FDA Rejects Atezolizumab in Combination With Paclitaxel as Treatment for Breast Cancer
On September 8, 2020, the U.S. Food and Drug Administration (FDA) announced it did not approve atezolizumab (Tecentriq®) in combination with paclitaxel for treatment of breast cancer after a clinical trial studying the use of atezolizumab and paclitaxel in patients with previously untreated inoperable locally advanced or metastatic triple negative breast cancer (mTNBC) showed the drug combination did not work to treat the disease.
Oncology Drug Reference Sheet: Rucaparib
Rucaparib (Rubraca®) has U.S. Food and Drug Administration approval for both maintenance and treatment indications in gynecologic cancers. It originally received accelerated approval in 2016 for the treatment of deleterious, BRCA variant–associated advanced ovarian cancer that has failed two or more chemotherapies. In 2018, it was approved for maintenance therapy of various gynecologic malignancies. Most recently, rucaparib received approval for BRCA-positive metastatic castration-resistant prostate cancer treatment after androgen-directed and chemotherapy.
Oncology Drug Reference Sheet: Enfortumab Vedotin-Ejfv
Enfortumab vedotin-ejfv (Padcev™) was granted accelerated approval in December 2019 for adults with locally advanced or metastatic urothelial cancer who previously received an immune checkpoint inhibitor (PD-1 or PD-L1 inhibitor) and platinum-containing therapy.
Myeloproliferative Neoplasm Symptoms, Diagnosis, Treatment, and Survivorship Recommendations
Myeloproliferative neoplasms are a group of blood cancers that start with a small mutation in the stem cells of the bone marrow. Although MPNs are quite rare, essential thrombocythemia, polycythemia vera, and myelofibrosis are the most common types. Each represents a mutation of a different source of stem cell.
Help Patients Understand Genomic Variants of Unknown Significance
Patients approach genetic testing, either for germline (inherited) or somatic (tumor) alterations, hoping it will provide valuable information about their cancer risk, prognosis, or treatment options. Next-generation sequencing makes it possible to test for panels of 40 or more genes simultaneously. By testing more genes, the possibility of finding an actionable, informative result improves, but so does the chance of having a result with one or more variants of unknown clinical significance.
FDA Approves Nivolumab for Esophageal Squamous Cell Carcinoma
On June 10, 2020, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo®) for patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.
Investigational Maintenance Therapy Extends Survival in AML
A new drug is extending both remission and survival in adults with acute myeloid leukemia (AML), according to findings reported at the American Society of Hematology annual meeting in December 2019. The study was funded by Celgene, the drug’s manufacturer.
Nurses Address Barriers to Care Through CoC’s Revised Standards
Many factors can affect the way patients access their care. But one thing is certain: if patients don’t get the care they need, their chances for success decline. To address barriers to cancer care, the American College of Surgeons’ Commission on Cancer (CoC) outlined specific, measurable actions that institutions must take.
Harnessing the Abscopal Effect May Change Cancer Care
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.
FDA Approves Daratumumab and Hyaluronidase-Fihj for Multiple Myeloma
On May 1, 2020, the U.S. Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro™) for adult patients with newly diagnosed or relapsed or refractory multiple myeloma. The product allows for subcutaneous dosing of daratumumab.
Oncology Drug Reference Sheet: Daratumumab
Daratumumab (Darzalex®) was originally approved by the U.S. Food and Drug Administration in 2015 with additional indications added since. The most recent new indication was approved in September 2019 for newly diagnosed patients with multiple myeloma who are eligible for autologous stem cell transplantation. In May 2020, daratumumab and hyaluronidase-fihj (Darzalex Faspro™), a subcutaneous (SQ) formulation, was approved.
Oral and Oropharyngeal Cancer Prevention, Screening, Treatment, and Survivorship Recommendations
Approximately 53,000 cases of oral and oropharyngeal cancer are diagnosed in the United States each year. Men are twice as likely to develop the disease, and it typically affects people older than 55.
New Treatments Show Promise for Metastatic HER2-Positive Breast Cancer
Two new drugs in clinical trials are extending survival for women with metastatic HER2-positive breast cancer that had progressed with previous treatment. One of the drugs was effective for brain metastasis, which is particularly difficult to treat. Results from both studies were reported in the New England Journal of Medicine.
Oncology Drug Reference Sheet: Tocilizumab
Tocilizumab was approved in August 2017 for the treatment of chimeric antigen receptor T cell–induced cytokine release syndrome. In March 2020, the U.S. Food and Drug Administration approved a randomized, double-blind, placebo-controlled, phase III clinical trial to assess the safety and efficacy of tocilizumab plus standard of care in patients hospitalized with severe COVID-19 pneumonia.
The Case of the Cryotherapy Consequences
Janice is 32 years old and was recently diagnosed with triple-negative breast cancer. She is receiving neoadjuvant chemotherapy with doxorubicin and cyclophosphamide, followed by weekly paclitaxel. Janice is a nationally recognized performer (vocal and piano) and is distraught over the possibility of losing her hair or developing chemotherapy-induced peripheral neuropathy and mouth sores. She asks the nurse what can be done to prevent those unwanted side effects.
Pembrolizumab Is More Cost Effective Than Atezolizumab for NSCLC
Adding atezolizumab to treatment with bevacizumab, carboplatin, and paclitaxel as first-line therapy for metastatic, nonsquamous non-small cell lung cancer (NSCLC) is associated with survival benefit—but it comes at a cost, researchers said in study results published in JAMA Network Open. In comparison, pembrolizumab offers a more cost-effective survival benefit.
Colorectal Cancer Prevention, Screening, Treatment, and Survivorship Recommendations
Colorectal cancer (CRC) is the third most common cancer affecting men and women in the United States. When CRC is found at an early stage before it has spread, the five-year relative survival rate is about 90%, yet it remains a leading cause of cancer-related death among both genders.
Staffing Levels in Ambulatory Oncology Nursing
Convenience. Flexibility. Normalcy. Ambulatory oncology clinics deliver on those three crucially important aspects of treatment to many patients with cancer, offering expert care without a hospital stay or traveling far from home.
ONS Members Help Drive the Ambulatory Staffing Discussion
With evolving treatments and novel approaches to care, outpatient oncology practice has grown exponentially during the past two decades. As a vital stop on the cancer journey for many patients, ambulatory clinics have seen a boom in acuity, patient needs, and staffing demands. ONS has been actively researching the growing staffing dilemma in ambulatory oncology nursing to help institutions understand and address nurse-patient staffing and which best practices can accommodate the varied challenges.
BRAF Mutations Guide Treatment in Metastatic Colorectal Cancer
Molecular profiling has become essential for the treatment of metastatic colorectal cancer (CRC) when surgery cannot be considered and systemic therapy is recommended. CRC has several potential mutations that are diagnostic, prognostic, and predictive. National Comprehensive Cancer Network (NCCN) guidelines recommend that advanced practice providers conduct RAS, BRAF, HER2, and MSI testing as part of a full molecular panel, review the results, and acted on them prior to starting patients on systemic therapy.
FDA Grants Regular Approval to Cabometyx for First-Line Treatment of Advanced Renal Cell Carcinoma
On December 19, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to cabozantinib for treatment of patients with advanced renal cell carcinoma (RCC).
Address the Challenge of Polypharmacy in Older Adults Undergoing Cancer Treatment
Polypharmacy is the use of several medications simultaneously for different medical conditions. Data confirm that polypharmacy is prevalent in older adults with cancer, with one study reporting a minimum of four prescriptions to define polypharmacy. Many medications prescribed during cancer care are intended to treat other comorbid conditions that occur prior to a patient’s cancer diagnosis (e.g., heart disease, hypertension, hyperlipidemia, reflux disease). Reportedly, one third of individuals older than 65 years use more than one pharmacy to fill prescription medications. This can lead to further confusion for patients regarding medication management.
FDA Approves First Biosimilar for Cancer Treatment
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.
Senate Passes Bill to Focus on Childhood Cancer Treatments
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.
FDA Approves Liposome-Encapsulated Combination of Daunorubicin-Cytarabine for Patients With AML
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.
Safely Provide Outpatient Care to Patients Receiving Hematopoietic Stem Cell Transplantations
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.
How the Evolution of Immunotherapy Will Impact Oncology Nurses
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.
FDA Approves Midostaurin for FLT3-Positive Adult AML, Advanced Systemic Mastocytosis
On April 28, 2017, the U.S. Food and Drug Administration (FDA) approved midostaurin for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive (FLT3+), as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation.
FDA Issues Warnings to Fraudulent Cancer Treatment Companies
On April 25, 2017, the U.S. Food and Drug Administration (FDA) issued warning letters to 14 companies that were selling fraudulently marketed products claiming to prevent, diagnose, treat, or cure cancer. In total, the companies produced more than 65 products that have been sold in the United States without FDA approval.