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.
Nurses Humanize and Normalize Digital Health as Technology Becomes Part of the Care Team
COVID-19 forced healthcare providers to pivot to digital health, but an estimated 70% of patients still deferred or canceled their care, including routine cancer screening. Technology is an essential tool in cancer care, according to Abigail Baldwin-Medsker, MSN, RN, OCN®, of Memorial Sloan Kettering Cancer Center, who presented a session at the ONS BridgeTM virtual conference on September 16, 2021.
FDA Grants Accelerated Approval to Mobocertinib for Metastatic Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Variants
On September 15, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to mobocertinib (Exkivity™) 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.
New Multiple Myeloma Treatments Present New Challenges in Side Effect Management
New strategies are emerging to manage the complex side effects and adverse events from multiple myeloma (MM) therapies, Lorraine Mack, APN/MSN CNL, OCN®, AOCNS®, and Dodi Georges, MSN, CWON, OCN®, both from Northwestern Medicine, said during a session held September 14, 2021, at the ONS BridgeTM virtual conference. They shared best practices for nursing interventions for patients undergoing new treatment options.
Don’t Delay When Managing irAEs From Immune Checkpoint Inhibitors
To prevent life-threatening complications that could affect treatment adherence and outcomes, oncology nurses must be vigilant in early recognition and treatment of immune-related adverse events (irAEs), Lisa A. Kottschade, MSN, APRN, CNP, from Mayo Clinic in Rochester, MN, said during a session held at the ONS BridgeTM virtual conference on September 14, 2021. She provided an overview of what to watch for and nursing considerations for common irAEs.
Patient-Advocacy-Provider Partnerships and Networks Support Rare Cancer Research
My area of research focus is adults with primary central nervous system (CNS) tumors, which represent less than 2% of all diagnosed cancers. Because of the cancers’ rarity, access to diagnosed patients for research initiatives is limited. My team’s program, NCI-CONNECT, a part of the Rare Tumor Patient Engagement Network supported by the Cancer Moonshot, is advancing our understanding of adults with rare CNS cancers by establishing patient-advocacy-provider partnerships and networks to improve care and treatment approaches.
A Body of Evidence Helps Nurses Manage CAR T-Cell Therapy Toxicities
When chimeric antigen receptor (CAR) T-cell therapies were first approved for cancer in 2017, nurses didn’t have years of clinical practice experience with the treatment to understand its full scope of nursing implications yet. Now that nearly five years have passed—and new CAR T-cell therapies have been approved, bringing the total number of treatments to five as well—oncology nurses and nurse scientists have built a robust knowledge base.
How One Organization Developed Tools to Predict Opioid Use Disorder Among Patients
Opioids are one strategy to help manage the cancer-related pain that nearly 75% of patients with cancer experience throughout the disease or its treatment. However, the prevalence of opioid misuse disorder (OUD) among patients with cancer is believed to be at least equal to that of the general population, Debra Rodrigue, MA, RN-BC, AOCNS®, explained during a session for the ONS BridgeTM virtual conference on September 9, 2021.
Bridge Educational Gaps by Maximizing the Effectiveness of Your Virtual Programs
From elementary to college environments, virtual education is now commonplace, and, according to Jillian A. Russell, MSN, RN, NPD-BC, program manager at the Association for Nursing Professional Development, careful planning and creativity can make remote experiences just as—or even more—effective as traditional, in-person learning.
Prognostic Biomarkers May Help Predict Rhabdomyosarcoma Outcomes
TP53 and MYOD1 variants are associated with more aggressive forms of rhabdomyosarcoma, a rare childhood cancer, and poorer outcomes, according to the results of the largest international genomic profiling study of the disease. The findings, which were published in the Journal of Clinical Oncology, have implications for somatic biomarker testing to guide tailored treatment approaches.
BTK Inhibitor Effective for Relapsed Hairy Cell Leukemia
Ibrutinib produces durable disease control for patients with high-risk hairy cell leukemia, a rare cancer, who have relapsed and for whom standard purine analogues are not a feasible therapeutic option, according to study results published in Blood.
Hope in Rare Cancers: Care Is Complex, but Oncology Nurses Are Making a Difference
As individual diseases, cancer diagnoses like pheochromocytoma (cancer of the adrenal gland), neuroendocrine cancers, and malignant mixed Mullerian tumors (also called carcinosarcomas) are rare, but collectively they’re more common than breast, colon, lung, or prostate cancer.
Study Shows Anti-Vaping Advertising Campaigns Are Effective in Educating Youth About Tobacco Dangers
Young people who see anti-vaping advertisements and prevention campaigns are more likely to have accurate e-cigarette knowledge, which can lead to a decrease in tobacco use and consequently, lung cancer diagnoses, according to a July 2021 study from the Truth Initiative, an organization devoted to educating youth about smoking and tobacco industries.
Study Ranks U.S. Healthcare Industry Dead Last Among Other High-Income Countries
The United States is worst among 11 high-income countries in delivery of and access to health care, according to an August 2021 study conducted by the Commonwealth Fund, despite spending the most, by far, of its gross domestic product (GDP) on health care than other countries surveyed. The survey used indicators across domains on access to care, care process, administrative efficiency, equity, and healthcare outcomes to compare healthcare system performance. Overall, the top-performing countries were Norway, the Netherlands, and Australia.
It’s Okay to Put Yourself First Sometimes
Are you at—or well over—the brink of burnout? Do you feel like you give, give, give and cannot find the time to refill? Those are common feelings for nurses, whose profession is a service to humanity. Although our work is rewarding, it’s also physically, emotionally, and mentally draining. Never feel guilty or judge yourself for stepping away and taking time for yourself—it’s essential to maintain the high level of care you provide every day.
FDA Approves Ivosidenib for Advanced or Metastatic Cholangiocarcinoma
On August 25, 2021, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo®) for adult patients with previously treated, locally advanced, or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test. FDA also approved the Oncomine Dx Target Test as a companion diagnostic device to aid in selecting patients with cholangiocarcinoma for treatment with ivosidenib.
Oncology Drug Reference Sheet: Tivozanib
On March 10, 2021, the U.S. Food and Drug Administration approved tivozanib (Fotivda®), an oral kinase inhibitor, for adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.
The Case of the GVHD Double-Take
Jeff is a 60-year-old patient with myeloproliferative disease. After his care team secured a 9/10 match, he received an allogeneic hematopoietic stem cell transplantation with a conditioning regimen of fludarabine and melphalan. Neutrophil engraftment occurred at day 20, and he was discharged to home shortly after engraftment. One month later, he presented to the clinic with abdominal pain and a new diffuse erythematous rash, which his care team initially treated with corticosteroids. However, his abdominal pain persisted, and Jeff was admitted to the hospital a few days later for further workup for suspected acute graft-versus-host disease (GVHD). A computed tomography scan of his abdomen demonstrated worsening enterocolitis because of Yersinia enterocolitica. What would you do?
FDA Approves Nivolumab for Adjuvant Treatment of Urothelial Carcinoma
On August 19, 2021, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo®) for the adjuvant treatment of patients with urothelial carcinoma (UC) who are at high risk for recurrence after undergoing radical resection.
FDA Expands Recall to Include Four Additional Lots of Varenicline Tablets Because of N-Nitroso Varenicline Content
On August 16, 2021, the U.S. Food and Drug Administration (FDA) reported Pfizer’s voluntary recall of an additional four lots of varenicline 0.5mg/1 mg tablets to the patient level because of the presence of N-nitroso-varenicline, a nitrosamine, above the Pfizer-established acceptable daily intake level. To date, Pfizer has not received any reports of adverse events that have been related to the recall. FDA reported Pfizer’s recall of 12 lots of varenicline tablets because of N-nitroso varenicline content on July 19, 2021.
FDA Grants Accelerated Approval to Dostarlimab-gxly for dMMR Advanced Solid Tumors
On August 17, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to dostarlimab-gxly (Jemperli®) for adult patients with mismatch repair deficient (dMMR) recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options.
Whole-Genome Sequencing May Guide Treatment Choices for AML and MDS
When compared to conventional testing on the same samples from patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS), whole-genome sequencing–based testing detected the same abnormalities—and new genetic information in about a quarter of patients, potentially changing treatment selection for more than half of those patients, researchers said in the New England Journal of Medicine.
FDA Approves Lenvatinib and Pembrolizumab for Advanced Renal Cell Carcinoma
On August 10, 2021, the U.S. Food and Drug Administration (FDA) approved the combination of lenvatinib (Lenvima®) and pembrolizumab (Keytruda®) for first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
FDA Approves Belzutifan for Cancers Associated With Von Hippel-Lindau Disease
On August 13, 2021, the U.S. Food and Drug Administration (FDA) approved belzutifan (Welireg®), a hypoxia-inducible factor inhibitor for adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), that do not require immediate surgery.
Baxter Healthcare Recalls Dose IQ Software Version 9.0.x Because of Software Defect
On August 12, 2021, the U.S Food and Drug Administration (FDA) reported Baxter Healthcare’s recall of the Dose IQ Safety Software used with the Spectrum IQ Infusion System because a software defect may lead to mismatched drug information in drug libraries that were created using version 9.0.x of the computer-based software. FDA identified it as a class I recall, the most serious type of recall, where use of the devices may cause serious injuries or death.
FDA Announces Recall for SterRX, LLC, Sodium Bicarbonate in 5% Dextrose Injection Because of Microbial Contamination
On August 10, 2021, the U.S. Food and Drug Administration (FDA) reported SterRx, LLC’s, voluntary recall of three lots of sodium bicarbonate in 5% dextrose injection 150 mEq per 1,000 ml due to waterborne microbial contamination.
APRN Leaders Mentor Students to Tackle Clinical Practice Issues
Nursing is among the top careers for job growth, with an estimated 7% increase in the nursing workforce by 2029. As new students train to enter or advance in the profession, advanced practice RNs (APRNs) must mentor and empower them to integrate evidence-based practice (EBP) into their care.
Researchers Tie More Cancers, Mortality to NF1 Disorders
The genetic disorder neurofibromatosis type 1 (NF1) is linked to the development of and mortality for more types of cancer than previously identified, researchers reported in results from a new study. They published the findings in JAMA Network Open.
Coaching Roles Give Nurses New Avenues to Provide Patient-Centered Care
Nurses don’t always have to venture beyond the bedside for unique career change opportunities. Always innovating and evolving, the profession identifies new roles for clinical practice nurses to meet patients’ needs.
AHRQ Envisions Plan to Address Historical Racism and Inequality in Health Care
Historical and structural racism is a huge barrier to quality health care that has created two tiers of access to care and a lack of understanding of the healthcare system. Government health agencies and leaders, such as the U.S. Agency for Healthcare Research and Quality (AHRQ), are tackling racial disparities in health care directly to change the dynamic to equality for all Americans. AHRQ says it is assessing its own agency and examining how professionals can make the health services research field more diverse and inclusive by building on a foundation that includes producing and promoting the annual National Healthcare Quality and Disparities Report and AHRQ’s social determinants of health database. By recognizing disparities related to race and ethnicity, income, and other social determinants, the organization plans to further address historical racism in health care.
Nursing Considerations for Lung Cancer Survivorship Care
As Americans reduce tobacco use and treatment and diagnosis advance, lung cancer survivorship rates are improving; however, it still remains the second most common type of cancer. The growing population needs appropriate survivorship care.
Nursing Informaticists Are the Backbone of Technology-Driven Care
Emerging healthcare technologies require a significant investment in time, money, and training. It starts with ensuring that quality improvement efforts are consistent to support positive clinical and patient outcomes, which is why clinical and information technology (IT) representation is critical in making decisions and exploring solutions. Nursing informatics bridges that gap.
Beyond the Bedside: Oncology Nurses Have Endless Opportunities in Unexpected Careers
As a nurse, you have a diverse arsenal of skills, from clinical competencies and leadership to problem-solving and interprofessional communication. That skillset easily transfers to a variety of careers outside of direct care.
ONS Response to Mandated COVID-19 Vaccinations for Nurses and All Healthcare Professionals
On July 26, 2021, the American Nurses Association (ANA) signed onto a statement released by a large group of healthcare systems and other associations in support of healthcare employers mandating nurses and all healthcare personnel be vaccinated against the COVID-19 coronavirus. This is in response to increasing circulation of COVID-19 variants and lagging vaccination rates. Although ONS was not listed on the statement as a supporting organization because of a late request, ONS agrees that vaccinations are critical for healthcare providers, particularly those caring for immunocompromised patients.
FDA Alerts About Possible Increased Risk of Death Associated With Melphalan Flufenamide
On July 28, 2021, the U.S. Food and Drug Administration (FDA) reported that a clinical trial (OCEAN, Study OP-103) evaluating melphalan flufenamide (Pepaxto®) with dexamethasone to treat patients with multiple myeloma showed an increased risk of death.
HHS Launches Network of Leaders and Organizations to Encourage COVID-19 Vaccinations
As of July 2021, more than 159 million individuals in the United States have been fully vaccinated against the COVID-19 coronavirus, totaling about 48.1% of the U.S. population. However, approximately 173 million others have not, or suggested they will not, receive the vaccination. President Biden’s goal of having 70% of Americans receive at least one vaccine dose and 160 million adults to be fully vaccinated against COVID-19 by July 4, 2021, fell short.
FDA Grants Regular Approval to Pembrolizumab and Lenvatinib for Advanced Endometrial Carcinoma
On July 21, 2021, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda®) in combination with lenvatinib (Lenvima®) for patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy in any setting, and are not candidates for curative surgery or radiation.
FDA Announces Recall for 12 Lots of Varenicline Tablets Because of N-Nitroso Varenicline Content
On July 19, 2021, the U.S. Food and Drug Administration (FDA) reported Pfizer’s voluntary recall of two lots of varenicline 0.5 mg tablets, two lots of varenicline 1 mg tablets, and eight lots of a varenicline kit of 9.5 mg/1 mg tablets to the patient level because of the presence of N-nitroso-varenicline, a nitrosamine, above the Pfizer-established acceptable daily intake level. Varenicline is a treatment to help patients quit smoking and is intended for short-term use. To date, Pfizer has not received any reports of adverse events that have been related to the recall.