NHS Breast Screening Evidence resource on information about the NHS Breast Screening Programme Informed Choice about Cancer Screening September 2013 Contents 1. Introduction ................................................................................................................. 3 2. What is breast cancer? ................................................................................................ 4 3. What is breast screening? ......................................................................................... 13 4. What happens at the breast screening appointment? ............................................. 17 5. What are the possible results of breast screening? .................................................. 21 6. What happens if the tests show breast cancer? ....................................................... 25 7. Treatment for women diagnosed with invasive and non-invasive breast cancer .... 26 8. How good is breast screening at finding cancer? ...................................................... 27 9. Weighing up the possible benefits and risks of breast screening ............................. 28 10. Sources of more information about breast screening .............................................. 37 Acknowledgments............................................................................................................. 38 Glossary ............................................................................................................................. 39 Notes on methods used to compile this evidence resource ............................................ 44 References ........................................................................................................................ 45 1 Figures Figure 1: Frequency of breast cancer in UK women by age at diagnosis ........................... 9 Figure 2: A woman having a mammogram with a mammographer ............................... 20 Figure 3: Outcomes for 100 women attending breast screening at a given time. ........... 22 Figure 4: The difference between a normal milk duct, non-invasive breast cancer and invasive breast cancer ...................................................................................................... 25 Figure 5: Benefits and risks of breast screening, as estimated by the Independent UK Review of Breast Screening .............................................................................................. 31 Figure 6: Benefits and risks of breast screening as estimated by the Independent UK Review of Breast Screening (alternative version) ............................................................. 32 Figure 7: Weighing up the main benefit and risk of breast screening ............................. 34 2 1. Introduction The NHS offers breast screening to women aged 50 to 70 every three years. It aims to detect breast cancers at an early stage, before they have started to cause symptoms, and thereby to save lives from breast cancer. Breast screening does, however, have some risks. The main risk is that some women who have screening will be diagnosed and treated for breast cancer that would never otherwise have been found, or caused them harm. This document provides information on the benefits and risks of breast screening and what to expect at an NHS breast screening appointment. It is for anyone who would like more detailed information than is provided in the leaflet sent to women invited for NHS breast screening. People who may find this information helpful include women who have been invited for NHS breast screening (and their partners, family, or carers) and health professionals. This document has been structured in a similar way to the leaflet sent to women invited for NHS breast screening to make it easier to find the evidence relating to each section of the leaflet. Some complex and scientific words throughout this document have been put into bold print like this. These words are explained in the glossary on page 39. 3 2. What is breast cancer? Breast cancer happens when cells in the breast start growing in an irregular, uncontrolled way. As the cancer grows, cancer cells can spread to other parts of the body and this can be life-threatening, if it is not treated. How common is breast cancer? Breast cancer is the most common cancer among women. Around 1 in every 3 cancers diagnosed in women is a breast cancer.1 About 1 in 8 women in the UK will develop breast cancer in their lifetime.2 In 2010 in the UK, 55,329 women were diagnosed with breast cancer,3 4 and 11,556 women died from breast cancer.5 Men can get breast cancer, although this is much less common. In 2010, 375 men were diagnosed3 4 with breast cancer in England and 77 men died of this cancer.5 Men are not invited for screening by the NHS Breast Screening Programme. The risk of breast cancer increases with age, particularly after age 50. About 4 out of every 5 breast cancers diagnosed are in women over 50 years old.3 4 How does breast cancer start? Like the rest of the body, the breasts are made up of cells, which together form what is called tissue. Milk is made in parts of the breast called lobules. It then flows to the nipple through tubes, called milk ducts. The space between the lobules and ducts contains blood vessels and lymph vessels. Blood vessels carry oxygen to and from the cells of the breast. Lymph vessels carry a fluid called lymph to lymph nodes near the breast (usually in the armpit). Lymph nodes filter lymph and help protect the body from disease by removing unwanted things, such as bacteria and cancer cells. Most breast cancers begin in the cells that line the milk ducts.6 Normally, cells grow, divide, die, and get replaced in an orderly way. In cancer, the cells start growing in a disorderly, uncontrolled way, and much more quickly. How does breast cancer spread? As the cancer cells grow, they may spread from the milk ducts into nearby tissue. If these cells enter the blood vessels or lymph vessels, they can be carried to other parts of the body and start growing there. When a cancer spreads, this is called metastasis; this is when breast cancer becomes life-threatening. 4 What are the types of breast cancer? There are several types of breast cancer. The main types are: Ductal breast cancer: cancer that starts in the ducts of the breasts. This is the most common type of breast cancer.7 Lobular breast cancer: cancer that starts in the lobules of the breast. This is the second most common type of breast cancer.7 Inflammatory breast cancer: a less common cancer that blocks the lymph vessels in the skin of the breast. This makes the skin look pitted or dimpled, like orange peel. The skin may also feel warm and often looks red. Some women with this kind of breast cancer will develop an obvious lump in the breast but others will not. This type of cancer can develop and spread quickly.8 Paget’s disease of the breast: a less common cancer that affects the skin on and around the nipple. Signs of Paget's disease can include itching, redness, and flaking of the skin.9 In its early stages, Paget's disease is often confused with eczema and other skin conditions. Women with Paget's disease often have cancer within their breast as well. What are the stages of breast cancer? Once a woman is diagnosed with breast cancer, a breast cancer specialist will do a number of tests to work out how advanced it is. Breast cancer specialists usually use stages to describe how advanced a cancer is. Knowing the stage of a breast cancer can help a woman and her doctor decide on the best treatment. There are five stages of breast cancer. These range from stage 0 (the earliest stage, when the cancer has not spread from where it started) to stage 4 (the most advanced stage, where it has spread around the body).10 To work out what stage a cancer has reached, doctors look at three main things: How big the tumour (lump) is, and whether it has spread from the breast tissue into the nearby skin or chest wall. Whether the breast cancer has spread to the lymph nodes, how many, and which ones. Whether the breast cancer has spread from the breast to other parts of the body beyond the nearby skin, lymph nodes, or chest wall. 5 Stage 0 This is the earliest stage of breast cancer. It is also called non-invasive cancer. Most stage 0 cancers are a type called ductal carcinoma in situ (DCIS). Cancer cells have formed within the ducts of the breast, but they have not grown into (invaded) the surrounding tissue or lymph nodes.11 The cancer may eventually grow into the surrounding breast tissue or spread to the lymph nodes and other parts of the body in the future, or it may not. Doctors cannot tell whether a woman with DCIS will have a cancer that will grow and spread if left untreated.12 13 Lobular carcinoma in situ (LCIS) is also described as stage 0, although it is not usually thought of as cancer. It means some of the cells in the lobules of the breast are abnormal. Women with LCIS have an increased risk of eventually getting cancer in either breast.12 Stage 1 This is also known as early stage invasive cancer. Stage 1 breast cancer has grown out of the ducts or lobules into the surrounding breast tissue. The tumour, if present, is small (2 centimetres or less across) and the cancer has not spread to the lymph nodes, or only very few cancer cells are in the lymph nodes.10 Stage 2 This is invasive cancer. Stage 2 breast cancers can be divided into three main categories: the tumour measures less than 2 centimetres across and has spread to lymph nodes under the armpit. the tumour is between 2 centimetres and 5 centimetres across whether or not it has spread to the lymph nodes under the armpit. the tumour is larger than 5 centimetres across but has not spread to any lymph nodes. 6 Stage 3 This is invasive cancer that has spread further than stage 2. Stage 3 breast cancers are larger than 5 centimetres across (if a lump is present), or have cancer cells in the lymph nodes, or are growing into nearby areas. Smaller tumours can be classed as stage 3 cancers if10: the cancer has spread to many lymph nodes in the armpit or has matted together the lymph nodes under the armpit, or the cancer has spread into the chest wall or the skin, or the cancer has spread to lymph nodes above or below the collarbone (clavicle) or near the breastbone (sternum). Inflammatory breast cancer is usually stage 3 or 4 when it is diagnosed.14 Stage 4 This is advanced invasive cancer, also known as metastatic cancer. Stage 4 cancer is any breast cancer that has spread beyond the breast, lymph nodes, or nearby areas to other parts of the body.10 The parts of the body most likely to be affected are the bones, lungs, liver, more distant lymph nodes, or brain.15 What are early, locally advanced, and advanced cancers? These names are another way that doctors describe how advanced an invasive cancer is16: Early invasive breast cancer: This means the cancer is still fairly small (around 2 centimetres or less) and hasn't spread beyond the breast and nearby lymph nodes. Locally advanced breast cancer: This means the cancer is in a large part of the breast and may also be in the lymph nodes. However, it hasn't spread to other parts of the body. Advanced breast cancer: This usually means the cancer has spread to other parts of the body. It can also mean that the cancer hasn't spread but has grown directly into tissues close to the breast and cannot be removed through surgery. What is the grade of a breast cancer? Doctors also look at how much the cancer cells resemble normal breast cells when viewed under a microscope. This is called grading (see grade). Doctors usually grade cancers as 'low grade', 'intermediate grade', or 'high grade'. Low-grade cancer cells look similar to normal breast cells. High-grade cancer cells look very different to normal cells. Higher grade cancers tend to grow more rapidly and spread faster than lower grade cancers. Cancer grade can also be described as a number between 1 and 3. A lower number means a lower grade.15 7 What are the symptoms of breast cancer? The symptoms of breast cancer are9 17: A lump or thickening in the breast or the armpit. A change in the nipple. The nipple might be pulled back into the breast (known as an inverted nipple), or change shape. There may be discharge from the nipple, such as blood or other fluid, or there may be a nipple rash that makes the nipple look red and scaly. A change in how the breast feels or looks. It may feel heavy, warm or uneven, or the skin may look dimpled. The size and shape of the breast may change. Pain or discomfort in the breast or armpit. Women who experience any of these symptoms should make an appointment to see a GP straight away. These symptoms do not necessarily mean a woman has breast cancer. But if she does, being diagnosed and treated at an early stage may mean she is more likely to survive breast cancer. About 32 in 100 women with breast cancer are diagnosed through screening, when they do not have symptoms. The remaining 68 women in 100 are diagnosed because they have symptoms, in other words, changes to their breasts.18 What increases the risk of breast cancer? Age The chance of getting breast cancer increases with age; the older a woman is, the more likely she is to get breast cancer. About 4 out of 5 women diagnosed with breast cancer are older than 50.3 4 19-27 Figure 1 shows how the frequency of breast cancer changes by age group at diagnosis in the UK (it shows the average number of new breast cancers diagnosed each year and the number per 100,000 women in that age group: this is known as age-specific incidence.3 4 19-28 The incidence of breast cancer increases with age. It is high in the age group invited for screening because screening means that some breast cancers are diagnosed earlier. If there were no breast screening, some of the cancers diagnosed in the screening age group would be diagnosed later when women reach their 70s and 80s. 8 Figure 1: Frequency of breast cancer in UK women by age at diagnosis 10000 500 9000 450 8000 400 7000 350 6000 300 5000 250 4000 200 3000 150 2000 100 1000 50 0 0 Year 0-29 30-34 35-39 40-44 45-49 50-54 55-59 60-64 65-69 70-74 75-79 80-84 85 and over Age group at diagnosis Number of cases Incidence rate *The age-specific rate of new cases (incidence) presented in Figure 1 is standardised to the UK population. This means that age-specific incidence rates are calculated separately for each of England, Wales, Scotland and Northern Ireland, and are then weighted according to their respective population sizes before being added together to produce an incidence rate for the entire UK. This is done to account for the different age structures of the populations of the four countries making up the UK. Family history and inherited genes Most breast cancers are not due to family history or inherited breast cancer genes. This means that women who have no family history of breast cancer are still at risk. Many women with breast cancer do have relatives with breast cancer, but often this is because breast cancer is so common, not because it is inherited. However, a family history of breast cancer does increase the risk. The chance of a 20 year old developing breast cancer by the time she is 80 is about 8 in 100 if she has no close relatives with the disease, 13 in 100 if she has one close relative with the disease and 21 in 100 if she has two or more close relatives with it.29 Some women have inherited genes that make breast cancer more likely. About 10 in 100 cases of breast cancer in Western countries like the UK are due to inherited genes. 30 The most important genes that increase breast cancer risk are BRCA1 and BRCA2, which are estimated to cause between 3 in 100 and 7 in 100 breast cancers.31 Studies show that women with a faulty BRCA1 gene have a 65 in 100 chance of getting breast cancer by age 70. Those with a faulty BRCA2 gene have a 45 in 100 chance.32 9 Age-specific rate of new cases of breast cancer per 100,000 women Average number of new cases of breast cancer Average number of new breast cancers diagnosed and age-specific rate* of new breast cancers diagnosed per 100,000 women each year between 2007 and 2011. Lifestyle Being overweight or obese: Being overweight or obese can slightly increase a woman's risk of getting breast cancer once she has past the menopause.33 This could be because fat helps the body make oestrogen, and oestrogen seems to promote the growth of some breast cancers. In a UK study with more than 1.2 million women aged 50 to 64, researchers looked at how many women developed breast cancer over an average of five years, based on their weight. About 4 in 1,000 healthy-weight women developed breast cancer, compared with 5 in 1,000 women who were overweight, and 6 in 1,000 women who were obese. The researchers estimated that women who were overweight were 10-20% more likely to develop breast cancer than healthy-weight women, and women who were obese were 40% more likely to develop breast cancer.34 Drinking alcohol: Drinking alcohol can increase the risk of breast cancer.35 The more a woman drinks on a regular basis, the greater her risk. One review of 53 studies found that women who had about four drinks per day increased their risk of breast cancer by about a third, and women who drank around five or more drinks a day increased their risk by almost half. The authors of the review estimated that about 9 in 100 women who do not drink will develop breast cancer by age 80, compared to about 11 in 100 women who have 3 alcoholic drinks per day, and 13 in 100 women who have 6 or more alcoholic drinks per day. 36 Another study estimated that around 6 in 100 breast cancers in the UK in 2010 were linked to alcohol.37 Being inactive: Doing little or no physical activity is linked to an increased risk of breast cancer. A review found that, overall, the least active women had a 25 percent higher risk of breast cancer, compared with the most active women.38 A UK study estimated that, in 2010, more than 3 in 100 breast cancers among women after the menopause were linked to too little exercise (less than 150 minutes of moderate activity per week). 39 Eating a high-fat diet: Eating a lot of high-fat foods seems to increase a woman's risk of breast cancer, particularly if she eats a lot of saturated fat.40 In a study of nearly 320,000 European women, those who ate the most saturated fat were 13 percent more likely to develop breast cancer than those who ate the least.41 Saturated fat is found in foods such as red meat, butter, and cream. Hormones Starting periods early or going through the menopause late: Both of these increase the risk of breast cancer, probably because the female hormone oestrogen promotes the growth of some breast cancers.42 If a woman starts her periods early (before age 11) or goes through the menopause late (after age 54), then she will have higher levels of oestrogen in her body for longer.30 43 44 10 Taking hormone replacement therapy (HRT): Some women take HRT to help with symptoms of the menopause. Women may take oestrogen-only or combined oestrogen and progestogen HRT. HRT increases a woman’s risk of breast cancer while she is taking it, and for up to five years after she stops.45 For every 1,000 women taking combined HRT for 10 years, about 19 more women will get breast cancer during this time than they would have if they did not take it. For every 1,000 women taking oestrogen-only HRT for 10 years, about 5 more women will get breast cancer during this time than if they did not take it. Within five years of stopping HRT, a woman's risk of breast cancer drops to the same level as for a woman who has not taken HRT.46 Taking oral contraceptive pills: Studies don't provide a clear answer about whether taking the contraceptive pill increases the risk of breast cancer.47 Some studies have found that a woman's risk of getting breast cancer increases by a small amount while she is taking the pill.48 But once she stops taking it, this extra risk goes away over the next 10 years. Other studies have found that taking the pill doesn't seem to increase the risk of breast cancer.49 Other breast conditions Hyperplasia: This is an overgrowth of cells in the breast. It isn't cancer but it raises a woman's risk of breast cancer. If the cells look close to normal, this is called ‘usual hyperplasia’. Overall, women with usual hyperplasia are about twice as likely to get breast cancer as women without hyperplasia. If the cells look abnormal, this is called ‘atypical hyperplasia’. Women with atypical hyperplasia are between four and five times more likely to get breast cancer as those without hyperplasia.50-53 Lobular carcinoma in situ: Women with lobular carcinoma in situ (LCIS) have a raised risk of getting breast cancer in either breast. It is most likely to occur in the breast where LCIS was found. It isn't certain how many women with LCIS develop breast cancer, as different studies have had different results. One review of studies found that between 4 and 9 women out of 100 diagnosed with LCIS develop breast cancer within the next five years.54 55 Previous breast cancer: Women who have had cancer in one breast have an increased risk of getting a new cancer in the other breast or in another part of the same breast. 5658 Dense breasts: Breasts that contain a low percentage of fatty tissue are described as being dense. Having denser breasts raises the risk of breast cancer. Women with the densest breasts are four to six times more likely to develop breast cancer than those with the least dense breasts.59-61 11 Birth and breastfeeding Older age at birth of first child: This increases a woman's chance of getting breast cancer, although the reasons why aren't clear. Women who never have children also have an increased risk. 44 62 In one study, which followed women up for up to 27 years, about 1 in 100 women who had their first baby around the age of 23 developed cancer, compared with about 4 in 100 women who gave birth around the age of 34, and nearly 5 in 100 who gave birth around the age of 38.63 Not breastfeeding, or not breastfeeding for very long: Breastfeeding reduces the risk of breast cancer. The longer a woman breastfeeds, the lower her chance of getting breast cancer.64 65 One study estimated that around 3 in 100 breast cancers in the UK would be prevented if women breastfed each of their children for six months or longer.66 Radiotherapy A woman's risk of breast cancer is higher if she had radiotherapy to her chest as a child or young adult.67 Radiotherapy is often used to treat other cancers, such as Hodgkin's disease, non-Hodgkin's lymphoma, and leukaemia.68 The younger a woman was when she had radiotherapy, the higher her chance of developing breast cancer. The risk is especially high for women who had radiotherapy at a young age for Hodgkin's disease, as this type of cancer is treated with a higher dose of radiation.69 12 3. What is breast screening? Breast screening uses an X-ray test called a mammogram to check the breast for signs of cancer. It can spot cancers that are too small to see or feel. What is the purpose of breast screening? The purpose of breast screening is to reduce the number of women who die from breast cancer. Screening does not prevent breast cancer. In breast screening, mammograms are used to find breast cancers at an early stage when they are too small to see or feel. Women with breast cancer diagnosed at an early stage are more likely to survive breast cancer than women diagnosed at a later stage. What is the NHS Breast Screening Programme? All women aged 50 to 70 in England are invited for breast screening every three years. When a woman is invited for screening, she receives an invitation in the post from her local screening unit. Her invitation letter gives her a date, time, and location for a mammogram. There are about 80 screening services throughout England.70 The units can be mobile, in a hospital, or at a convenient location in the local community, such as a shopping centre. When a woman receives an invitation to breast screening, she has a choice. She can attend the appointment, reschedule the appointment if it's not convenient, or decide not to have breast screening. To help her decide, the screening unit will enclose a leaflet along with the invitation letter. This leaflet gives information about the benefits and risks of breast screening and what it is like to have a mammogram. The NHS Breast Screening Programme Age Extension Trial In England, the NHS Breast Screening Programme is currently inviting some women aged 47 to 49 and 71 to 73 to have breast screening. This is being done as part of a randomised controlled trial of the benefits and risks of breast screening in older and younger women. As part of the trial, half of the women aged 47 to 49 and 71 to 73 in certain parts of the country are being randomly selected and invited for breast screening, in addition to the screening carried out for women aged 50 to 70. Over 10 years, researchers will compare breast cancer diagnoses and deaths in these women, to those offered screening from ages 50 to 70 only. The aim of the study is to find out more about the benefits and risks of offering breast screening to women in these age groups.71 72 The reason for the study is that little is known about the balance between the benefits and risks of offering breast screening to women aged 47 to 49 and 71 to 73. For more information about this, please see the sections on benefits and risks on page 28. 13 Why aren't women below the age of 50 offered breast screening? Younger women aren't offered breast screening because: Their risk of breast cancer is lower. 4 out of 5 breast cancers occur in women over the age of 50. In 2010, about 30 in every 100,000 women under the age of 45 were diagnosed with breast cancer. This is compared to about 353 in every 100,000 women aged 45 and over.73 74 Younger women's breasts tend to be denser than older women’s, which can make mammograms more difficult to read and less accurate. After the menopause, women's breasts contain more fat, which means they are less dense. Most women go through the menopause around the age of 50.75 76 Starting screening at a younger age would mean a woman would have more mammograms over her lifetime. This would increase her exposure to radiation from the X-rays. The radiation dose used in mammograms is small but not riskfree (see section on radiation risk on page 36). There isn't enough evidence to say whether the benefits of breast screening outweigh the risks for younger women. We know that screening can reduce the number of women who die from breast cancer, by finding cancers early. But screening also sometimes finds cancers that would never otherwise have been found or caused a woman harm. This is called overdiagnosis. As a result, some women are diagnosed and treated for a cancer that would never otherwise have been found. Researchers aren't sure whether screening younger women would save enough lives to outweigh the risk of finding and treating cancer that may never have caused harm. (Please see page 28 for information on the benefits and risks of breast screening.) In 2002, the World Health Organization's International Agency for Research on Cancer reviewed the research on the most appropriate age group for women to have breast screening. It found evidence that the benefits of screening outweighed the harms for women aged 50 to 69.77 More recent reviews of studies in the US and Canada came to similar conclusions. They found that the benefits of screening are more likely to outweigh the harms for women aged 50 and older, than they are for women aged 40 to 49.78 79 Research on this subject continues, including the NHS Breast Screening Programme Age Extension Trial which is investigating the benefits and risks of breast screening in women aged 47 to 49 and 71 to 73.71 14 Why is breast screening offered every three years? How frequently women should be offered breast screening is also a matter of debate. Some countries encourage women to have a screening mammogram every year, or every two years. In the UK, women are invited to have breast screening every three years. One large, high-quality study (a randomised controlled trial) in the UK looked at this question. The study compared women screened every three years with women screened every year. Based on the number of cancers detected over three years, the researchers predicted the number of women who would die of breast cancer if they were screened every year versus every three years. The researchers found that screening women every year would have no significant effect on the risk of dying from breast cancer compared to screening every three years.80 Women over age 70 (or over 73 if they are part of the age extension trial) do not receive screening invitations from the NHS Breast Screening Programme. If they wish to, they can continue to have screening mammograms every three years by making an appointment with their local breast screening unit. Screening for women with a family history of breast cancer Some women are offered screening more often than every three years and from a younger age than 50. This is because breast cancer runs in their family and these women may have inherited genes that put them at higher risk of getting breast cancer. Cancer that is due to inherited genes is called familial breast cancer or hereditary breast cancer. Having one or more relatives with breast cancer does not necessarily mean that breast cancer runs in a woman's family. Most cancers happen by chance, with less than 10 in 100 thought to be related to inherited genes.30 But if a woman has more than one close relative diagnosed with breast cancer, particularly if close relatives have developed breast cancer at a young age or in both breasts, this could be a sign of inherited genes in the family. If a woman is concerned about familial breast cancer, she can talk to her GP, who may refer her for an assessment based on her family history. If a woman is found on assessment to have a raised or high risk of breast cancer, she may be offered annual screening with a mammogram, a magnetic resonance imaging (MRI) scan, or possibly both. Once the woman reaches age 50, she will usually stop being offered annual screening and instead be invited to have three-yearly breast screening as part of the NHS Breast Screening Programme. Some women with a very high risk of breast cancer may continue to have more frequent screening, for example for women whose family is known to carry an abnormal breast cancer gene.81 15 Genetic counselling and testing If a woman's family history suggests she is at high risk of developing breast cancer, she will be offered a referral to a genetic counsellor. The counsellor will estimate the woman's risk based on her family history and other risk factors.81 If the genetic counsellor finds that the woman has more than a 20 in 100 chance of having a breast cancer gene in her family, the woman will be offered genetic testing. Genetic testing looks for three types of faulty genes in a sample of blood: BRCA1, BRCA2, and TP53. It's the woman's choice whether she has this testing. The genetic counsellor will explain what the test involves and the possible results. He or she will also answer any questions the woman might have. If a woman decides to have genetic testing, the test must first be carried out on a relative who has had either breast cancer or ovarian cancer. This provides the best chance of detecting a faulty gene. If a faulty gene is found, then the woman and other members of her family have the test. 16 4. What happens at the breast screening appointment? NHS Breast Screening uses an X-ray test called a mammogram to check the breast for signs of cancer. All mammograms are carried out by women. These women are sometimes called mammographers and are specially trained to take mammograms. They could be either radiographers (healthcare professionals specialised in taking X-rays) or assistant practitioners (healthcare professionals specialised in taking X-rays who work under the supervision of radiographers). When a woman arrives at a breast screening unit, the staff there will check her details, ask about any previous breast problems, and answer any questions.82 Having a mammogram To have a mammogram, women need to undress to the waist. For this reason, they may prefer to wear a skirt or trousers (rather than a dress) to their appointment. Before taking the mammogram, the mammographer explains what is about to happen. She then places the woman's breast onto the mammogram machine and lowers a plastic plate onto the breast to compress it. This helps to keep the breast still and to get the clearest X-ray possible, with the lowest dose of radiation. Usually, two X-rays are taken of each breast (a so-called two-view mammogram) – one from above (called cranio-caudal) and one from the side (called oblique). Research shows that taking two X-rays increases the chance of detecting small cancers, compared with taking only one.83 The mammographer goes behind a screen while the X-rays are taken so that she is not exposed to unnecessary X-rays. The woman has to keep still for several seconds each time. The mammogram takes only a few minutes and the whole appointment usually takes less than half an hour. What does having a mammogram feel like? Some women feel uncomfortable or embarrassed about removing their clothes for a mammogram, or are anxious about the test and its possible results.84 Very little has been published in the scientific literature about how women feel about the experience of having a mammogram. One UK study looked at the reasons why women decide not to have screening again after their first mammogram. About 3 in 100 women said it was because they had felt embarrassed at their first appointment. About 6 in 100 said it was because screening was stressful for them. However, this study was done in 1994. We can't be certain that it reflects how women might feel about screening today.85 Having a mammogram can be physically uncomfortable because the breast is squeezed between the two plastic plates on the mammogram machine. Some women say they 17 find it painful but others don’t. Usually, any pain from the mammogram passes quickly, but some women have pain or soreness for a few days.86 We don't know for certain how many women experience pain when having a mammogram because different studies show very different results.87 A systematic review of research on breast screening in women aged 40 to 49 found that the number of women who said they experienced pain during breast screening varied considerably across 22 studies reviewed. The authors mention one study in which 77 in 100 women found mammography painful compared to another in which 28 in 100 women said they experienced considerable pain. The authors suggested that the wide range in the prevalence of pain may be because of variations in how the studies defined and measured pain, and how soon after having a mammogram women were asked about pain.88 Some research suggests that if women are given detailed information about what to expect before their mammogram, they feel less pain and discomfort.89 If women experience pain during breast screening, they should inform the mammographer, who may be able to make them more comfortable. Mammograms for special circumstances Special arrangements may need to be made for some women to have breast screening. Women who have a physical disability. Women should contact their breast screening unit if they have a physical disability that might make it difficult for them to have a mammogram (for example, if they cannot stand up or find climbing steps difficult, because many mammograms are done in mobile vans). The unit will advise them on whether a mammogram is technically possible, and where it can be performed. For example, if a woman is unable to walk and uses a wheelchair, she will probably be advised to have a mammogram at a hospitalbased unit, rather than at a mobile unit. A mammogram also requires some upper-body mobility and strength, as the woman is carefully positioned on the mammogram machine and must hold the position for several seconds at a time. This may not be possible for women with limited upper-body mobility or who are unable to support their upper body without assistance. If a woman is not physically able to have a mammogram, she will continue to receive screening invitations in case her mobility improves.90 Women who have breast implants. Women with breast implants can still have mammograms. The pressure put on the breasts during the mammogram should not damage or cause problems with the implants. Women with implants need to attend a screening unit that has the ability to view mammogram images straight away. This is to make sure the mammogram shows as much of the tissue around the implant as possible. When a woman receives her screening invitation, she should let her screening unit know about her implants to find out whether she should attend a different location for her mammogram.91 If a woman has 18 implants because she previously had all her breast tissue removed through a mastectomy, she does not need breast screening. Women who are pregnant or breastfeeding. Most women who receive an invitation for breast screening are past the menopause and cannot get pregnant. If a woman is pregnant or breastfeeding when she receives an invitation, she should contact her breast screening unit to see whether she should delay screening.92 Women who have recently had a mammogram. Most women invited through the Screening Programme will not have recently had a mammogram. If a woman has, for example, because she had some breast symptoms and has been referred to a specialist to check these, she should contact her local screening unit as she may be advised to delay her next breast screening appointment. Women who have a learning disability. The process of having a mammogram is the same for women with a learning disability as for other women. However, the potential benefits and risks of breast screening, and the mammogram process, will need to be explained in terms that the woman can understand, so she can make a decision about whether to participate. If a woman does not have the mental ability to make her own decision about screening, her carer may make a decision on her behalf. This is called a 'best interests' decision. It's the same as the other care and treatment decisions that a carer might make for someone unable to make their own decisions. If a woman's mental ability improves from time to time, the decision about screening should be delayed until she can make a decision for herself.90 92 What happens to a woman’s mammogram after screening? The NHS Breast Screening Programme keeps a woman’s mammograms for at least eight years. These are saved securely. The Screening Programme regularly checks records to make sure the service is as good as possible. Staff in other parts of the health service may need to see a woman’s screening records for this, including her previous mammograms. These records are only shared with people who need to see them. If a woman would like more information or would like to know the results of these regular checks she can contact her local screening unit. 19 Figure 2: A woman having a mammogram with a mammographer 20 5. What are the possible results of breast screening? The mammograms are checked by a team of health professionals trained in reading mammograms. Within two weeks of her appointment, the woman will receive a letter with her breast screening results. The results will also be sent to her GP. Most women have a normal result from breast screening, while some women need more tests. 13 Most women will have a normal result Most women (about 96 in 100) have a normal result,13 which means their mammogram shows no signs of breast cancer. This may also be called a ‘negative’ mammography result. A woman who has a normal result will continue to receive invitations for breast screening every three years until she reaches 70 years of age, or 73 if she is part of the age extension trial (see page 13). Once a woman is over the age of 70 (or 73) she will no longer automatically receive invitations from the NHS Breast Screening Programme. She can still have breast screening every three years but will need to ask her local breast screening unit for an appointment. It is important to remember that a woman should see her GP straight away if she notices any changes in her breasts, because cancer can develop between breast screening appointments (please see page 8 for more information on the symptoms of breast cancer). Some women will need more tests because they have an abnormal result Some women (about 4 in 100) may receive a results letter saying they need more tests.13 Professionals sometimes call this an ‘abnormal’ or a ‘positive' mammography result, because something has been found which does not look normal. This does not mean the tests will find cancer. 21 Figure 3: Outcomes for 100 women attending breast screening at a given time. 22 What happens if a woman as an abnormal result? If a woman has an abnormal result, she will be invited for an appointment at a breast assessment clinic to have more tests. Breast assessment clinics are usually in hospitals. Of the 4 in 100 women who need more tests because of an abnormal result, about 3 will find out they do not have cancer and 1 will find out she does. 13 Tests at the breast assessment clinic can include clinical examination, imaging (mammograms or ultrasound), and tissue sampling (needle aspiration or biopsy). This is sometimes called triple assessment because it involves three types of assessment. Not all women will need all of these tests. Clinical examination: A doctor or a nurse practitioner carefully examines and feels the woman’s breast tissue as well as the lymph nodes under her arms and in her neck. Mammogram: Additional mammograms may be done at different angles or with magnification to get more detailed X-ray images of the breast tissue. Ultrasound: An ultrasound uses sound waves to make images of the inside of the breast. This test can sometimes show whether a lump is solid or whether it's a cyst filled with fluid. During an ultrasound, a specialist puts gel on the woman's breast and rubs a small probe over the breast. Images of the breast tissue show up on a screen. Fine needle aspiration: A doctor uses a fine needle and syringe to collect some cells from a woman's breast. The sample is sent to a laboratory where it is examined for signs of cancer. Core needle biopsy: A doctor uses a bigger needle than in fine needle aspiration to collect a small sample of tissue (a biopsy) from the breast. The woman will be given an injection to numb the area so she won't feel pain (a local anaesthetic). The sample removed during the biopsy is sent to a laboratory where it is examined for signs of cancer. Core needle biopsies are now more common than fine needle aspirations. Both tests work, but it's easier for the doctor to get enough cells to test with a core biopsy.93-95 This means that the woman is less likely to need a second test to collect more cells. In both tests, the doctor may guide the needle by feeling the lump in the woman's breast. If it's not easy to feel the lump, the doctor might use an ultrasound or mammogram to guide the needle to the right place. Occasionally, a woman will have an open biopsy. This involves having an operation to remove one or more tissue samples through a small cut in the breast. The woman is usually given a general anaesthetic, so she won't be awake during the operation. Fewer than 3 in 100 women invited for more tests need an open biopsy.96 The waiting time for the test results varies. Some women will find out their results the same day as their test, or a few days later. If a sample needs to be sent to a laboratory, the waiting time can be longer. Women can usually expect their results within one week but can ask at their breast assessment clinic when to expect their results. 23 However long a woman has to wait, this will be an anxious time. If she wants someone to talk to, her breast assessment clinic may be able to put her in touch with a health professional who may be able to help. Some women will need another mammogram before they get their result Occasionally, a woman will receive a letter saying there was a technical problem with her mammogram. This usually means that the X-rays were not clear enough to read. Before she can get her result, she will be called back for another mammogram to get clearer X-rays. 24 6. What happens if the tests show breast cancer? For every 100 women aged 50-70 who have a mammogram, about 1 of them will be diagnosed with breast cancer.13 Non-invasive breast cancer Out of 100 women diagnosed with breast cancer through screening, about 20 will have non-invasive breast cancer.13 This means there are cancer cells in the breast, but they are only found inside the milk ducts (tubes) and have not spread into surrounding breast tissue. This is also called ‘ductal carcinoma in situ’ (DCIS). In some women with noninvasive breast cancer, the cancer cells stay inside the ducts and may never cause harm. In other women, the cancer cells will grow into (invade) the surrounding breast tissue in the future. When a woman is diagnosed with non-invasive breast cancer, doctors can’t tell whether it will grow into the surrounding breast or not. Invasive breast cancer Out of 100 women diagnosed with breast cancer through screening, about 80 will have invasive breast cancer. 13 This is cancer that has grown out of the milk ducts and into the surrounding breast. Most invasive breast cancers will spread to other parts of the body if left untreated. But in some cases, an invasive breast cancer can grow so slowly that it would never cause a woman harm in her lifetime. Figure 4: The difference between a normal milk duct, non-invasive breast cancer and invasive breast cancer 25 7. Treatment for women diagnosed with invasive and non-invasive breast cancer All women diagnosed with invasive and non-invasive breast cancers are offered treatment. A woman found to have breast cancer will have the care and support of a team of breast cancer specialists. The team will explain the type of cancer found, answer questions, and discuss the woman’s treatment options with her. Nearly all women diagnosed with breast cancer through screening will have surgery to remove their cancer and to reduce the risk of the cancer returning. Women may be offered either mastectomy or breast-conserving surgery (usually called lumpectomy or wide local excision). In a mastectomy, the entire breast with cancer is removed, and some lymph nodes or small muscles near the breast may also be removed. In breast-conserving surgery, only the area where the cancer is growing in the breast is removed. Women may also have other treatments to reduce the risk of their cancer returning. These can include: Radiotherapy: This treatment directs radiation at the breast and possibly the lymph nodes to kill any cancer cells that might have been left behind after surgery. Chemotherapy: Chemotherapy drugs are used to kill any cancer cells left in the breast, lymph nodes, and other parts of the body. Hormonal therapy: The growth of some breast cancers is promoted by the hormone oestrogen. Hormonal therapy reduces the amount of oestrogen in the body or blocks the effects of oestrogen. This helps stop the cancer growing or spreading, and can stop the cancer coming back after surgery. Some women take medicines (tamoxifen, goserelin (Zoladex), anastrozole, exemestane or letrozole). Others have radiotherapy to stop their ovaries making oestrogen, or have surgery to remove their ovaries. 97 Biological therapy: Biological therapy can change the way cancer cells behave to make them stop dividing and growing. It can also kill any cancer cells and encourage the body’s immune system to attack them.98 Each woman’s cancer cells are tested to see if biological therapy (for instance, trastuzumab (also known as Herceptin) or lapatinib (also known as Tyverb)) may be effective. What treatment a woman is offered will depend on several things, including: The size of her cancer Where the cancer is in her breast What type of breast cancer she has Whether the cancer cells are likely to respond to biological therapy Whether it has spread to other areas and, if so, where it has spread Her general health The potential benefit of each treatment weighed against its potential harms. If a woman is diagnosed with breast cancer, a breast cancer specialist will discuss the treatment options available with her, and answer any questions. Together they will decide on the best treatment approach. 26 8. How good is breast screening at finding cancer? Research shows that when women have the type of mammography used in the NHS Breast Screening Programme, breast screening finds most breast cancers. Rarely, it misses a cancer. Also some cancers might grow in between screening appointments. Cancers that grow and are diagnosed between screening appointments are called Interval cancers. One study in Norway found that about 17 women in every 10,000 who received a normal screening result developed breast cancer in the two years before their next screen. It is not possible to tell whether the interval cancers diagnosed were present but too small to detect at breast screening or whether they only started to develop after the woman’s last breast screening appointment and grew more quickly. On rare occasions, a breast cancer may be visible on a screening mammogram but is missed by the team checking the mammogram for cancer. If a woman is diagnosed with breast cancer between screening appointments and her most recent breast screening result was normal, the mammogram will be checked again to see if there was an abnormality that should have been spotted. Breast cancer is missed in between 2 and 4 in every 10,000 women aged 50 to 70 who attend for breast screening every three years.99 Because of the possibility of breast cancers being missed or growing in between screening appointments, it is important for women to get to know how their breasts normally look and feel. They should know about the symptoms of breast cancer and see their GP straight away if they notice any changes to their breasts (please see page 8 for more information about the symptoms of breast cancer). 27 9. Weighing up the possible benefits and risks of breast screening The main benefit of breast screening is that it saves lives from breast cancer. This is because cancers are diagnosed and treated earlier than they would have been without screening. The main risk of breast screening is that it can find cancers that would never otherwise have been found and would not have become life-threatening. Doctors cannot always tell whether a breast cancer that is diagnosed will go on to become life-threatening or not, so they offer treatment to all women diagnosed with breast cancer. This means that some women will be offered treatment that they do not need. Screening saves lives from breast cancer Women who attend breast screening have a lower chance of dying from breast cancer than women who do not attend. An independent UK panel of experts reviewed the evidence on the benefits and risks of breast screening in 2012 and estimated that99: For every 200 women screened every three years between the ages of 50 and 70, about 3 women will die of breast cancer by the time they are 80. For every 200 women not screened every three years between the ages of 50 and 70, about 4 women will die of breast cancer by the time they are 80. So, about 1 less woman dies from breast cancer for every 200 women who attend breast screening every three years between the ages of 50 and 70. This adds up to about 1,300 lives saved every year from breast cancer in the UK. There is debate among doctors and scientists about how effective breast screening is at reducing breast cancer deaths. The numbers given here are the current best estimate of the benefits of breast screening. The figures come from combining the results of 11 large high quality studies (randomised controlled trials) that looked at what happened to women who were randomly selected either to be invited for screening, or not to be invited for screening. However, these studies have some limitations. Most were carried out at least 20 years ago, and treatment for breast cancer has improved since then. Techniques for detecting breast cancer have also improved. The results vary a lot between the studies, because the studies looked at women of different ages, and over different periods of time. Although we know that screening saves lives from breast cancer, we do not know whether breast screening reduces the overall numbers of deaths among women screened every three years between the ages of 50 and 70. Women who would otherwise have died of breast cancer may die of other causes instead. So we can't say that breast screening reduces deaths overall, only that it reduces deaths from breast cancer. 28 Breast screening finds breast cancer that would never have caused harm to a woman The main risk of breast screening is that some women will be diagnosed with breast cancer that would never otherwise have been found and would not have become lifethreatening. This is known as overdiagnosis. Breast cancer only becomes lifethreatening when it grows and spreads to other parts of the body, and some breast cancers that show up on a mammogram are either growing very slowly or not growing at all. Some women can live their entire life with an invasive or non-invasive breast cancer that never causes them harm. These women would never need treatment for their breast cancer, unless it is found through screening. Overdiagnosed breast cancers are not wrong diagnoses – they are genuine breast cancers. When breast cancer is found through screening, doctors cannot always be certain about whether it will grow and become life-threatening or not. So they offer treatment to all women found to have breast cancer. This means that some women are offered treatment that they do not need. Nearly all women who have a cancer found through screening have surgery to remove all or part of the breast.13 Some will have other treatments too, such as radiotherapy to the breast, and hormone therapy or chemotherapy treatments. These treatments can have serious side effects. Unfortunately, there is no way of knowing whether or not a treatment was necessary, or which women were overdiagnosed. There is uncertainty among doctors and scientists about how many women are overdiagnosed with breast cancer. The numbers we give here are a best estimate from the Independent UK Breast Screening Review which estimated that99: about 15 out of every 200 women who are screened every three years between the ages of 50 and 70 will be diagnosed with breast cancer. about 3 of these women will be diagnosed and treated for a breast cancer that would never have become life-threatening, in other words an overdiagnosed breast cancer. The independent UK review estimated that about 19% of breast cancers diagnosed in women invited for screening aged 50-70, are overdiagnosed. This means that every year about 4,000 women in the UK are diagnosed and treated for breast cancer that would never have become life-threatening. However, because of the limitations of the studies, uncertainty around this estimate is very great. Scientists have estimated that it could be anything between 0% (no breast cancers are overdiagnosed) and 50% (half of all screening-detected breast cancers are overdiagnosed). 29 Figures 5 and 6 both show the benefits and risks of breast screening, as estimated by the Independent UK Review of Breast Screening. 99 100 Figure 5 shows what would happen to 200 women who choose to have breast screening every three years, when invited as part of the NHS Breast Screening Programme. As such, it shows the benefits and risks of having breast screening. Figure 6 shows what would happen to 200 women who choose to have breast screening and 200 women who choose not to have breast screening. In this way, the benefits and risks of both having breast screening and not having breast screening can be weighed up against each other. Different people prefer and understand different ways of representing information. This is why we have chosen to present the benefits and risks of screening in two different ways in these diagrams. 30 Figure 5: Benefits and risks of breast screening, as estimated by the Independent UK Review of Breast Screening 31 Figure 6: Benefits and risks of breast screening as estimated by the Independent UK Review of Breast Screening (alternative version) 32 How can we tell that some women are diagnosed with cancer that would never have caused them harm? Breast screening increases the number of women who are diagnosed with breast cancer between the ages of 50 and 70, because it finds breast cancers that are usually too small to see or feel and that would not therefore have caused symptoms until later on. So you might expect that by the age of 80 the numbers of women with breast cancer would be the same as if there was no screening. However, the evidence shows that some of the cancers diagnosed through screening would never have been diagnosed if screening had not been done.99 Before women were offered breast screening, non-invasive cancers were not often detected, as they don't usually cause symptoms. Since the start of the NHS Breast Screening Programme in 1988, the number of non-invasive cancers diagnosed has risen dramatically. But these cancers are still not well understood. We know that most invasive cancers are non-invasive when they first start. But not all non-invasive cancers become invasive. Some will never spread, or they will grow so slowly that they would have never caused a woman harm in her lifetime. Non-invasive breast cancers only account for some of the cancers diagnosed through screening that would never otherwise have been diagnosed. Research suggests that some invasive cancers diagnosed through screening might never otherwise have been found or caused a woman harm.101 In some cases, it might be that the cancer would never put the woman's life at risk, because she would die of something else before it started to cause problems. There is no way for a woman or her doctors to know for certain whether or not a breast cancer that is diagnosed through screening would have ever become life-threatening. Almost all women diagnosed with cancer have surgery to remove their cancer, including 99 in every 100 women diagnosed with non-invasive cancer.13 For some women, this early detection and treatment will be lifesaving. But for others, it will mean having potentially harmful treatments that they don't need. They will also have unnecessary stress and anxiety about a cancer they would never have found out about if they hadn't had screening. Researchers are trying to find better ways of telling which women have breast cancers that will be life-threatening and which women have cancers that will not. 33 What is the balance of the main benefits and risks of breast screening? On average, for every 1 woman who has her life saved from breast cancer through breast screening, 3 women are diagnosed and treated for a breast cancer that would never otherwise have been found or caused a woman harm in her lifetime. Figure 7: Weighing up the main benefit and risk of breast screening 34 Other benefits of breast screening Reassurance from a normal result A normal breast screening result can be reassuring.84 102 It is important to remember that it is still possible to develop breast cancer after a normal breast screening result. It is, therefore, useful for women to know how their breasts normally look and feel so that they can detect any changes. Women should make an appointment to see their GP straightaway if they experience any symptoms of breast cancer. (Please see page 8 for more information about the symptoms of breast cancer.) Chance of having a mastectomy It has been suggested that breast screening might make women with breast cancer less likely to have a mastectomy, because cancers found by screening tend to be at an earlier stage, when breast-conserving surgery, for example, removal of the lump only (lumpectomy), is more likely to be possible. However, studies of whether breast screening decreases or increases rates of having a mastectomy rather than breast-conserving surgery do not provide a definitive answer.103-106 Other factors such as surgeon and patient preference have an important influence on rates of breast-conserving surgery and mastectomy.107-110 When offered the choice about whether to have breast-conserving surgery or mastectomy, women’s preferences vary.107-109 Some women may prefer to have their entire breast removed, while others may prefer breast-conserving surgery. It is important that the team of specialists providing care for a woman diagnosed with breast cancer provide her with accurate information about the benefits and risk of the treatments so she can make an informed decision. Other risks Psychological effects of abnormal results Having an abnormal result on a mammogram (which some professionals call a positive result) does not mean a woman definitely has cancer. For 80 in 100 women who have an abnormal result, further tests show they do not have cancer. These women are said to have had a false positive result. This can be worrying for women even if they turn out not to have cancer, and some may feel distress which affects their ability to do their normal day-to-day activities at the time.111-116 The evidence on how much distress a false positive result can cause is not clear. Two large studies of over 700 women have found that six weeks later there was no difference in levels of poor mental health between women who had a false positive result and those who had a normal result six weeks after the mammogram.113 117 Another, smaller study suggests that women who have had a false positive result may 35 have more psychological problems after three years than women who had normal results115 116 118: in 99 women with a normal result, 25% had a score of 12+ on the Psychological Consequences Questionnaire; in 280 women with false positives, 63% had a score of 12+ (possible range of scores 0-36). Women with a score of 12+ would have said they experienced varying degrees of a range of negative thoughts and behaviours. These may have included a change in appetite, feeling worried, nervous or panicky, trouble sleeping, feeling depressed or feeling withdrawn. Having psychological problems is more likely when women have a tissue or cell sample taken from their breast (a biopsy).118 False reassurance from a normal result Very rarely, breast screening can miss a cancer. It is also possible for breast cancer to develop between a woman’s three-yearly screening appointments (this is called an Interval cancer). The potential risk is that after a normal screening result, a woman might be reassured, and so ignore any symptoms of breast cancer she experiences. She might delay reporting her symptoms because she thinks her recent normal result shows there is nothing to worry about. This could delay diagnosis and treatment of her cancer. For this reason, it is important for women to look out for the symptoms of breast cancer and to get to know how their breasts normally look and feel. They should make an appointment to see their GP straightaway if they experience any breast cancer symptoms, even if their most recent mammogram was normal. Radiation exposure Mammograms are X-rays, which means they use a small amount of radiation to create a picture of the breast. Having many X-rays increases a woman's exposure to radiation. Rarely, X-rays can cause cancer. Among women who have screening every 3 years from age 47 to 73, about 3 to 6 in every 10,000 may develop cancer due to X-rays from screening.119 36 10. Sources of more information about breast screening Women should contact their local breast screening unit with any questions about NHS Breast Screening. If they would like to talk to someone about whether to have breast screening, their GP will be able to help. Together, they can weigh up the possible benefits and risks, to help the woman decide. More detailed information on breast screening can be found on: The NHS Breast Screening Programme website: www.cancerscreening.nhs.uk/breastscreen The Informed Choice about Cancer Screening website: www.informedchoiceaboutcancerscreening.org The following charity websites may also provide helpful information about breast screening: Cancer Research UK www.cruk.org Healthtalkonline www.healthtalkonline.org Breakthrough Breast Cancer www.breakthrough.org.uk Breast Cancer Campaign www.breastcancercampaign.org Breast Cancer Care www.breastcancercare.org.uk 37 Acknowledgments We would like to acknowledge the contributions of the British Medical Journal Evidence Centre and Best Health. They were involved in reviewing the evidence necessary to write this document. They also contributed to the early stages of writing. We would also like to acknowledge Professor David Spiegelhalter for his contributions to the development of the diagrams (icon arrays) showing the benefits and risks of breast screening, as estimated by the Independent UK Review of Breast Screening. 38 Glossary Advanced breast cancer: Also referred to as stage 4 breast cancer, advanced invasive breast cancer or metastatic cancer. This usually means the cancer has spread to other parts of the body. It can also mean that the cancer hasn't spread but has grown directly into tissues close to the breast and cannot be removed through surgery. Benefit: A benefit is a good outcome. In the case of breast screening, the main benefit is lives saved from breast cancers. The opposite of a benefit is a harm (a bad outcome). We refer to the possible harms of breast screening as ‘risks’ in this evidence resource. Biological therapy: A way of treating breast cancer and trying to stop it coming back. Biological therapy can change the way cancer cells behave to make them stop dividing and growing. It can also kill any cancer cells and encourage the body’s immune system to attack them. Biopsy: A procedure in which a tiny sample of tissue is taken from the body (in this case, the breast) to examine more closely under a microscope. Core needle biopsy, fine needle aspiration and open biopsy are three ways in which a biopsy is taken following an abnormal breast screening result. Breast assessment clinic: Clinics that are usually based in hospitals where further tests after an abnormal mammography result are carried out. Breast-conserving surgery: Surgery used to treat breast cancer in which only the area of the breast with the cancer, and a small amount of healthy breast tissue around it, is removed. This is usually called a lumpectomy or a wide local excision. A less common type of breast-conserving surgery is quadrantectomy in which about a quarter of the breast is removed. Chemotherapy: A way of treating breast cancer and trying to stop it coming back. Chemotherapy drugs are used to kill any cancer cells left in the breast, lymph nodes, and other parts of the body. Clinical examination: This is when a doctor or a nurse practitioner carefully examines and feels the woman’s breast tissue as well as the lymph nodes under her arms and in her neck. Core needle biopsy: This is used as a follow-up procedure after an abnormal breast screening result. A doctor uses a bigger needle than in fine needle aspiration to collect a small sample of tissue (a biopsy) from the breast. A local anaesthetic is given to numb the area. The sample removed during the biopsy is sent to a laboratory where it is examined for signs of cancer. Ductal breast cancer: Cancer that starts in the ducts of the breasts. It is the most common type of breast cancer. 39 Ductal carcinoma in situ: Also known as non-invasive breast cancer. This is when there are cancer cells in the breast but they are only found within the milk ducts and have not spread any further. Early invasive breast cancer: Also referred to as stage 1 breast cancer. It has grown out of the ducts or lobules into the surrounding breast tissue. The tumour, if present, is small (2 centimetres or less across) and the cancer has not spread to the lymph nodes, or only very few cancer cells are in the lymph nodes. False positive: A false positive occurs when someone tests positive for a certain medical condition but in fact does not have the medical condition. In breast screening, a false positive occurs when a woman receives an abnormal (positive) mammography result, but then goes for further tests and finds out that she does not have breast cancer. This might also be called a false alarm. Familial breast cancer: Breast cancer that is due to inherited genes, also called hereditary breast cancer. Fine needle aspiration: This is used as a follow-up procedure after an abnormal breast screening result. A doctor uses a fine needle and syringe to collect some cells from a woman's breast. The sample is sent to a laboratory where it is examined for signs of cancer. Grade: This is a way used by breast cancer specialists to describe how different the cancer cells look from normal breast cells when they are looked at under a microscope. Grades are usually described as 'low grade', 'intermediate grade', or 'high grade'. Genetic counsellor: A genetic counsellor is a health professional who is specialised in medical genetics and counselling. Genetic testing: Genetic testing is offered to women with a higher than 20 in 100 chance of having a breast cancer gene in their family. Genetic testing looks for three types of faulty genes in a sample of blood: BRCA1, BRCA2, and TP53. Genetic testing must first be carried out on a relative who has had either breast cancer or ovarian cancer. This provides the best chance of detecting a faulty gene. If a faulty gene is found, then the women and other members of their family have the test. Harm: A harm is a bad outcome. In the case of breast screening, the main harm is that of being diagnosed and treated for a cancer that would never otherwise have been found or caused harm. In this evidence resource and in the leaflet about NHS breast screening, we refer to the possible harms of breast screening as risks. We chose to use ‘risk’ rather than the word ‘harm’ because members of the public who contributed to the development of the NHS breast screening information found the work ‘risk’ more useful and less alarming: they felt that ‘harm’ implied something inflicted on purpose. Hereditary breast cancer: Breast cancer that is due to inherited genes, also called familial breast cancer. Hormonal therapy: A way of treating breast cancer and trying to stop it recurring. Hormonal therapy reduces the amount of oestrogen in the body or blocks the effects of 40 oestrogen to help stop breast cancer growing or spreading. It can also help stop cancer coming back after surgery. It involves taking medicines, for instance tamoxifen, anastrozole, exemestane or letrozole, or having treatment or surgery to stop the ovaries making oestrogen. Inflammatory breast cancer: A less common breast cancer that blocks the lymph vessels in the skin of the breast. This makes the skin look pitted or dimpled, like orange peel. The skin may also feel warm and often looks red. Some women with this kind of breast cancer will develop an obvious lump in the breast but others will not. This type of cancer can develop and spread quickly. Interval cancer: An interval cancer is one that develops between screening appointments. This does not mean the cancer was missed at screening. It means that it started to grow and cause problems in the interval between screening appointments. Invasive breast cancer: This is when the cancer cells have spread out of the milk ducts and into the surrounding breast. Lobular breast cancer: Cancer that starts in the lobules of the breast (parts of the breast where milk is made). This is the second most common type of breast cancer. Lobular carcinoma in situ: Is when some of the cells in the lobules of the breast are abnormal. Although described as stage 0 breast cancer, it is not usually thought of as cancer, because it is not life threatening and has not spread out of the lobules of the breast. However, women with lobular carcinoma in situ have an increased risk of eventually getting cancer in either breast. Locally advanced breast cancer: Also referred to as stage 2 or 3 breast cancer. This means the cancer is in a large part of the breast and may also be in the lymph nodes. However, it hasn't spread to other parts of the body. Lumpectomy: Breast-conserving surgery to treat breast cancer in which only the area of the breast with the cancer, and a small amount of healthy breast tissue around it, is removed. Also called a wide local excision. Mammogram: An X-ray image of the breast. Mammographer: Woman (usually a radiographer or assistant practitioner) specially trained in taking mammograms. Mastectomy: Surgery to treat breast cancer in which the entire breast with cancer is removed. Some lymph nodes or small muscles near the breast may also be removed. Metastasis (metastatic breast cancer): This is when a cancer spreads to other parts of the body and becomes life-threatening. Non-invasive breast cancer: Also known as ductal carcinoma in situ (DCIS). This is when there are cancer cells in the breast but they are only found within the milk ducts and have not spread any further. 41 Overdiagnosis: The main risk of breast screening. It happens when breast screening finds cancers that would never otherwise have been found or caused a woman harm in her lifetime. Open biopsy: This is a follow-up procedure occasionally used after an abnormal breast screening result. It involves having an operation to remove one or more tissue samples through a small cut in the breast. A general anaesthetic is usually offered. Paget’s disease of the breast: A less common breast cancer that affects the skin on and around the nipple. Signs of Paget's disease can include itching, redness, and flaking of the skin. In its early stages, Paget's disease is often confused with eczema and other skin conditions. Women with Paget's disease often have cancer within their breast as well. Quadrantectomy: Breast-conserving surgery to treat breast cancer in which about a quarter of the breast is removed. Radiotherapy: A way of treating cancer and stopping it recurring. To treat breast cancer, radiation is directed at the breast and possibly the lymph nodes to kill any cancer cells that might have been left behind after surgery. Randomised controlled trial: Randomised controlled trials are considered the gold standard in scientific research for evaluating health care. In a randomised controlled trial, participants are randomly assigned to either receive an intervention or not (for example to have breast screening or not). The researchers can then look at differences in outcomes among the people who received the intervention and those who did not. Risk: A risk is a chance of something occurring. This may be a good or a bad thing. In this document and in the NHS breast screening leaflet, the term ‘risk’ is also used to describe the possible harms of breast screening. The main risk of breast screening is of being diagnosed and treated for a cancer that would never otherwise have been found or caused harm. The word ‘risk’ was chosen rather than ‘harm’ because members of the public who contributed to the development of the information found the work ‘risk’ more useful and less alarming. To them, ‘harm’ implied something inflicted on purpose. Stage: This is how cancer specialists describe how advanced a cancer is. Breast cancers are usually described as stage 0 to 4 (with stage 4 being the most advanced cancer). Symptom: Something that is felt by a person and indicates that a disease might be present. Symptoms are sensed by the person and are not necessarily apparent to other people (for instance, pain or a lump or thickening in the breast). Systematic review: A systematic review provides a thorough summary of all of the relevant literature on a given research question and follows methods which make the conclusions less likely to be biased. The findings of systematic reviews of randomised controlled trials are considered to be very high quality scientific evidence. Ultrasound: An ultrasound uses sound waves to make images of the inside of the breast. This test is used as a follow-up test after an abnormal screening result. It can sometimes show whether a lump is solid or whether it is a cyst filled with fluid. During an 42 ultrasound, a specialist puts gel on the woman's breast and rubs a small probe over the breast. Images of the breast tissue show up on a screen. Wide local excision: Breast-conserving surgery to treat breast cancer in which only the area of the breast with the cancer, and a small amount of healthy breast tissue around it, is removed. Also called a lumpectomy. 43 Notes on methods used to compile this evidence resource Two systematic searches were conducted. The first search was designed to identify relevant papers providing background information on breast screening. It was run once in Embase and Ovid MEDLINE and included relevant articles published between 2000 and 2012. The British Medical Journal and NHS Cancer Screening Programmes websites were also searched for relevant articles published between 2007 and 2012. The second search was designed to identify systematic reviews, randomised controlled trials and observational studies on specific effects of breast cancer screening. It was run in Ovid MEDLINE, Embase and the Cochrane Library and included studies published between 1992 and September 2012. Studies were selected for the evidence resource if the type of breast screening used was a close match for the type used in the NHS Breast Screening Programme. UK-based papers were prioritised in the selection process. Data on estimates of overdiagnosis, mortality, and the probability of different screening outcomes were drawn from the report of the Independent UK Review of Breast Screening.99 100 44 References 1. Office for National Statistics. Cancer registrations in England - 2010. 2012 http://www.ons.gov.uk/ons/dcp171778_263537.pdf. 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