Biosimilars and Oral Agents Lead New Approvals in the Cancer Setting
A majority of the U.S. Food and Drug Administration (FDA) approvals for cancer agents in the latter part of 2018 represented second and third approvals for new indications in other disease sites. Many were given expedited approval, but with that comes the potential that the incidence of adverse events may be underrepresented because fewer patients received the agents in a clinical trial setting.
FDA Approves Romiplostim for Pediatric Patients With Immune Thrombocytopenia
On December 14, 2018, the U.S. Food and Drug Administration (FDA) approved romiplostim for pediatric patients one year of age and older with immune thrombocytopenia for at least six months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
Manage Afatinib’s Adverse Events to Keep Patients on Treatment
Ongoing therapy with afatinib—an oral, irreversible ErbB family blocker—for as long as it is effective and tolerable is considered first-line treatment for metastatic non-small cell lung cancer in patients with EGFR mutations. In their article in the October 2018 issue of the Clinical Journal of Oncology Nursing, Edwards, Adan, Lalla, Lacouture, O’Brien, and Sequist discussed the most common adverse events (AEs) associated with afatinib and their real-life experiences managing them in clinical practice to keep patients on therapy.
Breast MRI Protocol Improves Patient Care
Magnetic resonance imaging (MRI) can help diagnose breast cancer, but it is costly. Leadership at the University of Washington in Bellingham developed a protocol to improve the timeliness of care, moving the time of MRI prior to surgeon evaluation, and found that it led to enhanced patient care, eliminated delays in treatment, avoided unnecessary tests, shifted appropriate care to primary-care providers, and provided all necessary data prior to initial surgical consultation. They presented the findings at the .
Overall Survival From Breast Cancer Differs Based on Tumor Type and Location
Triple-negative breast cancer tumors are thought to be more immunogenic than other breast cancer subtypes, such as luminal A/B or human epidermal growth factor receptor 2-positive (HER2+) tumors. Among all breast cancers, tumors appear more commonly in the upper outer quadrant. However, it is not clear whether expression of immune response genes vary with tumor location among the different subtypes. Researchers assessed gene expression associated with immune response pathways to identify potential treatment targets and presented the findings at the .
How Can Oncology Nurses Support Surgical Patients With Esophageal Cancer?
In 2000, I was diagnosed with stage III esophageal cancer—adenocarcinoma—and was put on a treatment regimen of chemotherapy, radiation therapy, and ultimately surgery to my esophagus. After talking with my doctors and nurses, heartburn was determined to be the cause of cancer. I didn’t realize at the time that survival rates for my disease were extremely low.
Under the Knife: Supporting Patients’ Needs Throughout Surgical Oncology Care
People often use idioms—such as “going under the knife” as a euphemism for surgery—to avoid confronting distressing situations, which is even more pronounced when it comes to life events as serious as cancer. But for many patients with cancer, undergoing a surgical procedure is key to positive outcomes, and they count on the expert clinical care and support of their surgical oncology nurses to see them through it.
FDA Approves Rituximab-ABBS as Biosimilar to Rituximab for Non-Hodgkin Lymphoma
On November 28, 2018, the U.S. Food and Drug Administration (FDA) approved rituximab-abbs as the first biosimilar to rituximab for patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL) to be used as a single agent or in combination with chemotherapy.
FDA Approves Gilteritinib for Relapsed, Refractory AML With an FLT3 Mutation
On November 28, 2018, the U.S. Food and Drug Administration (FDA) approved gilteritinib for treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.
APRN-Led Clinics Enable Comprehensive Survivorship Care
A survivorship clinic allows APRNs to practice autonomously and highlights their strengths and skills, including assessing long-term toxicities, providing expert symptom management, coordinating with other disciplines, and making referrals as appropriate. Long-term toxicities from cancer treatment are disease- and treatment-specific and will be unique to each patient.
Chemotherapy Is Still a Staple in Treatment Plans. Here’s a Fresh Look at a Familiar Treatment Option
Despite all of the new drugs approved in recent years—particularly immunotherapies, oral agents, and biosimilars—that have forced nurses to consider many novel approaches to patient care, the importance of chemotherapy in cancer treatment has remained a constant. In a field where it feels like no two days are the same and new drugs emerge on a rolling basis, chemotherapy continues to be a staple in cancer treatment plans and safety and administration principles remain constant.
FDA Approves Glasdegib for AML in Adults Aged 75 or Older or Who Have Comorbidities
On November 21, 2018, the U.S. Food and Drug Administration (FDA) approved glasdegib in combination with low-dose cytarabine, for newly-diagnosed acute myeloid leukemia (AML) in patients who are 75 years old or older or who have comorbidities that preclude intensive induction chemotherapy.
FDA Approves Brentuximab Vedotin for Previously Untreated sALCL and CD30-Expressing PTCL
On November 16, 2018, the U.S. Food and Drug Administration (FDA) approved brentuximab vedotin in combination with chemotherapy for previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified. This is the first FDA approval for previously untreated PTCL including sALCL.
WHO Cautions About Inactivity Pandemic and Disease Risk
No improvement in worldwide exercise levels has been seen since 2001, and, in fact, inactivity has worsened, data in a new report from the World Health Organization (WHO) indicated. The findings were published in Lancet Global Health.
The Case of the Emotional Emergency
Sharon, age 40, was diagnosed with invasive ductal carcinoma. Pathologically, her tumor was grade I, estrogen- and progesterone-receptor positive, and HER2 negative. The mass measured 0.5 cm on ultrasound. Sharon has no family history of cancer and is devastated by the diagnosis. One of her close friends recently died from metastatic breast cancer, and she is certain will have the same fate. She tells Jennifer, an RN in the breast center, that she is going home to “get her affairs in order.”
The Integrative Oncology Nurse: New Role for a New Era in Cancer Care
When patients or loved ones receive a cancer diagnosis, they often experience fear, worry, and a desire to do everything possible to increase the chance of survival. It is also a pivotal time for patients to assess their well-being and lifestyle and make positive changes. For many, complementary therapies become part of their cancer care journey. Internationally, 40% of patients with cancer have reported using complementary therapies to address cancer-related symptoms, improve the effectiveness of conventional treatments, and provide hope.
Recent NSAID Use May Improve Ovarian Cancer Survival
Researchers have found that use of nonsteroidal anti-inflammatory drugs (NSAIDs) after diagnosis appears to improve survival for patients with epithelial ovarian cancer. The study results were published in Lancet Oncology.
Action Plan May Reduce CLABSIs in Hospitalized Patients With Cancer
Despite being preventable, central line-associated bloodstream infections (CLABSIs) result in thousands of deaths each year and cost the U.S. healthcare system billions of dollars. Infection is a common problem in patients with cancer, particularly those receiving chemotherapy and radiation.
Oncology Nursing Foundation Refocuses Commitment to All Oncology Nurses
Support for oncology nursing is critical to the advancement of the profession and the future of care for patients with cancer. The Oncology Nursing Foundation—formerly known as the Oncology Nursing Society (ONS) Foundation—is a nonprofit, tax-exempt, charitable organization dedicated solely to supporting oncology nurses both nationally and internationally. Today, the Foundation announced its name change to wholly encapsulate the organization’s longstanding focus and goals. Through continuing education scholarships, research grants, and career development funding, the Oncology Nursing Foundation supports oncology nurses in their pursuits to provide safer and more effective cancer care for their patients.
FDA Grants Accelerated Approval to Pembrolizumab for Hepatocellular Carcinoma
On November 9, 2018, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for patients with hepatocellular carcinoma who have been previously treated with sorafenib.
An Oncology Nursing Overview of Biosimilars
Since the first biosimilar agent was approved by the U.S. Food and Drug Administration (FDA) in 2015, patients and providers have had concerns about the implications for their care and practice, respectively. Because 6 of the 12 biosimilar drugs currently approved in the United States have indications for oncology practice, oncology nurses have a responsibility to understand the drugs’ safety and efficacy for the patients in their care.
This Week, Recognize and Thank Your Oncology Nurse Practitioner Colleagues
Nurse practitioners (NPs) play an undeniably valuable role in producing quality outcomes in cancer patients. For National NP Week from November 11–17, 2018, pause with ONS to recognize, thank, and support the oncology NPs who relentlessly pursue excellence, striving for the best for their patients from diagnosis through survivorship.
How Oncology Nurses Provide Quality Care Through Telephone Triage
As a direct line to the oncology team, the phone conversations between nurses and their patients can help address symptoms, foster valuable patient education, provide useful interventions, encourage side effect reporting, and identify potentially life-threatening situations. Ultimately, successful telephone triage requires a unique skill set for oncology nurses to communicate with their patients and recognize underlying issues.
FDA Approves Pembrolizumab in Combination With Chemotherapy for First-Line Treatment of Metastatic Squamous NSCLC
On October 30, 2018, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) in combination with carboplatin and either paclitaxel or nab-paclitaxel as first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC).
Oral Adherence With Nerlynx® (Neratinib) Tablets: Patient Case
AS is a 58-year-old woman who was diagnosed at age 55 with a right infiltrating ductal carcinoma of the breast, identified as grade III, ER and PR positive, and HER2 positive. She had bilateral mastectomy, and tumor size was noted to be 2.8 cm. She had a positive sentinel lymph node. She was staged at IIB (pT2, pN1, M0). Her left breast was noted to have usual ductal epithelial hyperplasia and a 1.2 cm fibroadenoma. AS’s genetic testing revealed a BRCA1 mutation (BRCA1 c.3748G>T [p.Glu1250*]), which may confer an increased risk for breast cancer in the range of 46%–87%, and 39%–63% risk for ovarian cancer by age 70. As her patient history shows, she has some risk factors for nonadherence, including no support at home and some financial issues. Throughout her care, the team worked to communicate and prepare AS to help ensure adherence as much as possible.
Oral Adherence With Nerlynx® (Neratinib) Tablets: Introduction
The cancer treatment landscape has shifted with the emergence of new, targeted therapies. Development and use of oral oncolytics, targeted cancer therapies that can be taken by patients orally in their own homes, has increased in recent years. This increase is due in part to research in extra- and intracellular signaling pathways. By interfering with or blocking these signals, targeted drugs have become standard agents in cancer therapy. Oral oncolytics currently account for about 25% of the oncology pipeline of drugs in clinical development, and experts project that oral oncoloytic use will continue to rise.
Institution Meets Magnet Designation by Incorporating ONS Standards in Care Delivery
To meet or maintain Magnet designation, the American Nurses Credentialing Center (ANCC) Magnet Recognition Program expects organizations to incorporate specialty standards and guidelines into the care delivery system.
Neuroendocrine Prostate Cancer Subtype Is Aggressive and More Common Than Expected
Nearly 20% of men with metastatic, castration-resistant prostate cancer had tumors that developed into the treatment-emergent small-cell neuroendocrine (t-SCNC) subtype, which is associated with shorter survival than other subtypes, according to findings from a study published in the Journal of Clinical Oncology.
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.