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.
CAR T-Cell Therapy Offers Rapid QOL Improvements in Younger Patients
Children and young adults with relapsed or refractory B-cell acute lymphoblastic leukemia reported rapid improvements in quality of life (QOL) after treatment with tisagenlecleucel, a CAR T-cell therapy, according to the results of a study published in Lancet Oncology.
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.
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.
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.
irAEs Linked to Improved Benefit From Pembrolizumab
Patients with advanced melanoma who received adjuvant therapy with pembrolizumab and subsequently developed immune-related adverse events (irAEs) saw a 63% reduced risk of recurrence, compared to 44% for those who did not develop irAEs. The study findings were presented at the 2019 American Society of Clinical Oncology annual meeting.
Patient Education Is Critical to Managing irAEs for Immune Checkpoint Inhibitors
By rebalancing the immune system and re-engaging mechanisms that tumor cells have shut off, immunotherapies such as immune checkpoint inhibitors enable patients’ own bodies to fight their cancers for them. But those same mechanisms can also result in immune-related adverse events (irAEs).
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.
Pneumonitis With Immunotherapy Treatment
Pneumonitis is inflammation of the lung parenchyma; although rare, it can be fatal. Nishino et al. found that the overall incidence of pneumonitis with PD-1 inhibitor monotherapy was 2.7% for all-grade and 0.8% for grade 3 or higher pneumonitis. Naidoo et al. reported an approximate 5% incidence of all-grade pneumonitis, although the incidence of all-grade pneumonitis is higher with combination immunotherapy (up to 10%). The incidence is more common with higher grades in PD-1 inhibitors (versus PD-L1 inhibitors), but it occurs less often with anti-CTLA4 monoclonal antibodies.
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.
Medicare Covers CAR T; HPV Vaccine Confusion; Officials Target Drug Makers
The decision to allow Medicare to cover the cost of CAR T-cell therapy—a new and expensive form of immunotherapy—is an important one for patients seeking the treatment, especially after rounds of failed tradition therapies. Educating federal agencies and government representatives about the importance of new treatments like CAR T cells have helped drive coverage decisions, and the patient advocacy community—like ONS’s very own advocates—are to thank.
CMS Makes CAR T-Cell Cancer Therapy Available to Medicare Beneficiaries
It’s an extraordinary time for biomedical research. Advancements in science, investments in research studies, and an increased access to patients through clinical trials have continued to transform the medical community’s understanding of cancer care and the best ways to treat and cure tumors. Achieving successful outcomes requires specific and dedicated therapies, tailored to each individual.
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.
Immunotherapy Experts Identify Key Oncology Nursing Priorities at ONS Summit
Care coordination, appropriate adverse event assessment and treatment, and rapid, continuous learning are essential priorities for oncology nurses to care for patients receiving immunotherapy, according to the experts who participated in ONS’s immunotherapy summit in March 2018.
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.
Diagnose and Manage Dermatologic Toxicity Secondary to Immunotherapy
Dermatologic toxicity is the most common side effect secondary to immunotherapy. The majority of dermatologic adverse events are mild to moderate rashes on the truck of the body and upper extremities, pruritis, and vitiligo. The most common is maculopapular rash with erythematous macules, papules, and/or plaques that can sometimes be scaly; pruritis is also frequent but often underreported and undertreated and may affect quality of life.
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.
Fresenius Kabi Issues Voluntary Nationwide Recall of Two Lots of Fluorouracil Injection Because of the Potential for Glass Particulate
Fresenius Kabi USA, LLC, is voluntarily recalling two lots of fluorouracil injection, USP 5 g/100 mL (50 mg/mL), 100 mL fill in 100 mL vials, to the user level because of the potential for glass particulate. The affected lots, distributed between December 6, 2018, and February 20, 2019, are listed below:
Collaboration Is Key to CAR T-Cell Therapy Management Across Settings
As of February 2019, only 160 institutions across the United States are certified to administer CAR T-cell therapy, meaning many eligible patients may need to be referred to a treatment center outside of the local ambulatory or community cancer center where they had previously received treatment. The transition from primary oncologist to certified center and back again requires careful coordination to ensure important steps and information aren’t lost.
FDA Approves Daratumumab for Multiple Myeloma Ineligible for Autologous Stem Cell Transplant
On June 27, 2019, the U.S. Food and Drug Administration (FDA) approved daratumumab (Darzalex®) in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
FDA’s Latest Approved Drugs and Indications Include Two Oral Agents
Because two oral therapies received new indications in the U.S. Food and Drug Administration’s (FDA’s) most recent round of approvals, oncology nurses will want to focus on ways to manage patients in the home. Assessing oral adherence, encouraging patients to report adverse events, and ensuring their understanding of complex dosing regimens are critical components of nursing care. ONS offers an oral adherence toolkit and oral chemotherapy patient education sheets to help with patient management.
FDA Approves Pembrolizumab for Metastatic Small Cell Lung Cancer
On June 17, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda®) for patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.
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.