FDA Approves Atezolizumab for PD-L1 Positive Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer
On March 8, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval to atezolizumab in combination with paclitaxel protein-bound for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells [IC] of any intensity covering ≥ 1% of the tumor area), as determined by an FDA-approved test.
Testing in the Era of Precision Oncology
Every cancer diagnosis is as individualized and unique as the person receiving it. From family history to societal and economic background to a patient’s genetic make-up and composition, cancer affects each person with cancer differently. Initiatives like precision medicine are based in data that suggest that a personalized disease should have its own personalized treatment. As a subset of precision medicine, precision oncology assesses a patient’s unique genetic profile to help align targeted therapies to hit the right cancer subtypes.
FDA Approves Trastuzumab and Hyaluronidase-oysk Injection for Subcutaneous Use
On February 28, 2019, the U.S. Food and Drug Administration (FDA) approved a trastuzumab and hyaluronidase-oysk injection, for subcutaneous use (Herceptin Hylecta). The drug is a combination of trastuzumab, a HER2/neu receptor antagonist, and hyaluronidase, an endoglycosidase, for the treatment of HER2‑overexpressing breast cancer.
FDA Approves Trifluridine and Tipiracil Tablet for Recurrent Metastatic Gastric or GEJ Adenocarcinoma
On February 22, 2019, the U.S. Food and Drug Administration (FDA) approved trifluridine/tipiracil tablets (Lonsurf)—a fixed combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor—for adult patients with metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.
Oncology Drug Reference Sheet: Ribociclib
Ribociclib is a CDK 4/6 inhibitor first approved by the U.S. Food and Drug Administration in early 2017 for postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine therapy, based on the MONALEESA trial results.
Shorter EBRT for Early Prostate Cancer Has Similar Outcomes
Patients receiving hypofractionated external-beam radiation therapy (EBRT) for early-stage prostate cancer experienced similar outcomes and toxicities as those receiving standard radiation at lower doses over a longer period of time, the American Society for Radiation Oncology, American Society of Clinical Oncology, and American Urological Association say in a new clinical guideline.
FDA Approves Pembrolizumab for Adjuvant Treatment of Melanoma
On February 15, 2019, the U.S. Food and Drug Administration (FDA) approved pembrolizumab for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.
NHLBI Advances Kidney Cancer Therapies
Although the National Cancer Institute on the National Institutes of Health (NIH) campus bears the bulk of research dollars for new discoveries and treatments, other campus institutes engage in cancer research and support. Researchers from the National Heart, Lung, and Blood Institute (NHLBI) are conducting a new study investigating novel immunotherapy treatments for metastatic kidney cancer.
Be Alert for Severe, Early-Onset Toxicities From 5-Fluorouracil and Capecitabine
Although 5-fluorouracil (5-FU) and capecitabine (the oral prodrug of 5-FU) are generally well tolerated, patients can experience severe toxicities from either drug that can be life-threatening if not treated quickly. Of the 275,000 patients who receive 5-FU each year, more than 1,300 die from 5-FU toxicity, or approximately 3–4 patients per day.
Which of the Following Drug Is Most Likely to Have a Synergistic Effect When Combined With Radiation Therapy?
Which of the Following Drug Is Most Likely to Have a Synergistic Effect When Combined With Radiation Therapy?
Oncology Drug Reference Sheet: Lutetium Lu 177 Dotatate
Lutetium Lu 177 dototate (Lutathera®) was approved in January 2018 by the U.S. Food and Drug Administration to treat a specific group of neuroendocrine tumors (NETs) in the gastrointestinal tract. NETs are rare, and the tumors produce hormone-like substances in response to signals from the nervous system.
The Role of the APRN in Monitoring Patients Receiving Peptide Receptor Radionuclide Therapy
Neuroendocrine cancers are rare malignancies; however, their incidence is thought to be increasing. Such tumors are characterized by their overexpression of somatostatin receptors, present in up to 80% of cases. However, a novel radiopharmaceutical may give advanced practice RNs (APRNs) a new option to treat certain gastroenteropancreatic neuroendocrine tumors.
Take a Closer Look at Immune Checkpoint Inhibitors
One way that cancer has been able to evade the immune system is through overexpression of immune checkpoint proteins (immune inhibitory pathway), which allow cancer cells to be considered “self” instead of foreign and block T-cell action. Immune checkpoint proteins cytotoxic T-lymphocyte–associated 4 (CTLA-4) and programmed cell death protein (PD-1) are receptors that are expressed on the surface of cytotoxic T cells. Immune checkpoint inhibitors prevent those receptors from binding to their natural ligands, disrupting the immune inhibitory pathway. See Table 1 for a list of approved agents and indications.
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.
Glutathione Plays a Role in Treatment-Related CINV
Chemotherapy-induced nausea and vomiting (CINV) can negatively affect nutritional intake, ability to work, and treatment adherence. Research suggests that younger age and female gender are the strongest predictors of CINV, but those may not be the only factors, particularly for delayed nausea, according to research findings presented at the San Antonio Breast Cancer Symposium on December 5, 2018.
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.
Study Identifies Novel Triplet Therapy for HR+/HER2+ Breast Cancer
Researchers from the University of Colorado Denver Young Women Breast Cancer Translational Program in Aurora identified a potential triplet combination for the treatment of hormone receptor-positive (HR+) human epidermal growth factor receptor 2-positive (HER2+) breast cancer: HER2-targeted small molecule inhibitor tucatinib, CDK4/6 inhibitor palbociclib, and selective estrogen receptor blocker fulvestrant. They presented the findings at the San Antonio Breast Cancer Symposium on December 7, 2018.
Time to Treatment Discontinuation Shorter in Patients Who Receive First-Line Palbociclib
Current treatment guidelines recommend sequential hormone therapy for patients with hormone receptor-positive (HR+) metastatic breast cancer who are not in visceral crisis and whose disease is not refractory to endocrine treatment. Second-line fulvestrant monotherapy is a treatment option for patients in whom disease progresses after first-line palbociclib. Researchers used real-world data to evaluate the time to treatment discontinuation (TTD) of second-line fulvestrant in patients with HR+ human epidermal growth factor receptor 2-negative (HER2–) metastatic breast cancer who did (n = 88) and did not (n = 100) receive first-line palbociclib and found it was shorter in patients who received palbociclib. They presented the findings at the San Antonio Breast Cancer Symposium on December 7, 2018.
Majority of Real-World Patients With DLBCL Are Eligible for CAR T-Cell Therapy
Patients with diffuse large B-cell lymphoma (DLBCL) often experience long-term survival after initial anthracycline-containing therapy; however, relapse leads to poor outcomes. Some patients with relapsed or refractory disease may receive additional chemoimmunotherapy followed by hematopoietic cell transplantation (HCT), but as many as 50% of patients cannot undergo HCT because of lack of response to chemoimmunotherapy or comorbidities. Chimeric antigen receptor (CAR) T-cell therapy may be an option for those patients, but real-world data on CAR T-cell therapy for DLBCL are limited.
Risk Assessment Tool Predicts Survival in Older Patients Undergoing HCT
Older patients are at increased risk for complications and death following allogeneic hematopoietic cell transplantation (alloHCT), and traditional transplant-specific prognostic indices such as the hematopoietic cell transplant comorbidity index (HCT-CI) may not adequately predict survival. Researchers found that routine pretransplant assessments by interdisciplinary clinical providers, including advanced practice providers and nursing staff, may uncover additional geriatric deficits. Richard J. Lin, MD, PhD, of Memorial Sloan Kettering Cancer Center in New York, NY, discussed the findings at the ASH Annual Meeting on December 1, 2018.
CBT May Improve Response to Subsequent Treatment in Heavily Pretreated Patients With HL
Patients with relapsed or refractory Hodgkin lymphoma (HL) after checkpoint blockade therapy (CBT) have limited options. However, researchers found that CBT may impact response to subsequent therapies. Nicole A. Carreau, MD, of New York University Langone Health in New York City, discussed the findings at the ASH Annual Meeting on December 1, 2018.
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.
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.