INTRODUCTION BREAST CANCER CARE

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1 INTRODUCTION Breast Cancer Care welcomes the HFEA s consultation on embryo selection for inherited cancer. This is an extremely important and complex issue. Because of this, Breast Cancer Care has encouraged people affected by breast cancer to respond directly to the consultation, in addition to our formal submission that follows. BREAST CANCER CARE Breast Cancer Care is the UK's leading provider of information, practical assistance and emotional support for anyone affected by breast cancer. Every year we give direct support to over 22,000 people with breast cancer or breast health concerns through our helpline, peer support and other direct services. In addition, we respond to 2 million requests for support and information about breast cancer or breast health concerns through our publications, website and outreach work. All our services are free. We are committed to campaigning for better treatment and support for people with breast cancer and their families. BREAST CANCER CARE S RESPONSE PGD represents a major breakthrough for inherited genetic conditions because when carried out with IVF, it offers high-risk couples a pregnancy with no chance of genetic disorder transmission. Testing for some genetic conditions, such as sickle cell anaemia, is relatively uncontroversial as there are significant benefits to be derived from early diagnosis and medical treatment. However, genetic diagnosis for PGD becomes more controversial when the benefit derived in terms of prevention and treatment is more difficult to determine, as is the case for inherited breast cancer. Inherited Breast Cancer The consultation deals with inherited cancer, in particular breast cancer, which is the most common cancer in the UK and accounts for almost one in three of all cancer cases in women. About 1 in 9 women in the UK will develop breast cancer by the time they are 80 years old. 1 1 NHS Cancer Breast Screening Programme, 2002.

2 Inherited breast cancer represents a very small percentage of breast cancer cases. Whilst people who inherit faults in these genes have a higher chance of developing breast cancer, these faults are rare accounting for less than 1 in 20 breast cancer cases. 2 Over 85% of women who have a close relative with breast cancer will never develop the disease, and more than 85% of women with breast cancer have no family history of it. 3 Lower penetrance of breast cancer Faults in known high-risk breast cancer genes such as BRCA1 and BRCA2 account for fewer than 5% of breast cancer cases, and because of the lower penetrance nature of the condition, not everyone carrying the faulty gene will develop breast cancer. The risk of developing breast cancer in a person carrying either of the BRCA1 and BRCA2 gene faults is not clearly defined, with reports ranging from %, and variations between BRCA1 and BRCA 2 carriers. Whilst it is estimated that half of all women (50%) who carry a faulty BRCA1 or BRCA2 gene will have developed breast cancer by the time they are 50 years old, the risk to carriers of BRCA1 mutations have been estimated to be 60-80% by age 70 while the risk to carriers of BRCA2 mutations is lower. 4 As a result, in contrast with other genetic conditions in which a gene carrier will always develop the particular condition, not everyone carrying a faulty BRCA1 or BRCA2 gene will develop breast cancer. At the same time, over this lifetime, many people who do not have an identified gene will go on to develop breast cancer. Age of onset In contrast with some genetic conditions which affect a person at an early age (childhood), inherited breast cancer is an adult genetic condition. Whilst in women with a genetic susceptibility, breast cancer tends to occur at an earlier age than in sporadic cases, the mean age of breast cancer diagnosis among women carrying BRCA1 or BRCA2 mutations is in the 40s 5 compared to 50s-60s in sporadic cases (80% of breast cancers occur in women over the age of 50). 6 2 Cancer Research UK. 3 Collaborative Group on Hormonal Factors in Breast Cancer (2001) Familial breast cancer: collaborative reanalysis of individual data from 52 epidemiological studies including 58,209 women with breast cancer and 101,986 women without the disease. Lancet; 358; 9291; NICE, Familial breast cancer: The classification and care of women at risk of familial breast cancer in primary, secondary and tertiary care, May 2004, page Rebbeck TR, Levin AM, Eisen A, et al., Breast cancer risk after bilateral prophylactic oophorectomy in BRCA1 mutation carriers, Journal of the National Cancer Institute 91(17): , 1999; l. c. Hartman et al., Efficacy of bilateral prophylactic mastectomy in women with a family history of breast cancer, New England Journal of Medicine 340; 77-84, Cancer Research UK, 2004.

3 Definition of high risk and eligibility Breast Cancer Care would like to emphasise the issue of PGD for people identified as high risk but who do not have an identified inherited gene. The consultation document states that the person seeking PGD will have a confirmed faulty copy of the gene. In terms of breast cancer there may be some confusion about people classified as being at high risk of inherited breast cancer but who do not have an identified gene, and therefore would not be eligible for PGD. As a result, Breast Cancer Care would like to draw the HFEA s attention on the potential need to make a judgment about whether is necessary to consider patients who are identified as high risk as well as patients who are known to have an identified inherited gene. If patients who are identified as high risk but do not carry an identified gene were to be excluded from PGD, clear information would need to be available about why they do not qualify. Further to this point, potentially people with lower (moderate rather than high) risk of inherited breast cancer may request PGD. The NICE clinical guidelines on familial breast cancer state that genetic testing for breast cancer is appropriate only for a small proportion of women who are from high risk families. This means that the majority of people with a family history do not fall into a high risk category. This may cause confusion from those not considered at high enough risk to be eligible for genetic testing and therefore PGD and it is crucial that clear information around this issue be available. These points raise interesting questions about the definition of high risk. Not all those classified as high risk of breast cancer by genetic services currently choose to have a genetic test in fact only small numbers actually go on to be tested. Importantly, of the 5-10% in whom breast cancer is truly hereditary, only about one third will have a faulty gene detected. 7 In some cases where people receive a negative genetic test result because technology cannot find the gene, geneticists may inform people that they are probably still gene carriers because the family history is so strong. It is already the case that some people who have risk reducing mastectomy will not be confirmed gene carriers but will be deemed at high enough risk (usually 2 ½ times population risk) to be eligible for surgery anyway. Therefore the notion of confirmed gene carriers becomes blurred. The NICE clinical guidelines on familial breast cancer 8 estimating the risk of developing inherited breast cancer: highlight the complexity of In most instances it is unlikely that a family history of breast cancer will be due to known high-risk genes such as BRCA1 or BRCA2 and we are only beginning to appreciate the contribution of other lower risk genes that may account for more breast cancer overall. (at page 23) 7 See fn.4. 8 Ibid.

4 Impact of other factors on breast cancer The activity of faulty genes can also be affected by other genes, hormones and environmental factors. Current research has identified links between cancer and a host of non-genetic factors including some chemicals, pesticides, radiation, bovine growth hormone, diet and exercise, which impact on the evolution of faulty genes. Risk of developing sporadic breast cancer There is an important difference between children born from breast cancer PGD and those with other inherited conditions: the children from selected healthy embryos can still go on to develop sporadic breast cancer. Conditions, such as Huntingdons are only inherited, so if one is clear of faulty genes, you will not get the condition. Breast cancer occurs most frequently outside of an inherited line, and therefore even if a child was born using PGD, this would not remove the risk of them developing sporadic breast cancer later in life. Risks of PGD As mentioned in the consultation document, PGD is not without risks and is still very much a new technology in which the long-term effects are unknown. Risks to consider are: - PGD relies on IVF, a burdensome and risky procedure with a low success rate. The likelihood of failure is important when consenting women and helping them reach a decision about PGD. The figures from HFEA in May 2003 state that the average live birth rate for IVF is approximately 17% with fresh eggs and sperm and 12% with frozen embryos. Therefore IVF may not result in a child. This is always an important consideration but especially if the mother had treatment for breast cancer that had led to her becoming infertile. If she has PGD, she knowingly consents to her faulty embryos being allowed to perish. This would need to be very clear to a couple as these might later prove to be her only chance of pregnancy lost. - False or inconclusive test results. The genetic tests used in PGD are not 100% reliable, meaning a theoretical long term risk of inherited breast cancer remains for the person born following PGD. Generally, good practice denotes that counselling support and surveillance are key for those at high risk of breast cancer. It is extremely important that the HFEA makes it clear what support will be offered to those born after PGD and who will be responsible for providing it. There are obvious resource issues considering the potential for lifetime risk. This has to be a major consideration if PGD is offered. - Lack of long-term data on the procedure s success and long-term health of babies born as a result of PGD.

5 Psychological Implications The effect that offering PGD may have on increasing the complex decisions facing people at high risk of inherited breast cancer because of family history needs to be considered, as these people already have many complex decisions to make, for example whether to have a bilateral risk reducing mastectomy or surveillance, and may also have been through the difficulty of multiple bereavements. Given that they may never go on to develop breast cancer, and that their children may not either, the option of PGD may lead to further anxiety and pressure of decision making as well as heighten fears. Other breast cancer genes The guidance refers to BRCA 1 & 2 but it is highly likely that other genes predisposing to breast cancer will be discovered (e.g. TP53) which may have lower prevalence or penetrance. If this is the case, the HFEA will need to consider whether all breast cancer gene carriers will be eligible for PGD or only if the newer genes have a certain level of penetrance. Process Women considering risk reducing surgery for high risk of breast cancer have to go through a rigorous process, including genetic assessment and psychological counselling before being given the operation. If PGD for inherited breast cancer is agreed, it is crucial that the HFEA makes it clear whether similar levels of support will be available to women considering it and who will be responsible for this. Difficulty may arise if a woman with a family history develops breast cancer at young age and then chooses to freeze some embryos because of the risk of chemotherapy induced infertility. Could she then have PGD and will there be enough time to prepare her adequately before starting chemotherapy? Prevention and Treatment The proposal for PGD breast cancer must also be considered in light of preventive measures and treatment options available now and those anticipated in the forthcoming years. Although breast cancer is not preventable, its impact and implications may be improved through early detection, for example, through being picked up by attending routine breast screening (e.g. mammography) and being breast aware. Five-year survival rates from breast cancer in the UK have been steadily improving since the 1970s. Almost two thirds of women now diagnosed with breast cancer are likely to survive for at least 20 years. Women aged between 50 and 69, who are most likely to be diagnosed with the disease, have an even better prognosis, with 72% surviving for 20 years. 9 9 Cancer Research UK, October 2005.

6 New hormonal therapies have had a significant impact on breast cancer survival rates. In recent years, there has been an increase in the number of life-saving treatment advances against breast cancer. Instead of only one or two options, today there is an overwhelming catalogue of treatment choices that fight the complex mix of cells in each individual cancer. For example, recently, Herceptin has been shown to reduce the chance of recurrence in HER2 positive early stage cancer by half and a new class of drugs, the aromatase inhibitors, has been shown to reduce the risk of the disease recurring in post menopausal women. Some experts are starting to suggest that within the next years, breast cancer may become seen as a long term manageable condition. In a survey carried out in 2003, Breast Cancer Care asked 80 UK cancer experts their views on possible advances in breast cancer. 83% said that they believe breast cancer will be considered a long-term manageable condition in 20 years. 10 There are also strategies to reduce the risk of breast cancer developing in high risk women. For example, Tamoxifen has been shown to reduce the risk of breast cancer in high risk women and trials are now looking at the role of aromatase inhibitors in prevention. Prophylactic surgery has also proven to be highly effective in preventing breast cancer: following prophylactic mastectomy, the risk reduction of breast cancer has been estimated at 90% over 14 years following prophylactic oophorectomy, the risk reduction for breast cancer has been estimated at 50% over 9 years. 11 In addition, there are significant developments in the area of gene profiling which may positively alter outcomes for gene carriers in future generations. CONCLUSION Breast Cancer Care would like to emphasise the importance of consulting with people who are or may be affected by this issue. Whilst PGD has strong scientific and ethical implications, it also has significant psychological and emotional consequences that only people affected by the issue can explain appropriately. In particular, we would like to acknowledge that the fear of passing on breast cancer to their children is a very significant concern voiced to us by breast cancer patients and PGD will inevitably be seen as vital by some hence the views of those with a significant family history should be sought to establish needs and the level of support required. 10 Breast Cancer Care, Breast cancer in the UK What s the prognosis, July L. C.Hartmann, et al. Efficacy of bilateral prophylactic mastectomy in women with a family history of breast cancer, New England Journal of Medicine, 14 January 1999, Vol. 340(2), pp See also T.R. Rebbek et al., Double Preventive Mastectomy Lowers Risk in Women with BRCA1 or BRCA2 Mutations, Journal of Clinical Oncology, 15 March 2004.

7 Breast Cancer Care s response also makes it clear that the current and foreseeable medical advances would call for a regular review of PGD should it be agreed, as advances in prevention may somewhat negate the need for PGD. Breast Cancer Care will follow-up the developments arising from this consultation very closely and will provide any relevant information and evidence that may have implications for the issues at stake. January 2006

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