A majority of the U.S. Food and Drug Administration (FDA) approvals for cancer agents in the latter part of 2018 represented second and third approvals for new indications in other disease sites. Many were given expedited approval, but with that comes the potential that the incidence of adverse events may be underrepresented because fewer patients received the agents in a clinical trial setting. 

On December 14, 2018, the U.S. Food and Drug Administration (FDA) approved romiplostim for pediatric patients one year of age and older with immune thrombocytopenia for at least six months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.

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.

Dollars spent on cancer drugs increased from $26.8 billion in 2011 to $42.1 billion in 2016, according to the results of a study reported in the Journal of Oncology Practice.

On November 28, 2018, the U.S. Food and Drug Administration (FDA) approved rituximab-abbs as the first biosimilar to rituximab for patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL) to be used as a single agent or in combination with chemotherapy.

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 28, 2018, the U.S. Food and Drug Administration (FDA) approved gilteritinib for treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.

On November 26, 2018, the U.S. Food and Drug Administration (FDA) granted accelerated approval to larotrectinib for adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, that are either metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory alternative treatments or whose cancer has progressed following treatment.

Despite all of the new drugs approved in recent years—particularly immunotherapies, oral agents, and biosimilars—that have forced nurses to consider many novel approaches to patient care, the importance of chemotherapy in cancer treatment has remained a constant. In a field where it feels like no two days are the same and new drugs emerge on a rolling basis, chemotherapy continues to be a staple in cancer treatment plans and safety and administration principles remain constant. 

On November 21, 2018, the U.S. Food and Drug Administration (FDA) approved glasdegib in combination with low-dose cytarabine, for newly-diagnosed acute myeloid leukemia (AML) in patients who are 75 years old or older or who have comorbidities that preclude intensive induction chemotherapy.

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.

When patients or loved ones receive a cancer diagnosis, they often experience fear, worry, and a desire to do everything possible to increase the chance of survival. It is also a pivotal time for patients to assess their well-being and lifestyle and make positive changes. For many, complementary therapies become part of their cancer care journey. Internationally, 40% of patients with cancer have reported using complementary therapies to address cancer-related symptoms, improve the effectiveness of conventional treatments, and provide hope.

Researchers have found that use of nonsteroidal anti-inflammatory drugs (NSAIDs) after diagnosis appears to improve survival for patients with epithelial ovarian cancer. The study results were published in Lancet Oncology.

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.

To ensure that patients and providers are equipped with the latest, most up-to-date knowledge and resources, ONS routinely works with patient advocacy groups, subject matter experts, and other provider organizations to develop and refine critical information for clinical practice. Following safety standards and meeting patient education requirements are critical to successful oral chemotherapy practice.

On November 2, 2018, the U.S. Food and Drug Administration (FDA) granted accelerated approval to lorlatinib (Lorbrena) for patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease.

Which RN is Competent in Chemotherapy Administration?

1. One that took a chemotherapy course online 2 years ago and recently completed their annual education.
2. One that witnessed a chemotherapy competent nurse administer chemotherapy orally and parenterally on five separate occasions
3. One that took a chemotherapy course offered by her hospital and completed an administration checklist with a chemo competent nurse          
4. One who works on a unit that cares for patients receiving chemotherapy

On October 30, 2018, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) in combination with carboplatin and either paclitaxel or nab-paclitaxel as first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC).

On October 16, 2018, the U.S. Food and Drug Administration (FDA) approved talazoparib, a poly (ADP-ribose) polymerase inhibitor, for patients with deleterious or suspected deleterious germline BRCA-mutated, HER2‑negative locally advanced or metastatic breast cancer. Patients must be selected for therapy based on an FDA-approved companion diagnostic for talazoparib.

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.

On September 28, 2018, the U.S. Food and Drug Administration (FDA) approved cemiplimab-rwlc for patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.

On September 24, 2018, the U.S. Food and Drug Administration (FDA) granted regular approval to duvelisib for adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies.

As researchers learn more about how combination therapy combats drug resistance and lessens the changes of tumor evasion of the immune system, immune checkpoint inhibitors are receiving approval for a broader range of indications. However, recent U.S. Food and Drug Administration (FDA) approvals have centered around hematologic malignancies and the emergence of two new biosimilars. 

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.

Lung cancer is the second most common cancer in both men and women (after skin cancer) and is the leading cause of cancer death among both men and women. Histology has become an important determinant in choosing therapy for various types of cancer, including non-small cell lung cancer (NSCLC). Currently, biomarker testing is the standard of care in lung cancer; with biomarker testing, patients likely to respond to targeted therapy can be identified. As the number of targeted agents continues to increase, so does the demand for continued biomarker testing and adequate tumor tissue samples.

On September 13, 2018, the U.S. Food and Drug Administration (FDA) approved moxetumomab pasudotox-tdfk (Lumoxit), a CD22-directed cytotoxin indicated for adult patients with relapsed or refractory hairy cell leukemia who received at least two prior systemic therapies, including treatment with a purine nucleoside analog.

Radiation therapy can be an incredibly draining form of treatment for patients with cancer. Side effects such as fatigue can be debilitating for many before, during, and after treatment. Because symptom management is a crucial component to cancer care and central role of oncology nursing, ensuring that patients are able to mitigate their symptoms and side effects can help improve their quality of life. Recently, a team at the National Institute of Nursing Research (NINR) identified certain genes associated with fatigue in men being treated for prostate cancer.

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.

Oral agents offer many patient benefits, one of which is the freedom to take the medication at home, allowing them to keep their daily routine and gain additional time and independence they would have spent traveling to the clinic for treatment. However, with that freedom comes additional patient responsibilities, and preparation from advanced practice RNs (APRNs) is necessary to ensure patients can self-manage symptoms and adhere to administration regimens. Research shows that patients experience severe symptoms on oral agents that may cause them to miss as many as one-third of the prescribed doses. How can APRNs empower patients to adhere to the treatment plan and ensure safe symptom self-management at home? 

Whereas chemotherapy induces apoptosis by interfering with cell division of both cancerous and healthy cells, targeted therapy exploits targets, proteins, enzymes, or genes specific to malignant cells through a variety of mechanisms of action, which helps prevent drug resistance. The agents work by either inhibiting angiogenesis, blocking chemical signals that tell cells to divide or carry out normal function, or delivering toxic substances to a cell. 

Nearly a century ago, cancer staging was a simple categorization of disease as either local, regional, or distant. Then in the 1940s, a French surgeon developed the concept for a staging system that uses the size of the primary tumor (T), its lymphatic involvement (N), and the presence of metastases (M) to stage a patient’s cancer based on the anatomic extent of the disease at the time of diagnosis.

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.

On July 20, 2018, the U.S. Food and Drug Administration (FDA) approved ivosidenib for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test.

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.

What is unique about the most recent U.S. Food and Drug Administration (FDA) approvals in the oncology/hematology area is that almost all are for new indications of existing agents as opposed to new agents. This is not surprising because many of the agents target specific bioassays or tumor markers instead of a specific disease site. Oncology nurses need to be aware of the changes because treatments that they have become accustomed to giving for one indication may soon be given for others as well.

It’s a rote but important phrase: Necessity is the mother of invention. When a need presents itself, developing novel, inventive solutions can lead to important change. But inventive change doesn’t have to come on a massive scale: small inventions can still have a big impact.