FDA Expands Ribociclib Indication in HR-Positive, HER2-Negative Advanced, Metastatic Breast Cancer
On July 18, 2018, the U.S. Food and Drug Administration (FDA) expanded the indication for ribociclib (Kisqali) in combination with an aromatase inhibitor for pre/perimenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy.
The Case of the Coercive Consent
Betty, age 70, was diagnosed with metastatic colon cancer and started treatment with FOLFOX. Her medical oncologist changed the treatment to capcitabine after Betty developed grade 3 peripheral neuropathy. Because of disease progression, bevacizumab was added to her treatment plan. She lives with her daughter, is insured by Medicare, and receives $800 per month from Social Security.
FDA Grants Accelerated Approval to Ipilimumab for Certain Metastatic Colorectal Cancers
On July 10, 2018, the U.S. Food and Drug Administration (FDA) granted accelerated approval to ipilimumab for use in combination with nivolumab for the treatment of patients 12 years of age and older with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
APNs Give Practical Advice for Establishing Clinics and Implementing Programs
Advanced practice nurses (APNs) are creating new and innovative programs that educate patients and help them live better, healthier lives. Lorraine Drapek, DNP, FNP-BC, AOCNP®, Geline Joy Tamayo, MSN, RN, ACNS-BC, OCN®, TTS, Suzanne McGettigan, MSN, CRNP, AOCN®, ANP-BC, and Edward Bentlyewski, MSN, APN, NP-C, AOCNP®, discussed their experiences with APN-run clinics and program implementation during a session at the 43rd Annual Congress in Washington, DC.
What to Do When Your Patients Talk About Medical Aid in Dying
Despite groundbreaking treatments, novel medications, fast-tracked drug approvals, and cutting-edge science, a terminal diagnosis is still a reality for many patients with cancer. Having end-of-life discussions with patients and their family members is a difficult part of oncology nursing, but it’s necessary to provide the highest quality of care and education possible. With more news reports emerging about states introducing—and passing—medical aid in dying legislation, oncology nurses will face questions about the process from patients and caregivers.
Latest FDA Cancer Treatment Approvals Trend Toward New Indications
What is unique about the most recent U.S. Food and Drug Administration (FDA) approvals in the oncology/hematology area is that almost all are for new indications of existing agents as opposed to new agents. This is not surprising because many of the agents target specific bioassays or tumor markers instead of a specific disease site. Oncology nurses need to be aware of the changes because treatments that they have become accustomed to giving for one indication may soon be given for others as well.
How One Institution Used Evidence-Based Practice to Reduce CAUTIs
Catheter-associated urinary tract infections (CAUTIs) are associated with significant morbidity and mortality, with an estimated 93,300 urinary tract infections (UTIs) and 13,000 UTI-related deaths occurring each year in acute care hospitals. A preventable cause of UTIs is the use of long-term indwelling urinary catheters, an ideal focus of evidence-based practice initiatives.
Oncology Nurse Develops Monitoring Document for Monoclonal Antibodies
It’s a rote but important phrase: Necessity is the mother of invention. When a need presents itself, developing novel, inventive solutions can lead to important change. But inventive change doesn’t have to come on a massive scale: small inventions can still have a big impact.
FDA Approves Mircera for Anemia Associated With Chronic Kidney Disease in Pediatric Patients on Dialysis
On June 7, 2018, the U.S. Food and Drug Administration approved methoxy polyethylene glycol-epoetin beta (Mircera®, Vifor Pharma Inc.) for the treatment of pediatric patients aged 5–17 years on hemodialysis who are converting from another erythropoiesis-stimulating agent (ESA) after their hemoglobin level was stabilized with an ESA.
FDA Approves Venetoclax for CLL or SLL
On June 8, 2018, the U.S. Food and Drug Administration (FDA) granted regular approval to venetoclax (Venclexta) for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy.
FDA Approves First Biosimilar to Pegfilgrastim to Decrease Cancer Treatment Infection Risk
On June 4, 2018, the U.S. Food and Drug Administration (FDA) approved pegfilgrastim-jmdb (Fulphila) as a biosimilar to pegfilgrastim (Neulasta) to decrease the chance of infection as suggested by febrile neutropenia in patients with non-myeloid cancer who are receiving myelosuppressive chemotherapy that has a clinically significant incidence of febrile neutropenia.
The Intersection of Radiation and Medical Oncology Nursing
Misconceptions about radiation treatments, associated side effects, and impact on patient care still permeate medical oncology for patients and providers alike. As educators, patient advocates, and caregivers, radiation oncology nurses play a critical role in the successful treatment and support of patients with cancer.
Health Policy Advances Cancer Treatment Options in the Era of Biosimilars
Options and cost are a double-edged sword as biomedical research marches forward and the list of approved drugs expands. More targeted drugs for specific diseases means that more patients have treatment plans that can directly fight their specific disease, possibly resulting in cures.
Which Breast Cancers Benefit from Treatment With Cyclin-Dependent Kinase 4/6 Inhibitor Treatment?
Which Breast Cancers Benefit from Treatment With Cyclin-Dependent Kinase 4/6 Inhibitor Treatment?
A. Newly diagnosed DCIS
B. Metastatic, triple negative
C. Premenopausal, neoadjavant
D. ER+ metastatic
Overcome Barriers to Applying an Evidence-Based Process for Practice Change
The evidence-based practice (EBP) process starts with a clinical question and then proceeds to searching and critically appraising the evidence. Once you have determined that a practice change is necessary, the next step is to integrate that evidence with clinical expertise and patient preferences and values. The last step in EBP is to evaluate the outcomes and disseminate the results. On paper, this flows in an orderly fashion. As clinicians, however, we know that it’s not often that easy or straightforward to change clinical practice. We often face barriers that can make it hard to change, but strategies exist to help facilitate practice change.
Here’s an Overview of the Types, Mechanisms, and Side Effects of Currently Approved Immunotherapies
Immunotherapy drugs fall into varying classes, each carrying its own mechanism of action and anticipated side effects. Although some side effects of immunotherapy may appear similar to those of chemotherapy (e.g., diarrhea, fatigue), they actually result from a totally different mechanism—meaning they require a different approach to management. Treating immunotherapy side effects as you would chemotherapy effects would likely result in patient harm.
What You Need to Know About Obtaining Informed Consent
Informed consent is a comprehensive process as opposed to a check mark on a list of tasks to complete prior to starting cancer therapy. The American Society of Clinical Oncology/ONS Chemotherapy Administration Safety Standards explain that informed consent provides a patient with “sufficient information about the disease diagnosis and treatment options so that the individual can make a reasonable decision about treatment on the basis of an understanding of the potential risks and anticipated benefits of the treatment.”
Oncology Nurses Have a Responsibility to Identify and Prevent Opioid Abuse in Patients With Cancer
As the opioid abuse epidemic prevails in the United States, patients with cancer can be affected. Yu-Ping Chang, PhD, RN, FGSA, associate dean for research and scholarship in the School of Nursing at the University at Buffalo in New York, and Tonya Edwards, MS, MSN, BSN, FNP-C, a nurse practitioner of supportive care at MD Anderson Cancer Center in Houston, TX, discussed how the opioid epidemic affects patients and how to identify and prevent opioid and substance abuse during a session at the 43rd Annual Congress in Washington, DC.
How to Have Ethical Discussions in Your Practice
Having an outlet to consider, discuss, and reflect on oncology ethical issues that affect our daily practice is important in caring for each other in our profession. On our solid tumor oncology unit, monthly nursing ethics lunch and learns allow our nurses the opportunity to identify and discuss their concerns with recent patient cases involving ethical issues. Our hospital’s ethics committee chair facilitates the hour-long discussions held on the unit, along with a senior oncology nurse with significant training and background in clinical ethics.
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.