October is recognized as Breast Cancer Awareness month, and it is difficult not to notice the theme at every turn, from worldwide landmarks with pink lights—Buckingham Palace, the White House, and Tokyo Tower, to name a few&mdash;to professional athletes altering their uniforms with pink socks, sweatbands, and caps. During this month, you can also find seminars, conferences, and screenings centered around breast cancer. Advertisements on television and social media, too, are loaded with the color pink and the symbolic pink ribbon.

Despite all these efforts to bring awareness to breast cancer, as an African American woman, it is heartbreaking to read the statistics about my ethnic group and the treatment disparity that still exists in 2019. 

 reports that among African American women with breast cancer younger than 50 years old, they have a mortality rate double that of white women with breast cancer.

Not only are more aggressive forms of breast cancer diagnosed in African American women than white women

—such as triple-negative breast cancer (TNBC), which has limited treatments available and can’t be treated with hormonal therapies&mdash;but the disease is being diagnosed at more advanced stages. Contributing factors to these inequalities include social and economic disparities, cultural differences, biological differences, and lack of access to high-quality healthcare. The socioeconomic disparities stem from fewer opportunities and lack of access to resources, such as employment, income, education, housing, healthy foods, and standard of living compared to white Americans. The higher cancer burden may also reflect different rates of behavioral risk factors for cancer such as smoking.

Are we looking close enough at the biological differences? Why are black women more opt to develop TNBC that is most likely not due to a 

 Does socioeconomic status determine the type of breast cancer diagnosed in these women? Could there be a gene mutation expressed in black women that has not yet been identified? In order to dive further into the germline DNA, clinical trials need to include more African American women.

With what we already know, how can we begin to close this disparity gap? I believe knowledge is power and without knowledge, life is lost. Education is key to closing this gap. The American Cancer Society has done a lot of work to bring awareness to underserved communities through prevention and early detection programs and services, by providing transportation to treatment and lodging during treatment, and by assisting with navigation through the healthcare system.

 Community leaders, cancer advocates, health care workers, organizations, associations, and anyone who has an interest in the community must join forces to help bring their own awareness to the unique challenges that African American women with breast cancer face.

The technology is available, and new breakthroughs and treatments are continuing to be revealed, but African American women are not receiving many benefits from these advancements. Much work is still needed to improve the mortality rate and close the disparity gap of African American women with breast cancer.

DeSantis CE, Ma J, GHaudet MM, et al. Breast cancer statistics, 2019 [published online October 2, 2019]. 

Forster V. Breast cancer death rate continues to drop, but black women have far higher mortality rates. 

forbes.com/sites/victoriaforster/2019/10/02/breast-cancer-death-rate-continues-to-drop-but-black-women-have-far-worse-chance-of-survival/#681548922054

Cancer Facts & Figures for African Americans 2019-2021

. Atlanta, GA: American Cancer Society; 2019. 

cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/cancer-facts-and-figures-for-african-americans/cancer-facts-and-figures-for-african-americans-2019-2021.pdf

The biology of cancer health disparities. National Cancer Institute website. 

cancer.gov/research/progress/discovery/biology-cancer-health-disparities

Articles

Despite advanced technology and new treatment breakthroughs in cancer care, treatment disparity remains among African American women with breast cancer.
 

African American Women Aren't Receiving the Benefits of Breast Cancer Awareness

The Food and Drug Administration (FDA) has issued a new draft guidance for labeling recommendations for breast implants to manufacturers that they hope will provide patients with more information on the benefits and risks associated with them.

The new draft guidance offers measures to make sure women have access to pertinent information concerning the implants, such as suggesting manufacturers include updated guidelines for rupture screenings. They proposed that patients without symptoms be screened using either ultrasound or MRI at 5-6 years after receiving implants and then every 2 years thereafter. If a patient has symptoms at any time or uncertain ultrasound results for breast implant rupture, an MRI is recommended. The FDA also hopes to provide easier access to information on both saline-filled and silicone gel-filled breast implants.

The new recommendations come after the FDA came under scrutiny for not addressing patient complications with breast implants. In March, the agency held a hearing where patients brought multiple issues to light about their breast implants and subsequent illnesses. The FDA came out of the hearing 

 on cancer and illness caused by breast implants, including breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). While the FDA announced that it would 

 against BIA-ALCL, the organization had yet to issue new action until this week.

“We have heard from many women that they are not fully informed of the risks when considering breast implants. They’ve stated that they need more information to facilitate meaningful conversations with their doctors and to make appropriate decisions for themselves. Many stakeholders suggested that a boxed warning and patient decision checklist could provide this information,” the agency said in a press release. “The agency appreciates this important feedback and, in today’s draft guidance, has proposed a number of recommendations designed to help inform conversations between patients and healthcare professionals when breast implants are being considered.”

One of the major recommendations proposed by the FDA is to provide a boxed warning on the label of the breast implant. The label would include a warning that breast implants are not lifetime devices and the risk of developing complications increases the longer a patient uses the implant, which could lead to more surgery to address these complications. The warning would also include that breast implants have been associated with BIA-ALCL.

The FDA also recommends a patient decision checklist, which will allow patients to easily understand the risks associated with the breast implant, and if the implant is right for them. The agency recommends that the information in the checklist should include situations where the device should not be used, what makes a successful breast implant candidate, risks of undergoing breast implant surgery, importance of physician understanding and experience with breast implants, risk of BIA-ALCL, and alternative options to using breast implants. This checklist would also have the patient and physician initial that they have gone through the checklist together.

Other recommendations included adding product ingredient information simplified in a way for patients to read and understand. The abridged information is a way to provide patients with access to information that they otherwise wouldn’t get or have to ask their physician to explain to them. The FDA also would like manufacturers to provide the device’s unique identifier on the patient card in order for both the patient and physician to better track the device's information.

“Taken as a whole we believe this draft guidance, when final, will result in better labeling for breast implants that will ultimately help patients better understand breast implant benefits and risks, which is a critical piece in making healthcare decisions that fit patients’ needs and lifestyle,” the agency concluded in their statement. “After a period of public comment, once the guidance is finalized, manufacturers may choose to follow the recommendations in the final guidance or they may choose other methods of labeling their devices, so long as the labeling complies with applicable FDA laws and regulations.”

Statement on the Agency’s Continued Efforts to Protect Women’s Health and Enhance Safety Information Available to Patients Considering Breast Implants. FDA. Published October 23, 2019. https://bit.ly/35WzONY. Accessed October 24, 2019.

Breast Implants-Certain Labeling Recommendations to Improve Patient Communication: Draft Guidance for Industry and Food and Drug Administration Staff. FDA. Published October 23, 2019. https://bit.ly/33V42z1. Accessed October 25, 2019.

Following concerns over breast implant-associated cancer and illnesses, the Food and Drug Administration issued draft guidelines for additional labeling measures on devices.
 

FDA Recommends New Labeling Guidelines For Breast Implants

Nursing involves truly unique stressors, that if left unmanaged, can lead to equally unique negative outcomes. These include Burnout (A state of physical, emotional, and mental exhaustion caused by a depletion of the ability to cope with one’s environment, particularly the work environment)

 and Compassion Fatigue (Physical, emotional, and spiritual exhaustion resulting from caring for patients and witnessing pain and suffering).

 The principles of Stress Management are the same regardless of one’s job but can provide a very helpful framework for nurses to decrease job stress and improve health outcomes for themselves and their patients 

Stress Awareness involves identifying one’s personal 

 of stress (stressors) as well as identifying one’s personal 

 to stress.  There are six work domains relevant to a nurses’ stress levels. 

 involves the amount of work required, the frequency of unexpected events and the suffering acuity of patients.

refers to participation in work decisions, quality of management leadership, and patient outcomes.

 describes recognition for achievements as well as opportunities for bonuses and raises.

 includes the frequency of supportive work interactions and the closeness of personal friendships at work.

 refers to the administration’s dedication to equal consideration for everyone and clear procedures for allocating rewards and promotions.

involve the confidence that one’s personal and organizational mission is meaningful and that there is the potential to contribute to the greater good.

Nurses can go through these domains to identify their own stressors and think about how they are reacting physiologically (e.g., headaches), psychologically (e.g., anxiety or depression), and behaviorally (e.g., missing work, or getting angry with colleagues).

Once aware, one can recognize when suffering from stress and can begin to implement a number of practical management techniques. First, try to eliminate or modify the severity of the stressor via problem-solving.  Relax and focus on nothing but the issue at hand. Identify the real problem.  Brainstorm for possible solutions. Select one possible solution and implement it. If it works, celebrate! If it not, go back to brainstorming and trying different solutions.

The six nursing work domains can be a framework for brainstorming ideas. Talk with co-workers to see who may have some of the same concerns and think of ways to make changes among yourselves. Then, approach the administration as a group to ask for help with larger issues, which can also enhance the credibility of the problem if a number of your colleagues echo the same issues.

Next, one can try changing one’s attitude toward or cognitive appraisal of the stressor.  There are a number of ways to do this that are quite relevant to nurses. First, a nurse must be clear about the scope of their professional role.  A nurse cannot always cure a patient’s illness or disease or solve all problems, however, a nurse can always do 

 to make a patient, family member, caregiver and/or colleague feel better. A nurse must be absolutely, positively convinced about the incredible value of every nursing intervention performed!

Hope related to health status is a prime example of how nurses can change their cognitive appraisal. There is no such thing as “false hope.” However, what is hoped for, probably will change over time. What is first hoped for in the face of illness or disease is cure or return to full physical and mental health. What is next hoped for is a positive adaptation to partial physical and/or mental health with a good quality of life. This can be a long trajectory with diminishing yet important and valuable hopes.  What is finally hoped for is an end of life with all instrumental and emotional business completed in a dignified, pain-free manner, and in the presence of people who care/matter.

Fears and perceptions about the End of Life, both for oneself and one’s patients, are major stressors for nurses. First, our fears about the process of dying that include loss of dignity, pain, and sadness about leaving loved ones. Palliative and Hospice Care are major resources that can significantly mitigate these issues. Next, are fears about being dead. One way to cognitively approach this is the “Two Option Plan.” Option 1 is that there is an Afterlife/Heaven. Most references describe this as beautiful, peaceful, and joyful. There is no pain, suffering, or sadness. The deceased will join ones who have died earlier and in a blink of celestial time, loved ones left behind will also arrive. Option 2 is there is no Afterlife, everything just ends, there is nothing. However, there is no pain, suffering, or sadness. There is no consciousness at all.  This is akin to the best night’s sleep one ever had, one just doesn’t wake up. The bottom line is that this is not bad! Everyone has their own personal beliefs about what comes next, and it’s important to not only be conscious of your own but also your patient’s.

The final stress management technique is learning how to change one’s physiological reaction to a stressor from negative to positive by shutting off the chronic release of stress hormones and turning on positive neuro-endocrine-Immune responses such as endogenous opioids. These are naturally occurring opiate-like substances and are pain killers. They are also anti-depressants and enhance the immune system. Fortunately, there are a number of mechanisms that serve both functions. These include exercise, laughter, music (listening to, singing, playing), pets, aromatherapy, meditation, and much more. Allowing you a wide variety of options to find the best technique that fits you.

Stress and its management, particularly for nurses, are complex issues but ones that can be successfully managed. For more information on Stress Management go to 

1. Maslach C. (1982) Burnout-The cost of caring. Englewood Cliffs, NJ;Spectrum.

2. Aycock, N, Boyle, D. (2009) Interventions to manage compassion fatigue in oncology nursing 

3. Fawzy FI, Fawzy NW, Pasnau RO. (1991) Burnout in the health professions.  In Judd, Burrows, Lipsitt (eds.), 

Handbook of Studies on General Hospital Psychiatry

, Elsevier Science Publishers B.V.:New York, 119-130.

4. Figley, CR. Treating compassion fatigue. New York,NY: Brunner-Routledge

5. Henry BJ. (2014) Nursing burnout interventions: What is being done? 

6. Houck, D. (2014) Helping nurses cope with grief and compassion fatigue: An educational intervention. 

Stress management is vital for any profession, but for oncology nurses, stress management is crucial to not only helping themselves but also helping their patients.

Stress Management for Nurses

As cancer survival rates increase, healthcare professionals may be treating more patients who are considered long-term survivors (5 years or more after treatment). The 5-year survival milestone is often a cause for celebration, but results from studies show that 20% to 30% of long-term survivors continue to have needs that nurses and other members of their healthcare team can address, at least in part.

Survivorship comes with its own set of physical, emotional, and financial challenges. To promote good quality of life and autonomy, long-term survivors will need ongoing support. Healthcare teams can provide this by implementing survivorship care plans, using telemedicine, or bringing on more support staff, such as patient navigators.

Even 5 years or more after treatment, patients can continue to experience the physical effects of cancer treatment, which may affect their ability to perform typical daily activities. These effects can include pain, neuropathy, sexual dysfunction, incontinence, and fatigue, among others. Some treatments lead to other health risks, such as damage to the heart, bones, or other organs, as well as an increased risk for other cancers.

Patients often feel as if they’ve been cut off from their healthcare team a few years after treatment and that they have been left to deal with these issues on their own. Once patients stop seeing their oncologist regularly, nurses are perhaps in the best position to let them know who can address these salient concerns. Providing patients with detailed guidance can help them recognize that they have support as they continue through survivorship. Nurses can encourage some to call their primary care physician or educate others on how to stay in touch with their oncologist.

Long-term cancer survivors often have similar psychosocial needs as patients who have recently completed treatment. Although anxiety is highest in the first year or two after treatment completion, long-term survivors often continue to experience anxiety related to fear of recurrence. Survivors also sometimes experience ongoing depression, post-traumatic stress disorder, and poor body image.

Patients should be screened for mental health and psychosocial needs on an ongoing basis. Ideally, this evaluation would be part of the conversation during follow-up visits and yearly checkups. Even if a patient is coping well during their first year in recovery, new issues may arise throughout their survivorship trajectory.

Although not all patients may be willing, or able, to seek formal mental health or counseling support, some may benefit from psychoeducation or peer support through groups or mentors.

Patients need information and tools to guide them in the right direction, and nurses are uniquely qualified to provide these resources. Patients want to get healthy, lose weight, and take action to prevent a recurrence. Information on diet, exercise, and lifestyle changes is an important part of cancer survivorship. This affords patients some control of their own and provides new ways to care for their health.

Nurses can steer patients toward excellent online and mobile resources for diet, such as Ina, the Intelligent Nutrition Assistant from Savor Health and CancerCare. This service provides patients and survivors with on-demand nutrition guidance through text messages, and many health insurance companies offer vouchers or reimbursement for gym memberships. 

Nurses can also help keep patients informed through survivorship care plans. Cancer survivors want to know what to expect once treatment is complete. After seeing their doctor frequently for months or years, patients may experience increased anxiety as they adjust to fewer visits. Survivorship care plans maintain the conversation about what the patient is experiencing throughout survivorship.

This tool assesses the patient as a whole person and can address many facets, including physical well-being, ongoing symptoms, mental and emotional health, financial needs, and reproductive or sexual concerns. These plans also allow providers, especially those outside the oncology team, to understand the specific needs of a patient.

Unfortunately, only about half of the top cancer centers in the United States use a survivorship care plan,4 even though they can access many versions of the tool online, such as the OncoLife Survivorship Care Plan from OncoLink (

Although many cancer survivors can move forward post-treatment with minimal psychological or physical distress, some need support 5 years or more after treatment.

 Healthcare providers, especially oncology nurses, are well-positioned to connect patients with the appropriate avenues of support for life after treatment.

Burg, MA, Adorno G, Lopez ED, et al. Current unmet needs of cancer survivors: analysis of open-ended responses to the American Cancer Society Study of Cancer Survivors II. 

2015;121(4):623-630. doi: 10.1002/cncr.2895

Foster C, Wright D, Hill H, Hopkinson J, Roffe L. Psychosocial implications of living 5 years or more following a cancer diagnosis: a systemic review of the research evidence. 

2009;18(3):223-247. doi: 10.1111/j.1365-2354.2008.01001.x.

Painter K. Life after cancer: more survivors live longer, face new health challenges. 

usatoday.com/in-depth/news/50-states/2019/02/13/life-after-cancer-survivors-oncology-survivorship-plans-long-term-health/2794121002/

Harrison SE, Watson EK, Ward AM, et al. Primary health and supportive care needs of long-term cancer survivors: a questionnaire survey. 

2011;29(15):2091-2098. doi: 10.1200/JCO.2010.32.5167.

For patients with cancer, their journey does not end after treatment is over.

What Are the Needs of Cancer Survivors 5 Years or More After Treatment?

A flood of information about genetic tests for cancer risk is available outside the clinic—in the media and even in public places like senior centers, churches, and community fairs. If these promotions have caught your attention or that of your patients and their families, and they are considering DNA or genetic testing, you need to be armed with important information that you should first share with your patients. As an oncology nurse, you can be the first line of defense against fraudulent genetic tests and help steer patients and their family members to tests that are trustworthy and can provide reliable information to act on.

Genetic testing can provide important, potentially lifesaving information if performed in the right way. If a patient is considering genetic testing to learn more about their cancer risk, or if they have already received genetic test results, speaking with a genetic counselor, a doctor, or other healthcare provider who has advanced training in genetics is crucial. This is the most reliable way to obtain and understand information about their cancer.

With the growing interest and availability of genetic testing, the industry has witnessed a striking uptick in advertisements and sales representatives aggressively promoting genetic tests directly to consumers at community events, on Facebook, and in other nonmedical settings. The vast majority of these salespeople and “health advocates” have no medical background and little or no training in genetics.

These marketing representatives often target the Medicare population. Some are evasive about the lab performing the testing, and most provide misleading information, making false promises of “free” genetic testing to individuals who do not qualify. Ultimately, unwitting consumers may hand over sensitive information such as their health insurance ID number and Social Security number, enabling fraudulent billing of insurance companies—or worse.

Contrary to most health insurance policies, these businesses claim that the broad genetic test panels they offer are free to individuals

who have certain health insurance coverage. Although genetic counseling and testing for a BRCA mutation is considered an essential health benefit for certain women under the Affordable Care Act (ACA),

 the tests for hereditary cancer genes (CGX) and pharmacogenetic tests (PGX) offered by companies are rarely covered at 100%, if they are covered at all.

Importantly, the BRCA testing requirement under the ACA does not apply to Medicare or Medicaid. In fact, a Medicare policy imple- mented in late 2018 severely restricts genetic testing for hereditary cancer mutations. In most cases, it covers testing only for individ- uals with “recurrent, relapsed, refractory, metastatic, or advanced stage III or IV cancer” who are seeking additional treatment. Even before this policy took effect, Medicare rarely covered multigene panel testing for cancer survivors, and it has never covered genetic testing for previvors (those with a strong predisposition to cancer who do not have a diagnosis of the disease).

Despite complaints filed with the Federal Trade Commission, the Office of Inspector General, and state attorneys general, the number of unscrupulous companies and concerns is growing. These companies take advantage of individuals by misinforming them about their need and eligibility for hereditary cancer genetic testing, providing a medical service without the expertise of qualified healthcare providers, and committing fraud by stealing personal information

and/or billing insurers for services not provided.

Reliable Genetic Testing is Still Important

National guidelines recommend genetic counseling with a qualified expert before and after genetic testing. Talking to a healthcare provider with expertise in cancer

genetics is important. This helps assure that the right test is performed (many are available) at a reliable, high-quality lab; that results are interpreted correctly; and that you or patients receive accurate infor- mation about what the results mean and the available medical options.

When genetic testing for cancer risk is performed outside a healthcare setting, the like- lihood of misinformation is high and could lead to harm, including misinterpretation or misuse of the results. This includes “recreational” genetic tests such as 23andMe, which are not comprehen- sive or reliable measures of disease risk.

All individuals can benefit from meeting with a qualified and trustworthy healthcare professional who has their best interests at heart. Former teachers, pyramid marketing representatives, and insurance salespeople should not be involved in genetic testing— even if it involves just taking a cheek swab. Too much rides on the results of these tests.

So please, talk to your patients’ family members and friends. Warn them about the bad actors and fraud that is taking place. If they are interested in genetic testing, encourage them to seek out trust- worthy medical professionals such as yourself, a trusted colleague, or their primary care provider for guidance and expertise.

Alternatively, the Facing Our Risk of Cancer Empowered website has information on finding a cancer genetics specialist.

Affordable Care Act implementation FAQs - set 12

Centers for Medicare & Medicaid Services website. cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/aca_implementation_faqs12.html. Accessed August 19, 2019.

Genetic testing has come a long way in cancer care, but not all genetic tests are as defentive as some would have you or your patients beleive.

Protect Yourself and Your Patients From Fraud in Genetic Testing

5. New Guidelines Published for Oral Mucositis Relief

Researchers and clinicians from around the world have issued new guidelines for the treatment of oral mucositis that involve 

. Learn more about these updates in this piece.

Here, we take a closer look at the increased risk of 

 that adolescent and young adult cancer survivors face, and how oncology nurses can help.  

 for oncology nurses everywhere, contributor and oncology nurse Karen Harris takes a look at how nurses will have to take an active role to minimize burnout.

nurse practitioners and physician assistants

 comprise the largest group of cancer care providers for Medicare beneficiaries in some regions. Learn more, with this piece.

1. FDA Takes Action Against Implant-Associated Cancer 

In our top story of the month, learn how the FDA is taking action to protect women from 

breast implant-associated anaplastic large cell lymphoma

 by requiring the implant manufacturers to recall the products in question.

Here are the top 5 Oncology Nursing News stories for July 2019.

ONN's Top 5 Stories: July 2019

An exercise intervention was no more effective than a more passive health promotion program in affecting nutrient intake in female cancer survivors, according to study results presented at the ONS 44

The findings highlight the need for nurses to repetitively assess and monitor diet and exercise among cancer survivors to promote a healthy lifestyle, one of the study’s authors said.

“Healthy eating and regular physical activity are critical behaviors to minimize health risks in cancer survivors,” So-Hyun Park Ph.D, ANP-BC, RN, assistant professor at Hunter Bellevue School of Nursing at the City University of New York, said during her presentation. “It is important to understand cancer survivors' current diet and whether physical activity levels may affect their dietary behavior.”

In the randomized, controlled trial, the researchers evaluated whether participation in an exercise intervention compared with more passive health promotion would affect nutrient intake over a 12-month period among 154 perimenopausal or early postmenopausal female cancer survivors. Women were assigned to either an aerobic resistance exercise intervention arm or a health promotion arm that involved home-based physical activity.

Both groups received written information on dietary guidelines, calcium and vitamin D supplementation and national recommendations for physical activity.

Dietary records were collected at baseline, 6, and 12 months, and International Physical Activity Questionnaire (IPAQ) results were collected via telephone for 12 months.

Mean age was 51.9 years. The majority of women were white (88.3%), married (70.0%), employed (82.0%) and had children (78.6%) and a high level of education (57% college or graduated high school). The study included survivors of breast cancer (83.1%), gynecologic cancer (11.7%), and lymphoma or colorectal cancer (5.2%).

At baseline, energy and mean daily intake of 4 major nutrients were as follows:

energy: 1535.0±406.1 kcal; energy per unit of weight: 21.2±8.0 kcal/kg

protein: 70.4±18.4 g; protein per unit of weight: 1.0±0.3 g/kg

Of note, protein intake was significantly higher among the health promotion arm versus the exercise intervention arm at baseline (1.0±0.4 g/kg vs. 0.9±0.3 g/kg; 

 = .03). The researchers found no other significant differences between groups at baseline.

Over the 12-month period, women in both groups demonstrated a reduced intake of energy, protein, total fat, and carbohydrates. Meanwhile, fiber intake at 6 months increased slightly in both arms.

The researchers observed no significant differences in changes between both study arms at 6 and 12 months.

“Although the physical activity level of participants in the exercise intervention group increased over the 12 months of the study, it did not affect their nutrient intake behavior. Thus, targeted interventions specific to diet are needed to promote healthy dietary behavior in female cancer survivors,” Park said.

Next steps, she said, should involve testing both exercise and nutrition interventions to assess whether multitargeted interventions improve healthy lifestyle behaviors. In addition, she recommended that qualitative inquiry be made about the factors that influence the physical activity and diet of this population.

Park SH, Knobf T, Kerstetter J, Jeon S. Effect of an exercise intervention on nutrient intake in cancer survivors. Presented at: ONS 44th Annual Congress; April 11-14, 2019; Anaheim, CA. Abstract 4570.

Despite increased physical activity, nutritional intake behavior among female cancer survivors did not improve with an exercise intervention program, according to a randomized, controlled trial.

Targeted Dietary Interventions Necessary to Promote Healthy Lifestyle

Ninety percent of patients with cancer enter their first oncology appointment with a nutritional issue, according to Susan Bratton. However, Savor Health, who works in conjunctions with Merck’s Your Cancer Game Plan, has set out to combat just that.

, Bratton, founder and CEO of Savor Health, discussed the importance of nutrition for patients and caregivers before, during and after treatment, as well as the nurse’s role in the multidisciplinary approach.

: What prompted you to create Savor Health?

I had lost a very close friend to glioblastoma. My friend struggled with nutritional issues and when he asked, “Can I strengthen my immune system to fight alongside chemotherapy and radiation?” he was told that nutrition doesn’t matter and to eat whatever he wanted. This struck me as really odd. I was working in the healthcare industry at the time and so I went to the evidence-based literature because that was really how I had been trained. What I found was that nutrition does matter, and it matters a lot.

In fact, 90% of patients (with cancer) at the time that they walk in to their first oncology appointment are already experiencing addressable nutritional issues ranging from under 5% (who experience) weight loss and up to about 8% to 9% who already have severe malnutrition, and of course, everything in between those two points. But what my research also found is that 85% of patients are actively seeking solutions to address their nutritional issues and to answer the question of what to eat. Because there is only one dietitian for every 2,700 patients, it’s just physically impossible to address these issues from a systemic perspective. So, I looked at this and said, “Wow, there is this huge unmet need that can, not only when addressed, improve patients’ clinical outcomes, but it can also improve their quality of life — as well as their family and caregivers’ quality of life, too.

Can you briefly explain what Savor Health is?

Our mission and goal is to make the lives of patients (with cancer) and their caregivers easier and less stressful by addressing their nutritional needs and issues from point of diagnosis through treatment and in to survivorship.

How we do that is through a personalized nutrition technology platform that provides highly-personalized, clinically appropriate nutrition support and advice that is based on evidence-based science and clinical best practices. So, what that is from a patient perspective is customized tips to managing or preventing side effects or recommendations of what to eat based on what they are telling us about their situation, individually customizing recipes, and (delivery) solutions. So, it’s an end-to-end solution (that is free to patients).

How does a multidisciplinary health care approach play a role in Savor Health’s mission? In particular, what role can nurses play in helping patients with nutrition?

We are big believers in the multidisciplinary role. If I think about the multidisciplinary team that should surround a patient, it includes doctors, nurse practitioners, nurses, potentially physical therapists, pharmacists, and nutritionists. Nutritionists and registered dietitians are important members of the multidisciplinary team. It is our objective to work with the medical team to understand what the patient’s issued and concerns are, and what direction the doctors and nurses are giving us. We need to work collaboratively with them.

This specifically relates to nurses. Nurses really are in the front line from a patient perspective. Doctors are also, but they don’t have as much time with the patients. (Nurses) are the unsung heroes. They are with the patients for a much longer period of time. They know when nutritional issues are happening. They have so much wisdom to provide. They know a great deal, and like doctors they are incredibly compassionate. So our goal is to work collaboratively with every one of those members of the multidisciplinary team.

Savor Health Addresses Unmet Medical Need: Nutrition for Patients With Cancer

The FDA has expanded the approval of aprepitant (Cinvanti) injectable emulsion to include a 2-minute intravenous (IV) use for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV).1

The decision is based on results of a two-part, phase I study that demonstrated bioequivalence and a similar safety profile for patients who received aprepitant as a standard 30-minute IV infusion compared with a 2-minute IV injection, which is also referred to as an IV push.2

Aprepitant is a polysorbate 80-free, IV formulation of an NK1 receptor antagonist, which is designed to significantly reduce CINV in both the acute and delayed phases following chemotherapy. The FDA previously approved aprepitant as a 30-minute IV infusion in November 2017, making it the first IV formulation to directly deliver aprepitant, which is the active ingredient in fosaprepitant (Emend) capsules.

"Cinvanti, delivering the efficacy of aprepitant, but without polysorbate 80, has been an important addition for the prevention of CINV. Notably, data now show that the 2-minute IV push has comparable safety to the 30-minute IV infusion,” said Rudolph M. Navari, MD, PhD, Division of Hematology Oncology, University of Alabama, Birmingham School of Medicine. “This approval will enable physicians to leverage the operational advantages of this method of administration and will contribute to a reduction in total patient time spent in the infusion suite."

Part A of the study randomized 24 patients to receive aprepitant at 130 mg IV via injection over 15 minutes (cohort 1), 5 minutes (cohort 2), or 2 minutes (cohort 3). The primary endpoint was tolerability and safety of single doses of aprepitant across the 3 cohorts. Patients then progressed to Part B of the trial, which was a two-sequence crossover study, following establishment of acceptable tolerability in cohorts 2 and 3.

In Part B, 50 patients were randomized to receive a 2-minute injection of 130 mg aprepitant at 9 ml/min or a 30-minute infusion at 296 ml/h. The primary endpoint was pharmacokinetics of plasma aprepitant following a single dose as an injection or infusion; secondary endpoints were safety and tolerability. The mean age of patients was 34; 19 patients were female and 31 were male.

Results showed bioequivalence between the 2 administration arms, confirming the short injection as an alternative method to administer aprepitant to patients. The values for area under the curve (AUC)0-last, AUC0-inf and t1/2 were similar between injections and infusions. Additionally, Cmax was higher in patients who received aprepitant via injection than in those who received it via infusion, and Tmax occurred earlier with the injection versus the infusion.

Regarding safety, 8 patients on the injection arm experienced 11 treatment-emergent adverse events (TEAEs; 6 related) versus 9 patients who experienced 14 TEAEs (9 related) in the infusion group. The most prevalent treatment-related TEAEs were headache and fatigue; 1 patient in each arm reported feeling hot ≤30 minutes following treatment.

The initial approval of aprepitant was based on findings from 2 randomized, crossover studies that demonstrated the bioequivalence of aprepitant to fosaprepitant IV for the prevention of acute and delayed CINV following highly emetogenic cancer (HEC) chemotherapy and moderately emetogenic cancer (MEC) chemotherapy.3,4 Specifically, results showed that patients who received aprepitant reported fewer adverse events (AEs) than those who received IV fosaprepitant, including substantially fewer infusion-site reactions.

"We are pleased to have strengthened our CINV franchise with today's label expansion for Cinvanti, as we now have the only NK1 [receptor antagonist] that offers the benefits and flexibility of an IV push method of administration," said Barry Quart, PharmD, president and chief executive officer of Heron Therapeutics. "Administration of Cinvanti by 2-minute IV push is an important advantage for our customers compared to Emend IV, which requires reconstitution and an IV bag for infusion."

FDA Approves Aprepitant Injection for CINV

1. Heron Announces FDA Approval of Supplemental New Drug Application to Expand CINVANTI® Label for IV Push. Heron Therapeutics. Published February 26, 2019. https://prn.to/2EDxtvR. Accessed February 28, 2019.

2. Ottoboni T, Lauw M, Keller MR, Cravets M, Manhard K, Clendeninn N, Quart B. HTX-019 via 2-min injection or 30-min infusion in healthy subjects [published online ahead of print December 21, 2018]. Future Med. doi: 10.2217/fon-2018-0809.

3. Heron Therapeutics Announces U.S. FDA Approval of CINVANTI (aprepitant) Injectable Emulsion for the Prevention of Acute and Delayed Chemotherapy-Induced Nausea and Vomiting (CINV). Heron Therapeutics. Published November 9, 2017. https://bit.ly/2NyINfA. Accessed February 28, 2019.

4. Ottoboni T, Boccia G, Keller MR, Cravets M, Clendeninn N, Quart B. Bioequivalence of HTX-019 (aprepitant IV) and fosaprepitant in healthy subjects. Presented at: 2017 Hematology/Oncology Pharmacy Association Annual Conference; March 29-April 1, 2017; Anaheim, CA.

The FDA has expanded the approval of aprepitant (Cinvanti) injectable emulsion to include a 2-minute intravenous (IV) use for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV).

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