Oncology Drug Reference Sheet: Combination Trastuzumab and Hyaluronidase-Oysk
A new product that combines trastuzumab and hyaluronidase (Herceptin Hylecta™) received U.S. Food and Drug Administration approval in February 2019 for the treatment of HER2-overexpressing breast cancer. The approval was based on the results of two randomized trials: HannaH and SafeHER.
FDA Approves Pembrolizumab for First-Line Treatment of HNSCC
On June 10, 2019, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda®) for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC).
FDA Approves Polatuzumab Vedotin-piiq for Diffuse Large B-Cell Lymphoma
On June 10, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval to polatuzumab vedotin-piiq (PolivyTM), a CD79b-directed antibody-drug conjugate indicated in combination with bendamustine and a rituximab product for adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, after at least two prior therapies.
Nurses Are Crucial to Developing Tools, Best Practices for Novel Therapies
Advanced practice RNs (APRNs), especially those with Doctorate of Nursing Practice degrees, in clinics across the country must not only focus on managing care for patients on novel therapies like immunotherapy but must also look at toxicities and adverse events from a population perspective. APRNs should look across all patients and disease types receiving the same novel treatments and recognize toxicity patterns to determine best practices for patient management.
Novel Therapies: How CAR T Cells and Biosimilars Are Changing Cancer Care
Clinical practice is in a constant state of evolution as new guidelines are released, drugs are approved for new indications, and technology reshapes the way care is delivered. Patients are also arming themselves with a more-advanced-than-ever knowledge and understanding of health care, and providers may be fielding new questions from patients and caregivers about novel treatments such as chimeric antigen receptor (CAR) T-cell therapy and biosimilars.
FDA Updates REMS and Black Box Warnings for Blinatumomab
In May 2019, the U.S. Food and Drug Administration (FDA) added new clarifications to its risk evaluation and mitigation strategy and black box warnings for blinatumomab (Blincyto®). Blinatumomab is a bispecific, CD19-directed CD3 T-cell engager indicated for the treatment of adults and children with (a) B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease greater than or equal to 0.1% or (b) relapsed or refractory B-cell precursor ALL.
FDA Approves Lenalidomide for Follicular and Marginal Zone Lymphoma
On May 28, 2019, the U.S. Food and Drug Administration (FDA) approved lenalidomide (Revlimid®) in combination with a rituximab product for previously treated follicular lymphoma and previously treated marginal zone lymphoma.
FDA Approves Alpelisib for Metastatic Breast Cancer
On May 24, 2019, the U.S. Food and Drug Administration (FDA) approved alpelisib (Piqray®) in combination with fulvestrant for postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.
FDA Approves Ruxolitinib for Acute Graft-Versus-Host Disease
On May 24, 2019, the U.S. Food and Drug Administration (FDA) approved ruxolitinib (Jakafi®) for steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older.
Oncology Drug Reference Sheet: Talazoparib
Initially approved in 2018, talazoparib (Talzenna®) capsules are indicated for the treatment of adult patients with deleterious or suspected deleterious germline breast cancer susceptibility gene HER2-negative locally advanced or metastatic breast cancer.
FDA Approves Avelumab Plus Axitinib for Renal Cell Carcinoma
On May 14, 2019, the U.S. Food and Drug Administration (FDA) approved avelumab (Bavencio®) in combination with axitinib for first-line treatment of patients with advanced renal cell carcinoma.
FDA Approves Ado-Trastuzumab Emtansine for Early Breast Cancer
On May 3, 2019, the U.S. Food and Drug Administration (FDA) approved ado-trastuzumab emtansine (Kakcyla®) for the adjuvant treatment of patients with HER2-positive early breast cancer (EBC) who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment.
FDA Approves Ivosidenib as First-Line Treatment for AML With IDH1 Mutation
On May 2, 2019, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo®) for newly-diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test, in patients who are at least 75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy.
Stay Up to Date on Clinical Treatments for Metastatic CRC
Metastatic colorectal cancer (CRC) remains a significant health problem as the second leading cause of cancer death in the United States and the fourth most frequently diagnosed cancer. Despite improvements in some age groups, its incidence has actually been increasing in patients younger than 50 years. The cause of this trend is currently unknown.
Oncology Drug Reference Sheet: Cabozantinib
Cabozantinib (Cabometyx®) received an additional U.S. Food and Drug Administration (FDA)-approved indication in January 2019 for use in patients with hepatocellular carcinoma (HCC) who have already been treated with sorafenib. It received prior approval for the treatment of renal cell carcinoma in 2017. The research leading to the approval in the HCC setting showed improved overall survival, progression-free survival, and overall response in the cabozantinib treatment arm.
Which Ambulatory Infusion Pump Is Best for 5-FU?
Because of its long infusion time over 46–48 hours, 5-fluorouracil (5-FU) is usually administered with an ambulatory infusion pump in the outpatient setting. However, two types of pumps exist. On one side of the spectrum is the elastomeric pump: small, compact, but gets the job done. On the other is the electronic pump: bigger, flashy, with lots of bells and whistles (literally). Here are the advantages and disadvantages of each.
Nurses Must Recognize, Manage Toxicities of CAR T-Cell Therapy
Chimeric antigen receptor T-cell (CAR T-cell) therapy is an exciting but complex novel form of immunotherapy with multiple potential toxicities that nurses must be prepared to recognize and manage, Misty Lamprecht, MS, APRN-CNS, AOCN®, BMTCN®, of the Ohio State University Comprehensive Cancer Center – James in Columbus said during a session on Saturday, April 13, 2019, at the ONS 44th Annual Congress in Anaheim, CA. Lamprecht’s copresenter was Yi Lin, MD, PhD, of the Mayo Clinic Cancer Center in Rochester, MN.
Oncology Drug Reference Sheet: Glasdegib
In November 2018, the U.S. Food and Drug Administration (FDA) approved glasdegib (Daurismo™) for use in combination with low-dose cytarabine for treatment of patients with newly diagnosed acute myeloid leukemia who are not eligible for intensive chemotherapy. Data from clinical trials indicated that the regimen is safe for older adults and those with significant comorbidities, such as cardiac disease, poor performance status, or elevated serum creatinine.
FDA Approves Atezolizumab for Extensive-Stage Small Cell Lung Cancer
On March 18, 2019, the U.S. Food and Drug Administration (FDA) approved atezolizumab in combination with carboplatin and etoposide, for the first-line treatment of adult patients with extensive-stage small cell lung cancer.
Biosimilars, Oral Agents, and Drugs Targeting Genetic Mutations Are Creating a Paradigm Shift in Cancer Treatment
New treatment options continue to emerge for diseases that until recently had limited, if any, treatment choices. Nurses are seeing more changes in the way treatment regimens come together, biosimilars are presenting viable options for patients, and genetic mutations, as opposed to disease sites, are at the forefront of drug development.
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 .
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 .
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.