It's Time For a More Individualized Approach to Breast Cancer Treatment

As our body of research on breast cancer has grown in breadth and depth over the last 45 years, we now have a better understanding of breast cancer and its treatment than we once did.¹ Studies have shown that deaths due to breast cancer are steadily decreasing in the United States.¹

While breast cancer is the second most common cancer diagnosed in women in the US, accounting for about 30% of all new female cancers each year,² no two people experience cancer in the same way, whether in terms of biology, presentation, or emotional journey.

Along with this increase in knowledge has come the conventional wisdom that there should be an individualized approach to cancer treatment plans.

That is why a significant focus of oncology research conducted over the last two decades has been devoted to helping identify targets in breast cancer, with the hope of developing and expanding the use of targeted therapies which are specific for an individual’s cancer.^3,4

The goal of taking an individualized approach to developing a breast cancer treatment plan is to help those diagnosed with breast cancer and their healthcare team make more informed decisions.

How an individualized approach works

After receiving a breast cancer diagnosis, early questions can often center on the stage of the disease’s progression. And while that information is important, there are several other characteristics of a person’s tumor that are also crucial to developing a treatment plan.⁵

Treatment decisions can be affected by multiple factors, including the patient’s general health, characteristics of the tumor such as subtype and stage, and the presence or absence of certain biomarkers such as the estrogen receptor.⁶ This places an emphasis on gaining as much of an understanding as possible about an individual’s cancer.

As this information is gathered and potential courses of action are discussed with a team of doctors, a personalized treatment plan can be created.

One consideration as part of an individualized treatment plan is testing for BRCA1 and BRCA2 (Breast Cancer gene 1 and 2) mutations. BRCA genes encode BRCA proteins that help to repair damage to DNA. Mutations (changes or alterations to the DNA) in BRCA genes may result in BRCA proteins that are not able to repair DNA, which can lead to cancer. However, there is a targeted treatment option that may help kill cancer cells with a BRCA mutation for certain types of breast cancer.^7,8

A targeted treatment option for a certain type of breast cancer

Because not all breast cancers are the same, doctors approach breast cancer treatment based on specific aspects of a person’s cancer. Approximately 5%-10% of people with breast cancer have an inherited (also known as germline) mutation, meaning they inherited a mutated copy of the gene from a parent.⁹ The most common mutation in hereditary breast cancer is an inherited mutation in the BRCA1 or BRCA2 gene. Around 7 in 10 women with an inherited BRCA mutation will develop breast cancer by the age of 80.⁹ The risk of getting breast cancer increases if more family members have had breast cancer. In people diagnosed with breast cancer, especially HR+ breast cancer or TNBC (Triple Negative Breast Cancer), testing for genetic mutations – such as those in the BRCA genes – can help healthcare providers determine appropriate treatment options based on the genetic characteristics of a person’s cancer, thus further tailoring treatment plans for individual needs.⁵

Mutations in the BRCA1 and BRCA2 genes are examples of information which can inform personalized treatment.⁸ Certain mutations in BRCA1 and BRCA2 result in BRCA1/2 proteins which are unable to do their normal job of repairing damaged DNA.⁸This can lead to cells accumulating DNA damage which can lead to cancer.^10,11 Because not all breast cancers are the same, doctors may approach breast cancer treatment based on specific aspects of a person’s cancer. One potential option is a class of drugs called PARP (poly [ADP-ribose] polymerase) inhibitors, which may be appropriate for certain breast cancer patients with inherited BRCA1 or BRCA2 mutations.⁷

Knowing the patient’s type of breast cancer helps healthcare teams know if certain PARP inhibitors may be appropriate. PARP is a protein that helps to repair damaged DNA. Inhibiting PARP leads to additional DNA damage. In cancer cells with mutated BRCA proteins that cannot repair damaged DNA, inhibiting PARP may help lead to the cancer cells dying.⁸Since PARP is also found in healthy cells, they may be affected too.⁸

LYNPARZA^® (olaparib), the first targeted PARP inhibitor therapy, was approved in 2014.¹² LYNPARZA, like the other drugs in the PARP inhibitor class, targets the mechanisms that respond to DNA damage in cells.¹²

In early 2022, LYNPARZA was approved in the US for the adjuvant treatment (meaning treatment after surgery) of human epidermal growth factor receptor 2(HER2)-negative (HR+ or TNBC) early breast cancer with an inherited BRCA mutation who have received chemotherapy either before or after surgery. Your doctor will perform a test to make sure LYNPARZA is right for you. LYNPARZA dosage is 2 tablets (150 mg each), taken by mouth twice a day, with or without food. It is an oral treatment that can be taken anywhere. It is not an infusion or chemotherapy.¹²See Important Safety Information below for additional information on how to take LYNPARZA.

In the OlympiA trial, a study that evaluated adults with TNBC or HR+ HER2-negative early breast cancer with an inherited BRCA mutation, LYNPARZA reduced the risk of breast cancer returning, new cancers occurring or death by 42% compared with placebo.¹³ In this study, patients had surgery and received chemotherapy either before or after their surgery, and those with hormone receptor-positive breast cancer may have also received hormonal therapy.¹³ 921 adults were treated with LYNPARZA and 915 were treated with placebo.
LYNPARZA lowered the risk of death by 32% in HER2-negative early breast cancer compared with placebo.¹³In this study, 846 out of 921 patients treated with LYNPARZA were alive at the time of follow-up as compared with 806 out of 915 treated with placebo.¹³

LYNPARZA has serious risks that may lead to death. These include bone marrow problems called Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML), lung problems (pneumonitis), and blood clots (venous thromboembolic events (VTE). Signs or symptoms of MDS/AML may include weakness, weight loss, fever, frequent infections, blood in urine or stool, shortness of breath, feeling very tired, or bruising more easily. Signs or symptoms of pneumonitis may include new or worsening lung problems, including shortness of breath, fever, cough or wheezing. Signs or symptoms of VTE may include pain or swelling in an extremity, shortness of breath, chest pain, breathing that is more rapid than normal, or heart beats faster than normal. Tell your doctors right away if you have any of these signs or symptoms. These are not all the side effects of LYNPARZA. Please see additional Important Safety Information below.

People always have the right to be an active participant in their treatment plan and know the specifics of their cancer inside and out. Everyone’s experience with cancer is different, so their treatment journey should be too. An individualized approach may help patients make informed decisions with their doctor about treatment, which may include options like LYNPARZA.

For more information about LYNPARZA, visit LYNPARZA.com.

IMPORTANT SAFETY INFORMATION

LYNPARZA may cause serious side effects, including:

Bone marrow problems called Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML). Some people who have ovarian cancer or breast cancer and who have received previous treatment with chemotherapy, radiotherapy, or certain other medicines for their cancer have developed MDS or AML during treatment with LYNPARZA. MDS or AML may lead to death. If you develop MDS or AML, your healthcare provider will stop treatment with LYNPARZA.

Symptoms of low blood cell counts are common during treatment with LYNPARZA, but can be a sign of serious bone marrow problems, including MDS or AML. Symptoms may include weakness, weight loss, fever, frequent infections, blood in urine or stool, shortness of breath, feeling very tired, bruising or bleeding more easily.

Your healthcare provider will do blood tests to check your blood cell counts:

before treatment with LYNPARZA
every month during treatment with LYNPARZA
weekly if you have low blood cell counts that last a long time. Your healthcare provider may stop treatment with LYNPARZA until your blood cell counts improve

Lung problems (pneumonitis). Tell your healthcare provider if you have any new or worsening symptoms of lung problems, including shortness of breath, fever, cough, or wheezing. Your healthcare provider may do a chest x-ray if you have any of these symptoms. Your healthcare provider may temporarily or completely stop treatment if you develop pneumonitis. Pneumonitis may lead to death.

Blood clots (venous thromboembolic events). Some people may develop a blood clot in a deep vein, usually in the leg (venous thrombosis) or a clot in the lungs (pulmonary embolism), which may be severe or lead to death. Tell your healthcare provider right away if you have any symptoms such as pain or swelling in an extremity, shortness of breath, chest pain, breathing that is more rapid than normal (tachypnea), or heart beats faster than normal (tachycardia). Your healthcare provider will monitor you for these symptoms and may prescribe blood thinner medicine.

Before taking LYNPARZA, tell your healthcare provider about all of your medical conditions, including if you:

have lung or breathing problems
have kidney problems
are pregnant, become pregnant, or plan to become pregnant. LYNPARZA can harm your unborn baby and may cause loss of pregnancy (miscarriage)
- If you are able to become pregnant, your healthcare provider may do a pregnancy test before you start treatment with LYNPARZA
- Females who are able to become pregnant should use effective birth control (contraception) during treatment with LYNPARZA and for 6 months after the last dose of LYNPARZA. Talk to your healthcare provider about birth control methods that may be right for you. Tell your healthcare provider right away if you become pregnant or think you might be pregnant following treatment with LYNPARZA
- Males with female partners who are pregnant or able to become pregnant should use effective birth control (contraception) during treatment with LYNPARZA and for 3 months after the last dose of LYNPARZA
- Do not donate sperm during treatment with LYNPARZA and for 3 months after your last dose
are breastfeeding or plan to breastfeed. It is not known if LYNPARZA passes into your breast milk. Do not breastfeed during treatment with LYNPARZA and for 1 month after receiving the last dose of LYNPARZA. Talk to your healthcare provider about the best way to feed your baby during this time

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking LYNPARZA and certain other medicines may affect how LYNPARZA works and may cause side effects.

How should I take LYNPARZA?

Take LYNPARZA tablets exactly as your healthcare provider tells you
Do not change your dose or stop taking LYNPARZA unless your healthcare provider tells you to. Your healthcare provider may temporarily stop treatment with LYNPARZA or change your dose of LYNPARZA if you experience side effects
Your healthcare provider will decide how long you stay on treatment
Do not take more than 4 LYNPARZA tablets in 1 day. If you have any questions about LYNPARZA, talk to your healthcare provider or pharmacist
Take LYNPARZA by mouth 2 times a day
Each dose should be taken about 12 hours apart
Swallow LYNPARZA tablets whole. Do not chew, crush, dissolve, or divide the tablets
Take LYNPARZA with or without food
If you are taking LYNPARZA for early breast cancer and you have hormone receptor-positive disease, you should continue to take hormonal therapy during your treatment with LYNPARZA
If you are taking LYNPARZA for prostate cancer and you are receiving gonadotropin-releasing hormone (GnRH) analog therapy, you should continue with this treatment during your treatment with LYNPARZA unless you have had a surgery to lower the amount of testosterone in your body (surgical castration)
If you miss a dose of LYNPARZA, take your next dose at your usual scheduled time. Do not take an extra dose to make up for a missed dose
If you take too much LYNPARZA, call your healthcare provider or go to the nearest hospital emergency room right away

What should I avoid while taking LYNPARZA?

Avoid grapefruit, grapefruit juice, Seville oranges, and Seville orange juice during treatment with LYNPARZA since they may increase the level of LYNPARZA in your blood.

LYNPARZA may cause serious side effects (see above). The most common side effects of LYNPARZA are:

nausea or vomiting. Tell your healthcare provider if you get nausea or vomiting. Your healthcare provider may prescribe medicines to treat these symptoms
tiredness or weakness
low red blood cell counts
diarrhea
loss of appetite
headache
changes in the way food tastes
cough
low white blood cell counts
shortness of breath
dizziness
indigestion or heartburn
low platelet counts

These are not all the possible side effects of LYNPARZA. Call your healthcare provider for medical advice about side effects.

You may report side effects related to AstraZeneca products by clicking here. If you prefer to report these to the FDA, either visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

WHAT IS LYNPARZA?

LYNPARZA is a prescription medicine used to treat adults who have:

advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a certain type of inherited (germline) or acquired (somatic) abnormal BRCA gene. LYNPARZA is used alone as maintenance treatment after the cancer has responded to your first treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you
advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a certain type of abnormal BRCA gene or a positive laboratory tumor test for genomic instability called HRD. LYNPARZA is used in combination with another anti-cancer medicine, bevacizumab, as maintenance treatment after the cancer has responded to your first treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you
ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, as maintenance treatment, when the cancer has come back. LYNPARZA is used after the cancer has responded to treatment with platinum-based chemotherapy
human epidermal growth factor receptor 2 (HER2)-negative early breast cancer with a certain type of inherited (germline) abnormal BRCA gene. LYNPARZA is given after surgery (treatment after surgery is called adjuvant therapy). You should have received chemotherapy medicines before or after surgery to remove the tumor. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you
a certain type of abnormal inherited BRCA gene, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread to other parts of the body (metastatic). You should have received chemotherapy medicines, either before or after your cancer has spread. If you have hormone receptor (HR)-positive disease, you should have been treated with hormonal therapy. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you
metastatic pancreatic cancer with a certain type of abnormal inherited BRCA gene. LYNPARZA is used as a maintenance treatment after your cancer has not progressed on at least 16 weeks of treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure LYNPARZA is right for you
prostate cancer with certain inherited or acquired abnormal genes called homologous recombination repair (HRR genes). LYNPARZA is used when the cancer has spread to other parts of the body (metastatic), and no longer responds to a medical or surgical treatment that lowers testosterone, and has progressed after treatment with enzalutamide or abiraterone. Your healthcare provider will perform a test to make sure LYNPARZA is right for you

It is not known if LYNPARZA is safe and effective in children.

Please see complete Prescribing Information, including Medication Guide.

You may report side effects related to AstraZeneca products by clicking here.

References

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American Cancer Society. Key Statistics for Breast Cancer. Available at
https://www.cancer.org/cancer/breast-cancer/about/how-common-is-breast-cancer.html. Accessed January 2023.
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American Cancer Society. How Targeted Therapies Are Used to Treat Cancer. Available at https://www.cancer.org/treatment/treatments-and-side-effects/treatment-types/targeted-therapy/what-is.html. Accessed January 2023.
Cancer.net. What Is Personalized Cancer Medicine. Available at: https://www.cancer.net/navigating-cancer-care/how-cancer-treated/personalized-and-targeted-therapies/what-personalized-cancer-medicine. Accessed January 2023.
American Cancer Society. Understanding Your Options and Making Treatment Decisions. Available at https://www.cancer.org/treatment/treatments-and-side-effects/planning-managing/making-decisions.html. Accessed January 2023.
NIH: National Cancer Institute. BRCA Gene Mutations: Cancer Risk and Genetic Testing. Available at: https://www.cancer.gov/about-cancer/causes-prevention/genetics/brca-fact-sheet. Accessed January 2023.
American Cancer Society. Targeted Drug Therapy for Breast Cancer. Available at: https://www.cancer.org/cancer/breast-cancer/treatment/targeted-therapy-for-breast-cancer. Accessed January 2023.
American Cancer Society. Breast Cancer Risk Factors You Cannot Change. Available at https://www.cancer.org/cancer/breast-cancer/risk-and-prevention/breast-cancer/risk-factors-you-cannot-change.html. Accessed January 2023.
Slade D. PARP and PARG Inhibitors in Cancer Treatment. Genes Dev. 2020;34(5-6):360-394. doi: 10.1101/gad.334516.119.
National Center for Biotechnology Information. Genetics, Cancer Cell Cycle Phases. Available at: https://www.ncbi.nlm.nih.gov/books/NBK563158/. Accessed January 2023.
LYNPARZA^® (olaparib) [prescribing information]. Wilmington, DE. AstraZeneca Pharmaceuticals LP; 2022.
Tutt ANJ, Garber JE, Kaufman B, et al. Adjuvant Olaparib for Patients with BRCA1– or BRCA2-Mutated Breast Cancer. N Engl J Med. 2021;384(25):2394-2405.

LYNPARZA is a registered trademark of the AstraZeneca group of companies.