), Cowdens syndrome, Peutz-Jeghers and Muir-Torre syndromes, Ataxia Telangiectasia syndrome (caused by the ATM gene). 48-51 New breast cancer susceptibility genes are being reported and they include the CHEK2 or CHK2 gene, cytochrome P450 genes (CYP1A1, CYP2D6, CYP19), glutathione S-transferase family (GSTM1, GSTP1), alcohol and one-carbon metabolism genes (ADH1C and MTHFR), DNA repair genes (XRCC1, XRCC3, ERCC4/XPF) and genes encoding cell signaling molecules (PR, ER, TNFalpha or HSP70). All these factors contribute to a better understanding of breast cancer risk but the degree of penetrance of these genes are far less than the BRCA1 and BRCA2 genes 43,51 Risk assessment Several statistical models are currently in use in North America to 92 <strong>Hospital</strong> and Healthcare Innovation Book 2009/2010
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International Hospital Federation I
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Introduction Sterile Barrier System
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Contents Healthcare transformation
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Introduction Introduction ERIC DE R
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How Can Health Organizations Get th
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