Genetic Disorder Reference Sheet: HOXB13
An altered HOXB13 gene may increase a patient’s risk for developing prostate cancer. The HOXB13 gene is expressed in the prostate beginning in early development and affects prostate cell proliferation and differentiation and androgen receptor regulation. When it acts as a tumor suppressor gene, HOXB13 codes for a protein that regulates cell division. However, altered copies of HOXB13 are inactivated, meaning that it does not function properly or does not produce the protein it codes for, resulting in uncontrolled cell division.
Help Your Patients Prepare for the End From the Beginning
Few things carry more stigma in the United States than death and hospice. Death is familiar in oncology, yet providers may not discuss it with patients until their cancer has progressed to the point that medical intervention is no longer an option. With the American Cancer Society estimating more than 600,000 American deaths from cancer in 2022, it’s time to change our practice.
FDA Approves Second Dosing Regimen for Asparaginase Erwinia Chrysanthemi (Recombinant)-Rywn
On November 18, 2022, the U.S. Food and Drug Administration approved a Monday-Wednesday-Friday dosing option for asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze®). Under the alternative regimen, patients receive 25 mg/m2 intramuscularly on Monday and Wednesday mornings and 50 mg/m2 intramuscularly on Friday afternoons. It also is approved at a dose of 25 mg/m2 intramuscularly every 48 hours.
Oncology Drug Reference Sheet: Tebentafusp-Tebn
When the U.S. Food and Drug Administration approved tebentafusp-tebn (Kimmtrak®) in January 2022 as an orphan drug for unresectable or metastatic uveal melanoma in adults, it became the first—and only, at the time of this reference sheet’s publication—drug approved for the indication.
Monica Bertagnolli Delivers First NCI Director’s Report, Outlines Principles to Evolve Cancer Research
In her first report as National Cancer Institute director, Monica M. Bertagnolli, MD, laid out her eight core principles to guide the agency’s work in reformulating clinical trials and strengthening cancer research during the Clinical Trials Advisory Committee meeting in November 2022.
FDA Approves Brentuximab Vedotin in Combination With Chemotherapy for Pediatric Patients With Classical Hodgkin Lymphoma
On November 10, 2022, the U.S. Food and Drug Administration (FDA) approved brentuximab vedotin (Adcetris®) plus doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide for pediatric patients aged two years and older with previously untreated, high-risk classical Hodgkin lymphoma. This is the first pediatric approval for brentuximab vedotin.
FDA Grants Accelerated Approval to Mirvetuximab Soravtansine-Gynx for FR Alpha–Positive, Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer
On November 14, 2022, the U.S. Food and Drug Administration granted accelerated approval to mirvetuximab soravtansine-gynx (Elahere®) for adult patients with folate receptor alpha–positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, as detected with an FDA-approved test, who received one to three prior systemic treatment regimens. Mirvetuximab soravtansine-gynx is a FR alpha–directed antibody and microtubule inhibitor conjugate. FDA also approved the VENTANA FOLR1 (FOLR-2.1) RxDx Assay (Ventana Medical Systems, Inc.) as a companion diagnostic device to identify patients for the indication.
What the Evidence Says About Probiotics and Cancer Immunotherapy
Growing evidence suggests that the gut microbiome, a diverse and complex mix of microorganisms and their metabolites, is closely linked to the immune system, and researchers are studying whether modulating the gut microbiome affects cancer immunotherapy treatment outcomes. In particular, probiotics—which are flora typically obtained through dietary sources such as yogurt and fermented foods or via supplemental forms—are gaining prominence as a potential strategy to modulate the gut microbiome during cancer treatment.
PARP Inhibitors and Ovarian Cancer
Before poly (adenosine diphosphate-ribose) polymerase inhibitors were approved for ovarian cancer, traditional treatment consisted of surgical cytoreduction and platinum-based chemotherapy with a taxane, with or without bevacizumab, depending on stage and type. With the surgery-chemotherapy combination, 70%–75% of patients had recurrence and overall five-year survival rate were 29%, indicating a need for additional therapies.
Educational Resources Will Help Biomarkers Have Even More Impact
My passion for biomarkers lies in research, specifically clinical trials. The incorporation of biomarkers in oncology clinical trials has been an important advancement in research, and we’ve seen the effect on improving patient outcomes. Identification of pathogenic variants is essential to prescribing personalized therapy for patients with cancer.
Predictive and Diagnostic Biomarkers
Biomarkers, also called molecular markers or signature molecules, can help clinicians characterize alterations in tumors through the detection of specific DNA, RNA, protein, or metabolomic profiles. These pieces of the cancer puzzle are part of precision oncology that the cancer care team can use to assess patients’ cancer risk and prognosis or monitor disease progression. Biomarkers are also a key factor in determining and tailoring treatment methods and their likelihood of success.
NCI Awards $23 Million to Establish Centers to Study Telehealth for Cancer Care
Four academic institutions will create centers of excellence dedicated to telehealth in cancer care to help healthcare providers increase its use in oncology practice, thanks to $23 million in National Cancer Institute (NCI) funding. The awards are part of NCI’s Telehealth Research Centers of Excellence initiative, which is supported by President Joe Biden’s Cancer Moonshot initiative.
FDA Recommends Reusing Tracheostomy Tubes or Switching to Appropriate Alternatives Because of Shortage
On October 31, 2022, the U.S. Food and Drug Administration alerted patients, caregivers, and healthcare providers of a tracheostomy tube shortage, including Bivona tracheostomy tubes manufactured by ICU Medical, because of difficulty obtaining required raw materials. FDA said it is working with manufacturers and other stakeholders to help resolve supply challenges and support the devices’ availability.
FDA Recommends Healthcare Providers Consider Alternatives for MRI-Guided Breast Biopsy Grid Plates Because of Shortage
On October 31, 2022, the U.S. Food and Drug Administration recommended that healthcare providers discuss alternative options for magnetic resonance imaging–guided breast biopsy procedures with patients if a facility is unable to perform it because of a shortage of Philips Invivo MRI breast biopsy grid plates and other Philips Invivo MRI disposables.
Genetic Counselors Help Patients and Oncology Nurses Predict Current and Future Cancer Diagnoses
Many of our patients are individuals who haven’t developed cancer but might have a concerning family history of the disease. We rely on healthcare providers like oncology nurses to identify individuals with concerning cancer histories and refer them to genetic counselors for a complete risk assessment, including genetic testing when appropriate, to determine their risk and recommend proactive measures to reduce it.
FDA Approves Teclistamab-Cqyv for Relapsed or Refractory Multiple Myeloma
On October 25, 2022, the U.S. Food and Drug Administration granted accelerated approval to teclistamab-cqyv (Tecvayli®), the first bispecific B-cell maturation antigen–directed CD3 T-cell engager, for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
FDA Approves Tremelimumab in Combination With Durvalumab for Unresectable Hepatocellular Carcinoma
On October 21, 2022, the U.S. Food and Drug Administration approved tremelimumab (Imjudo®) in combination with durvalumab for adult patients with unresectable hepatocellular carcinoma.
Oncology Drug Reference Sheet: Asparaginase Erwinia Chrysanthemi (Recombinant)–Rywn
After more than 93% of patients maintained nadir serum asparaginase activity in the therapy’s clinical trials, on June 30, 2021, the U.S. Food and Drug Administration approved asparaginase erwinia chrysanthemi (recombinant)–rywn (RylazeTM) for use as a component of a multiagent chemotherapeutic regimen for treatment of acute lymphoblastic leukemia and lymphoblastic lymphoma in adult and pediatric patients who have developed hypersensitivity to E. coli-derived asparaginase.
Researcher Reflects on How Cancer Was Reported on in the Mid-20th Century
Our understanding of cancer has come a great ways over the past few decades, and some of the progress can be traced back to the 1950’s film Challenge: Science Against Cancer, explained David Cantor, PhD, researcher at the Instituto de Desarrollo Económico y Social, Buenos Aires Argentina, adjunct professor in the School of Public Health at the University of Maryland, College Park, in a July 2022 essay for the National Library of Medicine.
Communication Models Help Nurses Confidently Address Sexual Concerns in Patients With Cancer
Sexual dysfunction is one of the most common side effects of cancer treatment, yet oncology professionals often under address patients’ sexuality and sexual dysfunction concerns. Providers cite lack of time, training, and resources as barriers to initiating important discussions about sexual side effects, and studies show that patients’ age and prognosis are additional hindering factors.
Nurses Have Immediate Access to Necessary Medications and Supplies With Hypersensitivity Reaction Kits
Biologic agents or chemotherapies can trigger hypersensitivity reactions, which occur when a patient’s immune system identifies an agent as an antigen and initiates a complex reaction involving sensitization of T lymphocytes and macrophages, production of antibodies, and release of histamine. Developing and implementing a hypersensitivity kit containing all necessary medications and associated protocols allows nurses to immediately implement management when reactions occur.
Understand Genomic Variants to Confidently Educate Your Patients
Nurses’ consistent and correct use of genomics terminology is critical to reduce confusion and provide safe genomics care to patients and their families, especially when explaining the meaning of genomic tests or findings.
Precision Oncology Models Guide Tailored Nursing Interventions for Ovarian Cancer Symptom Clusters
Using the National Institutes of Health Symptom Science Model and Nursing Science Precision Health Model helps oncology nurses to recognize symptoms more promptly in patients with ovarian cancer and provide precision interventions that address racial disparities and foster equity in symptom-focused, patient-centered care, Mahoney and Pierce reported in the October 2022 issue of the Clinical Journal of Oncology Nursing.
What Is HER2-Low Breast Cancer?
Human epidermal growth factor receptor 2 (HER2) proteins are involved in normal cellular growth and are found on the surface of all breast cells. Approximately 20% of breast cancers are HER2 positive, meaning they have high levels of HER2 protein, and those cancers typically grow and metastasize more quickly than other types of breast cancer.
Oncology Drug Reference Sheet: Fam-Trastuzumab Deruxtecan-Nxki
Bringing the first agent to market for the indication, on August 5, 2022, the U.S. Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki (Enhertu®) for patients with unresectable or metastatic HER2-low breast cancer based on results from the DESTINY-Breast04 trial that demonstrated improved progression-free and overall survival. FDA also gave fam-trastuzumab deruxtecan its fourth approval on August 11, 2022, for unresectable or metastatic HER2-activating non-small cell lung cancer (NSCLC).
Strategies to Promote Safe Medication Administration Practices
Medication administration is a high-risk process that requires critical thinking, efficient decision-making, attention to detail, and a foundational knowledge of basic pharmacology. The process is not a single task but a cascade of events that include handling, ordering, preparing, dispensing, administering, and monitoring. Although nurses’ involvement varies at each phase, the risk for errors always exists, and consequences can have a lifelong impact on patients, families, and healthcare workers. Nurses can use the following strategies in their responsibility as the last line of defense for safe medication administration.
Eugia US, LLC, Recalls AuroMedics Acyclovir Sodium Injection Because of Particulate Matter
On September 27, 2022, the U.S. Food and Drug Administration reported Eugia US, LLC’s, voluntary recall of AuroMedics acyclovir sodium injection 500 mg per 10 ml (50 mg/ml) single-dose vial to the consumer level because of reported presence of a dark red, brown, and black particulate inside the vial.
FDA Grants Accelerated Approval to Futibatinib for Cholangiocarcinoma
On September 30, 2022, the U.S. Food and Drug Administration granted accelerated approval to futibatinib (Lytgobi®) for adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 gene fusions or other rearrangements.
FDA Approves Selpercatinib for RET Fusion-Positive Non-Small Cell Lung Cancer and Locally Advanced or Metastatic Solid Tumors
On September 21, 2022, the U.S. Food and Drug Administration (FDA) granted regular approval to selpercatinib (Retevmo®) for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion and accelerated approval for adults with locally advanced or metastatic solid tumors with a RET gene fusion that progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.
FDA Approves Sodium Thiosulfate for Cisplatin-Associated Ototoxicity in Pediatric Patients
On September 20, 2022, the U.S. Food and Drug Administration (FDA) approved the use of sodium thiosulfate (Pedmark®) to reduce the risk of ototoxicity associated with cisplatin in pediatric patients aged 1 month and older with localized, nonmetastatic solid tumors.
Testicular Cancer Survivors May Need Fewer Monitoring Scans
Monitoring early-stage testicular cancer survivors for disease recurrence after surgery using either magnetic resonance imaging or fewer computed tomography scans is just as effective as more frequent intervals, researchers reported in study findings published in the Journal of Clinical Oncology.
Show Us Your Practice Through Our New Video Series
Do you have experience in educating your team on policies and procedures? How about a go-to nursing hack? Share your experiences and expertise through ONS Voice’s new video series, My Practice. Use this opportunity to connect with colleagues around the country and help us provide innovative ideas and solutions to nursing practice everywhere.
Baxter Healthcare Corporation Recalls Clearlink Basic Solution Set With Duovent Because of Leaks That Risk Exposure to Toxic Substances
On September 15, 2022, the U.S. Food and Drug Administration reported Baxter Healthcare Corporation’s recall of Clearlink basic solution set with Duovent because of reports of leaks. FDA identified it as a class I recall, the most serious type of recall, where use of the set may cause serious injuries or death.
Oncology Nurses’ Role in Translating Biomarker Testing Results
As oncology biomarker testing becomes a routine part of clinical practice, so does first-line use of their associated targeted therapies such as monoclonal antibodies, checkpoint inhibitors, and tyrosine kinase inhibitors.
FDA Reports Squamous Cell Carcinoma and Various Lymphomas in Capsule Around Breast Implants
On September 8, 2022, the U.S. Food and Drug Administration reported that cancers, including squamous cell carcinoma and various lymphomas, may develop in the capsule that forms around breast implants.
FDA Approves Durvalumab for Locally Advanced or Metastatic Biliary Tract Cancer
On September 2, 2022, the U.S. Food and Drug Administration approved durvalumab (Imfinzi®) in combination with gemcitabine and cisplatin for adult patients with locally advanced or metastatic biliary tract cancer.
FDA Approves Pemigatinib for Relapsed or Refractory Myeloid or Lymphoid Neoplasms With FGFR1 Rearrangement
On August 26, 2022, the U.S. Food and Drug Administration approved pemigatinib (Pemazyre®) for adults with relapsed or refractory myeloid or lymphoid neoplasms with fibroblast growth factor receptor 1 rearrangement.
FDA Approves Ibrutinib for Pediatric Patients With Chronic Graft-Versus-Host Disease, Including a New Oral Suspension
On August 24, 2022, the U.S. Food and Drug Administration approved ibrutinib (Imbruvica®) for pediatric patients aged less than 1 year with chronic graft-versus-host disease after failure of one or more lines of systemic therapy. Formulations include capsules, tablets, and oral suspension.
Oncology Drug Reference Sheet: Nivolumab and Relatlimab-Rmbw
When OpdualagTM (nivolumab and relatlimab-rmbw), a fixed-dose combination therapy that consists of two distinct monoclonal antibodies, received FDA approval on March 18, 2022, for the treatment of unresectable or metastatic melanoma for adult and pediatric patients 12 years of age or older, it became the first approved combination therapy that includes two distinct immunotherapy agents in a single infusion. Relatlimab-rmbw is also the first approved lymphocyte activation gene-3–blocking antibody.
FDA Grants Accelerated Approval to Fam-Trastuzumab Deruxtecan-Nxki for HER2-Variant Non-Small Cell Lung Cancer
On August 11, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu®) for adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating human epidermal growth factor receptor 2 (HER2) variants, as detected by an FDA-approved test, and who have received a prior systemic therapy. This is the first drug approved for HER2-variant NSCLC.
FDA Approves Capmatinib for Metastatic Non-Small Cell Lung Cancer
On August 10, 2022, the U.S. Food and Drug Administration (FDA) granted regular approval to capmatinib (Tabrecta®) for adult patients with metastatic non-small cell lung cancer whose tumors have a mutation leading to mesenchymal-epithelial transition exon 14 skipping, as detected by an FDA-approved test.
FDA Publishes Three New Biosimilars Resources for Healthcare Providers
To raise awareness and better educate patients and providers about biosimilars’ potential in clinical care, the U.S. Food and Drug Administration (FDA) added three new fact sheets to its healthcare provider resources in July 2022.
FDA Approves Darolutamide Tablets for Metastatic Hormone-Sensitive Prostate Cancer
On August 5, 2022, the U.S. Food and Drug Administration (FDA) approved darolutamide (Nubeqa®) tablets in combination with docetaxel for adult patients with metastatic hormone-sensitive prostate cancer.
FDA Approves Fam-Trastuzumab Deruxtecan-Nxki for HER2-Low Breast Cancer
On August 5, 2022, the U.S. Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki (Enhertu®) for use in adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH‑) breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy.
Genetic Disorder Reference Sheet: Multiple Endocrine Neoplasia Type 2
Multiple endocrine neoplasia type 2 is an autosomal dominant disease that occurs because of germline pathogenic variants in the rearranged during transfection (RET) proto-oncogene. The RET gene was isolated in 1993 and pathogenic variants affect 1–10 per 100,000 people. Approximately 50% of cases are de novo.
Legislation and Cancer Care
Research and practice changes funded through healthcare legislation have influenced today’s care delivery across all settings: hospitals, clinics, and even homes. And with their constituents laser-focused on health in today’s pandemic society, legislators have never made that happen so quickly.
Oncology Drug Reference Sheet: Lutetium Lu 177 Vipivotide Tetraxetan
After clinical trial results demonstrated a four-month improvement in overall survival compared to best standard care, in March 2022 the U.S. Food and Drug Administration approved lutetium lu 177 vipivotide tetraxetan (PluvictoTM) to treat prostate-specific membrane antigen–expressing metastatic castration-resistant prostate cancer.
Smiths Medical Recalls Medfusion 3500 and 4000 Syringe Infusion Pumps for Software Malfunctions That Can Affect Infusion Delivery
On July 20, 2022, the U.S. Food and Drug Administration (FDA) reported Smiths Medical’s recall of its Medfusion 3500 and 4000 syringe infusion pumps because of software malfunctions. FDA identified it as a class I recall, the most serious type of recall, where use of the devices may cause serious injuries or death.
What the Evidence Says About Traditional Chinese Medicine for Chronic Diarrhea
Diarrhea is a distressing condition that significantly affects patients’ quality of life and social functioning. Characterized by passage of more than three unformed stools in 24 hours, in cancer it can be caused by chemotherapy, radiotherapy, laxatives and antibiotics, enteral feeding, malabsorption syndromes, colectomy, or several types of malignant tumors. Diarrhea has also been reported in long-term cancer survivors. Standard treatment options such as opiate agonists and adsorbents are associated with side effects that may increase a patient’s symptom burden.
Oncology Nursing QI Project Shows Normal Saline Is Comparable to Heparin for Pediatric CVCs
Emerging evidence has consistently shown that flushing central venous catheters with normal saline is comparable to heparin flushes in the adult care setting, leading to updated guideline recommendations that include saline as an alternative. But to date, only two studies have evaluated the two options in pediatric patients, the older of which found increased complications when used in children with leukemia or lymphoma. Is normal saline an acceptable alternative in that population?