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Innovation and clinical specialities: oncology and the availability of radiation. BCT and breast radiation together offers equivalent survival to total mastectomy provided the BCT removes the entire tumor with negative margins. Generally a tumor less that 1/4 of the breast is amenable to BCT; anything much larger will result in significant breast distortion after surgery and radiation. The procedure can be done safely with local anesthesia and sedation unless axillary dissection is part of the procedure. A curvilinear incision lying parallel to the nipple-areola complex is made in the skin overlying the breast cancer. Radial scars are avoided because of poor cosmetic results. Skin encompassing any prior biopsy site is excised, but skin excision is not otherwise necessary. The breast cancer is removed with an envelope of normal-appearing breast tissue. Meticulous hemostasis is important because a large hematoma distorts the appearance of the breast and makes re-excision and follow-up more difficult. The excised specimen is orientated for the pathologist using sutures, clips, or dyes. Additional margins (superior, inferior, medial, lateral, superficial, and deep) can be taken from the surgical bed to confirm complete excision of the tumor. These six margins are marked with titanic clips as this may help the Radiotherapist in planning the boost. In addition, it helps the surgeon to do an adequate re-resection if the margins are not free of cancer cells at definitive paraffin-embedded histology sections. Attempts to re-approximate the cavity in the breast should be avoided, because this will usually distort the breast contour, which may not be apparent when the patient is supine on the operating table. Similarly, drains are not used. Allowing the cavity to fill with serum and fibrin maintains contour in the early postoperative period and helps to avoid deformity. The procedure is completed with two-layer closure of the deep dermis and the subcuticular layer, and a light dressing is used. There is no firm consensus on the extent of the excision or margins required. The main benefit of BCT is preservation of body image for the woman, which greatly improves her quality of life. Several randomized controlled trials have shown that BCT and radiation has a similar survival advantage as mastectomy as there were no significant differences in the two groups in disease-free survival, distant-disease-free survival, or overall survival and even in loco regional control. 74-80 Contraindications to breast conservation therapy (BCT) can be divided into absolute or relative. Absolute contraindications include lack of mammography facilities to ensure all tumors have been removed, adequate pathology facilities to ensure tumor- free resection margins and/or lack of radiotherapy facilities. 10,11 Other contraindications include pregnancy (first or second trimester because of the risk of radiotherapy to the fetus), patient’s preference, diffuse suspicious calcifications, inflammatory breast carcinoma, previous radiation to the region, and inability to achieve negative margins particularly with extensive intraductal carcinoma (EIC). Relative contraindications also include two or more gross tumors (multicentric disease) in different quadrants, tumor greater than 5 cm initially or after neoadjuvant chemotherapy, large tumorbreast ratio for cosmesis, and collagen vascular disease. 74 In Africa, many of the factors above make the practice of BCT difficult and these include lack of adequate diagnostic oncology services like mammography and surgical pathology, lack of adequate therapeutic oncology services like radiotherapy, advanced stage disease and poor follow up culture. 5 Thus the majority of the patients with early breast cancer in Africa should still undergo total mastectomy and axillary clearance. In a total or simple mastectomy, the patient is placed in the supine position with the ipsilateral arm extended horizontally. General anesthesia is used. The incision is in the form of an ellipse is designed to include the skin overlying the tumor or biopsy scar and the nipple–areola complex. Superior and inferior skin flaps are then raised. The plane between the subcutaneous tissue and breast tissue is not always obvious and is most easily identified at the medial superior flap; it is therefore easiest to begin here. The skin flaps must be thin, to ensure that all the breast tissue is removed, and yet enough subcutaneous fat to ensure adequate blood supply to the skin. Superiorly the dissection must include the tail of Spence laterally. Inferiorly, the dissection ends at the inframammary fold. The entire breast, the skin ellipse, nippleareola complex are then dissected off the pectoralis fascia. The procedure is completed with an en bloc excision of the axillary lymph nodes level I and II (see description below). The mastectomy site and axillary nodal basin are then irrigated with saline solution, and meticulous hemostasis is achieved. The wound is closed with a closed suction drainage bottle fixed to a catheter brought out through a separate stab incision. Modified radical mastectomy can be done alone or in association with breast reconstruction. Reconstruction, using implants or myocutaneous flaps, provides many women with an enhanced body image and self-esteem, and better psychosocial adjustment, but it does not impact on the probability of disease recurrence or survival. 81,82 One method becoming widely used is the skin-sparing mastectomy (SSM) that conserves an extensive section of skin, as well as the more recent skin and nipple-sparing mastectomy that preserves the nipple-areolar complex. 83-85 SSM is clearly contraindicated in patients with direct involvement of the skin by the underlying tumor. Nicotine, previous radiotherapy, diabetes and obesity increase the risk of skin envelope ischemia, skin necrosis and infection. However, the additional cost of reconstruction is an issue especially in resource poor countries. Treatment of the axilla Axillary lymph node dissection (ALND) The status of axillary and internal mammary lymph nodes is the most significant prognostic factor for survival in patients with breast cancer. In breast cancer, the status of axillary and internal mammary lymph nodes is the most significant prognostic factor for survival. The axillary nodal basin has been the main target in lymphatic staging in breast cancer because over 75% of the lymphatic flow from the breast is directed to the ipsilateral axilla. Axillary clearance (ALND) has been the gold standard in axillary staging in breast cancer, providing valuable information about the planning of adjuvant therapy, prognosis and an excellent regional disease control as well. Removal of 10 or more nodes as assessed by the pathologist provides accurate information about the axillary nodal status of the patient. The most accepted surgical axillary clearance procedure is a level I and II axillary dissection, detecting 98.5% of cases with positive axillary nodes. 86 Either at the time of mastectomy, or through a separate incision (if BCT), the lateral border of pectoralis major muscle is identified. The clavipectoral fascia, extending laterally from the edge of this muscle, is divided parallel to the edge of the muscle to allow entry into the axilla. The superior <strong>Hospital</strong> and Healthcare Innovation Book 2009/2010 97
Innovation and clinical specialities: oncology border of the dissection is the lower border of the axillary vein; dissection above the vein runs the risk of damage to the brachial plexus. The nerves to latissimus dorsi (thoracodorsal) and to serratus (long thoracic) are identified and are the posterior border of the dissection. The lateral border is the floor of the axilla, consisting of skin and subcutaneous tissue. Retraction of the pectoralis minor muscle medially allows for the removal of level II nodes. All the fatty tissue within these borders is removed. The sensory intercostal brachial nerve runs through the axilla and may or may not be preserved. Sentinel node biopsy Although long considered the standard management of the axilla for breast cancer, ANLD is associated with significant arm morbidity (20-25% risk of lymphedema) and risk of damage to the axillary vein, nerve to the latissimus dorsi and serratus anterior and hypoesthesia of the arm and the thorax. For these reasons, other less invasive but accurate methods have been sought for axillary staging in breast cancer, especially in the developed world, where three-quarters of patients present with early node negative disease. Clinical examination of the axilla and available diagnostic imaging techniques like US, CT and PDG-PET are manifestly inaccurate for axillary staging. Less invasive than ALND, sentinel lymph node biopsy (SLNB) is now accepted as an alternative to routine ALND for the detection of occult lymph node metastases in patients with clinically nodenegative breast cancer. 87,88 SNLD is based on the observation that specific areas of the breast drain by way of afferent lymphatics to a specific ‘sentinel’ node. This node can be detected by injecting vital blue dye (isosulfan blue dye, methylene blue or patent blue V dye) or a radioactive suspension (Tc99m radioisotope labeled colloids). The route of injections include intra parenchymal (peritumorally), intradermal or subareolar. 88,89 . The use of vital dye is resource efficient (cheaper and less time consuming) and safer, but may miss non axillary sites and also carries the risk of anaphylactic reactions while radioactive agents are more expensive, carries the risk of exposure to staff, and requires that the hospital have a nuclear medicine department. There are five principal aims for the excision and histopathological analysis of the SN: ✚ minimally invasive assessment of the nodal status; ✚ selection of patients with positive SNs for elective lymph node dissection (ELND) or adjuvant therapy; ✚ prevention of lymph node dissection and associated morbidity in SN negative patients; ✚ detection of aberrant or alternative lymphatic drainage; ✚ improvement of sensitivity of histopathological detection of lymph node metastasis. 90 Further surgery of the axillary nodes now depends on the results of the sentinel lymph-node biopsy – if negative, ALND is avoided. While SLNB is becoming widely used in the developed world as a method to assess the axilla, ALND remains the recommended management for treatment in any hospital that does not have access to a nuclear medicine department or a dedicated breast pathologist able to use specialized immunohistochemistry markers. Radiotherapy in early breast cancer The aim of radiotherapy to the whole breast after BCT is to establish local control. Numerous studies have shown reductions in local recurrences from 12-35% to 2-10% at 5-10 years. This compares to local recurrence rates after mastectomy of 5%.(91) In most developed countries, the current standard of care for patients with early-stage breast cancer consists of breastconserving surgery, followed by 5–6 weeks’ postoperative radiotherapy used on the whole breast. Probabilities of adequate local control rates and good cosmetic results are high with the use of conventional fractionation. Patients who cannot receive radiation are treated with mastectomy. Some recent papers suggest a small survival advantage which was rather offset by the long term toxicity from radiotherapy resulting in deaths from vascular and cardiac injuries. 92 Some data support the effectiveness of an additional dose applied to the tumor bed (i.e., boost irradiation) to reduce local recurrence. However, delivery of the boosting dose raises the rate of morbidity, which reduces cosmetic outcome. Recent advances in radiotherapy includes partial breast irradiation using various techniques such as such as low or highdose rate brachytherapy (interstitially or with an intracavitary balloon), conformal external-beam irradiation (including intensity modulated radiotherapy), and intraoperative radiotherapy (Electron Intra Operative Therapy-ELIOT). 93,94 Most reports of partial breast irradiation have provided results much the same as those achieved with conventional external beam, even though some caution is needed until the safety and efficacy of such irradiation have been shown in appropriate patients and analysis of long-term treatment outcomes. 95-97 Systemic treatment More than half the women with operable breast cancer who receive only locoregional treatment die from metastatic disease. This indicates that breast cancer is a systemic disease and that the micrometastatic process can occur early even independently from lymphatic spread. 76,98 The way to improve survival is to give these women systemic medical treatment, including endocrine therapy, chemotherapy, or targeted therapy with trastuzumab along with surgery/radiotherapy. Systemic treatment may be given after (adjuvant) or before (neoadjuvant, primary, or preoperative) locoregional treatment. Adjuvant treatment has been shown to be effective in randomized clinical trials, whereas the evaluation of neoadjuvant systemic therapy is ongoing. It is important to realize, especially in the African context, that any systemic therapy including hormonal therapies, will at least temporarily interrupt child bearing. The current recommendations of at least 5 years of Tamoxifen after diagnosis will significantly impact on the ability of a woman to bear many children. Chemotherapy will cause most women to stop menstruating and permanent premature menopause is common. These recommendations listed below, based on the culture of the developed world, may not be acceptable or applicable to African women. The choice of systemic adjuvant therapy in early breast cancer will depend on the following factors; estrogen (ER)/progesterone (PR) receptor status, menopausal status and over-expression of HER2. It will also depend significantly on the risk of recurrence and therefore the potential benefit of the treatment. Any systemic therapy carries with it a risk of toxicity, and can be quite expensive. A woman at high risk of recurrence will benefit significantly from 98 <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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International Hospital Federation H
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Introduction Introduction ERIC DE R
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Innovation and strategy 14 Creativi
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Innovation and strategy: creativity
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Page 119 and 120: Company Profile: Wipak Medical Wipa
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Page 133 and 134: IHF reference The International Hos
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Page 137 and 138: IHF reference IHF Governing Council
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Page 141 and 142: IHF reference JAPAN JAPAN HOSPITAL
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Page 145 and 146: IHF Corporate Member Profiles GE He
Page 147: How Can Health Organizations Get th
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