FDA Grants Accelerated Approval to Sotorasib for KRAS G12C-Mutated NSCLC
On May 28, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to sotorasib (Lumakras™), a RAS GTPase family inhibitor, for adult patients with KRAS G12Cmutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA approved test, who have received at least one prior systemic therapy.
FDA Grants Accelerated Approval to Amivantamab-Vmjw for Metastatic NSCLC
On May 21, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to amivantamab-vmjw (Rybrevant™), a bispecific antibody directed against epidermal growth factor receptor (EGFR) and MET receptor, for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. FDA also approved the Guardant360® CDx as a companion diagnostic.
Targeted Therapies Are Transforming the Treatment of Non-Small Cell Lung Cancer
Testing for molecular biomarkers has become a mainstay in determining treatment approaches for advanced-stage non-small cell lung cancer. Typically, next-generation sequencing identifies any potential genomic variants that are associated with oncogenic driver events and can be targeted with oral tyrosine kinase inhibitors.
Muscle Quality Predicts Efficacy of NSCLC Immunotherapy
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.
Lung Cancer Screening Guidelines to Reduce Disparities May Increase Them Instead—But Risk Model Can Help
The draft 2020 U.S. Preventive Services Task Force (USPSTF) lung cancer screening recommendations were intended to increase the number of high-risk minorities eligible for lifesaving tests. And they do, but not as much as USPSTF anticipated, still leaving gaps and disparities, researchers reported in the Journal of the National Cancer Institute. They created a risk model to augment the guidelines that eliminated the disparities for most racial groups.
FDA Approves Lorlatinib for ALK-Positive Metastatic NSCLC
On March 3, 2021, the U.S. Food and Drug Administration (FDA) granted regular approval to lorlatinib (Lorbrena®) for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive, as detected by an FDA-approved test. FDA also approved the Ventana ALK (D5F3) CDx Assay as a companion diagnostic for lorlatinib.
FDA Approves Cemiplimab-Rwlc for NSCLC With High PD-L1 Expression
On February 22, 2021, the U.S. Food and Drug Administration (FDA) approved cemiplimab-rwlc (Libtayo®) for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation and whose tumors have high PD-L1 expression (tumor proportion score ≥ 50%) as determined by an FDA-approved test, with no estimated aberrations to glomerular filtration rate, anaplastic lymphoma kinase, or receptor tyrosine kinase (encoded by the ROS1 gene).
FDA Grants Accelerated Approval to Tepotinib for Metastatic NSCLC
On February 3, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tepotinib (Tepmetko®) for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition exon 14 skipping alterations.
First-Time Smoking Age Increases Among Young Adults
Although overall smoking rates are decreasing among adolescents and young adults, a new trend is emerging: those who smoked their first cigarette between ages 18–23 increased from 21% in 2002 to 43% in 2018, researchers reported in JAMA Network Open. The increase in young adult first-time smokers comes at a time when smoking initiation rates are decreasing among younger teenagers.
U.S. Senate Designates November as National Lung Cancer Awareness Month
The U.S. Senate unanimously passed a resolution designating November as National Lung Cancer Awareness Month and supporting early detection of lung cancer, a crucial awareness with smoking on the rise among young adults.
FDA Approves Osimertinib as Adjuvant Therapy for NSCLC With EGFR Mutations
On December 18, 2020, the U.S. Food and Drug Administration (FDA) approved osimertinib (Tagrisso®) as adjuvant therapy after tumor resection for patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations, as detected by an FDA-approved test.
ONS Supports Bipartisan Resolution to Recognize November as National Lung Cancer Awareness Month
Lung cancer knows no state boundary or political ideology. But it can bring the two sides together, like it did when U.S. Senators Tina Smith (D-MN), member of the Senate Health Committee, and Marco Rubio (R-FL) introduced a resolution to recognize November as National Lung Cancer Awareness Month. The resolution, which ONS supports, promotes the importance of and need to improve lung cancer early detection.
Smoking Initiation Declines in Teens, Rises in Young Adults
The average age at which cigarette users start to smoke regularly has risen. Although the figures dropped from 45% of adults smoking cigarettes in the 1960s to 14% today, and teen smoking declined to 2.4% by 2019, results of a recent study show an upward trend of underage tobacco use in young adults.
Oncology Drug Reference Sheet: Selpercatinib
In May 2020, the U.S. Food and Drug Administration gave accelerated approval for selpercatinib (Retevmo®) to treat RET-altered non-small cell lung cancer or thyroid cancer based on overall response rate and duration of response. Selpercatinib fights cancer by impeding RET protein activity. The determining clinical trial results demonstrated that it reduced tumor size in more than 50% of patients and was associated with fewer adverse reactions than other drugs that block the RET protein.
Resource Helps Explain the Potential Dangers of E-Cigarettes to Providers and Patients
E-cigarettes are dangerous and their risks outweigh any potential smoking-cessation benefits, the U.S. Government Accountability Office explained in a new two-page resource that analyzes the science and technology behind the devices.
Non-Small Cell Lung Cancer Prevention, Screening, Diagnosis, Treatment, Side Effects, and Survivorship
Lung cancer is the leading cause of cancer death in the United States, accounting for about one quarter of cancer deaths, and more than a quarter of million lung cancer diagnoses are projected in the United States for 2020. Lung cancer has various types, pathologies, and histologies, each with its own prognosis and treatment plan. Non-small cell lung cancer consists of about 80%–85% of lung cancer diagnoses.
FDA Approves Pralsetinib for Lung Cancer With RET Gene Fusions
On September 4, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pralsetinib (Gavreto™) for adult patients with metastatic, RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test.
FDA Approves First Liquid Biopsy NGS Companion Diagnostic Test for NSCLC
On August 7, 2020, the U.S. Food and Drug Administration (FDA) approved the Guardant360 CDx assay as the first liquid biopsy companion diagnostic that also uses next-generation sequencing (NGS) technology to identify patients with specific types of mutations of the epidermal growth factor receptor gene in patients with metastatic non-small cell lung cancer (NSCLC). This is the first approval to combine two technologies in one diagnostic test to guide treatment decisions.
Manage Immune-Related Adverse Events in Patients on Durvalumab
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.
NIH Study Links Cigarette Smoking to Higher Stroke Risk in African Americans
The disproportionate adverse health impact from smoking on African Americans is striking. Although oncology nurses are well aware of tobacco’s carcinogenic effects, they also need to understand the implications for comorbid conditions they may see in smokers with cancer. A recent study, through the National Institutes of Health (NIH), confirmed that African Americans have a 2.5 times higher incident of smoking-related strokes than those who never smoke.
Nurses Obliged to End Racism; Tobacco Industry's Manipulative Marketing
Along with many other healthcare organizations, including ONS, last week the American Nurses Association (ANA) took a bold stand against racism, calling it a public health crisis. On June 12, 2020, ANA President Earnest Grant shared how racism is embedded in health care and what nurses should do to end it.
FDA Approves Atezolizumab for First-Line Treatment of Metastatic NSCLC With High PD-L1 Expression
On May 18, 2020, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq®) for first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1 staining ≥ 50% of tumor cells [TC] or PD-L1-stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area), with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations.
FDA Approves Nivolumab Plus Ipilimumab for First-Line Metastatic Non-Small Cell Lung Cancer
On May 15, 2020, the U.S. Food and Drug Administration (FDA) approved the combination of nivolumab (Opdivo®) and ipilimumab (Yervoy®) as first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥ 1%), as determined by an FDA-approved test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
FDA Approves Selpercatinib for Lung and Thyroid Cancers With RET Gene Mutations or Fusions
On May 8, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to selpercatinib (Retevmo™) for adult patients with metastatic, RET fusion–positive non-small cell lung cancer (NSCLC); adult and pediatric patients aged 12 or older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy; and adult and pediatric patients aged 12 or older with advanced or metastatic RET fusion–positive thyroid cancer who require systemic therapy and who are refractory to radioactive iodine (if radioactive iodine is appropriate). This is the first drug approval for RET genetic alterations.
FDA Grants Accelerated Approval to Capmatinib for Metastatic Non-Small Cell Lung Cancer
On May 6, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to capmatinib (Tabrecta™) for adult patients with metastatic non-small cell lung cancer whose tumors have a mutation that leads to mesenchymal-epithelial transition exon 14 skipping, as detected by an FDA-approved test. It is the first drug approval for this specific patient population and the first targeted therapy for the indication.
House Tells FDA to Ban E-Cigarettes During COVID-19
On April 1, 2020, the U.S. House of Representatives Subcommittee on Economic and Consumer Policy asked the U.S. Food and Drug Administration (FDA) to clear the market of e-cigarettes because of the COVID-19 coronavirus pandemic. It was responding to FDA’s request to give e-cigarette manufacturers four additional months to submit applications to stay on the market before enforcing a ban.
FDA Approves Durvalumab for Extensive-Stage Small Cell Lung Cancer
On March 27, 2020, the U.S. Food and Drug Administration (FDA) approved durvalumab (Imfinzi®) in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).
Smoking Rates Are Low, But Here’s How They Can Be Lower
Although U.S. smoking rates have hit an all-time low of 14%, 34 million American adults are still considered active smokers, according to the U.S. surgeon general’s January 2020 report on smoking cessation. It’s the first new report focused directly on smoking cessation from the surgeon general’s office in 30 years.
Cancer Death Rates See Largest-Ever Single-Year Drop
Overall U.S. cancer mortality fell 2.2% from 2016 to 2017, the largest reduction for a single year, according to the American Cancer Society’s “Cancer Statistics, 2020,” published in CA: A Cancer Journal for Clinicians.
Study Drug Plus Immunotherapy May Offer New Treatment Option for Lung and Kidney Cancer
Pegilodecakin, an investigational, first-in-class drug currently in clinical trials, is demonstrating positive safety results and measurable responses when used in combination with pembrolizumab or nivolumab in patients with non-small cell lung cancer (NSCLC) or kidney cancer. The findings from the multicenter, phase IB study were published in Lancet Oncology.
FDA Approves Atezolizumab With Paclitaxel Protein-Bound and Carboplatin for Metastatic NSCLC Without EGFR/ALK Aberrations
On December 3, 2019, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq®) in combination with paclitaxel protein-bound and carboplatin for the first-line treatment of adult patients with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.
CDC Promotes Lung Cancer Screening Awareness and Prevention
As the leading cause of cancer death in the United States, lung cancer is pervasive and deadly. But like many cancers, patients have a better chance at successful treatment outcomes and survival if caught early through screening and early detection efforts. Despite lung cancer being the second most diagnosed cancer for men and women, not all Americans are aware of its screening recommendations. To address the gap in awareness, the Centers for Disease Control and Prevention (CDC) is promoting a new public health campaign on the issue.
Model May Help Predict Lung Cancer Risk in Patients With Nodules
A risk-prediction model that combines patients’ health history with clinical characteristics of their lung nodules may help physicians determine which will develop into cancer, according to the results of a study published in Cancer Prevention Research.
Oncology Drug Reference Sheet: Atezolizumab’s Indications for Breast and Lung Cancer
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.
Liquid Biopsy Equivalent to Tissue for NSCLC
With faster and equally accurate results, liquid biopsy may be an option for identifying guideline-recommended targeted therapies for non-small cell lung cancer (NSCLC), according to findings presented at the 2019 American Association for Cancer Research Annual Meeting in Atlanta, GA.
Nurses Are Critical to Increasing Awareness of Lung Cancer Screening
Nurses, who are frequently on the front lines of communication with patients at high risk for lung cancer, can play a critical role in increasing awareness of the relatively new option to screen for this deadly condition, Lisa Carter-Harris, PhD, APRN, ANP-C, FAAN, of Memorial Sloan Kettering Cancer Center in New York, NY, said in the Victoria Mock New Investigator Presentation on Saturday, April 13, 2019, at the ONS 44th Annual Congress in Anaheim, CA.
FDA Approves Atezolizumab for Extensive-Stage Small Cell Lung Cancer
On March 18, 2019, the U.S. Food and Drug Administration (FDA) approved atezolizumab in combination with carboplatin and etoposide, for the first-line treatment of adult patients with extensive-stage small cell lung cancer.
Which of the Following Leads to the Greatest Percentage of Superior Vena Cava Syndrome Cases?
Which of the Following Leads to the Greatest Percentage of Superior Vena Cava Syndrome Cases?
A. Small cell lung cancer
B. Non-Hodgkin lymphoma
C. Non-small cell lung cancer
D. Kaposi sarcoma
Psychosocial Support May Reduce Stigma for Patients With Lung Cancer
Because of the relationship between cigarette smoking and lung cancer, patients who receive a lung cancer diagnosis may feel judgment compared to patients with other cancer diagnoses, which could affect social interactions between family, caregivers, and healthcare professionals. Perceived lung cancer stigma can lead to depression, anxiety, poor self-esteem, guilt, shame, blame, poor social identity, and reduced social support. A recent study indicated that lung cancer stigma might be behind the low lung cancer screening rates among high-risk smokers.
FDA Approves Lorlatinib for Second, Third-Line Treatment of ALK-Positive Metastatic NSCLC
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.
FDA Cracks Down on Vaping Pods Because of High Nicotine Levels in Young Users
In September 2018, the U.S. Food and Drug Administration (FDA) issued more than 1,100 warning letters and fines to retailers and issued 131 fines for selling vaping pod products to minors. The agency also told manufacturers that the industry has 60 days to provide a plan to limit underage access to these products or face penalties.
First-Line Osimertinib for Metastatic Non-Small Cell Lung Cancer
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.
FDA Grants Nivolumab Accelerated Approval for Third-Line Treatment of Metastatic SCLC
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.
Which of the Following Patient Types Is Not Indicated for Lung Cancer Screening With Low-Dose Helical Computed Tomography?
Which of the Following Patient Types Is Not Indicated for Lung Cancer Screening With Low-dose Helical Computed Tomography?
A. Is a current or former smoker
B. Is 55–74 years old
C. Has a 10–20 pack-year history
D. Has a 30 pack-year history but no signs or symptoms of lung cancer
Immunotherapy Plus Chemo Improves Survival in Metastatic Lung Cancer
Combining pembrolizumab and platinum chemotherapy plus pemetrexed doubles survival in patients with nonsquamous non-small cell lung cancer (NSNSCLC) without EGFR or ALK gene mutations, according to the results of a study published in the New England Journal of Medicine.
Patients Report More Satisfaction With Multidisciplinary Care Versus Serial Care for Lung Cancer
Despite the prevalence of multidisciplinary (MD) care for cancer, rigorous studies comparing it to serial care (SC) are lacking. To address the literature gap, researchers explored the use of MD versus SC for lung cancer and presented the findings at the 2018 American Society of Clinical Oncology Annual Meeting.
Tips for Creating a Multidisciplinary Research Team Focused on Symptom Management
Catherine Bender, PhD, RN, FAAN, of the University of Pittsburgh, and Amy Hoffman, PhD, RN, of Michigan State University, shared their experiences in building interdisciplinary research teams to assess symptom management during a session at the 43rd Annual Congress in Washington, DC.