Phase Iii Keynote 355 Trial
The much anticipated KEYNOTE-355 trial was presented at the inaugural virtual ASCO annual meeting in June 2020. This trial investigated pembrolizumab/chemo vs chemo in patients with treatment-naïve, metastatic TNBC. Patients were excluded if they had active brain metastases or recurrence of disease < 6 mo prior to primary treatment. PD-L1 was assessed with the IHC 22C3 pharmDx CPS assay in a central laboratory. The primary outcome measure was pre-defined as OS and PFS in the PD-L1 positive population and the ITT population. In this trial, a hierarchial statistical testing method involved statistical testing of OS and PFS in the CPS > 10 group initially, followed by CPS > 1 and then the ITT population. The trial included 566 patients in the chemotherapy/IO arm vs 281 in the chemotherapy arm. In patients with a CPS score of 10 or greater, the median PFS favoured pembrolizumab with a PFS of 9.6 mo vs 5.6 mo . In patients with a CPS score of 1 or greater, the median PFS favoured the pembrolizumab arm with a PFS of 7.6 mo vs 5.6 mo . This was not statistically significant. This was similar to the ITT population where the PFS was 7.5 mo in the pembrolizumab arm and 5.6 mo in the placebo arm . OS data is awaited. This progression free survival improvement led to accelerated FDA approval for pembrolizumab in combination with chemotherapy in the first-line setting in November of 2020.
Prognosis For Metastatic Breast Cancer
Metastatic breast cancer isnt the same for everyone who has it. According to the National Breast Cancer Foundation, your symptoms at stage 4 will depend on the degree to which the cancer has spread in your body.
Although metastatic breast cancer has no current cure, it can be treated. Getting the right treatment can increase both your quality of life and longevity.
Life expectancy for breast cancer is based on studies of many people with the condition. These statistics cant predict your personal outcome each persons outlook is different.
The following factors can affect your life expectancy with metastatic breast cancer:
How Is Tnbc Diagnosed
Imaging tests are usually the first tests done:
- Mammography, the most common screening tool for breast cancer, uses X-rays to take images of the breast and can uncover tumors that may be too small to feel.
- MRI uses a magnet, radio waves and a computer to make detailed images of the breast with a much greater resolution than a mammogram offers.
The next step is a biopsy to remove a sample of suspicious cells from the breast to analyze them. Techniques include:
The appropriate type of biopsy for you depends on factors such as the size and location of the tumor. You may also have a biopsy of your underarm lymph nodes at the same time to see if any cancer is there.
Breast cancer treatment: The care you need is one call away
Your multidisciplinary team will work with you to develop a personalized plan to treat your breast cancer in a way that fits your individual needs and goals.
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New Medications For Metastatic Breast Cancer
Immunotherapy drugs called checkpoint inhibitors have led to a significant improvement in survival rates for lung cancer and melanoma.
In 2019, Tecentriq became the first immunotherapy drug to be approved for triple-negative breast cancer that is metastatic or locally advanced but unresectable . However, in August 2021, Tecentriq’s manufacturer voluntarily withdrew that indication in the United States.
However, also in 2021, the Food and Drug Administration approved Keytruda for high-risk, early-stage, triple-negative breast cancer. It is used in combination with chemotherapy as a neoadjuvant treatment , and then continued as a single agent as adjuvant treatment .
PARP inhibitors are another class of medication that may alter survival rates in the future, particularly among women who have hereditary breast cancer .
For bone metastases, bone-modifying drugs may be effective in both treating metastases and possibly reducing the development of further metastases in bone.
Finally, for people who have only a single or a few metastases , treating these metastases locally may be an option. While studies are young, treating oligometastases may improve survival or even lead to long-term survival for a minority of people.
Where Do These Numbers Come From
The American Cancer Society relies on information from the Surveillance, Epidemiology, and End Results Program database, maintained by the National Cancer Institute , to provide survival statistics for different types of cancer.
The SEER database tracks 5-year relative survival rates for breast cancer in the United States, based on how far the cancer has spread. The SEER database, however, does not group cancers by AJCC TNM stages . Instead, it groups cancers into localized, regional, and distant stages:
- Localized: There is no sign that the cancer has spread outside of the breast.
- Regional: The cancer has spread outside the breast to nearby structures or lymph nodes.
- Distant: The cancer has spread to distant parts of the body such as the lungs, liver, or bones.
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What Are Breast Cancer Subtypes And Why Do They Matter
Your breast cancer subtype is one factor healthcare providers take into account when theyre deciding how to treat your cancer. Thats because not all cancer treatments are successful with all breast cancer subtypes.
Providers look at your cancer cells to identify subtypes. Specifically, they look for molecules on your cells surfaces. These molecules, called receptors, are built to order so only certain substances can climb on and start affecting what your cells do.
Breast cancer cells receptors are open to estrogen and progesterone. Understanding if your breast cancer cells have receptors and if theyre housing hormones helps providers determine how your breast cancer might spread and what treatment might be most effective.
The other type of breast cancer that has another receptor is called her-2 neu. This receptor makes the cells more active, but allows healthcare providers to treat the cancer with specific medicines that target her-2 proteins. If your breast cancer doesnt have her-2 neu and hormone receptors, its called triple negative.
Survival Rates For Breast Cancer
Survival rates can give you an idea of what percentage of people with the same type and stage of cancer are still alive a certain amount of time after they were diagnosed. They cant tell you how long you will live, but they may help give you a better understanding of how likely it is that your treatment will be successful.
Keep in mind that survival rates are estimates and are often based on previous outcomes of large numbers of people who had a specific cancer, but they cant predict what will happen in any particular persons case. These statistics can be confusing and may lead you to have more questions. Talk with your doctor, who is familiar with your situation, about how these numbers may apply to you.
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What Does Triple Negative Mean In Terms Of Breast Cancer
Normal breast cells have receptors that respond to hormones such as estrogen and progesterone, which allows them to grow and regress in response to the hormone level. Hormone receptors may or may not be present in breast cancer. About two-thirds of breast cancers are positive and contain these receptors like normal breast cells do. These are less aggressive cancers that are less likely to need chemo and are often treated with hormone therapy and surgery. Radiation may or may not be needed.
HER2/neu , is a protein molecule that has a role in cell proliferation in normal cells. In some breast cancers, this protein is overly produced or positive. For HER2-positive tumors, there a specific medication that targets this protein.
Triple-negative breast cancers are not positive for estrogen receptors, progesterone receptors or HER2 protein. Since these targets are absent in triple-negative breast cancer, chemotherapy is needed, Sun says. Triple-negative breast cancer is often very sensitive to chemotherapy, which, despite the side effects, is an effective treatment that can save lives. Because this is an aggressive cancer, treatment is aggressive also. But there are several ways we can address it.
What Are Causes And Risk Factors For Triple
Although there are known risk factors for the development of any kind of breast cancer, doctors do not understand the exact cause of breast cancer.
- Normal cells become cancer cells due to changes or mutations in the DNA.
- While people inherit some DNA changes, others acquire these DNA changes during a person’s life.
The following are causes and risk factors for any type of breast cancer, including triple-negative breast cancer:
- changes in the nipple, including inversion of the nipple and nipple discharge.
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Triple Negative Breast Cancer
With this type of breast cancer, the breast cancer cells dont have ER+ or PR+ receptors. They dont overproduce the HER2 protein, so hormone therapy isnt very effective.
Instead, triple negative stage 4 breast cancer is usually treated with chemotherapy. Radiation therapy may also be an option, depending on the site of metastasis.
A Note About Statistics
Survival rates are statistics. As such, they tend to tell us how the average person will do with an average triple-negative breast cancer. But people and tumors arent statistics. Some people will do better, and some people will do worse.
Very importantly, statistics are usually several years old. In order to calculate five-year survival rates, a person would have to have been diagnosed at least five years prior, and there is lag time. The treatment of triple-negative breast cancer is changing, and new drugs have been approved.
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What Is The Survival Rate For Triple Negative Breast Cancer
Survival rates are a way to discuss the prognosis and outlook of a cancer diagnosis. The number most frequently mentioned is 5-year survival. Many patients live much longer, and some die earlier from causes other than breast cancer. With a constant change and improvement in therapies, these numbers also change. Current 5-year survival statistics are based on patients who were diagnosed at least 5 years ago and may have received different therapies than are available today.
Below are the statistics from the National Cancer Instituteâs SEER database for survival of all patients with breast cancer, by tumor stage:
Recurrence Of Metastatic Breast Cancer
Metastatic breast cancer is considered a chronic disease, so it doesnt go away and recur.
But in recent years, people under age 50 have seen a particularly strong decline in death rates due to breast cancer, according to the Centers for Disease Control and Prevention .
These declines are due in part to improved screening and treatment for the disease.
There are a few general facts that are helpful to know about breast cancer outlook:
- Breast cancer is the most common cancer diagnosis in the United States, according to the
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Treatment And Outcome After Distant Metastasis
Treatments in patients diagnosed with distant metastasis are shown in Table Table3.3. Median distant disease-free interval among all patients who developed metastatic disease was 15 months: 24 among younger and 13 among older patients, although the difference between age groups did not reach statistical significance . Fifty six % in the whole group received palliative chemotherapy. Few patients received more than 1 line of palliative chemotherapy. Only 10% in the older group received palliative chemotherapy compared with 93% in the younger group . Fifty five % in the whole group received palliative radiotherapy and there was no significant difference between age groups .
Phase Iii Embrca Trial
In the pivotal phase 3 study EMBRCA, authors investigated talazoparib in 431 patients with gBRCA mutations and MBC. Approximately half of patients had TNBC with the remainder having ER/PR-positive breast cancer. Patients had a median of 2 prior lines of chemotherapy and were randomised in a 2:1 manner to receive talazoparib vs physicians choice . Median PFS was greater in the talazoparib group compared to the control group-8.6 mo vs 5.6 mo with an objective response rate of 62.6% vs 27.2%. Benefit within the TNBC and HR positive subgroups was equivalent. Crucially however, median OS was not significantly greater in the talazoparib group compared to the placebo group . Patients in the talazoparib group did however have improved health related quality of life outcomes. More than a quarter of patients suffered from a grade 3 or grade 4 adverse event in the talazoparib group which was similar to the control group . Notably, one patient suffered from the rare but well described PARPi toxicity of acute myeloid leukaemia.
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Morbidity Financial And Social Burdens Of Therapy
Chemotherapy is often feared by patients due to the side effects associated with treatment however, the costs for administering therapy have also become a major burden for both the United States healthcare system as well as the patients it serves. Financial toxicity is not frequently disclosed, and can be materially and psychologically debilitating for patients. Financial hardships induced by the cost of cancer care worsen patient psychological stress and financial insolvency has been identified as a risk factor for early mortality in cancer patients.,
Should You Have A Mastectomy With Triple
Because triple-negative disease is considered more aggressive than breast cancers that are HER2-positive or hormone-receptor-positive, many doctors believe that it should be removed with mastectomy rather than lumpectomy followed by radiation to reduce the risk of recurrence and improve survival chances.
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Phase Iii Olympiad Trial
In the phase 3 study, OLYMPIAD investigators 5) studied olaparib in patients with MBC and gBRCA. Half of patients had ER/PR-positive breast cancer with the remainder having TNBC. The cohort was heterogenous with 71.2% of patients having received any lines of treatments previously and 29.3% of patients having had prior exposure to platinum-based chemotherapy. Patients were randomised in a 2:1 manner to receive olaparib vs standard therapy . Median PFS was significantly longer in the olaparib group in contrast to the chemotherapy group . In a subgroup analysis, the HR of benefit was significantly elevated in the TNBC group . The response rate was 59.9% in the olaparib group vs 28.8% in the standard group. However, OS did not significantly differ between groups-19.3 mo in the olaparib group and 17.1 mo in the control group.
History Of Breast Diseases
The initial symptoms of cancer are cancerous lesions in the breast . Regarding the family history of disease, the other risk factors associated with breast cancer are in-situ carcinoma, atypical hyperplasia, proliferative lesions and non-proliferative lesions . Breast cancer risks include a family history of breast cancer and benign lesions .
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Progress In Treating Her2
HER2-positive and triple-negative breast cancer are among the most aggressive forms of breast cancer and traditionally have had lower survival rates than other types of the disease. However, early detection with routine screening has contributed to improved survival for both in recent years. Further, treatment advancesall available at Regional Cancer Care Associates , one of the nations largest networks of cancer specialists with locations in New Jersey, Maryland, and Connecticutalso have helped improve outcomes in HER2-positive cancer. Meanwhile, intensive research and emerging therapeutic strategies are offering new hope for women with triple-negative breast cancer.
Four RCCA medical oncologists recently explained what drives the development of these breast cancers, how they are treated, and how women can play an important and potentially life-saving role in identifying the cancers in their earliest stages, when they can be treated most effectively.
Aileen Chen, MD, a board-certified medical oncologist practicing with RCCA in Freehold and Holmdel, NJ says, Its an exciting time in the fight against breast cancer. Next-generation sequencing technology is detecting genetic mutations that we can treat with targeted therapies in many forms of the disease. This has enhanced our ability to practice personalized medicine by customizing a patients treatment based on her molecular and genetic profiles.
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Triple Negative Breast Cancer Facts
1. Hormone treatments is not possible with this type of breast cancer.2. This is a much rarer type of breast cancer that affects a higher rate of Hispanics, African Americans, younger people and people that have a BRACA 1 gene mutation.3. Approximately 80% of BRACA 1 gene mutation tumors are triple negative.4. There is a strong correlation between an autosomal inheritance pattern and TNBC but most studies fall short of calling it a causal relationship.5. This cancer is harder to treat, is more likely to recur in the first five years after treatment and can be more aggressive BUT all of the factors including successful treatment largely depend on the stage in which the cancer is identified and the grade of the tumor.6. TNBC has a higher recurrence rate in the first five years after remission while other cancers like estrogen receptor positive cancers have much lower rates of recurrence during the first five years of remission.7. While TNBC recurs at a higher rate in the first five years once the five year mark passes with each additional year of survival the odds of recurrence is drastically reduced.8. After 5 years the chance of recurrence of TNBC is reduced by 50%.9. With each year after the 5 year mark the chance of recurrence is reduced by an additional 10%-15%.10. Long term survivors have almost a 0% rate that the disease will recur. With other breast cancers the recurrence rate climbs after the first 5 years.
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