FDA Issues Safety Communication for BCMA- or CD19-Directed Autologous CAR T-Cell Immunotherapies While Investigating Serious Risk for T-Cell Malignancy
On November 28, 2023, the U.S. Food and Drug Administration (FDA) issued a safety communication to patients and healthcare professionals regarding BCMA- or CD19-directed autologous CAR T-cell immunotherapies. The agency said it received reports of T-cell malignancies, including CAR-positive lymphoma, in patients who received treatment with those products. The reports came from clinical trials and postmarketing adverse event data sources.
Cell-Based Therapy Shows Promise for Chemotherapy-Related Female Infertility
Cellular therapy has revolutionized cancer treatments and outcomes for many patients, and it may one day revolutionize the management of certain side effects as well. According to study findings published in eBioMedicine, induced pluripotent stem cell transplantation may help reverse chemotherapy’s endocrine and reproductive effects on female infertility.
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.
Tumor-Infiltrating Lymphocytes Activate Immune Response to Metastatic Breast Cancer
More than two-thirds of patients with hormone receptor–positive metastatic breast cancer respond to personalized immunotherapy with tumor-infiltrating lymphocytes and more than half of those treated experience measurable tumor shrinkage, according to study findings published in the Journal of Clinical Oncology.
Cutaneous Malignancies Have High Response to Oncolytic Virus Plus Immunotherapy
Combination treatment with an oncolytic virus plus a PD-1 inhibitor shows promise in patients with nonmelanoma skin cancers, researchers reported in early study results during the 2022 Multidisciplinary Head and Neck Cancers Symposium.
Studies Show Best Practices to Manage CAR T-Cell Therapies’ irAEs and Improve Outcomes
Rapid advancements in the science of chimeric antigen receptor (CAR) T-cell therapies present unique challenges and opportunities related to patient care. Nurses are at the forefront of those advancements—contributing to practice guidelines, developing center-specific protocols, publishing outcomes and best practices, and researching the patient experience, outcomes, and supportive interventions.
Oncology Clinical Social Workers Add Layers of Support for Patients and Families During CAR T-Cell Therapy
The interprofessional team for chimeric antigen receptor (CAR) T-cell therapy at Smilow Cancer Center at Yale New Haven includes a transplant team, cell collection and processing unit, intensive care unit, pharmacy, telehealth for home evaluations, and social work. On that team, the oncology clinical social worker’s role is chiefly to help patients and families manage the stress associated with therapy. We provide patients and family members with ongoing clinical social work support, including listening, counseling, educating, advocating, and referring them to resources and services.
CAR T-Cell Therapy Programs
Debuting in human clinical trials just a decade ago, chimeric antigen receptor (CAR) T-cell therapy was quickly hailed as a breakthrough cancer treatment for certain hematologic cancers. Today, patients and providers have access to 22 U.S. Food and Drug Administration (FDA)–approved cellular and gene therapy products, and CAR T-cell therapy is available beyond large academic research centers.
First-Line Combination Immunotherapy Prolongs Survival in BRAF Advanced Melanoma
Initial treatment with two monoclonal antibodies significantly improves survival for patients with BRAF V600-variant advanced melanoma compared to treatment with two targeted agents, researchers reported during the November 2021 ASCO Plenary Series meeting. The initial findings were so conclusive that the study’s data safety and monitoring board stopped the trial early.
Fiber—but Not Probiotics—Boosts Immunotherapy Response for Melanoma
Patients with melanoma who consume a high-fiber diet during treatment with immune checkpoint inhibitors (ICIs) or anti-PD-1 therapy experience longer progression-free survival than those who don’t, researchers reported in Science. And probiotic supplementation, often considered a healthy behavior, reduces immunotherapy response.
Nursing Considerations for ICI-Related Myocarditis
Before immunotherapies like immune checkpoint inhibitors (ICIs) became a cancer treatment option, myocarditis typically developed in the presence of infections, drug allergies, or autoimmune diseases. Activating the immune system with ICIs can also trigger autoimmune-like adverse events such as myocarditis, and although its incidence in patients with cancer is low, mortality is high.
Immunotherapy After Surgery May Prevent Early-Stage Melanoma Recurrence
Completing up to a year of pembrolizumab immunotherapy after surgical resection of stage IIB or IIC melanoma decreases patients’ risk for disease recurrence or death by 35%, according to study findings presented at the European Society for Medical Oncology 2021 annual meeting. The new findings led the U.S. Food and Drug Administration to expand its approval of pembrolizumab to use as adjuvant therapy in both adults and children aged 12 and older with early-stage melanoma.
Evidence Defines Nursing Implications for Combination Cancer Treatment Side Effects
Immune checkpoint inhibitors (ICIs) enhance immune response against foreign antigens, such as cancer, by manipulating checkpoints that have stopped the body from fighting them. In doing so, they also increase risk of the immune system attacking healthy cells and producing inflammatory side effects, resulting in immune-related adverse events (irAEs).
Today’s Immunotherapy Combinations
Immunotherapy has revolutionized cancer treatment, especially for patients with diseases considered otherwise incurable. Since May 2017, the U.S. Food and Drug Administration (FDA) has approved 27 immunotherapy combinations, including chemoimmunotherapy and regimens with targeted therapies, and researchers are reporting highly promising data from clinical trials of its combination with radiation.
Combination Immunotherapy May Further Increase Melanoma Survival Length
Using two agents that target two different receptors more than doubles length of survival for advanced melanoma than a single agent alone, researchers reported at the 2021 American Society of Clinical Oncology annual meeting.
Don’t Delay When Managing irAEs From Immune Checkpoint Inhibitors
To prevent life-threatening complications that could affect treatment adherence and outcomes, oncology nurses must be vigilant in early recognition and treatment of immune-related adverse events (irAEs), Lisa A. Kottschade, MSN, APRN, CNP, from Mayo Clinic in Rochester, MN, said during a session held at the ONS BridgeTM virtual conference on September 14, 2021. She provided an overview of what to watch for and nursing considerations for common irAEs.
Researchers Study Innate Immunity Throughout History to Determine New Methods of Cancer Treatment
Evolution may be the key to understanding immunity—or at least the National Institutes of Health (NIH) thinks so. Studies of the history of human life could uncover discoveries that have implications for all types of disease, including cancer.
New Form of CAR T Cells May Target Genetic Alteration Common to All Cancers
Scientists created a new cancer immunotherapy approach that uses a new type of CAR T cells to stimulate an immune response against cells that are missing one gene copy. They reported their findings in Proceedings of the National Academy of Sciences.
The Case of the Mysterious Myalgia
Randi is a 57-year-old patient who identifies as female. She was diagnosed with clear cell metastatic renal cell carcinoma (mRCC), and her past medical history includes mild hypertension managed with amlodipine and a two-year history of transient musculoskeletal pain managed with tramadol. She reports a family history of cardiovascular disease and rheumatoid arthritis (RA). Her primary care physician suspects Randi is at the beginning stages of fibromyalgia but has not made a conclusive diagnosis because she hasn’t experienced additional symptoms.
Immunotherapy Extends Survival in Uveal Melanoma
Patients with uveal melanoma who were treated with tebentafusp, an investigational immunotherapy, lived a median 5.7 months longer than those in comparison groups, researchers reported in study findings presented at the American Association for Cancer Research 2021 annual meeting.
Here’s Why Oncology Nurses Are Pivotal in Managing Immune-Related Adverse Events
Immune checkpoint inhibitors (ICPIs) mobilize the body’s own immune system to target cancer cells. However, the resulting immune-related adverse events (irAEs) vary in severity and may persist for months or years following treatment.
Gut Microbiome May Be a Factor With Immunotherapy Resistance in Advanced Melanoma
Altering a patient's gut microbiome through fecal transplant improved response to immune checkpoint inhibitor therapy in 40% of patients with advanced melanoma who initially did not respond to the immunotherapy in a small, single-arm clinical trial. Researchers reported the findings in Science.
Oncology Nurses Navigate the Changing Landscape of Immuno-Oncology
Immune checkpoint inhibitors (ICPIs) enhance treatment response while minimizing toxicities for patients with cancer. However, education is key to managing the therapies’ unique adverse events (AEs). During a session for the ONS 46th Annual Congress™, Marianne Davies, DNP, ACNP, FAAN, of the Yale Comprehensive Cancer Center, Smilow Cancer Hospital at Yale New Haven Hospital, and the Yale University School of Nursing, and Laura S. Wood, RN, MSN, OCN®, of Cleveland Clinic Cancer Center, provided oncology nurses with a foundation for evaluating and grading AEs in immuno-oncology.
Muscle Quality Predicts Efficacy of NSCLC Immunotherapy
Patients with higher muscle quality during treatment with PD-1/PD-L1 inhibitor monotherapy for non-small cell lung cancer (NSCLC) had higher overall response rates and longer progression-free survival than patients with lower-quality skeletal muscle, researchers reported in study findings published in Cancer Medicine.
Nurses Help Patients Weather the Storm of CAR T-Cell Therapy
Chimeric antigen receptor (CAR) T-cell therapy is at the forefront of care for a specific subset of patients with cancer. However, the severe side effects of this highly specialized treatment require unique management. During a session for the inaugural ONS Bridge™ virtual conference, Kathleen McDermott, RN, BSN, OCN®, BMTCN®, of Dana-Farber Cancer Institute, discussed how oncology nurses can temper the storm of CAR T-cell therapy.
Nurses Are Critical to Recognizing Adverse Events From Immune Checkpoint Inhibitors
Although immune checkpoint inhibitors can be highly effective cancer treatments, potentially even curative in several disease states, they can cause immune-related adverse events in any tissue or organ system, presenters said in a session at the inaugural ONS Bridge™ virtual conference.
Early Use of Immunotherapy Has Better Outcomes for Bladder Cancer
Starting immunotherapy for bladder cancer shortly after initial treatment with chemotherapy is better than taking an extended break from cancer treatment, according to results from a study reported at the American Society of Clinical Oncology annual meeting.
Research Is Needed to Better Understand Combination Immunotherapy Side Effects
Combination immunotherapy treatments are revolutionizing the way cancer care is delivered. As an ongoing evolution of care, nurses are administering different treatment modalities on a regular basis. Treatments include using multiple immunotherapy drugs in tandem, combining chemotherapy with immunotherapy, using targeted therapies with immunotherapy, and even involving radiation with immunotherapy. The move toward multiple-drug modalities will continue to change nursing practice, and nurses must have a basis of knowledge and evidence from which to work.
Harnessing the Abscopal Effect May Change Cancer Care
The abscopal effect is a unique phenomenon in cancer treatment that occurs when radiation shrinks untreated tumors found elsewhere in the body in addition to the targeted tumor. The effect has a long history, dating back to the 1950s, but it doesn’t commonly occur in practice and the mechanisms are not fully understood. Research has shown that combining immunotherapy with radiation increases the rate at which the abscopal effect occurs. Understanding how it appears in practice could potentially lead to new cancer treatments and a novel approach to combining immunotherapies with radiation.
Immunotherapies have revolutionized the approach to cancer treatment by leveraging patients’ own immune systems to fight the disease. But the novel therapies have also brought an evolution in traditional treatment regimens through their combination with chemotherapy, radiation, targeted therapy, or even other immunotherapy drugs.
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.