CMS, HHS Issue Emergency Regulation Requiring COVID-19 Vaccination for Healthcare Workers
In an effort to protect patients and control the COVID-19 coronavirus pandemic, the Centers for Medicare and Medicaid Services (CMS) and the U.S. Department of Health and Human Services (HHS) have issued an interim final rule requiring all staff at certain Medicare- and Medicaid-certified healthcare facilities to be vaccinated against COVID-19.
FDA Approves Sirolimus Protein-Bound Particles for Malignant Perivascular Epithelioid Cell Tumor
On November 22, 2021, the U.S. Food and Drug Administration (FDA) approved sirolimus protein-bound particles for injectable suspension (Fyarro™) for adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).
Oncology Drug Reference Sheet: Sotorasib
After clinical trials demonstrated an overall response rate of 36% and median response duration of 10 months, the U.S. Food and Drug Administration granted sotorasib (LumakrasTM) accelerated approval on May 28, 2021, for the treatment of adults with KRAS G12C–altered locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.
New NIH Program Aims to Increase Gene Therapies for Rare Diseases
To accelerate the development of gene therapies for the 30 million Americans who have been diagnosed with a rare disease, in October 2021 the National Institutes of Health (NIH), U.S. Food and Drug Administration (FDA), 10 pharmaceutical companies, and five nonprofit organizations announced the creation of the Bespoke Gene Therapy Consortium (BGTC). The consortium is optimizing and streamlining the gene therapy development process to help fill the unmet medical needs of people with rare diseases.
FDA Permits Marketing of E-Cigarette Products, Marking First Authorization of Its Kind
Under the authority given in the Family Smoking Prevention and Tobacco Control Act, in October 2021 the U.S. Food and Drug Administration (FDA) authorized the marketing of three new electronic nicotine delivery system (ENDS) products, “marking the first set of ENDS products ever to be authorized by FDA through the Premarket Tobacco Product Application pathway.” The agency made the announcement it continues its review of thousands of tobacco and e-cigarette products.
Mid-Century Antibiotic May Offer Options After PARP Inhibitor Resistance
Novobiocin, an antibiotic discovered during the 1950s, may be a potential second-line therapy for patients whose tumors have become resistant to poly (ADP-ribose) polymerase (PARP) inhibitors, researchers reported in Nature Cancer. The finding may open up new options for patients with BRCA-variant disease such as breast, ovarian, pancreatic, and prostate cancer.
Defining Individual Biosignatures Through Precision Health Symptom Science Helps Nurses Deliver Even Better Care
Understanding the underlying mechanisms of cancerrelated symptoms enables oncology nurses to provide the best patient-centered care. Biosignatures are indicators of life, and in disease, they contribute to the determination of clinical profiles. Identifying specific biologic markers associated with similar patient characteristics and symptoms may help us create tailored interventions for improved symptom management.
FDA Reports Recall of Custom Convenience Kits Because of Prefilled Syringe Plunger Defect
On November 9, 2021, the U.S. Food and Drug Administration (FDA) reported Aligned Medical Solutions’ recall of its custom convenience kits because of the potential for the plunger of the Cardinal Health monoject flush prefilled syringe (0.9% sodium chloride) to draw back after the air has been expelled and reintroduce air back into the syringe. FDA identified the recall as a class I recall, the most serious type of recall.
APRNs Can Lead by Example When Integrating Palliative Care in Practice
Early and regular integration of palliative care (PC) improves patient and caregiver outcomes in symptom management, quality of life, psychosocial health, communication, shared decision-making, overall satisfaction—and even survival. Health systems also benefit through reduced emergency department visits, hospitalizations, and intensive care stays; increased completion of advanced directives; and improved quality of end-of-life care. Both the Centers for Medicare and Medicaid Services’ (CMS’s) Oncology Care Model and many oncology organizations, including ONS, support the approach for patients with cancer.
Genetic Disorder Reference Sheet: Familial Adenomatous Polyposis
Individuals with 10–100+ polyps may have a germline pathogenic variant in the APC gene, placing them at higher risk for developing colorectal, gastrointestinal, and other cancers. The condition is known as familial adenosis polyposis (FAP), and loss of function in the APC gene is the first step in the adenoma-to-carcinoma sequence. Some people have an attenuated form (aFAP), with delayed polyp growth and fewer polyps (see sidebar). As many as 20% are de novo, meaning that they are the first in their family to have an identified pathogenic variant.
Clinical Full-Body Skin Examination Identifies Twice the Number of Cancers
A dermatologist-performed total-body skin examination (TBSE) identifies more than two times the number of skin cancers than patients or other providers discovered, researchers reported in the International Journal of Women’s Dermatology. The cancers may otherwise have gone undiagnosed, leading to later-stage disease and poorer outcomes.
Bringing Biosignatures to the Bedside
With the growth of genomics and targeted therapy, nurse scientists are gaining deeper understanding the vast facets of patients’ symptom experience, and biosignatures could be the key to unlocking the next frontier in symptom science research.
Many Popular Online Cancer Articles Contain Misleading Information, NCI Says
With a plethora of information available online, patients with cancer and their families have access to plenty of resources to learn more about their diagnosis and treatment options. However, one-third of the online articles about cancer circulating on social media contain incorrect information, according to findings from a 2021 study published in the Journal of the National Cancer Institute.
Find Solace in Silence
A balanced life allows us to function at our best. Our bodies do that naturally through homeostasis, a familiar term from nursing school, by self-regulating physiological processes to ensure equilibrium and optimal functioning. But our brains sometimes need help to self-regulate, and one way to do that is to practice silence. After a day of noise and action, silence and solitude can calm and restore you.
Oncology Drug Reference Sheet: Belantamab Mafodotin-Blmf
A first-of-its-kind antibody-drug conjugate for multiple myeloma, belantamab mafodotin-blmf (Blenrep) received accelerated approval from the U.S. Food and Drug Administration (FDA) in August 2020. The approval was based on clinical trial findings that demonstrated a 31% overall response rate that lasted at least six months in 73% of responders.
The Case of the Missing Oral Mucositis
Bob is a 68-year-old patient with early-stage cancer of the glottic larynx (right true vocal cord). He is receiving a hypofractionated three-dimensional conformal therapy without concurrent chemotherapy, 225 cGy each day for five days a week to a total dose of 6,075 cGy. He is now in his fourth week of treatment at 4,000 cGy and experiencing side effects. His voice is a high-pitched whisper and talking requires a lot of effort. He reports pain when swallowing his favorite foods like nachos and has lost 2 kg since his last weight check four days ago. Bob also reports some dizziness with position changes, and his pulse and blood pressure screenings show that he’s mildly orthostatic.
FDA Amends EUAs With Booster Doses for COVID-19 Vaccines
On October 20, 2021, the U.S. Food and Drug Administration (FDA) amended the emergency use authorizations (EUAs) for the Moderna and Janssen (Johnson and Johnson) COVID-19 vaccines to allow for the use of a single booster dose for certain populations.
The Case of the End-of-Life Evaluation
Ron, your 73-year-old patient, decides to transition to hospice care after receiving lung cancer treatment for three years. His partner finds Ron’s decision to move to hospice difficult to accept and encourages him to look for a clinical trial or try alternative treatments. You suggest that the couple speaks with a hospital chaplain, and Ron agrees. His surprised partner says, “Why do you want to talk with a chaplain? We’ve never been religious!”
Genetic Disorder Reference Sheet: ATM Pathogenic Variants
An estimated 1%–2% of adults have one pathogenic ataxia telangiectasia mutated (ATM) gene variant (heterozygous) and are considered carriers. People who are homozygous (two altered copies) have ataxia-telangiectasia (A-T), a hereditary condition that often appears in childhood and is characterized by progressive neurologic problems that lead to difficulty walking and an increased risk for developing various malignancies. Children with A-T may begin staggering and appear unsteady (ataxia) shortly after learning to walk.
FDA Approves Atezolizumab as Adjuvant Treatment for Non-Small Cell Lung Cancer
On October 15, 2021, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq®) for adjuvant treatment following resection and platinum-based chemotherapy in patients with stage II–IIIA non-small cell lung cancer (NSCLC) with PD-L1 expression on ≥ 1% of tumor cells as determined by an FDA-approved test.
NIH Provides $185 Million to Advance Understanding of Human Genome Functions
To drive the advancement of our understanding of the human genome, the National Institute of Health (NIH) is providing $185 million in funding over the next five years, the agency announced in September 2021.
Interprofessional Collaboration Helps Improve Cancer Care
Much of the care we provide is complex and requires the contributions of many knowledgeable and experienced professionals. To satisfy the National Academy of Medicine recommendations of providing safe, timely, effective, efficient, equitable, and patient-centered care, healthcare professionals must function as highly collaborative teams.
FDA Reports Worldwide Recall of Lidocaine HCl Topical Solution 4% Because of Super Potency
On October 13, 2021, the U.S. Food and Drug Administration (FDA) reported Teligent Pharma’s voluntary recall of five lots of lidocaine HCl topical solution 4% in a 50 ml screw cap glass bottle to the user level because the firm’s testing found it to be super potent based on an out-of-specification result obtained at the 18-month stability timepoint.
Legislators Call for Improvement in Palliative Care and Hospice Workforce
Legislators across the United States are recognizing what ONS has advocated for more than a decade: the need for improved access to and better understanding of palliative and hospice care. In September 2021, Senator Tammy Baldwin (D-WI) and Representative Yvette D. Clarke (D-NY) voiced their support for palliative care through a letter to the U.S. Congress.
FDA Approves Pembrolizumab Combination for First-Line Treatment of Cervical Cancer
On October 13, 2021, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda®) in combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥ 1), as determined by an FDA-approved test.
FDA Approves Abemaciclib With Endocrine Therapy for Early Breast Cancer
On October 12, 2021, the U.S. Food and Drug Administration (FDA) approved abemaciclib (Verzenio®) with endocrine therapy (tamoxifen or an aromatase inhibitor) for adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk for recurrence and a Ki-67 score ≥ 20%, as determined by an FDA-approved test. This is the first CDK4/6 inhibitor approved for adjuvant treatment of breast cancer.
HER2 Therapies May Be Effective in a Variety of Solid Tumors
Researchers have found that 2%–3% of all solid tumors overexpress or amplify HER2 protein that may be a target for drugs such as pertuzumab and trastuzumab, particularly in KRAS-variant disease. They presented their findings during the 2021 American Society of Clinical Oncology annual meeting.
Evidence-Based Practice Gives Oncology Nurses Knowledge and Standards for Clinical Care
We have an approximately 14- to 17-year gap between the inception of research discovery and the implementation of findings into clinical practice. As a profession, nurses have a shared responsibility to address the challenge of identifying and overcoming barriers to evidence-based practice (EBP) implementation to provide the best possible clinical care for patients. My primary area of focus as a researcher is on using EBP to improve patient, staff, and organizational outcomes through the Science and Practice Aligned Within Nursing (SPAWN) model, a framework for applying EBP to clinical nursing care.
It Takes a Team to Confront Moral Distress
Unbearable levels of stress, burnout, frustration, disappointment, and even fear are plaguing today’s healthcare providers more than ever before. But for oncology nurses, moral distress and compassion fatigue have always been in the background when caring for patients with a serious illness.
Nursing Considerations for Bladder Cancer Survivorship Care
Bladder cancer is the sixth most common cancer in the United States, with an estimated 83,730 adult diagnoses in 2021. Smoking is the greatest risk factor (47% of all cases occur in smokers), followed by advancing age and sex (assigned males are four times more likely to develop bladder cancer than those assigned female). The incidence rate in White people is double that of Black people, but Black people are twice as likely to die from the disease.
PhD and DNP Students Collaborate to Implement Practice-Driven Research
Evidence-based practice is dual sided: nurse scientists conduct research, and clinical nurses implement those findings into practice. Working together, they improve care by developing cancer survivorship programs, reducing cancer risk, and assessing cancer care in vulnerable populations. The University of Washington School of Nursing’s (UW SoN’s) partnership with Confluence Health, one of the largest healthcare providers in north central Washington, built a novel program to identify gaps in research and implementation and elicit projects that influence healthcare outcomes.
Practice Change: Transform Cancer Care Through Quality Improvement and Evidence-Based Practice
Most nurses have not received formal training in quality improvement (QI) methodology, and many workplaces lack the resources to efficiently implement evidence-based practice (EBP), which results in delays in translating science into practice. But ONS members are overcoming those barriers and leading the way in effectively developing, implementing, and sustaining practice changes.
FDA Approves Brexucabtagene Autoleucel for Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia
On October 1, 2021, the U.S. Food and Drug Administration (FDA) approved brexucabtagene autoleucel (Tecartus™) for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
FDA Issues Marketing Denial Orders for 55,000 Flavored E-Cigarette Products
In August 2021, the U.S. Food and Drug Administration (FDA) denied about 55,000 flavored e-cigarette products’ marketing applications for failing to provide evidence that they appropriately protect public health.
Can Compassion Bust Burnout and Restore Resilience?
Stress is a normal and necessary part of life. However, prolonged emotional tension takes stress to a new level for many people, including oncology nurses. But what is the antidote to cumulative pressure? The evidence for compassion’s benefits during stress is compelling.
State Cancer Registries Studies Find Nearly All Patients With Cancer Recovered From COVID-19
Many patients are delaying their recommended cancer screenings because of fear of death from COVID-19 coronavirus infection, according to the Centers for Disease Control and Prevention (CDC). However, those fears may not align with real-world outcomes, the agency said, when it reported July 2021 study findings from Arkansas and North Carolina.
Oncology Drug Reference Sheet: Sacituzumab Govitecan-Hziy
Initially marketed in April 2020 for treatment of adults with metastatic triple negative breast cancer, sacituzumab govitecan-hziy (Trodelvy®) received an additional approval in 2021 for the treatment of patients with locally advanced or metastatic urothelial cancer with prior treatments.
IntegraDose Compounding Services Issues Voluntary Nationwide Recall of Cefazolin Injection Products Because of a Lack of Sterility Assurance
On September 21, 2021, the U.S. Food and Drug Administration (FDA) reported IntegraDose Compounding Services’ voluntary recall of nine lots of cefazolin 2 g in 20 ml syringe for injection and two lots of cefazolin 3 g in 100 ml 0.9% sodium chloride bag for injection because of a lack of sterility assurance resulting from compounding in a newly installed biologic safety cabinet without completing dynamic smoke study testing.
What the Evidence Says for Traditional Chinese Medicine Ma Zi Ren Wan for Constipation
A common and distressing symptom among patients with a variety of health diagnoses as well as the general population, constipation is characterized by reduced stool frequency, incomplete evacuation, straining, and a sense of anorectal blockage. Nearly 43%–58% of patients with cancer report constipation caused by a variety of factors, including organic, functional, or drug associated. Standard treatment options such as fiber supplements, laxatives, and stool softeners are not entirely effective and can cause adverse effects.
FDA Approves Ruxolitinib for Chronic Graft-Versus-Host Disease
On September 22, 2021, the U.S. Food and Drug Administration (FDA) approved ruxolitinib (Jakafi®) for chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients aged 12 years and older.
FDA Approves Cabozantinib for Differentiated Thyroid Cancer
On September 17, 2021, the U.S. Food and Drug Administration (FDA) approved cabozantinib (Cabometyx®) for adult and pediatric patients aged 12 years and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior vascular endothelial growth factor (VEGFR)-targeted therapy and who are ineligible for or refractory to radioactive iodine treatment.
FDA Grants Accelerated Approval to Tisotumab Vedotin-Tftv for Recurrent or Metastatic Cervical Cancer
On September 20, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tisotumab vedotin-tftv (Tivdak™), a tissue factor-directed antibody and microtubule inhibitor conjugate, for adult patients with recurrent or metastatic cervical cancer whose disease has progressed on or after chemotherapy.
The Case of the Triple-Negative Breast Cancer Targeted Treatment
Ophelia is a 42-year-old patient who has been diagnosed with triple-negative breast cancer (TNBC). She completed neoadjuvant chemotherapy with dose-dense doxorubicin and cyclophosphamide, followed by paclitaxel and carboplatin. Her postsurgical pathology shows residual disease in the tumor (3.5 cm down from 4 cm) and 12 out of 18 lymph nodes that are positive for cancer. Ophelia tells you that she is very discouraged and expected a better treatment outcome.
Pfizer Expands Recall to Include All Lots of Varenicline Tablets Because of N-Nitroso Varenicline Content
On September 17, 2021, the U.S. Food and Drug Administration (FDA) reported Pfizer’s voluntary recall of all lots of varenicline 0.5 mg/1 mg tablets to the patient level because of the presence of N-nitroso-varenicline, a nitrosamine, at or above the FDA interim acceptable intake limit. FDA said that while Pfizer is undertaking the precautionary measure, alternative suppliers have been approved in the United States.
Understanding the Endocrine System Helps Nurses Be Vigilant in Watching for Common Symptoms
A basic understanding of the endocrine system is helpful in assessing and monitoring patients for common side effects of cancer and its treatments, Marianne Davies, DNP, ACNP, FAAN, from Yale Comprehensive Cancer Center, said during a session held at the ONS BridgeTM virtual conference on September 16, 2021. She provided attendees with a complete overview and associated disorders, emphasizing the need for nurses to be vigilant in watching for signs and symptoms in their patients.
Best Practices to Manage Electrolytes in Patients With Hypomagnesemia or Hypokalemia
Patients with cancer may experience low levels of magnesium and potassium for a variety of reasons throughout the course of their treatment, and both conditions can be serious or even fatal. Oncology nurses are critical in educating patients and understanding the benefits and potential concerns associated with electrolyte replacement, Puja Patel, PharmD, BCOP, from Northwestern Medicine Delnor Cancer Center in Geneva, IL, said during a session during the ONS BridgeTM virtual conference on September 16, 2021.