FDA Approves Neratinib for Metastatic HER2-Positive Breast Cancer
On February 25, 2020, the U.S. Food and Drug Administration (FDA) approved neratinib (Nerlyn®) in combination with capecitabine for adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting.
The Case of the CDK4/6 Inhibitors Checklist
Three years ago, Sarah, age 54, completed standard chemotherapy and radiation treatment for stage II, ER- and PR-positive, HER2-negative invasive breast cancer. A recent computed tomography scan, ordered to evaluate persistent hip pain, revealed bone lesions, and a biopsy and positron-emission tomography scan confirmed bone-only metastatic breast cancer. A CDK4/6 inhibitor, ribociclib, was added to the letrozole she was already taking.
Nurses Will Forge New Territory With Biosimilars in Cancer Care
Although cancer biosimilars have been used in European countries and in U.S. supportive care for some time, biologic medications are still new to cancer treatment in the United States. With greater support coming in at the federal level and from agencies like the U.S. Food and Drug Administration (FDA) and Federal Trade Commission, the rising biosimilar tide could soon reach a new highwater mark for healthcare professionals—and nurses specifically.
Immune-Related Adverse Events With PD-1 Inhibitors in Head and Neck Cancer
Clinical trial results show that PD-1 inhibitors offer improved survival and a better safety profile compared to standard, single-agent chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck. However, because of their mechanism of action as immunotherapy, patients receiving the agents may experience immune-related adverse events (irAEs).
Study Drug Plus Immunotherapy May Offer New Treatment Option for Lung and Kidney Cancer
Pegilodecakin, an investigational, first-in-class drug currently in clinical trials, is demonstrating positive safety results and measurable responses when used in combination with pembrolizumab or nivolumab in patients with non-small cell lung cancer (NSCLC) or kidney cancer. The findings from the multicenter, phase IB study were published in Lancet Oncology.
Prostate Cancer Prevention, Screening, Treatment, and Survivorship Recommendations
One in nine men will be diagnosed with prostate cancer, the second leading cause of death in men in the United States. Survival varies greatly depending on the disease’s severity and extent at diagnosis: five-year survival rates are near 100% for local or regional disease, but they drop to 30% for metastatic prostate cancer.
FDA Approves Tazemetostat for Advanced Epithelioid Sarcoma
On January 23, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tazemetostat for adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
Oncology Drug Reference Sheet: Entrectinib
Entrectinib was approved by the U.S. Food and Drug Administration in August 2019 as the third tumor-agnostic cancer drug, meaning it targets a specific mutation of the cancer, not the organ of origin. The other two currently approved tumor-agnostic drugs are larotrectinib and pembrolizumab.
FDA Approves Avapritinib for Gastrointestinal Stromal Tumors With a Rare Mutation
On January 9, 2020, the U.S. Food and Drug Administration (FDA) approved avapritinib (AyvakitTM) for adults with unresectable or metastatic gastrointestinal stromal tumor harboring a platelet-derived growth factor receptor alpha exon 18 mutation, including D842V mutations.
FDA Approves Pembrolizumab for BCG-Unresponsive, High-Risk Non-Muscle Invasive Bladder Cancer
On January 8, 2020, the U.S. Food and Drug Administration (FDA) approved pembrolizumab for the treatment of patients with Bacillus Calmette-Guerin unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.
Oral Chemo Education Sheets Provide Key Information to Patients
Oral oncolytics have introduced a different level of complexity to care. Many patients won’t ever receive their treatments in the infusion room, which is where nurses have traditionally offered in-depth patient education. Instead, nurses are using new tools—like the Oral Chemo Education Sheets—to ensure patients have the information they need to understand their treatment and its side effects.
FDA Approves Fam-Trastuzumab Deruxtecan-Nxki for Unresectable or Metastatic HER2-Positive Breast Cancer
On December 20, 2019, the Food and Drug Administration granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu®) for patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.
FDA Grants Accelerated Approval to Enfortumab Vedotin-ejfv for Metastatic Urothelial Cancer
On December 18, 2019, the U.S. Food and Drug Administration granted accelerated approval to enfortumab vedotin-ejfv (PadcevTM) for adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting.
Combining Tamoxifen and Blue Light Can Better Target CAR T Cells
Bioengineers may have found a way to use tamoxifen activated with blue light to control precisely which tissues and body areas CAR T cells attack, reducing toxicities in other parts of the body. They reported their work in ACS Synthetic Biology.
FDA Approves Enzalutamide for Metastatic Castration-Sensitive Prostate Cancer
On December 16, 2019, the U.S. Food and Drug Administration (FDA) approved enzalutamide (Xtandi®) for patients with metastatic castration-sensitive prostate cancer.
Newer Therapies at Last Offer Systemic Options for Metastatic HCC
Already the third leading cause of cancer deaths worldwide, hepatocellular carcinoma (HCC) is a continually growing burden as the incidence of obesity, type II diabetes, and hypertension also increase, which may lead to cirrhosis and nonalcoholic fatty liver disease. Its incidence is highest in Asia and Africa, where the prevalence of hepatitis B and hepatitis C may result in chronic liver disease and subsequently HCC.
FDA Approves Atezolizumab With Paclitaxel Protein-Bound and Carboplatin for Metastatic NSCLC Without EGFR/ALK Aberrations
On December 3, 2019, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq®) in combination with paclitaxel protein-bound and carboplatin for the first-line treatment of adult patients with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.
CDK4/6 Plus AI Is Effective for Older Women With Breast Cancer
Combination treatment with a CDK4/6 inhibitor and aromatase inhibitor (AI) results in similar progression-free survival (PFS) rates in women with hormone receptor-positive, HER2-negative metastatic breast cancer who are aged 70 or older compared to younger women, according to study findings published in the Journal of Clinical Oncology.
B. Braun Recalls Certain Lots of Blood Administration Sets
Because of the potential for leakage at the joint between the blood filters and tubing, B. Braun issued a voluntary recall of 22 lots of its y-type blood administration sets in November 2019. The recalled sets are used to deliver blood from a container to a patient's vascular system through an IV catheter inserted into a vein or central venous catheter.
Oncology Drug Reference Sheet: Blinatumomab
Blinatumomab received accelerated approval from the U.S. Food and Drug Administration (FDA) in 2014 for the treatment of B-cell precursor acute lymphoblastic leukemia. The drug’s unique administration procedures have prompted nurses to evaluate their practice for safety.
Do Antibiotics Affect Response to Immune Checkpoint Inhibitors?
Receiving antibiotics in the 30 days prior to starting immune checkpoint inhibitor treatment was associated with significantly reduced median overall survival, according to findings from a study published in JAMA Oncology. However, antibiotic use during treatment had no effect on survival.
The Case of the Efficacy Explanation
Jenni is an oncology nurse practitioner in an outpatient medical oncology clinic. She is meeting with 70-year-old Don after his first cycle of cabozantinib for treatment of metastatic medullary thyroid carcinoma when he asks why the oncologist put him on a pill instead of using IV chemotherapy. “Is it because I don’t have long to live?” Don wonders.
FDA Grants Accelerated Approval to Zanubrutinib for Mantle Cell Lymphoma
On November 14, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval to zanubrutinib (Brukinsa™) for adult patients with mantle cell lymphoma who have received at least one prior therapy.
FDA Approves Niraparib for HRD-Positive Advanced Ovarian Cancer
On October 23, 2019, the U.S. Food and Drug Administration (FDA) approved niraparib (Zejula®) for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD)-positive status. HRD is defined by either a deleterious or suspected deleterious BRCA mutation, or genomic instability in patients with disease progression greater than six months after response to the last platinum-based chemotherapy.
Small Study Shows T-Cell Activity in Pancreatic Cancer
When treated with their own nonengineered T cells plus chemotherapy, six of seven patients with inoperable or metastatic pancreatic cancer showed objective responses or stable disease, according to the results of a study reported at the American Association for Cancer Research’s Immune Cell Therapies for Cancer conference in July 2019.
Plan Ahead to Ensure Consistency in Patient Care and Communication During Drug Shortages
A manufacturing delay leading to a shipping delay caused the October 2019 vincristine shortage, according to a letter Pfizer sent to its customers on October 18; the U.S. Food and Drug Administration first reported the shortage on October 16. It affects both the 1 mg/ml and 2 mg/2 ml single-dose ONCO-TAIN™ glass fliptop vials.
Oncology Drug Reference Sheet: Darolutamide (Nubeqa®)
Based on the results of the phase III ARAMIS trial that demonstrated significant improvement in metastasis-free survival, the U.S. Food and Drug Administration approved darolutamide under priority review on July 30, 2019. Darolutamide is approved for nonmetastatic, castration-resistant prostate cancer in men receiving concurrent gonadotropin-releasing hormone therapy or who have had bilateral orchiectomy.
Getting the Right Treatment at the Right Time Reduces Inequities in Breast Cancer Survival
Although death rates from breast cancer have been falling, the trend has not been equal among all women. Looking at breast cancer survival on a population level can tell us how effective our public health and healthcare systems are at early diagnosis, delivery of evidence-based treatment, and management of follow-up care.
FDA Approves Daratumumab for Transplant-Eligible Multiple Myeloma
On September 26, 2019, the U.S. Food and Drug Administration (FDA) approved daratumumab (Darzalex®) for adult patients with multiple myeloma in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant.
FDA Rolls Out More New Indications for Existing Agents
Pembrolizumab, lenalidomide, and avelumab all received new treatment indications in spring 2019. Here’s what you need to know about dosing, adverse events, and other nursing considerations for these and other drugs that the U.S. Food and Drug Administration (FDA) approved from April–June 2019.
FDA Approves Apalutamide for Metastatic Castration-Sensitive Prostate Cancer
On September 17, 2019, the U.S. Food and Drug Administration (FDA) approved apalutamide (ErleadaTM) for patients with metastatic castration-sensitive prostate cancer. Apalutamide was initially approved in 2018 for patients with non-metastatic castration-resistant prostate cancer.
Vaccine May Boost CAR T-Cell Activity in Solid Tumors
Researchers are testing a new approach using an amphiphilic cancer vaccine to deliver CAR T-cell therapy to solid tumors, and the results of preclinical studies are promising, according to findings published in the journal Science.
FDA Approves Combination Pembrolizumab Plus Lenvatinib
On September 17, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the combination of pembrolizumab (Keytruda®) plus lenvatinib (Lenvima®) for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) and who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation.
Oncology Formulations Not Affected by Bevacizumab Recall
On September 3, 2019, AmEx Pharmacy issued a voluntary recall of two dosages of injectable bevacizumab. Although injectable bevacizumab is used in cancer treatment, the formulations affected by the recall are for much smaller dosages that are used to treat eye diseases (i.e., macular degeneration and diabetic retinopathy).
Oncology Drug Reference Sheet: Venetoclax
Venetoclax (Venclexta®) was approved by the U.S. Food and Drug Administration on May 15, 2019, for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) as a single agent or in combination therapy. Previously, it had been approved in late 2018 for use in combination therapy for acute myeloid leukemia (AML) in older adults or those with significant comorbidities.
FDA Approves Fedratinib for Myelofibrosis
On August 16, 2019, the U.S. Food and Drug Administration (FDA) approved fedratinib (Inrebic®) for adults with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis.
FDA Approves Entrectinib for NTRK Solid Tumors and ROS-1 NSCLC
On August 15, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval to entrectinib (RozlytrekTM) for adults and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory standard therapy.
CAR T Cells Show Promise in Solid Tumors
Two recent studies demonstrated CAR T-cell therapy activity in certain types of solid tumors, according to results presented at the American Society of Clinical Oncology annual meeting. The CAR T cells used new targets outside of the CD19 targets used for the therapy’s current approvals in leukemia and lymphoma.
Geriatric Oncology Ambulatory Care Clinics Address Older Patients’ Needs
Traditionally defined as patients aged 65 and older, older adults make up the majority of patients with cancer. Ambulatory care clinics with a specialized focus on older patients with cancer can provide age-specific care and an interprofessional team of providers well versed in cancer, aging, and geriatric assessment. Through geriatric oncology ambulatory care clinics, providers can work together to identify and coordinate plans to individualize treatment and supportive care for older patients.
The Case of the Pregnancy Predicament
A 33-year-old woman presents to the emergency department with fever, weight loss, and dyspnea. She is five months pregnant. A computed tomography (CT) chest scan without contrast shows a large mediastinal mass. Biopsy demonstrates Hodgkin lymphoma (HL), but magnetic resonance imaging (MRI) of her abdomen and pelvis without contrast is negative for lymphadenopathy. Her echocardiogram and pulmonary function testing are normal.
FDA Approves Pembrolizumab for Advanced Esophageal Squamous Cell Cancer
On July 30, 2019, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda®) for patients with recurrent, locally advanced or metastatic, squamous cell carcinoma of the esophagus (ESCC) whose tumors express PD-L1 (combined positive score [CPS] ≥10), as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.
Oncology Drug Reference Sheet: Atezolizumab’s Indications for Breast and Lung Cancer
The U.S. Food and Drug Administration (FDA) first approved atezolizumab (Tecentriq®) in 2016, but it received additional approvals when used in combination treatments for locally advanced or metastatic triple negative breast cancer (TNBC) and small cell lung cancer (SCLC) in March 2019.
Which Tumor Marker Can Be Used to Assess Stage, Prognosis, Response to Treatment?
Which tumor marker can be used to assess stage, prognosis, response to treatment in germ cell tumors, lymphoma, melanoma, acute leukemia, and neuroblastoma?
A. Programmed death ligand 1 (PD-L1)
C. Cytokeratin fragment 21-1
D. Lactate dehydrogenase