FDA Approves Larotrectinib for Solid Tumors With NTRK Gene Fusions
On November 26, 2018, the U.S. Food and Drug Administration (FDA) granted accelerated approval to larotrectinib for adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, that are either metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory alternative treatments or whose cancer has progressed following treatment.
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.
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.
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.
ONS Tackles Oral Chemotherapy Complexities
To ensure that patients and providers are equipped with the latest, most up-to-date knowledge and resources, ONS routinely works with patient advocacy groups, subject matter experts, and other provider organizations to develop and refine critical information for clinical practice. Following safety standards and meeting patient education requirements are critical to successful oral chemotherapy practice.
FDA Approves Lorlatinib for Second, Third-Line Treatment of ALK-Positive Metastatic NSCLC
On November 2, 2018, the U.S. Food and Drug Administration (FDA) granted accelerated approval to lorlatinib (Lorbrena) for patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease.
Study Finds Guideline Adoption Slow for Antiemetic Prophylaxis in Patients Receiving Carboplatin
In 2017, the National Comprehensive Cancer Network and American Society of Clinical Oncology released new antiemetic guidelines that recommended adding an NK1 receptor antagonist (RA) to standard 5-hydroxytryptamine RA plus dexamethasone upfront for patients receiving carboplatin area under the curve (AUC) ≥ 4. In January 2018, the Centers for Medicare and Medicaid Services instituted a new quality outcome measure, OP-35, which assesses “potentially avoidable” acute care for nausea, vomiting, or eight other common chemotherapy-related toxicities (anemia, dehydration, diarrhea, fever, neutropenia, pain, pneumonia, and sepsis).
Which RN Is Competent in Chemotherapy Administration?
Which RN is Competent in Chemotherapy Administration?
- One that took a chemotherapy course online 2 years ago and recently completed their annual education.
- One that witnessed a chemotherapy competent nurse administer chemotherapy orally and parenterally on five separate occasions
- One that took a chemotherapy course offered by her hospital and completed an administration checklist with a chemo competent nurse
- One who works on a unit that cares for patients receiving chemotherapy
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).
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.
Ketogenic Diet May Overcome Drug Resistance With PI3K Inhibitors
Researchers have shown in mouse models that using PI3K inhibitor targeted therapy along with a ketogenic diet may help prevent or overcome the drug resistance that can eventually occur. The findings were reported in Nature.
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.
Biosimilars and Gene Therapy Are Making Great Strides in Cancer Care
As researchers learn more about how combination therapy combats drug resistance and lessens the changes of tumor evasion of the immune system, immune checkpoint inhibitors are receiving approval for a broader range of indications. However, recent U.S. Food and Drug Administration (FDA) approvals have centered around hematologic malignancies and the emergence of two new biosimilars.
Older Patients Respond Better to Checkpoint Inhibitors for Melanoma
Patients aged 62 and older are more likely to respond to immune checkpoint inhibitors for melanoma, such as pembrolizumab, according to findings from a study published in Clinical Cancer Research. A follow-up study showed that it may be because of age-related changes in the immune cells in melanoma tumors.
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.
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.
NINR Study Identifies Genes for Fatigue in Cancer Treatment
Radiation therapy can be an incredibly draining form of treatment for patients with cancer. Side effects such as fatigue can be debilitating for many before, during, and after treatment. Because symptom management is a crucial component to cancer care and central role of oncology nursing, ensuring that patients are able to mitigate their symptoms and side effects can help improve their quality of life. Recently, a team at the National Institute of Nursing Research (NINR) identified certain genes associated with fatigue in men being treated for prostate cancer.
FDA Grants Approval for Pembrolizumab in Combination With Chemotherapy for First-Line Treatment of Metastatic Nonsquamous NSCLC
On August 20, 2018, the U.S. Food and Drug Administration (FDA) approved pembrolizumab in combination with pemetrexed and platinum as first-line treatment of patients with metastatic, non-squamous non-small cell lung cancer, with no EGFR or ALK genomic tumor aberrations.
FDA Grants Nivolumab Accelerated Approval for Third-Line Treatment of Metastatic SCLC
On August 16, 2018, the U.S. Food and Drug Administration (FDA) granted accelerated approval to nivolumab for patients with metastatic small cell lung cancer (SCLC) with progression after platinum-based chemotherapy and at least one other line of therapy.
How APRNs Can Support Patients During Oral Agent Treatment
Oral agents offer many patient benefits, one of which is the freedom to take the medication at home, allowing them to keep their daily routine and gain additional time and independence they would have spent traveling to the clinic for treatment. However, with that freedom comes additional patient responsibilities, and preparation from advanced practice RNs (APRNs) is necessary to ensure patients can self-manage symptoms and adhere to administration regimens. Research shows that patients experience severe symptoms on oral agents that may cause them to miss as many as one-third of the prescribed doses. How can APRNs empower patients to adhere to the treatment plan and ensure safe symptom self-management at home?
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.
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.
Men May Have Greater Survival Benefit From Immune Checkpoint Inhibitors
Researchers have found a significant difference in overall survival in men versus women receiving immune checkpoint inhibitors for advanced cancers. The findings from the systematic review and meta-analysis were reported in Lancet Oncology.
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.
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.
FDA Approves Encorafenib and Binimetinib in Combination for Unresectable or Metastatic Melanoma With BRAF Mutations
On June 27, 2018, the U.S. Food and Drug Administration (FDA) approved encorafenib and binimetinib (Braftovi and Mektovi) in combination for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.
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.
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.
Drug Offers Extended Adjuvant Treatment Option for HER2+ Metastatic Breast Cancer
An estimated 266,120 new cases of invasive breast cancer and 40,920 related deaths will occur in the United States in 2018. Patients with distant disease have a poorer five-year relative survival rate (26.9%) compared with localized (98.9%) and regional (85.2%) disease. HER2+ breast cancer accounts for approximately 20%–25% of all breast cancer diagnoses, and this type of breast cancer is more common in younger women, decreasing in frequency with age across all stages.
Boosting T-Cell Memory Enhances Immunotherapy Effectiveness
A combination of immunotherapies may increase the formation of memory T cells and lead to a more lasting response, according to findings from a study presented at the American Association for Cancer Research’s 2018 annual meeting.
The Case of the CTCAE Assessment for CDK4/6 Adverse Events
Mrs. Jones is a 66-year-old postmenopausal woman who developed left breast pain and a palpable mass. A mammogram and ultrasound showed a 4.6 cm mass with an enlarged axillary node. A core biopsy revealed invasive ductal carcinoma that is estrogen receptor positive, progesterone receptor positive, and HER2 negative. Positron-emission tomography and computed tomography scans revealed metastatic disease.
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.
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
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.
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).
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.”
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.
FDA Approves Tisagenlecleucel for Adults with Relapsed or Refractory Large B-Cell Lymphoma
On May 1, 2018, the U.S. Food and Drug Administration (FDA) approved tisagenlecleucel a CD19-directed genetically modified autologous T-cell immunotherapy, for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma.