On October 3, 2017, the U.S. Food and Drug Administration (FDA) announced updates to three final guidance documents, including Form FDA 3926 and its instructions, to simplify Institutional Review Board (IRB) review requirements for physicians seeking to treat an individual patient with an investigational drug under expanded access.  The updates allow for a waiver of the requirement for review and approval at a convened IRB meeting if the physician instead obtains concurrence by the IRB chairperson (or a designated IRB member) before treatment use begins.

Cancer treatment options continue to multiply as 2017 continues, with the U.S. Food and Drug Administration (FDA) granting multiple new drug approvals and broadening indications for others. Oncology clinicians and nurses are challenged with staying abreast of treatment option expansions and navigating the dynamic field of cancer treatment to effectively navigate their patients through the treatment trajectory, educating on vital points relative to treatment, minimizing morbidity and mortality, and optimizing quality of life. Following is an overview of the latest approvals for the second quarter of 2017.

Researchers have found a new feature of cancer stem cells that may be used with existing cancer treatments to help prevent cancer recurrence. The study was reported in Cell Chemical Biology.

On September 22, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to nivolumab for the treatment of hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib.

On September 14, 2017, the U.S. Food and Drug Administration (FDA) approved a lower dose of cabazitaxel (20 mg/m² every 3 weeks) in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen.  Cabazitaxel (25 mg/m² every 3 weeks) was approved for this indication in 2010.

On September 14, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to copanlisib for the treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies.

On September 14, 2017, the U.S. Food and Drug Administration (FDA) approved Mvasi (bevacizumab-awwb, Amgen Inc.) as a biosimilar to Avastin (bevacizumab, Genentech Inc.). Mvasi is the first biosimilar approved in the U.S. for the treatment of cancer.

New targeted and immunotherapy drug approvals have offered improved survival and disease outcomes for patients with melanoma, but the new therapies are also associated with a range of adverse events (AEs) that differ from those associated with chemotherapy. Oncology nurses will need to shift their thinking to best manage those AEs.

Clinical trials are responsible for discovering new treatments for cancer as well as the continued evolution of standards of care in clinical practice. Nationally, less than 5% of all eligible adult patients with cancer enroll in clinical trials. Additionally, it takes a drug an average of six to eight years from when it is first introduced in trials to become fully available to all patients who could benefit from it.

On September 1, 2017, the U.S. Food and Drug Administration (FDA) approved gemtuzumab ozogamicin (Mylotarg, Pfizer Inc.) for the treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and for treatment of relapsed or refractory CD33-positive AML in adults and in pediatric patients 2 years and older. Gemtuzumab ozogamicin may be used in combination with daunorubicin and cytarabine for adults with newly-diagnosed AML, or as a stand-alone treatment for certain adult and pediatric patients.

On August 31, 2017, based on data from two recently halted clinical trials, the U.S. Food and Drug Administration (FDA) is issuing a statement to inform the public, healthcare professionals, and oncology clinical investigators about the risks associated with the use of Keytruda (pembrolizumab) in combination with dexamethasone and an immunomodulatory agent (lenalidomide or pomalidomide) for the treatment of patients with multiple myeloma. Keytruda (pembrolizumab) is not approved for treatment of multiple myeloma.

On August 30, 2017, the U.S. Food and Drug Administration granted regular approval to tisagenlecleucel for the treatment of patients up to age 25 years with B-cell precursor acute lymphoblastic leukemia that is refractory or in second or later relapse.

On August 17, 2017, the U.S. Food and Drug Administration granted regular approval to olaparib tablets for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy.

Many Americans use dietary supplements, including herbal products, in the belief that they are natural and safe. Patients with cancer use them often to enhance the effects or to reduce the adverse reactions of cancer treatments. However, few herbs have been thoroughly studied in humans. Therefore, their interactions with prescription drugs and the clinical relevance, remain undetermined. These interactions could be pharmacokinetic in nature when an herb alters the absorption, metabolism, or excretion of other drugs, or pharmacodynamic in which it affects the mechanism of action of other drugs when consumed together. Following are a few relevant herb-drug interactions encountered in the oncology setting.

 

According to the results of a study published in the Journal of Clinical Oncology, African American and Hispanic patients with ovarian cancer who lived in Texas were more likely to receive invasive or toxic treatment and be admitted to intensive care in their final month of life than their Caucasian counterparts.

A new bill passed in the U.S. Senate last week will provide measures to ensure that drug companies are developing treatments for children with cancer. The RACE for Children Act is part of the U.S. Food and Drug Administration (FDA) Reauthorization Act of 2017, which aims to speed up the approval process for new treatments and medical devices and is expected to be signed into law by President Trump.

On August 3, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to a liposome-encapsulated combination of daunorubicin and cytarabine (Vyxeos™, Jazz Pharmaceuticals, Inc.) for the treatment of adults with newly-diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC), two types of AML having a poor prognosis.

High-dose chemotherapy with hematopoietic stem cell support is a well-established treatment for many hematologic malignancies. This treatment can be a difficult journey for patients and families. Historically, patients have been treated in a traditional hospital setting in anticipation of severe side effects, including mucositis, febrile neutropenia, thrombocytopenia, and pulmonary, renal, and hepatic complications. Patients can remain profoundly immunosuppressed for months while recovering from transplant. However, better supportive care in recent years has allowed many centers to move all or a portion of their transplant care into an outpatient setting.

On August 2, 2017, the U.S. Food and Drug Administration (FDA) approved ibrutinib (Imbruvica^®, Pharmacyclics LLC) for the treatment of adult patients with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy. This is the first FDA-approved therapy for the treatment of cGVHD.

On July 31, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to nivolumab for the treatment of patients 12 years and older with mismatch repair deficient and microsatellite instability high metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

Venous thromboembolism (VTE) is a potentially life-threatening event characterized by clots that form in the veins, and it is the second-leading cause of death for patients diagnosed with cancer. VTE affects up to 10% of the cancer population, making it essential for oncology providers to understand the associated risk factors and preventative measures. In addition, prompt recognition and treatment for VTE becomes crucial to patient care.

Advanced practice oncology nurses know how complex the care of patients with cancer can be. Every day seems to bring further advancements in the treatment and management of cancer. It can be difficult to keep up with the onslaught of new information, but our patients rely on us to bring them the latest, greatest, and safest treatment options available.

Advancements in medical records technology provide safeguards and contribute to overall patient safety. However, consider the following treatment scenarios and how they may present opportunities for error and jeopardize patient safety.

You may remember Jay, a 62-year-old man with inoperable stage IIIA non-small cell lung cancer (NSCLC), from the case study in the April 2017 issue of ONS Voice. He was symptomatic with a persistent cough, unintentional weight loss, and fatigue.

An ancient form of bodywork that encompasses hands-on manipulation of muscles and soft tissues, massage increases circulation, reduces muscular tension and promotes relaxation. It also produces emotional and psychological benefits.

Cancer centers across the country, especially those in larger medical centers, are seeing many immunotherapy agents in standard care now. Patients are hearing about advancements in immunotherapies, they’re excited by the possibilities, and the U.S. Food and Drug Administration is approving new drugs or indications almost every month. Although many patients still don’t recognize the distinction between standard treatment options and immunotherapy, it’s vital for nurses to stay educated and understand how these treatments work differently from traditional care options.

Immunotherapy is one of the fastest-evolving areas of oncology to date. Previously, it could take years for some cancers to see new treatment options; today, the U.S. Food and Drug Administration is approving new immuno-oncology agents or new indications for those agents every few weeks. It’s a boon and a challenge to medical professionals. On the one hand, potentially life-changing treatments are making way to patients who need them—patients who have exhausted first-line treatments and now have limited options. On the other hand, healthcare professionals may struggle to stay current with the emerging trends, cutting-edge science, and evolving treatment plans for their patients.

On May 23, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda^®, Merck & Co.) for adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options or with MSI-H or dMMR colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

No solid research exists regarding IV chemotherapy administration setups, because they can vary greatly based on the regimen, equipment availability, and patient status. Of the utmost importance is that the administration setup ensures chemotherapy is given safely and allows for prompt nursing intervention in the event of an adverse reaction or infiltration.

Jay is a 62-year-old man with newly diagnosed, stage IIIA (T3, N1), unresectable, non-small cell lung cancer (NSCLC) that tested negative for ALK, EGFR, and KRAS mutations. Additionally, PD-L1 (programed death receptor ligand) expression was less than 30%. Jay is symptomatic with a persistent cough, unintentional weight loss, and fatigue.

As immunotherapeutic options for cancer treatments continue to grow, oncology nurses need a deeper understanding of the therapies, how they work, and how to manage their side effects, so they can continue to provide the best patient care.

An interview with Beth Faiman, PhD, CNP, and Kimberly Noonan, NP