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).

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.

On June 10, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval to polatuzumab vedotin-piiq (Polivy^TM), 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.

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.

Preliminary results reported in Nature Medicine showed that a redesigned CAR T-cell therapy produced complete response with no severe toxicities in 25 patients with refractory B-cell lymphoma.

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. 

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. 

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. 

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. 

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.

A. Adoptive transfer 

B. Antibody-dependent cellular cytotoxicity 

C. Pathogen associated molecular patterns 

D. Phagocytosis 

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.

Using chemotherapy with immune checkpoint inhibitors may reactivate tumors’ responses to immunotherapy, researchers concluded in a review article published in the Annals of Oncology.

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.

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.

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.

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.

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. 

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.

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.

Still a popular program throughout the government, the Cancer Moonshot Initiative challenged the United States to meet goals to accelerate cancer research progress, 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.

Some patients receiving checkpoint inhibitors for lung cancer may experience increased risk for hyperprogressive disease (HPD), according to results of a study reported in JAMA Oncology.

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.  

Two researchers whose discoveries led to the development of the first cancer immunotherapy treatments, immune checkpoint inhibitors, were awarded the 2018 Nobel Prize in Medicine in October.

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.

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.

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.

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.

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.

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.

Wilson was diagnosed with B-cell lymphoma three days after his 63rd birthday. He underwent chimeric antigen receptor (CAR) T-cell therapy after his disease failed to respond to two lines of systemic chemotherapy.

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.

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.

On August 16, 2018, the U.S. Food and Drug Administration (FDA) approved lenvatinib capsules for first-line treatment of patients with unresectable hepatocellular carcinoma.

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.

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.

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. 

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.

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.

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.

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.

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.