FDA Reports Efficacy Issue for Patients Taking Pembrolizumab or Atezolizumab as Monotherapy to Treat Urothelial Cancer with Low Expression of PD-L1
The U.S. Food and Drug Administration (FDA) is alerting healthcare professionals, oncology clinical investigators, and the public about decreased survival associated with the use of pembrolizumab (Keytruda) or atezolizumab (Tecentriq) as monotherapy in clinical trials to treat patients with metastatic urothelial cancer who have not received prior therapy and who have low expression of the protein programmed death ligand 1 (PD-L1).
FDA Approves Epoetin Alfa-Epbx as a Biosimilar to Epoetin Alfa
On May 15, 2018, the U.S. Food and Drug Administration approved epoetin alfa-epbx (Retacrit™) as a biosimilar to epoetin alfa (Epogen/Procrit) for the treatment of anemia due to chronic kidney disease.
Huntington Disease May Hold Key to Novel Cancer Treatment
The mutated huntington (HTT) gene causes the body to generate a class of small molecules that are toxic to cancer cells but not most healthy cells, according to the results of a new study published in EMBO Reports. The researchers went as far as to call it a “super assassin against all tumor cells.”
The Case of the Blurred Boundaries
Roxanne, a blood and marrow transplant certified nurse, has been taking care of Jerome, a 20-year-old man diagnosed with acute myeloid leukemia. Jerome is the eldest of seven children; his mother works full-time, and with younger children at home has not been able to make the trip across country to be with her son.
Manage Diarrhea in Patients Receiving Nerlynx® (Neratinib) Tablets
Nerlynx® (neratinib) tablets, an oral kinase inhibitor, is approved by the U.S. Food and Drug Administration for the extended adjuvant treatment of adult patients with early-stage human epidermal growth factor receptor 2-positive (HER2+) breast cancer, following adjuvant trastuzumab-based therapy.
What’s the Preferred Method for Vincristine Administration When Treating a Patient With Lymphoma or Leukemia?
What is the preferred method to administer vincristine into a peripheral IV site when treating a patient with lymphoma or leukemia?
A. Direct IV push by syringe
B. By syringe through free-flowing IV fluids (side-arm technique)
C. Gravity drip using an IV minibag
D. By minibag using an IV pump
New Eligibility Criteria for Initial Oncology Certification Begin in 2019
Oncology nurses seeking basic oncology certification in 2019 will need to have more experience as an RN and more hours of specialty practice before they can take an initial certification test, according to the Oncology Nursing Certification Corporation’s (ONCC’s) new eligibility criteria. The new criteria affect OCN®, CPHON®, CBCN®, and BMTCN® initial test candidates. They do not affect nurses who are renewing certification.
Evidence for Nephrotoxicity Prevention With Cisplatin Therapy Is Still Limited
Cisplatin chemotherapy is used alone or in combination to treat a variety of cancers, including ovarian, testicular, lung, cervical, bladder, head and neck, and gastric cancers as well as lymphoma, melanoma, and more. Although it offers options for many cancer types, its use may result in nephrotoxicity, a dose-limiting side effect. Use of hydration and diuretics may help reduce its incidence, but no standards or best practices are in place to guide those treatments.
How DNA Revolutionized Oncology Care
April 25, 2018, marks National DNA Day. Why the hype? National DNA Day commemorates the successful completion of the Human Genome Project in 2003, and the discovery of DNA's double helix in 1953. Without DNA, understanding the diseases and treatments for cancer would be nearly impossible. Genetics and genomics play huge roles in treating malignancy, and it’s crucial to the care of patients with cancer for oncology nurses to understand genetics and genomics.
Biosimilars Offer New Options for Treatment and New Concepts for Patient Education
The list of pharmacologic agents used in cancer care is expanding: chemotherapy, biotherapy, immunotherapy, targeted therapy, hormonal therapy, and now biosimilars. Part of being a nurse leader is recognizing trends in cancer care, changes on the horizon, and their impact on your patients and cancer treatment options. Biosimilars represent one such trend that affects providers’ approach to care and the education that oncology nurses must provide to patients and caregivers.
FDA Approves Fostamatinib Tablets for ITP
On April 17, 2018, the U.S. Food and Drug Administration approved fostamatinib disodium hexahydrate tablets for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment.
The Case of the Checkpoint Inhibitor Side Effects
John is a 62-year-old man diagnosed with metastatic non-small cell lung cancer (NSCLC). His tumor tested positive for high PD-L1 expression, and he began pembrolizumab treatment. John presents to the clinic for his third treatment and mentions that during the past week his arms and chest have been itchy and he has noticed a red, bumpy rash on his chest. When assessing John’s skin, you note a maculopapular rash on both of his upper extremities, anterior chest, and upper abdomen. What would you do?
FDA Approves Nivolumab Plus Ipilimumab Combination for Renal Cell Carcinoma
On April 16, 2018, the U.S. Food and Drug Administration (FDA) granted approvals to nivolumab and ipilimumab in combination for the treatment of intermediate or poor risk, previously untreated advanced renal cell carcinoma.
FDA Approves Everolimus for TSC-Associated Partial-Onset Seizures
On April 10, 2018, the U.S. Food and Drug Administration (FDA) approved everolimus tablets for oral suspension for the adjunctive treatment of adult and pediatric patients aged 2-years and older with tuberous sclerosis complex (TSC)-associated partial-onset seizures. Everolimus is also approved for two other manifestations of TSC: TSC-associated subependymal giant cell astrocytoma (SEGA) and TSC-associated renal angiomyolipoma.
FDA Approves Rucaparib for Treatment of Recurrent Ovarian Cancer
On April 6, 2018, the U.S. Food and Drug Administration (FDA) approved rucaparib, a poly ADP-ribose polymerase inhibitor, for the maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
APRNs Bridge the Gap in Survivorship Care
As improved screening, diagnosis, and treatments lead to cancer’s classification as a chronic disease, people with cancer are surviving longer than ever before. However, with lengthened survival comes long-term physical and emotional symptoms and other sequelae that require ongoing surveillance and management. Advanced practice registered nurses (APRNs) are essential to delivering quality survivorship care.
Cancer and Immunotherapy Organizations Release Checkpoint Inhibitor Side Effect Guidelines
New guidelines and consensus recommendations for managing immune-related adverse events (irAEs) from checkpoint inhibitors are available from several key cancer and immunotherapy organizations: a collaboration between the American Society of Clinical Oncology and National Comprehensive Cancer Network, and a separate consensus recommendation from the Society for Immunotherapy of Cancer. ONS contributed to the development of both sets of guidelines.
FDA Grants Accelerated Approval to Blinatumomab for B-Cell Precursor ALL
On March 29, 2018, the U.S. Food and Drug Administration (FDA) granted accelerated approval to blinatumomab (Blincyto®) for the treatment of adult and pediatric patients with B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.
Newly Approved Cancer Treatments Indicate Growing Role of Genomics and Oral Therapies
It is becoming more commonplace for nurses to find orders for agents with which they are unfamiliar or quite possibly have never administered. Following is a summary of the latest new U.S. Food and Drug Administration (FDA) approvals or indications to keep you up to date in your practice. Of note, this summary contains the approval of yet another biosimilar in trastuzumab-dkst and rolapitant for chemotherapy-induced nausea and vomiting, which includes a safety alert. Early experiences with rolapitant, a NK-1 inhibitor, indicated a risk of hypersensitivity reactions.
Integrate Evidence With Clinical Expertise and Patient Preferences and Values
Nursing is often referred to as both an art and a science. Evidence-based practitioners must combine understanding the science of health, illness, and disease with the art of adapting care to individual patients and situations, all while thinking critically to improve patient outcomes.
FDA Approves Brentuximab Vedotin for Previously Untreated Stage III, IV Classical Hodgkin Lymphoma
On March 20, 2018, the U.S. Food and Drug Administration (FDA) approved brentuximab vedotin to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma in combination with chemotherapy.
The Case of the Pain Paradox: Follow-Up and Clinical Trial
The January 2018 case study introduced Vince, a 55-year-old man receiving chemotherapy and radiation for recurrent bladder cancer. He suffers from chronic back pain because of spinal stenosis and has been on opioid therapy for nearly two years.
Massage Therapy Helps Manage Breast Cancer-Related Lymphedema
Lymphedema, the chronic swelling of a limb resulting from fluid accumulation, is a common sequela of surgery or radiation treatment for breast cancer. Nearly 90% of women who develop lymphedema do so within three years of treatment. Survivors commonly report physical and emotional distress, limitations to daily activities in fear of exacerbating lymphedema, and body image issues because of an abnormally enlarged limb.
What Oncology Nurses Need to Know About Pharmacogenomics
A subset of precision medicine, pharmacogenomics, is also growing exponentially, especially in oncology. Currently, 165 drugs or combinations are influenced by pharmacogenetics, and 58 of those are specific to oncology/hematology.
FDA Approves Nivolumab Dosing Update
On March 6, 2018, the U.S. Food and Drug Administration (FDA) approved updated dosing information for nivolumab (Opdivo®). Nivolumab is now the first FDA-approved PD-1 inhibitor that offers a flexible dosing option of every two weeks at 240 mg or every four weeks at 480 mg for most approved indications.
What Is the Role of Interprofessional Teams in a BMT Unit?
The old saying, “it takes a village,” comes to mind. Many team members are needed to help a patient through one of the most critical times of their lives. Blood and marrow transplant (BMT) nurses play a large role, along with BMT physicians. However, we also depend on our BMT pharmacist, BMT dietician, and BMT social worker as part of the interprofessional team. Our patients not only need excellent nursing and medical care, but they also need care from members of the team to support them physically, psychologically, and nutritionally from transplant prep through the transplant itself and into the recovery phase.
Interprofessional Collaborations Improve Cancer Care
When faced with a difficult problem, it’s human nature to seek different perspectives, to work together with others facing similar issues to accomplish a common goal. Compromise, collaboration, and communication are essential to successful teams—whether it’s your daughter’s basketball team, the U.S. government, or any group in between. In oncology, teamwork is no different. Bringing together professionals from different disciplines can yield tremendous results for patients with cancer.
Get an Overview of Radiation Therapy for Cancer
Radiation therapy is a precise cancer treatment that targets tumor cells specifically and spares healthy surrounding tissues. Contrary to pharmacologic treatment methodologies, side effects are predominantly site-specific.
FDA Approves Abemaciclib As Initial Therapy for HR-Positive, HER2-Negative Metastatic Breast Cancer
On February 26, 2018, the U.S. Food and Drug Administration (FDA) approved abemaciclib (Verzenio™) in combination with an aromatase inhibitor as initial endocrine-based therapy for postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 HER2-negative advanced or metastatic breast cancer.
The Case of the Cancer Genetics Referral
Christina is a 29-year-old African American woman with a strong family history of breast and ovarian cancers and a personal history of benign ovarian fibroids. She was referred to your office because of a suspicious lump in her left breast. Because of her family history, Christina is especially worried. You are concerned that Christina could have a hereditary family cancer syndrome, and you know that a comprehensive family history must be obtained.
Prevent and Treat Venous Thromboembolism in Patients With Cancer
Venous thromboembolism (VTE), namely deep vein thrombosis and pulmonary embolism, is a common and serious complication. VTE is the second-leading cause of death in patients with cancer and has been connected to poorer prognoses. Other consequences include reduced short- and long-term mortality, increased risk for recurrent VTE and bleeding, a threefold increase in hospitalizations, and higher total healthcare costs. Advance practice nurses (APNs) must understand prevention strategies and treatment guidelines for this serious complication.
FDA Approves Durvalumab After Chemoradiation for Unresectable Stage III NSCLC
On February 16, 2018, the U.S. Food and Drug Administration (FDA) approved durvalumab (Imfinzi) for patients with unresectable stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.
FDA Approves Apalutamide for Nonmetastatic Castration-Resistant Prostate Cancer
On February 14, 2018, the U.S. Food and Drug Administration (FDA) approved apalutamide (Erleada) for patients with non-metastatic castration-resistant prostate cancer.
Motivational Interviewing Nursing Interventions Help Reduce Chemotherapy Symptom Burden
Nursing interventions such as coaching, telephone follow-up, and home care have been reported with inconsistent results. In their article in the January 2018 issue of the Oncology Nursing Forum, Coolbrandt et al. discussed the evaluation of a nursing intervention focused on patient education and self-management to reduce symptom distress in outpatients with cancer.
FDA Approves Abiraterone Acetate With Prednisone for High-Risk Metastatic CSPC
On February 7, 2018, the U.S. Food and Drug Administration (FDA) approved abiraterone acetate tablets in combination with prednisone for metastatic high-risk castration-sensitive prostate cancer (CSPC).
How Can Cognitive Behavioral Therapy Help Patients With Cancer Manage Insomnia?
Simply put, sleep impacts everything. I consider it to be even more foundational than diet and exercise for some. If patients don’t sleep well, they are more likely to make poor food choices and not exercise. Individuals with insomnia symptoms are at higher risk for a number of physical health problems, including diabetes, obesity, and cardiovascular diseases. Insomnia has been linked to mood and anxiety disorders, higher levels of perceived stress, and impaired cognitive functioning.
Sleep-Wake Disturbances in Patients With Cancer
In bedrooms across the United States, people are crawling into bed, turning down the lights, and lying awake for hours on end. Sleep-wake disturbances and short sleep duration are extremely common, and rates are even higher in patients with cancer. Unfortunately, screening, assessment, and interventions are lacking for patients experiencing sleep-wake disturbances during their cancer journey.
Immunotherapy Without Immune Cells May Be on the Horizon
Researchers have generated immunotherapy in the laboratory using nonimmune cells. If the findings can be translated into treatment, it may reduce some of the immune-related adverse events that patients experience with today’s cancer immunotherapy treatments. The study was reported in Nature Chemical Biology.
A Spirit of Inquiry Leads to Evidence-Based Answers to Practice Questions
Addressing a clinical problem through evidence-based practice (EBP) involves asking the right questions in the right way, finding the best available evidence, and assessing what practice change may be needed. A core factor in the EBP journey is the development of nurses who possess a spirit of inquiry within a culture that supports a systematic process for asking clinical questions.
Safety Information on Varubi (Rolapitant) Injectable Emulsion
The Oncology Center of Excellence of the U.S. Food and Drug Administration (FDA) is informing healthcare providers about new safety information for Varubi® (rolapitant) injectable emulsion, a substance P/neurokinin (NK-1) receptor antagonist indicated for the prevention of delayed nausea and vomiting associated with cancer chemotherapy in adults.
FDA Broadens Afatinib Indication to Previously Untreated, Metastatic NSCLC
On January 12, 2018, the U.S. Food and Drug Administration (FDA) granted approval to afatinib for a broadened indication in first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test.
What Competencies Are Required for Oncology Nurse Generalists?
Oncology nursing is rapidly evolving specialty. Nurses need to stay on top of a complex technologic environment, ever-changing science, and rapid assimilation of research into practice. In doing so, they attain and maintain a high level of competency to adequately and safely care for people with cancer.
Despite Regulations, Patients With Cancer Pain Still Need Safe Access to Opioids
Each day, more than 175 Americans die from an opioid-related overdose. Misuse of, addiction to, and overdose from opioids cost the United States $78.5 billion a year, “including the costs of health care, lost productivity, addiction treatment, and criminal justice involvement.”. Other alarming numbers abound: 21%–29% of patients who are prescribed opioids misuse them, 4%–6% of those transition to heroin, and 80% of people who use heroin first misused prescription opioids.
Understanding Medicinal Cannabis in Cancer Care
Medicinal cannabis, a topic that remains largely unstudied in human trials in the United States, is slowly becoming introduced in areas of health care and oncology in states that have legalized it for medical and adult recreational use.
FDA Approves First Biosimilar for Cancer Treatment, Among Other New Immunotherapy Dosing and Indications
Cancer treatment options continue to multiply as 2017 concludes, with the U.S. Food and Drug Administration (FDA) granting additional new drug approvals and broadening indications for others. Checkpoint inhibitors continue to explode on the scene with accelerated approvals for various indications. Treatment options for hematologic cancers are multiplying. Additionally, the first biosimilar for cancer treatment, bevacizumab-awwb, was approved as a biosimilar to bevacizumab.
FDA Grants Accelerated Approval to Bosutinib for Treatment of Newly-Diagnosed PH+ CML
On December 19, 2017, the U.S. Food and Drug Administration granted accelerated approval to bosutinib for treatment of patients with newly-diagnosed chronic phase Philadelphia chromosome positive chronic myelogenous leukemia.
FDA Grants Regular Approval to Cabometyx for First-Line Treatment of Advanced Renal Cell Carcinoma
On December 19, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to cabozantinib for treatment of patients with advanced renal cell carcinoma (RCC).
Sweet Dreams Discourage Inflammation
Do you consider sleep to be part of your self-care regimen? Does a spinning wheel of thoughts keep you from restful sleep, or do you consciously sacrifice sleep time? If so, you are not alone. The Centers for Disease Control and Prevention (CDC) declared that insufficient sleep is a public health epidemic with an estimated 25% of the United States population suffering from some type of sleep disturbance.