low-risk BCCs can be removed by each of the three groups of healthcare professionals working in the community

low-risk BCCs can be removed by each of the three groups of healthcare professionals working in the community
The guidance describes which low-risk BCCs can be removed by each of the three groups of healthcare professionals working in the community (and in which groups of patients). It explains when specialist skin cancer teams should be involved in care and treatment. Following a discussion with your healthcare professional, you should be referred to (offered an appointment with) a member of a specialist skin cancer team if:
•you are below the age of 25
•you have a weakened immune system or an inherited condition called Gorlin’s syndrome
•there is any doubt about the risk your tumour presents
•your healthcare professional does not have the necessary skills and knowledge to treat your low-risk BCC in the community.

Why has NICE said this?
•NICE has made these recommendations to make sure that healthcare professionals have the knowledge and skills needed for the risk level of each BCC they diagnose and treat.
What does this mean for me?
•You should only have your low-risk BCC diagnosed and removed by a healthcare professional in the community if they have the knowledge and skills to provide this service and have been accredited to do so. You should ask your healthcare professional to discuss treatment choices with you.

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The NICE guidance explains which health care professionals working in the community

The NICE guidance explains which health care professionals working in the community

The NICE guidance explains which health care professionals working in the community (at surgeries or clinics outside general hospitals) should diagnose and treat low-risk BCCs and how this service should be organised. It makes specific recommendations about:
•what information should be used to decide whether a person’s BCC is low risk
•how information on a person’s BCC should be obtained, recorded and acted on
•maintaining and checking the quality of care people receive
•providing information, advice and support for people with low-risk BCC and their families or carers.
In particular, it describes the training, education, qualifications and accreditation (official recognition and approval) that three different groups of healthcare professionals need to manage low-risk BCCs in the community. They are:
•GPs who only operate on low-risk BCCs that are easy to remove (such as those below the collar bone)
•Specialist GPs who remove an expanded range of low-risk BCCs (including some on the head and neck)
•Specialist doctors and nurses who remove both low- and high-risk BCCs.

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Treatment of low-risk basal cell carcinoma
What choices will I have?
Your healthcare professionals should explain the range of treatments available for low-risk BCC. They should cover possible benefits and risks related to your condition and personal circumstances.

You have the right to be involved in discussions and make informed decisions about your treatment and care. You should be given relevant information that reflects any religious, ethnic, or cultural needs you have and takes into account whether you have any physical or learning disability, sight or hearing problem, or language difficulties. All treatment and care should be given with your informed consent.

What does treatment involve?
Once the diagnosis of low-risk BCC has been confirmed, treatment is usually relatively simple and involves the removal or destruction of the cancer. Surgery is often used to treat low-risk BCCs by cutting out the cancerous cells, as well as some surrounding healthy tissue (to ensure that no cancerous cells remain).
Other treatments include ointments, drugs that become active when exposed to light (photodynamic therapy) and techniques that work by ‘burning’ or ‘freezing’ the cancer cells. Many BCCs that appear on the trunk (not on the head, neck and limbs) can be treated in this way.

Who will do the surgery if I need it?
Surgery to remove low-risk BCCs can often be performed by a healthcare professional with additional skills in skin cancer who is working in the community (such as in GP surgeries or local community hospitals/treatment centres rather than in a general hospital). This will usually be a GP with a special interest and training in this area. Sometimes skin specialists (dermatologists) or members of their team will offer services to manage low risk BCCs in the community too.

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Basal cell carcinoma - Deciding whether your BCC is low risk

Basal cell carcinoma
BCC is a type of skin cancer where some cells in the skin grow and divide in an uncontrolled way, leading to an abnormal growth on the skin (sometimes called a tumour or lesion). It usually develops on parts of the body that have been exposed to the sun.

BCC usually presents a low risk to a person’s health. However, if it isn’t diagnosed early and treated properly it can result in tumours that damage the affected area (including important body parts such as the nose, eye, ear and lip). Such tumours are very challenging to treat.

Deciding whether your BCC is low risk
Your healthcare professional will assess the risk of your BCC. How easy a BCC is to treat affects whether it is classed as high or low risk. This depends on a number of factors, including:
•the type, size and appearance of the tumour
•your age (if you are a child or young adult)
•the strength of your immune system and whether you have a genetic condition that increases your chance of developing BCC
•the location of the tumour (for example, if it is in an area that would make treatment difficult or greatly affect how the skin would look afterwards)
•whether it is a BCC that has reappeared because it was not completely removed the first time it was treated.

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The management of basal cell carcinoma
Additional considerations
Once the tumour has been assessed the most appropriate treatment options must be discussed with the patient. Although surgery is the gold standard there are some circumstances, which will affect the final decision. Patients reluctant to consider any form of surgery might be referred for radiotherapy. Similarly, co-existing medical conditions or drug medication may influence the choice between surgical and non-surgical treatment. Aggressive treatment might be inappropriate for patients of advanced age or poor general health, especially when dealing with asymptomatic low-risk lesions that are unlikely to cause significant morbidity. Some elderly or frail patients with symptomatic or high-risk tumours might prefer less aggressive treatments designed to palliate rather than cure their tumours. Local availability of various specialized services, together with the experience and preferences of the dermatologist managing the case are also factors that will influence the selection of therapy. A great variety of skills is needed to manage the spectrum of problems thrown up by basal cell carcinoma. Multidisciplinary teams are of great value in difficult high-risk tumours in order to obtain both the highest clearance rates and best cosmetic results. Essential members of such a team are likely to cover the specialties of dermatology, diagnostic imaging, histopathology, oncology, radiotherapy and specialised surgery e.g. dermatologists, plastics, maxillofacial, ophthalmology. Such close collaboration has an additional educational benefit for all parties.

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The management of basal cell carcinoma - Photodynamic therapy

The management of basal cell carcinoma
Photodynamic therapy
Mainly due to its good cosmetic outcome the use of topical photodynamic therapy (PDT) in the management of BCC becomes more and more available in dermatological centres. In a study of 151 BCCs treated with PDT without long-term follow-up, 88% demonstrated a complete response. 74 (Strength of Evidence C, II-iii) Long-term follow-up data on large series is needed to demonstrate whether or not topical PDT has a role in the management of BCC. Methyl aminolevulinate PDT was recently shown to be an effective treatment even for nodular BCC. 75 However, as depth of penetration of the photosensitizer appears to be a limiting factor with topical PDT, without previous curettage PDT it is only likely to be of benefit for the treatment of superficial BCC in low risk areas. 75-76 (Strength of Evidence C, III) A report from the British Photodermatology Group suggests topical ALA-PDT to be an effective therapy for superficial (<2 mm thick) BCC.

Chemotherapy

Chemotherapy has been used both for the management of uncontrolled local disease and for patients with metastatic BCC, which is both an extremely rare and a rapidly fatal condition. A cisplatin (CDDP)- based chemotherapy (including doxorubicin) as sole therapy and as neoadjuvant (NA) therapy revealed a complete remission in eight of 28 patients (28%) suffering from advanced basal cell and squamous cell cancers, a partial remission was achieved in 11 of 28 patients (40%)

Palliation and observation

In some instances the patient’s general health or condition may indicate palliation and / or observation. The risk /benefit ratio must be considered individually to assess whether the cases warrants only palliation, observation or both. In the debilitated patient aggressive treatment may be inappropriate. Observation alone or simple debulking or RT may achieve local control and improve quality of life.

Retinoids
Oral retinoid therapy may prevent or delay the development of new BCCs. Such therapy has mainly been used in patients with the basal cell nevus (Gorlin's) syndrome and may also have a lesser effect in producing partial regression of existing BCCs. A recent study questioned the benefit of acetretin in preventing BCCs. 81 Unfortunately, the relatively high doses necessary mean that compliance may be poor, and relapse occurs following the discontinuation of treatment.

Follow-up

Long-term hospital-based follow-up of all patients after treatment of BCC is neither necessary nor recommended. However, follow-up can be important for selected patients, although there is no clear consensus on either the frequency or total duration or such review. The main arguments for follow up are: (i) early detection of tumour recurrence; (ii) early detection and treatment of new lesions; and (iii) patient education, especially regarding sun protection measures. Most evidence suggests that the majority of BCCs that recur, will present within 5 years of treatment, although up to 18% will recur after this.A review of all studies published since 1947 suggested that for primary (previously untreated) BCCs treated by a variety of modalities less than one-third of all recurrences occurred in the first year following treatment, 50% appear within 2 years, and 66% within 3 years. 41 Patients who have had one BCC are at significantly higher risk of developing new primary lesions,many of which may go unnoticed by patients. In a 5-year prospective follow-up study of 1000 patients following treatment for BCC, 36% developed new primary BCCs and 20% of patients with very fair skin types and frequent sun exposure went on to develop multiple BCCs. 15 Consequently, some authors have recommended long-term, even lifetime follow-up, particularly for patients with high-risk or multiple lesions. 41,83 In contrast to this special group patients with single BCCs completely excised in low risk sites possibly do not require follow up.

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The management of basal cell carcinoma - Topical therapy

the management of basal cell carcinoma
Topical therapy
Treatment is especially useful for low-risk, extrafacial BCC but it cannot be expected to eradicate invasive BCC.

Topical Imiquimod
Imiquimod is an immune response modifier (IRM). It has been successfully used for the treatment of cutaneous neoplasias as well as viral skin diseases and acts as an antitumour agent principally by both production alpha interferon and other cytokines and induction of apoptosis.
The use of imiquimod 5% cream for the treatment of superficial (sBCC) and nodular BCC (nBCC) was recently investigated comparing low frequency dosing with and without occlusion for 6 weeks. In patients with superficial BCC the highest complete clearance rates ranged between 87% with occlusion (20 of 23 patients) and 76% without occlusion (19 of 25 patients). Several studies have shown a clearance rate (judged at 3 months with histology) of 87.9% with one application/day for 6 weeks and of 80.8% (with one application /day/5 days/w for 6 weeks)in sBCC without occlusion. If applied 5 times per week for 6 weeks (pooled analysis of two double-blind vehicle controlled clinical trials) a histological clearance was noted in 82% (152/185) of patients. Clearance was assessed by excisional histology at the completion of treatment. Interim results from a long-term open-label uncontrolled study indicate an estimated sustained clearance of 92% at 12 months. The recommendation of prescription of imiquimod for the treatment of sBCC is actually once/day, 5 times/week for 6 weeks.

In the nodular BCC group (7 days per week treatment, 12 weeks therapy) the percentage of complete responders was only 76% (16 of 21) and 71% (7 days per week, 6 weeks) . Therefore imiquimod is not actually recommended for the treatment of nodular BCC.
A successful treatment of multiple BCCs with topical imiquimod in nevoid basal cell carcinoma syndrome (Gorlin-Goltz syndrome) was also reported.

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the management of basal cell carcinoma - Radiotherapy

the management of basal cell carcinoma
Radiotherapy
Radiotherapy (RT) is an extremely efficient form of treatment, but faces the same problem of accurately identifying tumour margins as standard excisional surgery. RT includes a range of treatments using different types of equipment, each with its own specific indications and side-effects. It is therefore best performed by specialized dermatological centers or by clinical oncologists with a specialist interest in skin cancer.

Careful patient selection can result in very high cure rates; in a series of 412 BCCs treated with RT, 5-year cure rates of 90.3% were achieved. 18 In a prospective trial, where 93 patients with BCC were randomized to receive either cryosurgery or radiation therapy; the 2-year cure rate for the RT group was 96%. 52 A review of all studies published since 1947 suggested an overall 5-year cure rate of 91.3% following RT for primary BCC and a review of all studies published since 1945 suggested an overall 5-year cure rate of 90.2% following RT for recurrent BCC.
Radiotherapy can be used to treat many types of BCC, even those overlying bone and cartilage, although it is probably less suitable for the treatment of large tumours in critical sites, as very large BCC masses are often both resistant and require radiation doses that closely approach tissue tolerance. However, surgery should be preferred for BCC of the face measuring < 4cm in diameter.

Radiotherapy is also not indicated for BCCs on areas subject to repeated trauma such as the extremities or trunk and for young patients as the late-onset changes of cutaneous atrophy and telangiectasis may result in a cosmetic result inferior to that following surgery. It can also be difficult to use RT to re-treat BCCs that have recurred following RT. Modern fractionated dose therapy has many advantages but requires multiple visits to a specialist centre. Late-onset fibrosis may cause problems such as epiphora and ectropion following treatment of lower eyelid and inner canthal lesions, where cataract formation is also a recognized risk, although this can be minimized by the use of protective contact lenses.
There is some suggestion that BCCs recurring following RT may behave in a particularly aggressive and infiltrative fashion, although this may simply reflect that these lesions were of an aggressive, high-risk type from the very beginning.

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Non-surgical techniques - The management of basal cell carcinoma

The management of basal cell carcinoma
Non-surgical techniques
Destructive techniques without histological control
Curettage and cautery/electrodesiccation
There are wide variations in how this technique is performed (e.g. type of curette used, number of cycles of treatment) and both experience in the technique and appropriate selection of cases is crucial to success. Curettage and cautery is best used for selected low-risk lesions (small, well defined primary lesions with non-aggressive histology usually in non-critical sites where 5-year cure rates of up to 97% are possible. Curettage and cautery is not recommended for the management of large and other 'high-risk' tumours.42,45-48

Tumour size is an important factor as the recurrence rate rises dramatically with increasing tumour size.

A literature review of all studies published since 1947 suggested an overall 5-year cure rate of 92.3% following curettage and cautery for primary BCC. 41 However, a similar review of all studies published since 1945 suggested an overall 5-year cure rate of 60% following curettage and cautery for recurrent BCC. This supports the view that curettage and cautery is much less useful in the treatment of recurrent BCC, especially in high-risk sites.

Cryotherapy
Cryosurgery is widely used to treat solitary and multiple BCCs. Individual technique can vary considerably, using the open or closed spray techniques and single, double or triple freeze/thaw cycles.

Many large published series specifically exclude the treatment of very high-risk BCCs, emphasizing the importance of careful selection of appropriate lesions with non-aggressive histology, away from critical facial sites in order to achieve high cure rates. There are reports in the ophthalmological literature recommending the use of cryo-surgery for periocular BCC, although full-thickness eyelid defects may occasionally result and require subsequent plastic surgical reconstruction.
Thorough curettage immediately prior to cryosurgery may help to increase the cure rate.

As with most treatment modalities, cryosurgery is less useful in the treatment of recurrent BCC.
Post-operative wound care can be a problem. However, the treatment is usually well tolerated when performed on a local anaesthetic, outpatient basis and the cosmetic results can be excellent.

Carbon dioxide laser
Carbon dioxide (CO2) laser surgery is not a widely used form of treatment and there is little published follow-up data. The treatment is mainly recommended for low-risk lesions. When combined with curettage, CO2 laser surgery may be useful in the treatment of large or multiple superficial BCCs.

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Prognosis and the concept of “low-risk” and high-risk” basal cell carcinomas

Prognosis and the concept of “low-risk” and high-risk” basal cell carcinomas
The histological subtype may correlate with prognosis, and thereby may be used to describe BCCs as low or high risk .

Management
The aim is to completely cure the tumour with the best cosmetic result. The early detection and appropriate (re-)treatment of either recurrent BCCs or new primary BCCs may help to increase the chances of permanent cure and to minimize morbidity. Patient education together with close collaboration with colleagues in primary care should allow the vast majority of adequately treated patients to be discharged back to the care of their general practitioners or dermatologists in private practice.

Surgical techniques
The most commonly used surgical techniques can be divided into main categories:

A.) Excision with predetermined margins
The aim of any excisional procedure is to eradicate the tumour entirely. Discussion of the surgical excision of BCC is divided into the following sections:

1 Primary (previously untreated) BCC. Surgical excision is a highly effective treatment for primary BCC. 18-19 (Strength of Evidence A, II-ii) The excised tissue can be examined histologically and the peripheral and deep surgical margins can be grossly assessed. The overall cosmetic results are usually good. The use of thorough curettage prior to excision of primary BCC may help to increase the cure rate by more accurately defining the true borders of the BCC. The size of the surgical margins should correlate with the likelihood that subclinical tumour extensions exist. Few data exist on the correct deep surgical margin, as this will depend upon the local anatomy. Studies using horizontal frozen sectioning Mohs micrographic surgery (MMS) to detect accurately BCC at any part of the surgical margin suggest that, for a small (< 20 mm) well defined BCC, 3 mm peripheral surgical margins will clear the tumour in 85% of cases (and a 4-5 mm margin will increase the peripheral clearance rate to approximately 95%, i.e. approximately 5% of small, well-defined BCCs show subclinical spread of > 4 mm. 2, 23) In contrast to small primary BCCs, morphoeic and large BCCs require wider surgical margins for complete histological resection. For primary morphoeic BCC, the rate of complete excision with increasing peripheral surgical margins is as follows: 3 mm margin: 66%, 5 mm margin: 82%, 13-15 mm margin: > 95%. 23 Positive margins are most often seen in morphoeic and facial tumours and are associated with a 26% recurrence rate over 5 years compared to 14% with free margins. 24 In the lid or periorbital area incompletely excised and morphoeic tumours were shown to have a 50% risk of recurrence.

2 Recurrent (previously treated) BCC. The results of all published series on the surgical excision of BCC show that cure rates for recurrent BCC are inferior to those for primary lesions. 26 Recurrent BCCs require wider peripheral surgical margins than primary lesions with or without standard (non-Mohs) frozen section control. Peripheral excision margins for recurrent BCC of 5-10 mm have been suggested. (Strength of Evidence A, II-ii)

3 Incompletely excised BCC (positive histological margins). This scenario should not occur following excision with histological control of margins. However if closure is completed before histological assessment there will be instances that the pathologist reports tumour present at the lateral and/or deep margin of excision. In some cases this may be apparent, not real, and due to tangential slicing of the specimen or tissue shrinkage. A study in which 43 incompletely excised BCCs were re-excised and the tissue examined using standard tissue sectioning techniques suggested that only 7% contained residual BCC. 28 However, when 78 incompletely excised BCCs were re-excised and examined using horizontal frozen sectioning (Mohs micrographic surgery) in order to detect BCC more accurately at any part of the surgical margin, 55% were found to contain residual BCC. 29 (Strength of Evidence A, II-iii) These findings were in accordance with another study demonstrating a tumour persistence in 28% of cases following incomplete excision of BCC. 30
Several studies have demonstrated that not all tumours will recur despite positive margins but the recurrence rate varies from 17-58%. The lowest rates were for lateral margin involvement only. The higher rates were for deep and lateral margin involvement, for tumours which were previously recurrent and those which had been treated by radiotherapy.
In a series of 187 incompletely excised BCCs, with 93% occurring on the head and neck, 119 were immediately retreated with radiotherapy, one was excised and 67 were not treated. After a median follow-up period of 2.7 years, statistical analysis suggested a 5-year probability of cure in the radiotherapy group of 91%, and in the untreated group of 61%.

So what advice should the patient be given?
Several studies have strongly recommended the immediate retreatment of incompletely excised BCC especially those where the surgical defect has been repaired using skin flaps or skin grafts. There may be occasions when a patient with a low risk primary tumour with possible lateral margin involvement opts for a period of observation. However generally it seems appropriate to re-excise with or without frozen section control or Mohs micrographic surgery.

B.) Stepwise excision with histology control of margins
Micrographic surgery might serve as a treatment of choice for large or difficult primary BCC lacking distinct clinical boundaries. The histological mapping of the tumour’s margins preserves tumour-free adjacent tissue, optimizes wound reconstruction and reduces the percentage of additional excisions in order to remove the tumour completely. 38 (Strength of Evidence A II-iii) This specialized minimal surgery was initially developed by Mohs and offers highly accurate yet conservative removal of BCC.

A review of all studies published since 1947 suggested an overall 5-year cure rate of 99% following Mohs micrographic surgery for primary BCC 41 and a review of all studies published since 1945 suggested an overall 5-year cure rate of 94.4% following Mohs micrographic surgery for recurrent BCC. 26 In addition to Mohs micrographic surgery, further fresh tissue micrographic techniques exist: both the margin strip method (“Tübinger Torte”) as well as the “Munich” method follow the same aim of complete tumour resection though they differ in some points, for example in the preparation or technique of tumour excision. The latter method was the treatment of choice for the excision of 3065 BCCs in 2795 patients. In 53.3% of all BCC, the first excision led to a complete tumour removal, another 36.9% were free of BCC after a second excision. Interestingly, clearance with one step excision ranged between 80% of adenoid-cystic, >50% of solid but only 43% of morphea-like BCC. The follow-up period over more than 5 years resulted in recurrences of BCC in 41 of 1604 patients (2.6%). 36% of these recurrent BCCs were re-recurrent tumours, 64% of these tumours were initially primary BCCs.

When compared with other outpatient-based treatments for BCC, these specialized methods undoubtedly offer high cure rates but are relatively expensive and time consuming.

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The management of basal cell carcinoma

Disclaimer
This guideline for the management of basal cell carcinoma (BCC) is based on that prepared by the British Association of Dermatologists and has been prepared by the BCC subcommittee of the Guidelines Committee of the European Dermatology Forum. It represents an evidence-based guidance for treatment, with identification of the strength of evidence available at the time of preparation of the guideline, and a brief overview of epidemiological aspects and clinical management of patients with BCC.
Many different and well-accepted treatments are used in the management of BCC. This guideline aims to aid selection of the most appropriate treatment for individual patients.

Definition
BCC is a slowly growing, locally invasive malignant epidermal skin tumour, which exhibits a differentiation potential comparable to at the embryonic hair bud. BCC tends to infiltrate tissues in a three-dimensional contiguous fashion through the irregular growth of subclinical finger-like outgrowths. Metastases are extremely rare, and the morbidity associated with BCC is related to local tissue invasion and destruction; growth pattern largely correlates with the aggressiveness of the tumour. 3,4,5 The tumour is mainly located on the head and neck and mainly affects Caucasians. The multipotent differentiation potentential is reflected by a larger diversity in clinical appearance and morphology, i.e. nodular, cystic, ulcerated, superficial, morphoeic (sclerosing), keratotic and pigmented variants. Histological subtypes can also serve a prognostic factor

Incidence/prevalence
BCC is the most common cancer in the U.S.A., Australia and Europe; its incidence (new cases/100.000 inhabitants/year) increases worldwide with the following numbers being reported: 1998: 128/105 male/female/ 100.000 in South Wales, Great Britain; 2058/1195 male/female/100.000 in Northern Australia. 6-8 The most significant aetiological factor is exposure to ultraviolet radiation. Sun exposure during childhood may be especially critical in the development of BCC in adult life. 9,10
Patients with BCC on head and neck show different phenotypes, including one with continuous development of BCC clusters on the trunk. Such patients are generally younger than patients with BCC on head and neck only. 11 Further risk factors are increasing age, male sex (18-40% more common in white men than women, skin type I and II) and chronic immunosuppression.. 12,6 Multiple BCCs may also arise in basal cell nevus (Gorlin's) syndrome. 13 Once a person has developed a BCC there is a significantly increased risk of developing subsequent BCCs at other sites. 14-15
There is evidence that epidemic of BCCs in Australia is beginning to abate, especially in younger people, possibly as a result of adequate photoprotection. 16

Diagnosis and Investigation
Ideally the treatment of BCC is based upon a clinical diagnosis. Where clinical doubt exists, or when patients are referred for specialized forms of treatment, histology is crucial. Information on the prognosis will be provided by histological subtype of the BCC. Clinically the extent of penetration of tumours is impossible to judge. Scanning techniques such as CT and MRI may be rarely needed

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Algorithm : Postmenopausal women - Breast Cancer

Algorithm : Postmenopausal women
The use of an aromatase inhibitor (steroidal or non-steroidal) is an indication for evaluation of BMD by DXA. BMD assessments should be done at the lumbar spine and at one or both total 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 the baseline BMD, age, and presence of any major risk factors for osteoporotic fracture. These are defined as:

• previous fragility fracture above the age of 50 years;
• parental history of fracture;
• a body mass index (BMI) 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; and
• prior oral corticosteroid use for more than 6 months. 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.

For women aged under 75 years or without major risk factors, three groups of patients are defined based on baseline BMD:

High-Risk Group: Patients with a baseline T-score of <–2 at the lumbar spine or either hip site or whose BMD falls below this threshold should receive bisphosphonate therapy at osteoporosis doses in addition to lifestyle advice, calcium and vitamin D supplementation.

• The choice of bisphosphonate should be based on local protocols and funding arrangements. Weekly oral alendronate 70 mg or risedronate 35 mg, monthly oral ibandronate 150 mg, 3-monthly intravenous ibandronate 3 mg, or 6-monthly intravenous zoledronic acid 4 mg are all considered appropriate.

• Bisphosphonates are contraindicated in patients with a low glomerular filtration rate (<30 ml/min/1.73m2) or hypocalcaemia. Such
patients who require bone sparing therapy should be referred to the local bone service. Oral bisphosphonates must be used with
caution in patients with oesophageal disease, although intravenous bisphosphonates will usually be appropriate in such patients.

• Follow-up of patients requiring bisphosphonate treatment should include a repeat DXA after 24 months and/or measurement of a bone resorption marker, if desired, as an aid to judging compliance and response. If there is bone loss associated with bisphosphonate therapy, first check that the compliance with instructions is correct, then re-evaluate for secondary osteoporosis. Poor compliance and secondary osteoporosis explain most cases of poor response. However, some patients may be true non-responders and a switch of therapy, for example to an intravenous bisphosphonate, or a referral to the local bone service should be considered in these patients.

Medium-Risk Group: For those patients with a T-score between –1 and –2, lifestyle advice plus calcium (1 g/day) and vitamin D (400–800 IU) supplementation are recommended unless dietary intake of calcium exceeds 1 g/day and serum 25-hydroxyvitamin D is known
to be >20 ug/L.

• A follow-up DXA scan should be performed at 24 month intervals to exclude a clinically significant reduction in BMD (T-score of <–2 or >4% per annum decline in BMD at either the spine or hip [the forearm is not suitable for repeat assessments within such timeframes]).

• Patients who exceed these limits should commence bone protection therapy as described in the high-risk group.

Low-Risk Group: For those patients with normal BMD (T-score >–1), the risk of developing osteoporosis over a 5-year treatment period is very low. Advice on lifestyle (diet, weight-bearing exercise, reduced alcohol consumption and cessation of smoking) is sufficient and no specific intervention or follow-up assessment of BMD is required.

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Algorithm : Women who experience premature menopause

Algorithm : Women who experience premature menopause
The development of a treatment-induced menopause or planned ovarian suppression treatment before the age of 45 years are indications for evaluation of BMD by DXA. BMD assessments should be done at the lumbar spine and at one or both total 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 ovarian suppression therapy or oophorectomy and within 12 months of developing postchemotherapy amenorrhoea.

Monitoring and treatment thereafter depends on the baseline BMD and the type of any concomitant endocrine treatment. Owing to the very rapid bone loss observed with the use of ovarian suppression therapy plus an aromatase inhibitor, a

different threshold for follow-up, monitoring and intervention is recommended. Any patient with a documented vertebral fragility fracture or previous low trauma hip fracture should receive prophylactic bisphosphonate treatment irrespective of baseline BMD.

For patients who are not receiving a concomitant aromatase inhibitor, three groups of patients are defined based on baseline BMD:

High-Risk Group: Patients with a baseline T-score of <–2 at the lumbar spine or either hip site or whose BMD falls below this threshold

should receive bisphosphonate therapy at osteoporosis doses in addition to lifestyle advice, calcium and vitamin D supplementation.

• The choice of bisphosphonate should be based on local protocols and funding arrangements. Weekly oral alendronate 70 mg or risedronate 35 mg, monthly oral ibandronate 150 mg, 3-monthly intravenous ibandronate 3 mg, or 6-monthly intravenous zoledronic acid 4 mg are all considered appropriate.

• Bisphosphonates are contraindicated in patients with a low glomerular filtration rate (<30 ml/min/1.73m2) or hypocalcaemia. Such patients who require bone sparing therapy should be referred to the local bone service. Oral bisphosphonates must be used with caution in patients with oesophageal disease, although intravenous bisphosphonates will usually be appropriate in such patients.

• Follow-up of patients requiring bisphosphonate treatment should include a repeat DXA after 24 months and/or measurement of a bone resorption marker, if desired, as an aid to judging compliance and response. If there is bone loss associated with bisphosphonate therapy, first check that the compliance with instructions is correct, then re-evaluate for secondary osteoporosis. Poor compliance and secondary osteoporosis explain most cases of poor response. However, some patients may be true non-responders and a switch of therapy, for example to an intravenous bisphosphonate, or a referral to the local bone service should be considered in these patients.

Medium-Risk Group: For those patients with a T-score between –1 and –2, lifestyle advice plus calcium (1 g/day) and vitamin D (400–800 IU) supplementation are recommended unless dietary intake of calciumexceeds 1 g/day and serum 25-hydroxyvitamin D is known to be

>20 ug/L.

• A follow-up DXA scan should be performed at 24 month intervals to exclude a clinically significant reduction in BMD (T-score of <–2 or >4% per annum decline in BMD at either the spine or hip [the forearm is not suitable for repeat assessments within such timeframes]).

• Patients who exceed these limits should commence bone protection therapy as described in the high-risk group.

Low-Risk Group: For those patients with normal BMD (T-score of >–1), the risk of developing osteoporosis over a 5-year treatment and follow-up period is very low. Advice on lifestyle (diet, weight-bearing exercise, reduced alcohol consumption and cessation of smoking) is sufficient and no specific intervention or follow-up assessment of BMD is required.

For patients receiving a concomitant aromatase inhibitor, only two groups are defined:

High-Risk Group: Those patients with a T-score of <–1 should receive bone protection therapy with a bisphosphonate as described above.

Medium-Risk Group: Those patients with a T-score of >–1 should be monitored as indicated for all medium-risk groups.

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Treatment algorithms proposed by the Expert Group - Breast Cancer

Treatment algorithms proposed by the Expert Group
The choice of endocrine therapy should be based on the characteristics and prognosis of the underlying breast cancer, rather than pre-existing bone health, provided that appropriate monitoring and treatment of bone loss can be ensured.

Two algorithms for the management of bone loss in early breast cancer are proposed.

Algorithm 1: Women who experience premature menopause due to chemotherapy or ovarian suppression, ablation or removal.

Algorithm 2: Postmenopausal women receiving treatment with aromatase inhibitors.

There are no specific monitoring or treatment requirements for:

• women who continue to menstruate after treatment for early

breast cancer; or

• postmenopausal women above 45 years of age who do not require endocrine treatment or who are receiving tamoxifen therapy.

Any patient, regardless of age, with a baseline T-score of <–2 should be assessed for other causes of osteoporosis, based on erythrocyte sedimentation rate (ESR), full blood count (FBC), bone and liver function tests (calcium, phosphate, alkaline phosphatase, albumin, aspartate aminotransferase [AST] / γ-glutamyl transferase [γGT]), serum creatinine and thyroid function tests, and the serum protein electrophoretic strip.

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Algorithms and recommendations - breast cancer

Algorithms and recommendations
The American Society of Clinical Oncology (ASCO) has suggested an algorithm for the management of treatment- induced bone loss.84 In patients with a history of breast cancer, postmenopausal women receiving aromatase

inhibitors are considered as “high-risk” and recommended to undergo annual DXA assessment of the spine and hip, and receive calcium and vitamin D supplements. Those with BMD above the T-score threshold for a diagnosis of osteoporosis (T-score of >–2.5) are reassured and monitored on an annual basis, while those with a T-score of ≤2.5 are recommended to receive a bisphosphonate in addition to calcium and vitamin D supplementation and continue with annual DXA scans.

We have modified this algorithm to reflect the more recent findings summarised previously and the importance of risk factors other than BMD in selection of patients for intervention. Elderly (>75 years of age) women with one or more risk factors for osteoporotic fracture should receive bone protection with a bisphosphonate irrespective of BMD. Additionally, to reflect the speed of cancer treatment-induced bone loss, we suggest a more cautious BMD level for intervention. In postmenopausal women we recommend intervention when the T-score falls below –2 or if the rate of bone loss in women with pre-existing osteopaenia exceeds 4% per year. Similar recommendations apply to women with a premature menopause, with the exception of those receiving ovarian suppression plus an aromatase inhibitor in whom the recommended T-score threshold for intervention is –1, due to the very rapid losses of bone which occurs in this group of women averaging 16% over 3 years.

Where bisphosphonate therapy has been recommended, local protocols and funding arrangements should be taken into consideration when choosing the most appropriate product to use. Weekly oral alendronate 70 mg or risedronate 35 mg, monthly oral ibandronate 150 mg, 3-monthly intravenous ibandronate 3 mg, or 6-monthly intravenous zoledronic acid 4 mg are all considered appropriate. The dose of zoledronic acid used in postmenopausal osteoporosis is 5 mg annually given by the intravenous route. However the studies referenced in this document where zoledronic acid has been used to prevent breast cancer treatment-induced bone loss have used 4 mg biannually. The 4 mg dose every 6 months has thus been included in the algorithm, but individual clinicians may wish to use 5 mg annually.

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Breast Cancer treatment the ultimate treatment for Breast Cancer

Breast Cancer treatment the ultimate treatment for Breast Cancer:
Breast cancer is a disease found in most of the women in the world’s each nook and corner, the problem is that to recognize the problem at the very first level is not an easy task

How the breast cancer grows:

Breast cancer grows like a tumor in the breast tissues. Breast cancer is caused at two points in the breast one is in the ducts and other in the lobules one is responsible for movement of breast milk towards nipple and other is the producer of breast milk during pregnancy and feeding the baby. Sometime it can begin in the other areas of the breast too. Estrogen hormones also cause breast cancer, as body develops sensitivity to these hormones.

Understanding breast cancer NYC and Breast Cancer treatment

The main cause of the cancer is multiplication of diseased tissues, which can become tumors. In Breast Cancer NYC, The treatment of the breast cancer is dependent upon the size of the tumor and the criticalness the growth of the tumor. NYC Breast Cancer treatment comprises of surgery, body hormonal therapy, immunotherapy etc. By NYC Breast Cancer treatment the breast cancer tissues are removed then production of the cancer tissue stops growing that’s why this cure can be permanent, which is not there in other cases. Sometimes Radiation is also used in order to treat breast cancer. The problem of Radiations can be devastating as they can affect heart and cause heart failure. So the surgical treatment can be the best treatment Chemotherapy regimes too kill the endless increasing tissues and can be used to treat breast cancer.

NYC Breast Cancer treatment:

Breast thermograph the treatment in New York, provides possibility of regaining your health in the same spirit which you were enjoying earlier. This method is used to diagnose the diseases too, that’s why the earlier detection can be possible and stops reaching cancer in its critical stage, which causes irreparable damage to the body. So we don’t use this kind of treatment to cure Breast Cancer NYC.

Mammography scanning which causes ionizing radiation can cast more devastating impacts, since 1970 it is commonly used in ignorance. It multiplies the cancer tissues inside the body.

Precautions before and after:
After breast surgery the rest of three months is most necessary, otherwise after biopsy one month rest is sufficient. Consuming tobacco, coffee or tea can be most problematic. Using a skin cream or any other cosmetics like deodorant etc on the skin before and after the surgery is not good for your health. Even avoid using hair remover too.

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Treatment for Breast Cancer In New York City

Treatment for Breast Cancer In New York City
The treatment of Breast Cancer NYC is said to be the one of the best, foremost famous, most equipped and also it has latest treatment among the markets especially for the folks of NYC. The gynecologists NYC are in great demand and they are also the busiest of all. In NYC the health care is having prime importance and day by day its steps up the quality and good amount of treatment. This place provides a good and healthy environment to the suffering patient. In this biggest town it is one of the best among the health care business. The gynecologist NYC are the best among all the places ant they give their best services to treat the patient of breast cancer NYC.

In several towns and in several huge hospitals, the treatment of NYC breast cancer is easily accessible. It is also related with the services of insurance and with the health care financial services. It is a place where patients find themselves in a comfortable and secure condition in almost every field.

Here you can see the records of the celebrities and the top officials who came here to solve their problem. the record of the hospital shows and speaks about the volume of stories and it will tell you about the fact that how many percentage of the breast cancer patient takes the help of this particular hospital and for how many of then this hospital has proved to be a gift. It is said that this hospital is a great gift for the patient of breast cancer. It is very much famous for its treatment and particular services.

Gynecologist NYC constitutes qualified and foremost experienced set of doctors who are fully responsible for its set up and also for smooth running of this hospital. They give their appropriate services to the patients of the breast cancer depending upon the condition, seriousness and flexibility of the breast cancer patient. They are distinctive from all the other institutions of the same type because they take any case in such a way and create the things in such a way that it looks easy. It is their important characteristics.

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Monitoring the effects of treatment for breast cancer treatment-induced bone loss

Monitoring the effects of treatment for breast cancer treatment-induced bone loss
The response to anti-resorptive therapy can be monitored in the individual by the use of bone turnover markers or BMD. The goal of monitoring the individual is to identify nonresponse.
This might indicate inadequate compliance with therapy, underlying secondary osteoporosis or simply failure of the drug to be effective.

Bone turnover markers can be used to monitor response to treatments such as the once weekly (or once monthly) bisphosphonates risedronate, alendronate and ibandronate.

The primary mechanism of action of these drugs is to reduce bone resorption, and so it is logical to use bone resorption markers. The most commonly used markers are urinary NTX expressed as a ratio to creatinine and measured on a second morning void urine sample, serum CTX on a serum sample collected between 8 and 10am with the patient in the fasting state. These markers decrease on average by 55–75%, and the maximal response is complete by about 3 months of treatment. It may be helpful to have two measurements of bone resorption marker before the treatment is started and then further measurements can be made at 3 and 6 months.

The goal of anti-resorptive treatment is to reduce the bone resorption marker by more than the least significant change, into the lower half of the reference range for healthy young women. Bone turnover markers do vary from day to day, and the least significant change approach takes this into account. A decrease of 50% or more in bone resorption markers usually indicates that the least significant change has been exceeded. It is helpful to plot out the graph to show to the patient. The lower half of the reference range is taken as the second target. Women between the age of 35 and 45 years have reached peak bone mass and have not yet started to lose bone, and so this can be considered to be a period of stable bone health. The lower part of the reference range has been associated with the lowest risk of fracture. This approach is helpful when bone turnover markers are being measured for
the first time once the patient has started treatment. Care needs to be taken when interpreting bone turnover markers, as there may be changes due to intercurrent diseases or to
recent fracture. BMD can also be used to monitor response to anti-resorptive treatments. It is usual to recommend an 18-month to 2-year interval before making the second measurement, as the increase in BMD is quite small, even at the lumbar spine (the optimal site for measurement).

The only published study of bisphosphonates in aromatase inhibitor-associated bone loss is the use of zoledronic acid in women receiving letrozole. In this study, zoledronic acid therapy was associated with a mean increase in the spine and total hip at 1 year of 4% and 3%, respectively. The best site in the proximal femur for monitoring therapy is the total hip, as this shows the least variability. Care needs to be taken in interpreting change in BMD as there may have been changes to vertebral anatomy in the intervening period, for example degenerative changes in the spine, differences in the positioning of the femur or large changes in weight. The least significant change for the spine is about 5%.

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Treatment of aromatase inhibitor-induced bone loss

Treatment of aromatase inhibitor-induced bone loss
As in other forms of increased bone loss, the bisphosphonates are the preferred treatment for aromatase inhibitor-induced bone loss. The results of several intervention studies with zoledronic acid have been published recently; there are also ongoing studies with a number of oral bisphosphonates, such as anastrozole and risedronate in the SABRE trial, and anastrozole and ibandronate in the ARIBON trial. In SABRE, 138 women receiving anastrozole who were osteopaenic at baseline were randomised to risedronate 35 mg weekly or placebo. Risedronate led to a mean increase of 1.7% in BMD at 12 months compared with a 0.41% loss in the placebo arm. In this study, risedronate also improved BMD in a cohort of women with osteoporosis at baseline.76 In ARIBON, 50 osteopaenic women were randomized to monthly oral ibandronate 150 mg monthly or placebo during treatment with anastrozole. As expected, ibandronate prevented the bone loss observed in the placebo group. BMD changes at 12 months were +2.78% at the spine and +1.35% at the hip versus -2.61% at the spine and -2.34% at the hip for ibandronate and placebo treated patients, respectively (p<0.001).

These two studies suggest that bisphosphonates at the dose and schedule used in postmenopausal osteoporosis are effective in the setting of aromatase inhibitor bone loss.
The Austrian Breast Cancer Study Group (ABCSG) reported on 400 patients with early breast cancer undergoing ovarian suppression with goserelin plus either anastrozole or tamoxifen, with or without bone-protecting therapy comprising a 6-monthly schedule of zoledronic acid 4 mg.21 Without zoledronic acid, clinically important and significant bone loss occurred; the mean reductions in BMD at 3 years were 8% and 16% with tamoxifen and anastrozole, respectively. However, the addition of zoledronic acid prevented bone loss with either endocrine strategy. The effects of zoledronic acid on bone turnover and fracture rates have not been reported.

The Zometa-Femara Adjuvant Synergy Trials (Z-FAST [US)]/ (ZO-FAST [Europe]) (n=1668) recruited postmenopausal breast cancer patients with normal bone density or osteopaenia (T-score of >–2). Patients were treated with adjuvant letrozole and randomised either to immediate intravenous zoledronic acid (4 mg by intravenous infusion every 6 months) or to a delayed phase of treatment based on changes in BMD. In the Z-FAST study, the mean difference in BMD between the immediate and delayed groups at 12 months was 5.1% and 3.6% at the spine and hip, respectively (p≤0.001). Bone turnover was increased in the delayed group but reduced with zoledronic acid therapy. Similar results were seen in the ZO-FAST study.79 Follow-up is currently too short for a reliable assessment of the effect of prophylactic zoledronic acid on the incidence of fragility fractures, but the increase in BMD coupled with reduced bone turnover would be expected to prevent any increase in fractures associated with aromatase inhibitor use.

Raloxifene is an effective treatment for the prevention of osteoporosis. Unlike HRT, it does not increase the risk of recurrent breast cancer. However, in view of the interaction between tamoxifen and anastrozole, with the combination behaving like tamoxifen alone,the addition of raloxifene to an aromatase inhibitor cannot be recommended in the adjuvant treatment setting.

Strontium ranelate is licensed in most of the world for the treatment of postmenopausal osteoporosis. However, there is currently no research using this agent in cancer treatment-induced bone loss and so we cannot recommend its use.

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Exemestane and bone | Aromatase inhibitors Adjuvant breast cancer treatment associated with bone loss

Exemestane and bone Aromatase inhibitors Adjuvant breast cancer treatment associated with bone loss
Exemestane is superior to tamoxifen in the first-line treatment of advanced breast cancer, and has also been evaluated in the adjuvant treatment setting. Although results from direct comparisons with tamoxifen are not expected for some time, data from the Intergroup Exemestane Study (IES), evaluating sequential therapy with tamoxifen for 2–3 years followed by exemestane for 2–3 years, compared with 5 years of tamoxifen therapy, have shown a significant advantage in favour of the sequential treatment option, with improvements in both disease-free and overall survival. Exemestane, in contrast to the non-steroidal agents, has weak androgenic activity. It was postulated that this might result in less adverse effects on bone.70 This provided some support for the potentially different mechanism of action of exemestane. However, in another biochemical study, exemestane was found to increase levels of bone turnover markers71 and in the Letrozole, Exemestane, and Anastrozole Pharmacodynamics (LEAP) study, which compared the effects of all three clinically available aromatase inhibitors in postmenopausal women, no significant differences in the profile of biochemical markers of bone metabolism were seen. Of note, changes in parathyroid hormone were similar with all three agents, arguing against an anabolic effect of exemestane.

Results of a placebo-controlled trial of exemestane in early breast cancer have recently been published. In this study, 147 patients with low risk early breast cancer were randomized to receive treatment with exemestane 25 mg/day or placebo. Patients had a baseline DXA scan of the spine and hip, and follow-up assessments occurred annually. After 1 year, the BMD of patients in the exemestane group decreased by 2.17% and 2.72% at the spine and hip, respectively. However, bone loss in the placebo group was somewhat greater than expected, at 1.84% and 1.48% at the spine and hip, respectively. As a result, there was no significant difference between the two treatment groups at the lumbar spine, although the difference in hip BMD did reach statistical significance (p=0.024). None of the women were taking calcium or vitamin D supplements, and recent analysis has confirmed that many of these women were vitamin D deficient.74 In a 1-year follow up to the study after discontinuation of exemestane, the loss of BMD was partially reversed.

The effect of exemestane on markers of bone turnover was also assessed in this study. Exemestane was associated with significant increases in both markers of formation and resorption. In the exemestane group, levels of P1NP and CTX increased from baseline by 44% and 35%, respectively. However, levels of P1NP and CTX in the placebo group decreased by only 4% (p<0.001) and 5% (p=0.012), respectively.

The increase in bone resorption was consistent with the bone loss observed, while the increase in bone formation markers can be attributed to the coupling of bone formation to bone resorption.

Data from the bone sub-protocol of the IES study have recently become available.75 This study measured BMD and bone markers of resorption and formation in 206 patients at baseline, 6, 12 and 24 months. Patients who remained on tamoxifen showed no significant change from baseline in BMD. In patients who switched to exemestane, the mean rates of bone loss 6 months after tamoxifen cessation were 2.7% and 1.2% at the spine and hip, respectively. Thereafter, bone loss continued but at a slower rate of 0.5–1% per year. After 2 years, the change from baseline in BMD was 3.6% at the spine and 2.4% at the hip. Despite the more modest rate of bone loss seen in this bone sub-study, a significant increase in the incidence of fractures was observed in the IES study as a whole. With a median follow-up in all participants of 58 months and median exposure to exemestane of 30 months, 162 (7%) of patients in the exemestane group experienced a fracture compared with 115 (5%) patients in the tamoxifen group (odds ratio 1.45 [1.13–1.87]; p=0.003).

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