Using antibiotics during treatment with immune checkpoint inhibitors may limit the therapy’s effect, according to study results published in the American Journal of Clinical Oncology.

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.

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.

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.

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. 

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.

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.

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.

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.

A new type of remodeled CAR T-cell treatment is just as effective as the original therapy but may result in fewer neurologic side effects, researchers reported in Nature Medicine.

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.

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.

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.

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.

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.

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.

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.

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).

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 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. 

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.

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.

Two-year survival rates for patients with advanced melanoma increased quickly after the introduction of ipilimumab in 2011, according to an analysis published the journal Cancer.

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.

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.

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. 
 

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. 

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.

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.

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 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:

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.

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.

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. 

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.

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.