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).
Survivorship Considerations After CAR T-Cell Therapy
As more patients receive treatment with chimeric antigen receptor (CAR) T-cell therapy, oncology nurses will need to be aware of the long-term effects of treatment that may persist into survivorship. However, because the treatment is so new, studies measuring those patient-reported concerns are still forthcoming. The majority of today’s recommendations for survivorship management are based on experts’ clinical experience.
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.
Manage Immunotherapy-Related Diarrhea and Colitis
Although immunotherapy has a unique set of toxicities compared to traditional chemotherapy, in general, grade 3 or 4 toxicities are rare—with the exception of grade 3 diarrhea and colitis. The mechanisms by which immune-related diarrhea and colitis occur are not clear. However, T-cell activation leads to high levels of CD4 T-helper cell cytokines and cytolytic CD8 T-cell tissue infiltration. Some research suggests that depleting regulatory T cells also induces autoimmunity.
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.
Gut Microbiome Diversity May Improve Response to Melanoma Immunotherapy
A high-fiber diet leading to higher gut microbiome diversity may improve response to anti-PD-1 immunotherapy in patients with melanoma, according to the results of a new study presented at the 2019 American Association for Cancer Research Annual Meeting in Atlanta, GA.
How APRNs Can Manage Immunotherapy-Related Hypophysitis in Patients With Cancer
Immunotherapy may place patients at risk for distinctive toxicities that differ from traditional chemotherapy. One example is endocrine dysfunction, including hypophysitis, hypo- or hyperthyroidism, type 1 diabetes, and primary adrenal insufficiency.
FDA Approves Pembrolizumab Plus Axitinib for Advanced Renal Cell Carcinoma
On April 19, 2019, the U.S. Food and Drug Administration (FDA) approved pembrolizumab plus axitinib for the first-line treatment of patients with advanced renal cell carcinoma.
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.
Combining Radiation With Immunotherapy May Improve Survival
Combining radiation with immunotherapy can enhance the immune system’s ability to fight cancer, and evidence now suggests that this synergy may lead to improved patient survival, Annette E. Quinn, RN, MSN, of the University of Pittsburgh Hillman Cancer Center, said during a session on Thursday, April 11, 2019, at the ONS 44th Annual Congress in Anaheim, CA.
Resources Are Available to Guide Management of Immunotherapy-Related Adverse Events
Immunotherapy has evolved into the “fourth pillar” of cancer care, along with surgery, chemotherapy and radiation therapy, according to Laura S. Wood RN, MSN, OCN®, of the Cleveland Clinic Taussig Cancer Center in Ohio and Krista M. Rubin, MS, RN, FNP-BC, of Massachusetts General Hospital in Boston, who spoke during a session on Wednesday, April 10, 2019, at the ONS 44th Annual Congress in Anaheim, CA. Immunotherapeutic agents, however, are vastly different from chemotherapies and have a distinct toxicity profile that advanced practice nurses must be familiar with.
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.
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.
Trump Promises $500 Million Increase to Pediatric Cancer Research
Pediatric cancers have more than an 80% overall cure rate, and that, at first glance, seems like something to celebrate. However, in terms of lives lost to different pediatric cancers, the American Cancer Society estimated that more than 1,100 children under the age of 15 will die from their disease in 2019—roughly one in five children diagnosed. Although survival rates are improving in cancers like acute lymphocytic leukemia and Hodgkin lymphoma, other childhood cancer types haven’t seen increased survival since the early 2000s.
CMS Proposes Medicare Coverage for CAR T-Cell Therapy
To improve access to new cancer therapies and provide national consistency in coverage, on February 15, 2019, the Centers for Medicare and Medicaid Services (CMS) announced a proposed plan of coverage with evidence development for CAR T-cell therapy. The public is invited to share comments for the next 30 days.
How APRNs Can Manage Immunotherapy-Related Hypothyroidism in Patients With Cancer
Immunotherapy has a unique set of toxicities in comparison to traditional chemotherapy. Endocrine dysfunction, including hypo- or hyperthyroidism, hypophysitis, type-1 diabetes, and primary adrenal insufficiency, may occur. Advanced practice RNs (APRNs) have a role in monitoring and treating patients for endocrine-related toxicities.
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.
Survival Gains Make CAR T-Cell Therapy Cost-Effective for Pediatric Leukemia
When evaluated based on the cost per life-year gained, the chimeric antigen receptor (CAR) T-cell immunotherapy drug tisgenlecleucel is considered cost effective in pediatric B-cell acute lymphoblastic leukemia, researchers reported in a new study. The findings were published in JAMA Pediatrics.
Cancer Moonshot Moves to Research Phase
Still a popular program throughout the government, the , encourage collaboration in finding treatments and cures, and to improve data sharing to make a decade’s progress in half the time. Through NIH’s Moonshot Blue Ribbon Panel and the 2016 passage of the 21st Century Cures Act—allocating $1.8 billion over seven years for Moonshot—the initiative is moving out of planning and into the research phase.
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.
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.
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 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.
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.
Educational Approach Improves Oncology Advanced Providers’ Knowledge and Experience With Immunotherapy
As more immunotherapies come to market, advanced practitioners need to know how to prescribe and recognize, triage, and manage immune-related adverse events (irAEs) as well as champion education about the agents’ benefits and risks.
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.
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.
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.
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.
Using CTCAE to Report Immunotherapy Adverse Events
Although immunotherapy is changing the face of cancer care, it’s not exempt from side effects. As researchers and clinicians work to understand immune-related adverse events and how to manage them, a new challenge is emerging: reporting and grading them to get an accurate grasp on incidence rates and to standardize care to ensure better outcomes for patients. The Common Terminology Criteria for Adverse Events (CTCAE) is one tool that’s helping researchers and bedside nurses do just that.
The Oncology Nurse Experience in Managing Adverse Events in Patients Receiving Ibrutinib
Ibrutinib is a first-in-class Bruton’s tyrosine kinase inhibitor that is approved by the U.S. Food and Drug Administration to treat chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). The drug’s approval was based on results from the multicenter, open-label, phase III RESONATE trial.
Nurse Management of cGVHD in Patients on Ibrutinib Focuses on Education
Ibrutinib is a first-in-class, once-daily inhibitor of Bruton’s tyrosine kinase. In 2017, the U.S. Food and Drug Administration approved ibrutinib for the treatment of adult patients with chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy.
Instructional Class Improves CAR T-Cell Knowledge in ICU and BMT Nurses
Chimeric antigen receptor T-cell (CAR T-cell) therapy has become an integral part of the advancement of lymphoma and other cancer treatments. However, educational resources and available published literature are still lacking for oncology and intensive care nurses.
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.
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.