On August 14, 2024, the U.S. Food and Drug Administration (FDA) approved axatilimab-csfr (Niktimvo), a colony-stimulating factor–1 receptor-blocking antibody, for the treatment of chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg.

On June 5, 2024, the U.S. Food and Drug Administration (FDA) announced that HomeoCare Laboratories Inc. is voluntarily recalling two batches of StellaLife oral care products to the consumer level because of the presence of microbial contamination.

On March 27, 2024, the U.S. Food and Drug Administration (FDA) announced that Amneal Pharmaceuticals, LLC, is voluntarily recalling four lots of vancomycin hydrochloride for oral solution, USP, 250 mg/5 ml, packaged in 80 ml, 150 ml, or 300 ml pack sizes, to the consumer level.

Central line-associated bloodstream infections (CLABSIs) can cause serious harm or even death to patients and significantly increase healthcare costs. Nurses are critical contributors to infection prevention in any healthcare setting, particularly for oncology’s often-immunocompromised patient population, ONS member MiKaela Olsen, DNP, APRN-CNS, AOCNS^®, FAAN, clinical program director for oncology at the Johns Hopkins Hospital and Johns Hopkins Health System in Baltimore, MD, said. 

Many patients with cancer experience sleep disturbances, including insomnia, that can persist for years if not appropriately managed. The resulting increased risk for infections, anxiety, and depression can take a toll on patients’ quality of life.

Pharmacologic treatments for insomnia may contribute to adverse effects such as performance problems, memory disturbance, falls, and driving accidents, leading many patients to seek alternative or complementary therapies.

Listening to educational podcasts improves oncology nurse learners’ knowledge of managing treatment-related adverse events by 11%–27% and safety by 24%, researchers reported during a podium presentation at the 48th Annual ONS Congress® in April 2023.

Prescreening patients for immune-related adverse events during treatment with immune checkpoint inhibitors using text messaging may reduce the need for some in-person, preinfusion office visits, researchers reported in JAMA Network Open. The approach may help decrease the burden of cancer care for both patients and providers.

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.

More than 40% of patients with melanoma treated with nivolumab or pembrolizumab experience persistent long-term immune-related adverse events (irAEs) for at least 1.5 years, researchers reported in JAMA Oncology.

Research has identified an association between malnutrition and functional deficits in patients with cancer, regardless of age, and other studies confirm that malnutrition affects treatment tolerability, outcomes, and quality of life for patients with cancer. However, studies have also found that oncology clinicians do not consistently assess for malnutrition and functional deficits in clinical settings. 

Sofia is a 35-year-old patient who identifies as female who was recently diagnosed with breast cancer and is concerned with experiencing chemotherapy-induced alopecia (CIA) as an adverse event from treatment. She comes in for her first infusion of adriamycin plus cyclophosphamide and is using scalp cooling to prevent hair loss. She works as a project manager, which requires her to keep her camera on for her many daily video calls. She is very anxious about losing her hair and asks you if taking minoxidil in addition to the scalp cooling treatment would guarantee she maintains her hair. 

I am a clinician in my heart and soul. I was an ONS charter member and one of the first nurse practitioners (NPs) at Memorial Sloan Kettering Cancer Center in New York, NY, before any NP laws were in place and before colony-stimulating factors. The inability to prevent death secondary to chemotherapy-induced neutropenia (CIN) and febrile neutropenia (FN) haunted me and led me to conduct several funded studies. 

Once patients stop responding to platinum-based chemotherapy for locally advanced or metastatic urothelial cancer, their treatment options had been somewhat limited: PD-1/PD-L1 inhibitors were effective in only 13%–29% of patients and taxanes in only 11%–13%. When the antibody drug conjugate enfortumab vedotin was approved in late 2019, it offered new hope for patients and providers, with clinical trials reporting a 44% objective response rate.

On March 25, 2021, the U.S. Food and Drug Administration shared Zydus Pharmaceuticals Inc.’s notice of its voluntary recall of four lots of acyclovir sodium injection 50 mg/ml, supplied in 10 ml and 20 ml vials, after receiving reports of crystallization in the product.

Zhang is a 67-year-old man who had no history of medical concerns until he was hospitalized for pneumonia. A complete blood count taken during his workup for pneumonia showed pancytopenia, and a biopsy confirmed a diagnosis of acute myeloid leukemia. After multiple rounds of induction therapy, Zhang's bone marrow biopsy showed minimal residual disease and he entered remission. His oncologist recommends an allogeneic hematopoietic stem cell transplant as soon as possible because of the disease's aggressive nature, but he has no match in the registry. 

Epidermal growth factor receptor (EGFR)-targeted therapy is effective for several solid tumor malignancies, primarily non-small cell lung cancer with EGFR mutation and metastatic colorectal cancer. Although the agents spare patients from typical side effects seen with more conventional cytotoxic chemotherapies, such as nausea or vomiting, they do have a unique side-effect profile, including potentially dose-limiting cutaneous toxicity. 

In 2019, PI3K inhibitors became a new treatment option for postmenopausal women and men with HR-positive, HER2-negative, PIK3CA-mutated, advanced or metastatic breast cancer with the U.S. Food and Drug Administration’s approval of alpelisib in combination with fulvestrant. Although alpelisib remains the only PI3K inhibitor approved today, others are in clinical trials, and the new class of agents has a unique safety profile.

Three years ago, Tony, a 42-year-old man, began FOLFOX chemotherapy treatment for stage III colon cancer and achieved a complete response. Two years later, a biopsy of an intraabdominal lesion uncovered metastatic disease, and he was prescribed the epidermal growth factor inhibitor (EGFRi) cetuximab. Alex, the oncology nurse educating Tony on the side effects of EGFRi therapy, understands that skin toxicities are common with the class of drugs and looks for national guidelines for prevention and management direction.

Imagery is a mind-body practice with deep historical roots. It uses imagination to recreate mental images, sounds, smells and even tastes to help achieve relaxation and to promote healing. Guided imagery can be learned in an interactive manner from a licensed practitioner or from books and self-help tapes. Repeating the practice results in a conditioning effect that can empower the individual to use it whenever needed.

Painful skin reactions may develop in as many as 95% of patients receiving radiotherapy treatments for cancer. Patients report that it affects their quality of life and that purchasing interventions to soothe their skin increases their out-of-pocket costs. Supporting patients who experience the side effect is critical for their well-being.

On December 28, 2020, the U.S. Food and Drug Administration announced that Sunstar Americas, Inc., expanded its October 27, 2020, voluntary recall of Paroex^® chlorhexidine gluconate oral Rinse USP, 0.12%, because of possible contaminated with the bacteria Burkholderia lata.

An annual flowering herb native to East Asia, Cannabis sativa is cultivated around the world. It is used in traditional medicine as an analgesic, hypnotic, hallucinogenic, sedative, and anti-inflammatory. Preparations derived from its flowers, leaves, and hashish made from its resinous extract are taken orally, by smoking, or by vaporizing. Cannabis teas, tinctures, ointments, and oil-based extracts that can be mixed into food products are also popular.

On September 1, 2020, the U.S. Food and Drug Administration (FDA) designated three of the situations involved in BD’s June 30, 2020, previously announced voluntary recall of several models of its Alaris™ system as class I recalls. Class I recall designation indicates a reasonable probability that the use of the product will cause serious adverse health consequences or death.

Durvalumab immunotherapy became a new standard of care for patients with stage III unresectable non-small cell lung cancer whose disease did not progress following two cycles of platinum-based chemoradiotherapy after its approval in February 2018, and in March 2020, its indication was expanded for use as first-line treatment in patients with extensive-stage small cell lung cancer as well. Key to keeping patients on immunotherapy treatment and giving them the best chance at long-term survival is effective management of immune-related adverse events.

Tesla is a 24-year-old woman diagnosed with stage IIIA Hodgkin lymphoma. She enrolled in a clinical trial where she received a combination of chemotherapy and immunotherapy with pembrolizumab, an anti-PD-1 antibody. The clinical trial protocol required three doses every three weeks. At baseline, her thyroid function tests were normal. When she presented for her third dose, her labs showed grade 2 hyperthyroidism.

Clinical trial results show that PD-1 inhibitors offer improved survival and a better safety profile compared to standard, single-agent chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck. However, because of their mechanism of action as immunotherapy, patients receiving the agents may experience immune-related adverse events (irAEs).

Clostridium difficile infection is a dangerous and sometimes deadly adverse event in immunocompromised patients with cancer. Although transmission risk is high in the hospital setting, even with isolation precautions, oncology providers can use a variety of prevention techniques to reduce the chance for infection in their patients.

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.

Palbociclib (Ibrance), ribociclib (Kisqali), and abemaciclib (Verzenio) used to treat some patients with advanced breast cancers may cause rare but severe inflammation of the lungs, the U.S. Food and Drug Administration (FDA) announced on September 13, 2019. It approved new warnings about the risk on the prescribing information and package insert for the entire class of cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor medicines. However, “the overall benefit of CDK 4/6 inhibitors is still greater than the risks when used as prescribed,” the agency noted.

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. 

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.

After completing neoadjuvant chemotherapy for triple-negative invasive breast cancer, Madeline, age 32, had a bilateral mastectomy with reconstructive surgery. Final pathology showed residual disease in the breast and one lymph node, and her oncologist recommended adjuvant therapy with capecitabine (1,500 mg twice a day for 14 days, off for 7 days). Five weeks postoperatively, she started cycle 1. Eight days later, her husband called the cancer clinic reporting that over the past two days, his wife developed profound weakness, unremitting diarrhea despite using diphenoxylate and atropine as directed, and painful, red, swollen hands and feet. Her symptoms represented a drastic change from her usual routine and energy level.

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. 

As the use of oxaliplatin in the treatment of gastrointestinal, gynecologic, and other cancers continues to grow, so too does the incidence of hypersensitivity reactions connected to the drug. Because the development of HSRs may require patients to discontinue oxaliplatin even if it’s effective against their cancer, oncology nurses need to be able to prevent or minimize reactions whenever possible.

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.

Ongoing therapy with afatinib—an oral, irreversible ErbB family blocker—for as long as it is effective and tolerable is considered first-line treatment for metastatic non-small cell lung cancer in patients with EGFR mutations. In their article in the October 2018 issue of the Clinical Journal of Oncology Nursing, Edwards, Adan, Lalla, Lacouture, O’Brien, and Sequist discussed the most common adverse events (AEs) associated with afatinib and their real-life experiences managing them in clinical practice to keep patients on therapy.

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.

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.

Adverse events and traumatic moments send shockwaves through the entire care team. As families grieve the loss of a loved one, providers can often suffer from feelings of overwhelming guilt, remorse, or helplessness. When clinicians struggle with the aftermath of a tragic care event, they become known as second victims. Second victim experiences can lead to lapses in safety and care and could be potentially dangerous for future patients.