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New AI Tool Improves The Accuracy Of A Breast Cancer Prognosis

Artificial intelligence (AI) tumor analyses help pathologists predict the future course of a woman's breast cancer. The Challenge

All breast cancers aren't the same. A specialized doctor called a pathologist learns about each person's breast cancer by carefully evaluating how a sample of tumor cells look under a microscope. They're assessing how different the cells look from normal breast cells, the cells' arrangement, and the number of dividing cancer cells. Together, these characteristics help the pathologist determine how likely it is that the cancer will grow and spread.

Currently, the cancer's grade is combined with other features of the tumor, including the TNM stage and the ER/PR/HER2 hormone status, to determine the diagnosis and doctor's best estimate of the cancer's prognosis. The prognosis is a prediction about the patient's expected outcome—the likelihood of recovery from, or recurrence, of the cancer. The patient's oncologist uses this information to talk with the patient about the best course of treatment.

Recent research has shown that evaluating the noncancerous elements in the tumor microenvironment also supplies helpful information about how the cancer might progress. That microenvironment outside tumor cells includes immune cells and other structures that can either inhibit or promote cancer growth and provide shape around a tumor.

While there are some excellent, experienced pathologists who specialize in breast cancer, analyzing the microscopic cancerous and noncancerous cells with the human eye is neither expedient nor efficient. A modern innovation that supports and improves the pathologist's task is digital pathology. This process uses specialized computer scanners and software to convert glass slides of tissue samples into high-resolution digital images that pathologists view on a computer monitor. Just like photos, digital images can be more quickly shared with others via the internet and without the concern of damaging the slides.

The Research

A group of Northwestern University and American Cancer Society researchers recently developed a breast cancer prognosis score using an artificial intelligence (AI) analysis of breast cancer tissue. This research, published in the scientific journal Nature Medicine, was particularly novel because it incorporated information about noncancerous cells surrounding the tumor into the score.

The overall goal of the work was to improve the accuracy, reproducibility, and efficiency of a patient's prognosis. Using the newly identified elements of the score along with other clinical data already collected in routine practice allows pathologists and doctors to use the new prognosis score to better predict the prognosis of the patient, and therefore, decide if the patient would benefit from chemotherapy or other additional aggressive treatment.

Visual Grading by a Pathologist vs Computational Assessment with HiPS

This figure was created using BioRender. The faded white area of the image on the left demonstrates that there are more steps than shown.

The left side of the above graphic shows the qualitative steps a pathologist uses to visually determine a cancer's grade: Use a microscope to see how cancer cells appear and predict how they will grow to provide a grade to help the oncologist discuss treatment options with the patient. 

The right side of the above graphic shows the quantitative steps the AI model uses to determine the cancer's grade. To start the process, the computer monitor in the graphic demonstrates the digital image of the slide with breast tissue. The assessment of this whole-slide image (WSI) uses advanced deep-learning computer vision to identify different cells and examine the cells' relationship to one another. The result is a more comprehensive evaluation of the entire area around a cancer than what is currently evaluated. Pathologists who use these specialized methods of artificial intelligence and integrated, computerized assessments (known as machine learning) are part of a brand-new discipline called computational pathology.

The new AI-enhanced breast cancer prognosis score, called HiPS, analyzes 26 different features of a patient's breast tissue to generate the score. The computer program that calculates the score does "interpretable scoring," meaning that it also "explains" to the pathologist which exact features are important for survival. Women with breast cancer are categorized as high risk if their cancer is likely to progress and possibly lead to death. Oncologists prescribe more aggressive treatments, like chemotherapy for high-risk patients. Patients who have a low risk of dying from breast cancer can often avoid these aggressive treatments, which have many difficult side effects.

HiPS was developed using data from sample tissue of 3,177 breast cancer patients who were part of the large prospective cohort from the ACS Cancer Prevention Study-II (CPS-II), and it was validated using data from ACS CPS-3, along with two other non-ACS related cohorts.

The dataset from CPS-II includes women diagnosed in hundreds of US healthcare facilities ranging from large academic cancer centers to rural facilities from over 614 US counties in 48 states. CPS-II data also included a wide representation of breast cancers in terms of size and aggressiveness. This diversity allowed the AI model to capture the true spectrum of disease in the US and improve its accuracy across breast cancers with different characteristics.

Another valuable feature of the ACS studies is that we have more than just the cancer tissue samples that other tissue databases provide—we also have decades of follow-up data from patients. This long-term information provides many valuable insights including the date a patient dies and what they die of. The ACS CPS-II resources were what made this high-impact work possible.

The collaborative study relied on the computational pathologists Mohamed Amgad, MS, PhD, and Lee Cooper, PhD, from Northwestern University to develop the AI algorithm. Scientists from the American Cancer Society (ACS) provided expertise on breast cancer epidemiology and clinical outcomes for the study. ACS co-authors included James Hodge, JD, MPH, Clara Bodelon, PhD, MS, and Lauren Teras, PhD.

Next, researchers will need to evaluate the HiPS model using data from clinical trials before it can be used in clinical practice.

Why It Matters

The HiPS AI model has the potential to:

  • Improve current prognosis methods. When the HiPS score is approved for clinical practice, pathologists may be able to recategorize some women who are currently classified as high-risk (and thus, recommended aggressive treatment with chemotherapy) into a lower-risk category. That means that more women may be able to avoid chemotherapy or other intense and long treatments that often have many challenging side effects.
  • Increase the number of patients who receive a more evidenced-based prognosis. The internet allows a quick transfer of HiPS information across long distances. As digital technology continues to be more widely available, HiPS evaluations can follow, regardless of where patients are or their access to a pathologist specialized in breast cancer.

  • Breast Cancer Diagnosis Shouldn't Be A Death Sentence: A Filipina Picks Up The Pieces And Becomes Her Own Advocate

    When Lisa (not her real name) had her routine mammogram in mid-July, she didn't think anything would be amiss.

    The lump in her right breast that was discovered in 2019 was deemed benign.

    But what should have been a routine mammogram unfolded into a life-changing diagnosis. There alone in the doctor's clinic – she was told she had an invasive breast carcinoma. It turns out that the lump in her right breast had become cancerous.

    "The way I was shared the news, parang feeling ko mamamatay na ko kinabukasan. That's how bad the news was delivered. Parang ang helpless ko nun, walang assurance from the doctor I saw na, 'It will be okay, we will do everything,'" she told GMA News Online. 

    It was her first mammogram since 2019. Due to the COVID-19 pandemic, she had not been able to go back to the hospital for follow-up checkups. During this time, she was also taking care of her ailing father, who passed away from lung cancer in 2021. 

    "Syempre iniisip ko it's nothing, kasi nung 2019 sabi nila unlikely magiging cancerous 'yung lump na 'yun. So, imagine 'yung fear ko, mag-isa lang ako, I had to hold it together para matapos ko 'yung mga questions ko sa doctor," she said. 

    "It was like a range of feelings kasi syempre takot ako. I saw what cancer did to my dad and to another friend who had breast cancer. I saw how debilitating the disease is." 

    Had her circumstances been any different, she wouldn't think of putting up a fight, but there were bigger things at stake for the 47-year-old wife and mom of three. 

    "My kids, my family, kaya ko ba na wala ako dito? Kaya ko ba ma-miss ang milestones nila in life? Hindi, hindi ko kaya 'yun. It's really them. Kung single ako and childless, I'm ready to go, but I have kids," she said. 

    From the hospital, she texted her husband to inform him she was positive for cancer. As she lined up for her pathology test, she contacted her boss her availability when she seeks treatment. Come evening, she called her mom who was based in the United States to tell her the news and their next steps.

    She treated the diagnosis as a project, each move precise and purposive, and focused towards a specific goal. She wanted to live, and the diagnosis was not the end. 

    "Ano ba 'yung outcome na gusto ko? Gusto kong gumaling, hindi lang gumaling pero remove this cancer and prevent it from recurring," she said.

    She allowed herself to cry on the first night she received the news, resolving that she would let it all out this once and pick herself up the next morning to do everything else she needed to do.

    The breast cancer diagnosis changed her life overnight, from her diet (no more alcohol, junk food, red meat) to her lifestyle (regular walks and meditation, and not so much of HIIT anymore). 

    But it also changed the way she prayed. If before, she would only thank God profusely, her prayers now became more specific in supplication. 

    "I'm asking now for something, unlike before I just thank and thank and thank. I thank the Lord for everything pero ngayon may kasamang, 'Pwede bang pahingi naman nito?' 'Lord pahabain mo buhay ko, pagalingin mo ko, tanggalin mo 'yung cancer ko,'" she shared. 

    She prayed for her cancer not to spread; further tests showed that it did not metastasize. 

    Her pathology report also showed that her type of breast cancer is HER2-negative, which she was told was the "friendlier" type of cancer. 

    According to WebMD, the Human Epidermal Growth Factor Receptor 2 (HER2) is a type of protein that is responsible for cell growth in healthy and cancer cells. It influences how fast one's breast cancer grows and multiplies, and how the cancer reacts to different kinds of treatment. 

    Those whose breast cancer is HER2-negative means their cancer does not produce a lot of HER2. They tend to have a better outlook because their cancer is less aggressive than those with HER2-positive breast cancer. 

    Breast cancer in the Philippines

    In the Philippines, one in four Filipinos develop breast cancer, making it one of the countries with the highest incidences of breast cancer globally.

    According to the Asian Breast Center in 2023, breast cancer is the top cancer among Filipinas as to incidence, with over 27,000 diagnosed with it in 2020 alone. In comparison, one in eight women in the United States develop breast cancer.

    Asian Breast Center CEO, Dr. Norman San Agustin, told GMA News Online that the survival rate of breast cancer in the Philippines is "very low" despite it being a curable disease, adding that Filipinas don't get check-ups and mammograms much.

    But in breast cancer where early detection is absolutely crucial, getting regular examinations, including self-examinations, should be a priority.

    For women in their 40s, it is generally recommended to get breast cancer screening every year.

    In June, PhilHealth started offering free breast cancer screening, such as ultrasound and mammogram services, under its Konsulta package.

    Those who wish to avail of the PhilHealth Konsulta Package may register with their PhilHealth Konsulta Provider of choice. Here is the list of accredited Konsulta Package providers, as of April 30, 2024.

    Meanwhile, there is also the cost of cancer treatment to think about. For many Filipinos living with cancer and those who have loved ones with cancer, the costs can weigh heavy. 

    Under the National Integrated Cancer Control Act, there are two programs that those in need of cancer assistance may avail of.

    There's the Cancer and Supportive-Palliative Medicines Access Program (CSPMAP), which provides free medicines for cancer patients and their families, as well as the Cancer Assistance Fund (CAF), which offers financial assistance for cancer treatment, including diagnosis tests, therapeutic procedures, laboratory services, and cancer medicines.

    The CAF, implemented by the Department of Health, is available in 31 access sites in Luzon, Visayas, and Mindanao. It covers eight priority cancer types: breast; childhood; lung; prostate, urinary bladder, and kidney; blood (leukemia, lymphoma, and multiple myeloma); colorectal, liver, and other gastrointestinal cancers; cervical and other gynecologic cancers; and head and neck including thyroid.

    Mastectomy and reconstruction

    On August 30, Lisa underwent back-to-back surgery: four hours for the mastectomy of her right breast followed by three hours for its reconstruction. 

    Prior to undergoing the surgical procedure, she painstakingly consulted with four different doctors in search of the right specialist who was not just an expert in their field, but one that she could trust, build rapport with, and draw strength from. 

    Following the bad experience with her initial specialist – the one who broke the news of her diagnosis – and upon the recommendation of her uncle who is also a doctor, she chose Dr. Pierette Kaw, a breast surgeon, for her mastectomy and Dr. Eric Arcilla for her reconstructive surgery.  

    She shared how much it mattered to get a second opinion and look elsewhere when one does not feel comfortable with their initial doctor. 

    "It wasn't a hard decision to make. I found it very easy kasi this is me, this is my body, this is my life at stake also. Itong doctor that I first saw, kung ikaw 'yung magiging doctor ko in the long run, parang hindi tayo magkakasundo," she said. 

    With the doctors in her care team now, however, which also includes anesthesiologist Dr. Celina Ancheta and oncologist Dr. Marina Tan, she couldn't be happier. Their presence has made her feel calm and at ease before, during, and after the procedure. 

    She also emphasized that it's important to advocate for oneself when it comes to the treatment that one feels is best for them.

    While there were different treatment options laid before her, she ultimately chose to go with a mastectomy with reconstruction.

    The night before the mastectomy on August 29 to do the sentinel node mapping, a crucial step to locating where the cancer is draining. Beside *Lisa is Dr. Eddie Lim from the Nuclear Medicine department of the hospital. Photo supplied.

    The night before the mastectomy on August 29 to do the sentinel node mapping, a crucial step to locating where the cancer is draining. Beside *Lisa is Dr. Eddie Lim from the Nuclear Medicine department of the hospital. Photo supplied.

     

    Mastectomy involves the total removal of a breast, unlike a lumpectomy which only excises the site where the tumor is situated and leaves the rest of the breast intact. According to BreastCancer.Org, lumpectomy is usually followed by radiation therapy, while those who've undergone mastectomy may still need to undergo radiation therapy or chemotherapy depending on pathology results after the procedure. 

    "Mastectomy will give me peace of mind over the other treatment options presented to me, and having a reconstruction is part of the holistic approach to breast cancer management," she said.

    She also chose to have reconstructive surgery because she isn't ready "to go flat," noting that this decision was personal. 

    "With reconstruction, I believe it will help me maintain a positive body image and self-confidence. This isn't about the relative who says, 'Hmm... You don't really need that, pampaganda lang 'yan.' It's not about them — it is about me."

    After *Lisa's skin grafting procedure on October 7. Beside her are reconstructive surgeon Dr. Eric Arcilla and anesthesiologist Dr. Celina Ancheta. Photo supplied.

    After *Lisa's skin grafting procedure on October 7. Beside her are reconstructive surgeon Dr. Eric Arcilla and anesthesiologist Dr. Celina Ancheta. Photo supplied.

     

    Through the mastectomy, the mass, breast tissue, and lymph node that looked "hot" in her CT Scan, she said, were entirely removed and all cleared of metastasis. She does not need to go through radiation therapy. 

    However, her MammaPrint test results, which arrived two weeks after her surgical procedure, indicated that she is "high risk luminal-type b breast cancer," meaning there is an increased likelihood for the cancer to come back in 10 years. 

    With this development, Dr. Kaw required her to undergo chemotherapy as adjuvant therapy to decrease the chance of recurrence. 

    "I felt sad kasi I was really hoping na hindi ko kailangan. So, ang iniisip ko na lang, on the brighter side... The chemotherapy's not treating a tumor anymore, it's making sure there are no surprises in the next 10 to 15 years," she said. 

    Lisa has to undergo a total of eight rounds of chemotherapy for the next six months, or one round every three weeks. It would cost about P30,000 per round of chemotherapy for the first four, and then the costs will double from the fifth to eighth rounds when she switches medicines. 

    She is scheduled to begin chemotherapy on October 18. 

    Preparing for chemotherapy 

    Recently, Lisa found herself crying over a picture of their last family trip in California in 2022. On that trip, they visited Monterey Bay and Carmel-by-the-Sea, and got to swim in her sister-in-law's home. 

    "With the kids kasi complete kami. Sabi ko, 'Ah we can't do this again,' 'yung mga questions really pop up. 'Will my life go back to normal?' then I started crying," she said. 

    Her husband's family are all based in the U.S. And so they make it a point to visit them every year. This Christmas, she isn't sure if she'll be able to come, but she encouraged her husband and sons to still go on the trip. 

    "Ayoko silang malungkot. I talk to them, 'For the next six months, I will be focusing on myself, it doesn't have to be your focus but it will be my focus,' sabi ko, so we won't be doing the usual shopping and pasyal and the Simbang Gabi. Baka ma-lessen, not totally mawawala, kasi there are days I'm on chemo. I also said I might not be decorating the house," she continued. 

    While she and her husband spoke to her two older sons, ages 30 and 21, about her chemotherapy like adults, they were careful to be reassuring when it came to her youngest son, who is only 13 years old. 

    She chooses what she shows to her kids, she admitted. She only wants to show her best self to them, and not any weakness. 

    As for her husband, she described him as the MVP and the perfect partner amid all this. He has been the most encouraging and understanding partner in every difficult moment, as well as her constant source of love and support. 

    "I ask him kung okay lang siya, of course he said hindi naman niya ako iiwanan. We talked about this kasi nga sabi ko, I don't want this to be a burden to him, I don't want to be a burden to him. Sinabi ko from the start ayoko magpaalaga, so that's why ang ginagawa ko lang nag-a-apologize ako na we can't do the same things like before, we don't do fun things," she said. 

    She added that she is never alone in facing the hardships of breast cancer treatment and recovery because of him. 

    "With his dedication, I am able to focus on my health and healing.  His love, patience, and dedication have shown just how deeply he cares, and I am not alone in this fight against cancer." 

    With her first round of chemotherapy about to start this October, she has been making sure that she's at her best condition, from eating healthy food and going on regular walks to keeping properly hydrated as she heals. She has also set a dental appointment prior to chemo, got the flu vaccine and other tests like platelet count and ECG, as well as a cardiologist clearance.

    Aside from all these, the preparation has also translated into the seemingly quotidian, such as makeup and beauty.

    She has been browsing wigs online, and already ordered bandanas and hypoallergenic makeup to keep her mind off the dread of chemo.

    She noted, just as importantly, that she already got her eyebrows microbladed ahead of the first round. 

    Her doctor warned her about losing her eyebrows by January when they switch medicines for the fifth round of chemotherapy, and she would not be allowed to get cosmetic tattooing by then.

    "Nagpa-retouch na ko ng kilay, so hindi ako mukhang alien," she quipped. "Okay lang naman na walang hair eh, pero 'yung kilay 'yun 'yung weird, kasi 'yun 'yung nag-f-frame ng face mo."

    These forms of kakikayan, however small, have helped bring normalcy and joy to her life, a reminder, perhaps, that there are parts of herself that she need not lose or let go of even if chemo loomed just ahead.

    And when the bad days happen, and they do happen, she turns to her faith and meditation to ground herself. 

    "Most days, I feel positive and focused on healing, but there are times when sadness creeps in. I find myself wondering if my life will ever truly return to what it was before," she said. 

    "When I start feeling this way, I've found meditation to be a great source of comfort. It keeps me centered and in the moment letting me handle the emotional rollercoaster better." 

    The importance of breast cancer screening 

    Lisa would not have discovered she has breast cancer in the first place if it wasn't through a routine mammogram. She believes that other Filipinas, too, should have access to breast cancer screening and has advised women her age to get screened regularly. 

    "I would encourage women over 40 to get routine mammograms and ultrasound. Iba 'yung peace of mind na mabibigay nun and knowing also na malinis 'yung breast mo," she said.

    And if one does get diagnosed with breast cancer, not all hope is lost, as she reminded women not to be afraid to consult with other doctors. 

    "Be proactive in your care—whether it's asking for a second opinion, clarifying treatment timelines, or exploring treatment options. Understand your diagnosis, treatment options, and prognosis. I kept a list of questions, and raised them during appointments," she said.

    When she got diagnosed in July, she wanted to hear from somebody that things would be all right, but it was through doing her homework and keeping informed of her breast cancer that she found this assurance within herself. 

    She thus encourages women to equip themselves by also learning about their breast cancer, such as reading reputable studies and white papers from experts. 

    "It helped me reassure na it is going to be okay. Everything is going to be okay. From the start, I was waiting for someone to say that kasi nga, ako, iyak nang iyak eh," she said. "It helped me assure na may sagot sa sakit. It's not the end of the world, it's just a diagnosis."

    Here's how to do a self-exam for breast cancer.

    — LA, GMA Integrated News


    Breast Cancer: What Are Your Risks And What Can You Do About It?

    Did you know that breast cancer accounts for about 27% of all cancers in SA? It's the most common female cancer in the world. Males can also get breast cancer, albeit rarely.

    The good news is increased awareness and understanding, early diagnosis and advances in treatment have led to a decrease in advanced diagnoses and an increase in breast cancer survival rates.

    As early detection can save lives, PathCare — a people-focused, technology-driven pathology practice — answers some commonly asked questions about breast cancer, from symptoms and risk factors to how the disease is diagnosed and the importance of genetic counselling.

    What is breast cancer?

    Breast cancer happens when the breast cells grow out of control. 

    What are the symptoms?
  • Changes in the appearance of your breast, that is size, shape, symmetry or skin changes.
  • Lump or mass in your breast or under your arm.
  • Enlarged underarm lymph nodes.
  • Changes in the appearance of your nipple, that is discharge, shape, retraction or direction changes.
  • Puckering, dimpling or skin indentation (like orange peel).
  • Pain, swelling or tenderness.
  • Skin changes, rash or redness.
  • Having any of these symptoms does not necessarily mean that you have cancer, but a visit to your doctor to determine the cause is recommended.

    What are the risk factors?

    Age: Most cases occur in patients older than 50 years. It is less common in women younger than 35 years.

    Hormones and childbirth: Your risk increases when you have an early age of onset of first menstruation (< 12 years), menopause after 55 years, no children or children after 30 years of age, not breastfeeding and postmenopausal hormone replacement therapy.

    Lifestyle choices: Alcohol and tobacco use are linked to increased cancer risk.

    Weight and physical activity: Obesity or weight gain after menopause and physical inactivity increase your risk.

    Previous breast disease: A history of a previous breast cancer or an abnormal biopsy finding increases your risk.

    Family history of cancer: Your risk increases if you have a family history of cancer.

    How can I reduce my risk?
  • Maintain a healthy weight.
  • Exercise regularly.
  • Follow a healthy diet.
  • Eliminate tobacco use and minimise alcohol consumption.
  • Talk to your doctor about hormone therapy.
  • Get your breast cancer risk assessed.
  • Follow recommended screening guidelines according to your risk.
  • Be aware of your breasts and perform monthly breast self-examinations.
  • How is breast cancer diagnosed?

    Breast cancer is diagnosed after assessing a combination of clinical, radiologic (imaging) and pathologic (laboratory) features: 

    Clinical investigation:

    After your healthcare practitioner has performed a clinical assessment they may refer you for further radiologic investigations.

    Radiologic investigation:

    A mammogram and ultrasound are typical radiological investigations used to evaluate the breast to identify abnormalities and to better determine whether a lesion requires a biopsy or not.

    Some lesions are obviously benign on a mammogram and others require a biopsy to determine whether they are benign or malignant. 

    Breast biopsy and laboratory investigation:

    A breast biopsy may be performed by either a surgeon or radiologist.

    The biopsy is sent to a laboratory for evaluation. A pathologist will look at the biopsy under a microscope and may need to perform various special tests to determine whether a breast lesion is benign or malignant.

    There are various types of breast cancer. If a breast lesion is found to be malignant, additional tests will be performed to determine the specific type of breast cancer so that the surgeon and the oncologist will better be able to decide on the best treatment plan for that specific type of breast cancer.

    What about hereditary breast cancer (inherited risk)?

    One in every 10 women will develop breast cancer in their lifetime. The majority of breast cancers are sporadic and not caused by a genetic predisposition (inherited).

    Of those who develop a breast cancer, about 10% are caused by an inherited change in a gene. The majority of these cases are caused by inherited changes in the BRCA1 or BRCA2 genes, but other genes may also be involved.

    The following family history from either side of the family may suggest hereditary breast cancer:

  • Multiple individuals with breast, ovarian, pancreatic, prostate cancer, and/or melanoma in close relatives under the age of 50.
  • Breast cancer diagnosed under the age of 50.
  • Bilateral breast cancer.
  • Male breast cancer.
  • Triple negative breast cancer.
  • High-risk ancestry such as Ashkenazi Jewish.
  • A number of different genetic testing options for hereditary breast cancer (both in-house and international send-away tests) are available through PathCare.

    Risk assessment, the most appropriate testing strategy and test interpretation, depends significantly on an accurate family history. This should ideally be managed by a multidisciplinary team, including a genetic counsellor.

    Comprehensive pre- and post-test genetic counselling is highly recommended. This ensures informed decision making and consent.

    What does a genetic counsellor do?
  • Interpretation of family and medical histories to assess the chance of disease occurrence or recurrence.
  • Education about inheritance, testing, management, prevention, resources and research.
  • Counselling to promote informed decision making and adaptations to the risk or diagnosis.
  • Managing family risk and cascade testing/screening.
  • I think I need to see a genetic counsellor ‒ what now?

    Though PathCare does not offer a clinical genetic counselling service, it can provide you with contact details for genetic counsellors in SA. Call the company's genetics team on 021 596 3655 or email geneticconsult@pathcare.Org.

    This article was sponsored by PathCare and compiled by HPCSA-registered genetic counsellors.

    References: Parkin et al. (2005) J Clin Cancer 55:74-108 Evans DGRHowell A (2007) Breast Cancer Research 9:231-221Pharoah et al. (2008) NEJM 358: 2796-2803.






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