FDA Approves Talazoparib for gBRCAm HER2-Negative Locally Advanced or Metastatic Breast Cancer
On October 16, 2018, the U.S. Food and Drug Administration (FDA) approved talazoparib, a poly (ADP-ribose) polymerase inhibitor, for patients with deleterious or suspected deleterious germline BRCA-mutated, HER2‑negative locally advanced or metastatic breast cancer. Patients must be selected for therapy based on an FDA-approved companion diagnostic for talazoparib.
Priming Lines With Drug May Reduce Hypersensitivity Reactions From Rituximab
Monoclonal antibody cancer treatments such as rituximab have a high risk for hypersensitivity reactions from cytokine release syndrome. The symptoms, which can range from mild to life threatening, result from tumor antigen-expressing cells releasing cytokines (e.g., tumor necrosis factor, interleukin, interferon) into the blood as they are destroyed. Symptoms include fever, chills, rigors, rash, headache, hypotension, shortness of breath, bronchospasm, nausea, vomiting, and abdominal pain.
FDA Approves Cemiplimab-RWLC for Metastatic or Locally Advanced CSCC
On September 28, 2018, the U.S. Food and Drug Administration (FDA) approved cemiplimab-rwlc for patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.
FDA Approves Duvelisib for Adult Patients With Relapsed or Refractory CLL or SLL
On September 24, 2018, the U.S. Food and Drug Administration (FDA) granted regular approval to duvelisib for adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies.
How Advanced Practice Nurses Can Recognize It; Report It in an Era of Fast-Track Drug Approvals
It takes an average of 12 years to move a drug from a new application to approval for a specific indication. Twelve years of clinical trials, documentation of several endpoints, and data surrounding incidence of observed adverse events and expected severity. Twelve years until a broader subset of patients can access the drug.
First-Line Osimertinib for Metastatic Non-Small Cell Lung Cancer
Lung cancer is the second most common cancer in both men and women (after skin cancer) and is the leading cause of cancer death among both men and women. Histology has become an important determinant in choosing therapy for various types of cancer, including non-small cell lung cancer (NSCLC). Currently, biomarker testing is the standard of care in lung cancer; with biomarker testing, patients likely to respond to targeted therapy can be identified. As the number of targeted agents continues to increase, so does the demand for continued biomarker testing and adequate tumor tissue samples.
Global Cancer Burden Rises to 18.1 Million New Cases and 9.6 Million Deaths in 2018
As global populations grow, so does the cancer burden, a new study from the World Health Organization’s International Agency for Research on Cancer (IARC) reported. The results of the latest analysis of the incidence and mortality of 36 types of cancer in 185 countries were published in CA: A Cancer Journal for Clinicians in September 2018.
FDA Approves Moxetumomab Pasudotox-tdfk for Hairy Cell Leukemia
On September 13, 2018, the U.S. Food and Drug Administration (FDA) approved moxetumomab pasudotox-tdfk (Lumoxit), a CD22-directed cytotoxin indicated for adult patients with relapsed or refractory hairy cell leukemia who received at least two prior systemic therapies, including treatment with a purine nucleoside analog.
Evidence Is Building for Acupuncture as an Opioid Alternative for Cancer Pain
Pain is the most common and debilitating side effect that patients with cancer experience. Contributing factors include the disease itself via tumor invasion on surrounding tissue and bone; nerve compression; treatments including chemotherapy, radiotherapy and surgery, especially chemo-induced peripheral neuropathy (CIPN), which can be disabling; and aromatase inhibitors that can cause persistent diffuse joint pain. In addition, pain that “breaks through” continuous pain medicine can be difficult to predict and control.
How Inhaled Cannabis May Contribute to Pulmonary Toxicity in Patients With Cancer
As medical use of cannabis is increasingly legalized across the United States, oncology nurses need to become more familiar with the implications of patients using it for cancer symptom management. According to Merkle and Tavernier in their article in the August 2018 issue of the Clinical Journal of Oncology Nursing, little research has been conducted in medical cannabis use and the efficacy and toxicity of cancer treatment. Their article reviewed current literature to better understand the effects that cannabis may have on the lungs in patients with cancer.
An Oncology Nurse’s Guide to Targeted Therapy
Whereas chemotherapy induces apoptosis by interfering with cell division of both cancerous and healthy cells, targeted therapy exploits targets, proteins, enzymes, or genes specific to malignant cells through a variety of mechanisms of action, which helps prevent drug resistance. The agents work by either inhibiting angiogenesis, blocking chemical signals that tell cells to divide or carry out normal function, or delivering toxic substances to a cell.
Which of the Following Isn’t a Breast Cancer Surveillance Recommendation?
Mrs. Johnson has just been told she's in remission from breast cancer. Which of the following isn't a surveillance recommendation?
A. Routine mammography screening every 12 months for locally recurrent tumors or new primary cancers
B. Screening for cervical and colorectal cancer every six months for two years
C. Gynecologic evaluation every 12 months for women on tamoxifen therapy who have an intact uterus
D. Detailed history and physical examination every three to six months for three years
TNM Gets an Upgrade in Eighth Edition Staging Guidelines
Nearly a century ago, cancer staging was a simple categorization of disease as either local, regional, or distant. Then in the 1940s, a French surgeon developed the concept for a staging system that uses the size of the primary tumor (T), its lymphatic involvement (N), and the presence of metastases (M) to stage a patient’s cancer based on the anatomic extent of the disease at the time of diagnosis.
FDA Approves Mogamulizumab-kpkc for Mycosis Fungoides or Sézary Syndrome
On August 8, 2018, the U.S. Food and Drug Administration (FDA) approved mogamulizumab-kpkc (Poteligeo) for adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy.
Which of the Following Drug Spills Doesn’t Require a Full-Facepiece, Chemical Cartridge-Type Respirator or PAPR?
Which of the following drug spills doesn’t require a full-facepiece, chemical cartridge-type respirator or PAPR during clean up?
D. Nitrogen mustard
The Oncology Nurse Experience in Managing Adverse Events in Patients Receiving Ibrutinib
Ibrutinib is a first-in-class Bruton’s tyrosine kinase inhibitor that is approved by the U.S. Food and Drug Administration to treat chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). The drug’s approval was based on results from the multicenter, open-label, phase III RESONATE trial.
FDA Approves Ivosidenib for Relapsed or Refractory AML
On July 20, 2018, the U.S. Food and Drug Administration (FDA) approved ivosidenib for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test.
What Happens if Patients With Cancer Have Bedbugs?
Lurking in the dark corners of bedrooms across the country, unseen figures wait to feast of the blood of humans and animals alike. When the lights go dark, they come out for dinner. No, they’re not vampires or mystical beasts—they’re bedbugs. These parasitic insects feed exclusively on the blood of humans and animals and are a prevalent parasite in the United States.
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.”