FDA Approves Olaparib for Adjuvant Treatment of High-Risk Early Breast Cancer
On March 11, 2022, the U.S. Food and Drug Administration (FDA) approved olaparib (Lynparza®) for adult patients with deleterious or suspected deleterious germline BRCA variant (gBRCAm) human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Patients are selected for therapy based on an FDA-approved companion diagnostic for olaparib.
FDA Approves Ciltacabtagene Autoleucel for Relapsed or Refractory Multiple Myeloma
On February 28, 2022, the U.S. Food and Drug Administration (FDA) approved ciltacabtagene autoleucel (Carvykti™) for adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody. Ciltacabtagene autoleucel is a B-cell maturation antigen (BCMA)-directed genetically modified autologous chimeric antigen receptor (CAR) T-cell therapy.
FDA Approves Neoadjuvant Nivolumab and Platinum-Doublet Chemotherapy for Early-Stage Non-Small Cell Lung Cancer
On March 4, 2022, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo®) with platinum-doublet chemotherapy for adult patients with resectable non-small cell lung cancer (NSCLC) in the neoadjuvant setting, representing the first FDA approval for neoadjuvant therapy for early-stage NSCLC.
FDA Reports Recall of 0.9% Sodium Chloride for Injection USP 250 ml in Excel Because of Fluid Leakage or Low Fill Volume
On March 3, 2022, the U.S. Food and Drug Administration (FDA) reported B. Braun Medical’s voluntary recall of five lots of 0.9% sodium chloride for injection USP 250 ml in Excel within the United States at the hospital and user levels after receiving reports of fluid leakage or low fill volumes.
Mama at the Bar: Using Analogies to Understand Targeted Therapies
Analogies and visuals are powerful learning tools. If you’re one of the many nurses whose eyes glaze over when approaching genomics, consider connecting the “omics” concepts to interpretative visuals, clinical practice, and everyday life examples to enhance your learning and make the concepts more relevant to you. Here’s an example of how it can be done.
Nursing Considerations for ICI-Related Myocarditis
Before immunotherapies like immune checkpoint inhibitors (ICIs) became a cancer treatment option, myocarditis typically developed in the presence of infections, drug allergies, or autoimmune diseases. Activating the immune system with ICIs can also trigger autoimmune-like adverse events such as myocarditis, and although its incidence in patients with cancer is low, mortality is high.
Prevent Implicit Bias in Patient Care With These Cultural Conversation Starters
Each clinical encounter with a patient brings together three different cultural perspectives: the patient’s, the nurse’s, and health care’s own culture. Patient-centered care acknowledges and responds to the unique needs and preferences of each patient in the context of their culture. As we approach our patients with respect, humility, and curiosity to learn more, we must ask questions to help prevent assumptions, generalizations, and implicit bias from influencing our interactions.
FDA Reports Safety Announcement for Spectrum V8 and Spectrum IQ Infusion Pumps
On February 18, 2022, the U.S. Food and Drug Administration (FDA) reported Baxter International’s urgent safety communication to reinforce safety information regarding upstream occlusion alarms for all Spectrum V8 and Spectrum IQ infusion pumps.
Music Reminds You of the Love You Deserve
Does hearing a certain song suddenly energize you or make the day seem brighter? There’s a reason for that. Music can have a powerful effect on our well-being and is a tool nurses can use to help take care of their mental health.
Immune Checkpoint Inhibitors May Increase Risk of Serious Infection
Nearly a quarter of patients receiving a variety of drugs classified as immune checkpoint inhibitors develop infections during treatment and 15% are considered severe, researcher reported in study findings published in Cancer Medicine.
Oncology Drug Reference Sheet: Tisotumab Vedotin-Tftv
In clinical trials, 24% of patients achieved an objective response rate with tisotumab vedotin-tftv (TivdakTM) that lasted a median of 8.3 months, leading to the agent’s U.S. Food and Drug Administration September 2021 approval for use in adults with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
Master the Essentials of Effective Communication
Communication is central to an oncology nurse’s role—with patients and families, within the unit, and across interprofessional teams. The Joint Commission identified poor communication as a causative factor in 80% of medical errors, particularly during caregiving handoffs. Effective communication skills are both a science and an art, but oncology professionals can use a variety of tools and techniques to enhance their practice.
COVID-19’s Impact on Our Nursing Leaders
Rewind. I adjust the strap on my mask and pinch it tightly around my nose and move it just under my lower eyelashes to prevent my goggles from fogging. These days, I am grateful for the face cover as it hides the pallor from six months in and the dark circles from long hours and anxious sleep. I wait at the valet circle for my team. Another SOS text out to them this morning. All hands on deck.
Geriatric Assessments Reduce Side Effect Incidence in Older Adults With Cancer
Regularly conducting geriatric assessments in older patients and using the information to guide their care reduces their risk of side effects by nearly 30%, researchers reported in study findings published in Lancet.
Evidence Defines Nursing Implications for Combination Cancer Treatment Side Effects
Immune checkpoint inhibitors (ICIs) enhance immune response against foreign antigens, such as cancer, by manipulating checkpoints that have stopped the body from fighting them. In doing so, they also increase risk of the immune system attacking healthy cells and producing inflammatory side effects, resulting in immune-related adverse events (irAEs).
Combination CDK4/6 and Fulvestrant Has Survival Benefits in Late-Stage Breast Cancer
Combining a CDK4/6 inhibitor and fulvestrant improves overall survival consistently among patients with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer, according to a U.S. Food and Drug Administration (FDA) analysis. The agency reported the findings in Lancet Oncology.
The Pharmacist’s Role in Combination Cancer Treatments
Since the first checkpoint inhibitor was approved in 2011, we have made tremendous leaps in immunotherapy in a short span of 10 years. Now we see immunotherapy combined with a variety of options, including chemotherapy or other oral and IV targeted therapy.
What the Evidence Says About Traditional Chinese Medicine Herbal Formula Xiao Yao San for Depression and Anxiety
An estimated 16% of patients with cancer experience depressive spectrum disorders in oncologic, hematologic, and palliative care settings, seriously affecting their quality of life. Although conventional antidepressants can be effective in many situations, they are associated with adverse effects, such as fatigue, drowsiness, sleep difficulties, nausea, weight gain, nervousness, dry mouth, blurred vision and sexual dysfunction.
Oncology Drug Reference Sheet: Ivosidenib
Adding to its earlier approvals for use in adults with acute myeloid leukemia (AML), on August 25, 2021, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo®) for adults with previously treated, locally advanced or metastatic cholangiocarcinoma. Cholangiocarcinoma, or cancer of the bile ducts, is a rare cancer, and ivosidenib is the only currently approved agent for patients with an IDH1 variant.
Genetic Disorder Reference Sheet: CDH1 and Hereditary Diffuse Gastric Cancer
Pathogenic variants in the CDH1 gene are associated with hereditary diffuse gastric cancer (HDGC), a poorly differentiated adenocarcinoma that infiltrates into the stomach wall. It causes the stomach wall to thicken without forming a distinct mass, which limits effective screening strategies.
The Case of the Post-Transplant Pulmonary Problem
Benjamin, your 28-year-old patient with acute lymphoblastic leukemia, received a 10/10 matched, unrelated donor for his allogeneic hematopoietic stem cell transplantation. Two months post-transplant, Benjamin developed grade 4 skin and gastrointestinal graft-versus-host disease.
Break Bad News to Patients With This Step-by-Step Guide
When hearing results from blood work or repeat imaging—regardless of whether they are “good” or “bad”—patients want and deserve to be given information truthfully and objectively. Oncology advanced practice providers are often the bearers of bad news, which can be uncomfortable and stressful. But here’s how you can hold those conversations with finesse, empathy, and respect.
Team Training Develops Nurses’ Interprofessional Communication Skills
Oncology nurses must have effective communication and team-based skills to work across disciplines with other members of the care team. In an oncology setting, teamwork promotes safer, more efficient, and higher quality care, as well as a more positive and supportive practice environment. Dana-Farber Cancer Institute (DFCI) has used team training to develop those skills in our staff over the past 15 years.
Train and Retain: From Orientation to Leadership, Here Are the Strategies That Experienced Staff Developers Use
The oncology nursing specialty is in dire need of a solid foundation of eligible staff. As of 2020, more than 51% of the nursing workforce was aged 40 years or older, and the COVID-19 pandemic exacerbated underlying factors such as stress, physical and mental health, and inequities present in the profession for decades.
Mental Health Teams Build Programs That Prioritize Staff Well-Being
Given the inherent nature of caregiving, burnout has been part of the nursing profession since the beginning. As the complexities of the profession increase, so do nurses’ vulnerability. Oncology nurses have multiple physical, emotional, and mental demands, which, if left unaddressed, can lead to burnout, compassion fatigue, and moral distress.
Make Subcutaneous Administration More Comfortable for Your Patients
Much of oncology nursing education focuses on IV administration of systemic therapies because for years, that was the only route. Until 2004, only two cancer therapies were approved for subcutaneous (SC) administration, and just nine others were added through 2012. However, as more familiar IV therapies get SC counterparts, including the more recent approvals of four high-volume monoclonal antibodies (mAbs), infusion nurses are using them more regularly in practice.
Show the World Your Beautiful Mess
Embracing—not judging or hiding—our flaws and vulnerabilities makes us happier and more relatable, a research-supported concept called the beautiful mess effect. What we think are negatives or weaknesses, others see as courageous. Showing vulnerability can lead to stronger relationships, increased self-esteem, and better mental health.
Liver Cancer Diagnoses See Geographic, Racial, Income Disparities
The urban-rural disparity in hepatocellular cancer (HCC) diagnoses is widening, researchers said, particularly in certain racial, income, and age groups. The authors reported their study results in Clinical Gastroenterology and Hepatology.
Oncology Drug Reference Sheet: Amivantamab-Vmjw
After clinical trials demonstrated a 40% overall response rate with 63% of responses lasting six months or more, on May 21, 2021, the U.S. Food and Drug Administration (FDA) approved amivantamab-vmjw (RybrevantTM) for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion variants, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
Oncology Nurses Share Successes and Challenges Adapting to Telehealth During COVID-19
The COVID-19 coronavirus pandemic has forced healthcare providers to make unprecedented adjustments to patient care, including the pivot to telehealth. At a series of virtual events from October 2020–March 2021, ONS members shared their challenges, successes, and future needs to permanently adopt virtual cancer care visits.
The Case of the Clinical Trials Consultation
Don, age 72, was diagnosed with borderline resectable pancreatic adenocarcinoma more than a year ago. Genetic testing indicated a BRCA2 variant. He completed 12 cycles of FOLFIRINOX followed by a pancreaticoduodenectomy (Whipple procedure). He had no evidence of disease for six months until a liver lesion seen on surveillance imaging tested positive for metastatic pancreatic cancer. His medical oncologist suggests a clinical trial targeting the BRCA2 variant.
FDA Approves Abatacept for Prophylaxis of Acute Graft-Versus-Host Disease
On December 15, 2021, the U.S. Food and Drug Administration (FDA) approved abatacept (Orencia®) for prophylaxis of acute graft-versus-host disease (aGVHD), in combination with a calcineurin inhibitor (CNI) and methotrexate (MTX), in adults and pediatric patients aged 2 and older who are undergoing hematopoietic stem cell transplantation (HSCT) from a matched or one allele-mismatched unrelated donor.
Traits That Make You a Great Nurse Also Lead to Success as a Clinical Trials PI
Clinical trials are led by a principal investigator (PI) with a research team that may include physicians, nurses, social workers, and other healthcare professionals. PIs can represent a variety of disciplines, and nurse scientists often hold that role.
Nursing Considerations for Adolescent and Young Adult Cancer Survivorship Care
Adolescent and young adults (AYAs)—those diagnosed between the ages of 15 and 39—comprise about 5% of all annual cancer diagnoses. The population has unique challenges that must be considered as part of patient-centered survivorship care planning.
Use ClinicalTrials.gov to Find the Right Cancer Research Studies for Your Patients
Among the many online resources for identifying cancer clinical trials, including the National Cancer Institute (NCI), NCI-designated cancer centers or academic cancer centers, and drug and biotechnology companies, ClinicalTrials.gov may be the most comprehensive as a one-stop shop for patients and providers to find publicly and privately supported trials for patients.
FDA Reports Teligent Pharma’s Worldwide Voluntary Recall of Lidocaine HCl Topical Solution 4%
On December 7, 2021, the U.S. Food and Drug Administration (FDA) reported Teligent Pharma’s voluntary recall of two lots of lidocaine HCl topical solution 4% in a 50 ml screw cap glass bottle to the user level. The manufacturer’s testing found that the product is super potent based on an out-of-specification result at the 9-month (lot 16345) and 18-month (lot 15594) stability timepoint.
Patients Cope With Intense Emotions After Clinical Trial Withdrawal
When withdrawing from a clinical trial, patients experience a spectrum of emotions ranging from regret, urgency, frustration—and trust in their healthcare professionals, like oncology nurses, according to the results of a study published in JAMA Network Open.
Nursing Roles in Clinical Trials
Clinical trials provide evidence to support what you do in your work as a nurse every day. They are tools to discover new therapies and identify side effects while considering patient-specific factors like age, comorbidities, race, and sex. They build support for best practices in treatment and patient care.
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’ marketing applications.
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.