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Innovation and clinical specialities: oncology Table 6: Treatment and allocation of resources: Metastatic (stage IV) and recurrent breast Cancer LOCAL-REGIONAL TREATMENT SYSTEMIC TREATMENT (ADJUVANT) Level of resource Surgery Radiation therphy Chemotherphy Endocrine therphy Supportive and pallative ther Basic Total mastectomy for Ovarian ablation Nonopioid and opioid ipeilateral breast tumor recurrance* Tamoxifen analgesics Limited Pallative radiation therapy Classical CMF** Anthracycline montherapy or in combination** Enhanced Taxanes Aromatese inhibitors Biophosphonates Capecitabine Trastzumab Maximal Reconstructive surgery Growth factors Fulvestrant Vinorebine Gemcitabine Carboplatin * Required resources are the same as those modified radical masectomy ** Requires blood chemistry profile and complete blood count (CBC) testing. CMF, cyclophosphamides, methotrexate and 5-fluorouracil a heterogeneous group with mixed genetic heritage consisting of Hispanics, Caucasians and Africans. In addition other socioeconomic factors and environmental factors may contribute to the clinical outcome seen. 126,127 ✚ Immunohistochemistry • The most widely used tests are for the estrogen receptors (ER) and progesterone receptors (PR). Immunohistochemistry analysis of heat-treated paraffin sections has largely superseded the enzyme-linked immunosorbent assay (ELISA) ligand-binding assay. ER- and PR-positive status (ie, >10 fmol on ELISA; >15 H-score on immunohistochemistry) predict improved response to endocrine treatment, time to relapse, and overall survival. • Immunohistochemical positivity for c-erb-B2 and p53 is associated with a worse prognosis. • HER-2 status: The human epidermal growth factor receptor-2 (HER-2/neu) is a well-characterized biomarker in the biology of breast carcinoma that has had immediate impact on clinical medicine. The positive status of HER-2/neu is associated with a younger age and several adverse prognostic factors, i.e., advanced stage, absence of estrogen and progesterone receptors, metastasis to axillary lymph nodes, and high nuclear grade. In addition, women diagnosed with positiveHER-2/neu breast carcinoma generally have relative resistance to anthracycline-based chemotherapy, tamoxifen therapy, and have shorter disease-free and overall survival. 128 Other prognostic indicators Advances, in the knowledge of the molecular mechanisms that influence normal and aberrant cell growth, have led to the identification of an increasing number of surrogate biomarkers, which have been correlated with prognosis or used as predictors of response to specific treatments. These novel prognostic markers can be classified as follows: ✚ Oncogene products • Bcl-2 • p53 • HER-2/neu • Cyclin D1 • Nm23 ✚ Proteases • uPA • Cathepsin D • Tenascin C ✚ Markers of proliferation - Ki-67 HER-2/neu identifies patients with a poor prognosis. These patients are likely to respond to treatment with trastuzumab (Herceptin). Tumors positive for Ki-67 have a high metastatic potential and warrant the possible use of early aggressive therapy. uPA and cathepsin D identify poor prognosis node-negative tumors. In these cases, chemotherapy can be offered. The use of gene expression profiling to detect breast carcinoma has already shown that the differential expression of specific genes is a more powerful prognostic indicator than traditional determinants such as tumor size and lymph node status. These molecular assays are awaiting clinical validation. Prevention Screening as currently practiced can reduce mortality but not incidence, and then only in a particular age group. Advances in treatment have produced significant but modest survival benefits. A better appreciation of factors important in the etiology of breast cancer would raise the possibility of disease prevention. Currently, prevention strategies fall into two groups: chemoprevention and surgical prophylaxis. Chemoprevention is defined as the systemic use of natural or synthetic chemical agents to reverse or suppress the progression of a premalignant lesion to an invasive carcinoma 129 . Tamoxifen is currently the only agent that has been approved clinically for use in women with high risk of developing cancer. Raloxifene, selenium, retinoids, aromatase inhibitors and cyclo-oxygenase 2 inhibitors require further clinical investigation before adoption in this context. Surgical prophylaxis: by either a bilateral mastectomy or oophorectomy, is another avenue of prevention. Some studies <strong>Hospital</strong> and Healthcare Innovation Book 2009/2010 103
Innovation and clinical specialities: oncology Table 7: Healthcare systems and public policy LEVEL OF RESOURCE SERVICE FACILITIES RECORD KEEPING Basic Primary care service Health facility Individual medical records and servvice-based patient registartion Surgical services Operating facility Pathology services Pathology laboratory Oncology services Pharmcay Nursing services Outpatient care facility Pallative services Linked Imaging services Imaging facility Facility-based medical records and centrilized patient registration Radiation oncology services Radiation theraphy Peer support services Clinical information systems Local cancer registry Early detection programme Health system network Enhanced Opportunistic screening programme Centralized referal cancer centre(s) Facility-based follow-up registry Cancer follow-up Rehabilitation services Population based cancer registry Regional Cancer registry Maximal Population based Sarellite (non-centralized National Cancer registry screening programme or regional) Cancer centre Individual psychological care have demonstrated that women with definite BRCA1 or BRCA2 mutation may have an overall reduction in their breast cancer risk profile after such operation. 130 Dietary intervention If specific dietary factors are found to be associated with an increased risk of breast cancer dietary intervention will be possible. However, reduction of dietary intake of such a factor in whole communities may well be difficult to achieve without major social and cultural changes. Dietary fat reduction and exercise decrease the circulating serum oestradiol level, but whether this in turn leads to a reduction in the incidence of breast carcinoma has not been determined conclusively. 131 Breast cancer and pregnancy Pregnancy associated breast cancer is defined as breast cancer diagnosed during pregnancy or lactation or one year post partum. Breast cancer and pregnancy can be classified into three main situations; these are (a) breast cancer that is detected during the evolution of pregnancy, (b) breast cancer that is detected during lactation or postpartum, and (c) pregnancy in patients who have had a previous breast cancer. Cancer complicates approximately 1 per 1000 pregnancies and accounts for one-third of maternal deaths during gestation. The prevalence of breast cancer during pregnancy is increasing due to delayed onset of childbearing. Breast cancer is diagnosed in approximately 1 in 3000 pregnancies. The incidence ranges from 0.76% to 3.8% of breast cancer cases. The median age of pregnant women affected with breast cancer is 33 years. In a recent review in Nigeria, 12% of the patients with Breast Cancer were pregnant or lactating and 74% were premenopausal , making it the most frequently occurring malignancy during pregnancy, along with cancer of the uterine cervix.(5) Treatment decisions for breast cancer patients during pregnancy become most difficult because not only the mother but also the fetus is involved. The final advice should be based upon the following considerations: ✚ the parents’ decision whether or not to continue with the pregnancy, ✚ the period of pregnancy when the breast cancer is diagnosed, and ✚ the stage of the breast cancer. A detailed guideline on the management of breast cancer in pregnancy can be found in the NCCN Clinical Practice Guidelines in Oncology Breast cancer V.1.2007 at www.nccn.org. Early studies have indicated that the prognosis of breast cancer in pregnancy is very poor; however, more recent studies with more careful consideration of age and the stage of the disease show no significant differences. Evidence is lacking that termination of pregnancy changes the outcome of breast cancer. Pregnancy after breast cancer does not alter the outcome of treatment. The ideal interval between treatment for breast cancer and subsequent pregnancy is unknown. 132 Breast cancer in males Male breast cancer is an uncommon disease although the incidence has increased over the past 25 years. Less than 1% of all breast cancer patients are male. Rates of male breast cancer vary widely between countries: in Uganda and Zambia the annual incidence rates are 5% and 15%, respectively of all breast cancer cases. These relatively high rates have been attributed to endemic infectious diseases causing liver damage, leading to hyperestrogenism. By contrast, the annual incidence of male breast cancer in Japan is less than five per million, in parallel with the lower than average incidence of female breast cancer in that country. Jewish men are the only racial group with a higher than average incidence (2•3/100 000 per year), irrespective of living in Israel or the USA. 133 Risk factors for Breast Cancer include Genetic (BRCA2, Klinefelter’s syndrome), Lifestyle (Obesity, Alcohol, Estrogen intake), Work (High ambient temperature, Exhaust emissions), and Disease (Testicular damage, Liver damage, Radiotherapy to chest) The predominant histological type of disease is invasive ductal, which forms more than 90% of all male breast tumors. Much rarer tumour types include invasive papillomas and medullary lesions. Lobular carcinoma of the male breast has been reported not only in men with Klinefelter’s syndrome, but also in genotypically normal men with no previous history of oestrogen exposure or gynaecomastia. In large studies of male breast cancer, 104 <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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