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Showing 6401 - 6450FDA Accepts sBLA and Grants Priority Review for Brentuximab Vedotin in Cutaneous T-Cell Lymphoma
On August 16, the U.S. Food and Drug Administration (FDA) accepted a supplemental Biologics License Application (sBLA) and granted Priority Review for brentuximab vedotin (Adcetris) in patients with cutaneous T-cell lymphoma (CTCL). The sBLA and its acceptance is based on data from the phase III...
Recent FDA Actions Include New Drug Approvals in Leukemia, Expanded Approvals in Colorectal Cancer and Graft-vs-Host Disease
The U.S. Food and Drug Administration (FDA) recently granted approval, expanded approval, and breakthrough therapy designation to numerous treatments across a range of tumor types and malignancies. New Drug Approvals Daunorubicin-Cytarabine Combination (Vyxeos): On August 3, the FDA granted...
End-of-Life Care for Older Patients With Acute Myeloid Leukemia
As reported in the Journal of Clinical Oncology by Wang et al, many older patients with acute myeloid leukemia (AML) do not receive hospice care at the end of life, with those who do tending to enroll in hospice within days of death. Study Details The population-based retrospective cohort study...
Turmeric
The ASCO Post’s Integrative Oncology series is intended to facilitate the availability of evidence-based information on integrative and complementary therapies commonly used by patients with cancer. In this installment, Gary Deng, MD, PhD, and Jyothirmai Gubili, MS, present information on...
Unraveling the Complexities of Cellular Immunotherapy and Its Potential to Cure Some Cancers
This past fall, the Fred Hutchinson Cancer Research Center in Seattle opened an all-encompassing 9,222-square foot outpatient cellular immunotherapy clinic, specifically designed to serve patients participating in the center’s novel immunotherapy clinical trials, which mainly focus on chimeric...
Triple-Negative Breast Cancer: Practical Approach, Promising Research
Triple-negative breast cancer has a reputation for being a particularly challenging malignancy, but breast cancer specialist Nancy Davidson, MD, Senior Vice President of the Clinical Research Division at the Fred Hutchinson Cancer Research Center, Seattle, put this in perspective in a recent...
ASCO Guideline on Stage IV NSCLC Therapy Updated
An update of the ASCO clinical practice guideline on the systemic treatment of patients with stage IV non–small cell lung cancer (NSCLC) clarifies the role of immunotherapy in this setting. The update, published by Hanna et al in the Journal of Clinical Oncology, also provides new...
Surveillance Mammography by Life Expectancy in Older Breast Cancer Survivors
In a study reported in the Journal of Clinical Oncology, Freedman et al found that many older breast cancer survivors with a limited life expectancy still undergo annual surveillance mammography despite the absence of known benefits. Study Details The study involved analysis of National Health...
Clonal Hematopoiesis in Patients With Nonhematologic Cancers
In a study of nearly 9,000 people treated for solid tumors, researchers found that radiation treatment and tobacco use were linked to higher rates of blood-based DNA mutations that could lead to a higher risk for blood cancers such as leukemia. The study, published by Coombs et al in...
Imaging and Biomarker Test Could More Accurately Predict Longer-Term Patient Response to Regorafenib in Colorectal Cancer
Administering a magnetic resonance imaging (MRI) scan and a blood test to patients with metastatic colorectal cancer may help to select those who would benefit from a targeted cancer treatment, a new study published by Khan et al in Gutreported. Researchers found that after only 2 weeks on the...
FDA to Expand Public Education Campaign to Focus on Prevention of Youth E-Cigarette Use
On August 8, the U.S. Food and Drug Administration (FDA) announced it would pursue a strategic, new public health education campaign aimed at discouraging the use of e-cigarettes and other electronic nicotine delivery systems (ENDS) by children. The agency plans to expand its “The Real...
New Device to Test for Cervical Cancer May Be Less Painful for Patients, Produce Better Results
When a woman has an abnormal Papanicolaou (Pap) smear, she usually undergoes colposcopy—a procedure physicians use to closely examine the cervix, vagina, and vulva for signs of disease. Typically, a metal instrument is used to obtain a small sampling of cells inside the cervix, which is...
Health-Related Quality of Life With Immediate vs Delayed ADT in Prostate Cancer
In a health-related quality-of-life study among patients in the phase III TOAD trial, immediate vs delayed androgen-deprivation therapy was associated with early worsening of androgen-deprivation therapy–related symptoms but few other comparative adverse effects on functioning or quality of...
Higher Opioid Use Among Cancer Survivors
A new study found that opioid prescription use is more common in cancer survivors than in individuals without a history of cancer. This was true even among survivors who were 10 or more years past their cancer diagnosis. Published by Sutradhar et al in Cancer, the findings come at a time of rising...
Senate Passes the RACE for Children Act
On August 3, the leadership of Kids v Cancer, an advocacy group promoting pediatric cancer research, issued the following statement: Today, the U.S. Senate passed the FDA Reauthorization Act and with it, the RACE for Children Act. Now, new cancer drugs will be developed not only for...
Physician Orders for Life-Sustaining Treatment Form Use and End-of-Life Quality-of-Care Metrics in Cancer Patients
In a study reported in the Journal of Oncology Practice, Pedraza et al found that patients with advanced cancer who had Physician Orders for Life-Sustaining Treatment (POLST) forms in place were more likely to have hospice admission and death out of the hospital than those with only advance...
ASCO Resource to Help Your Patients Quit Tobacco
ASCO’s patient booklet Stopping Tobacco Use After a Cancer Diagnosis offers people with cancer and their caregivers information on why and how to quit tobacco use. With information on available treatments and resources, this booklet gives patients the practical tools to work with their health-care...
Blinatumomab in Advanced Acute Lymphoblastic Leukemia: A Brighter Therapeutic Outlook
NEW DRUGS that will improve the outcome of adult patients who develop a deadly disease such as acute leukemia are badly needed; combinations of cytotoxic chemotherapeutic drugs may have reached an upper limit of utility. Agents that eradicate leukemia by alternative mechanisms would be of...
Alectinib: A New Standard for First-Line Therapy of ALK-Rearranged NSCLC?
ANAPLASTIC LYMPHOMA KINASE (ALK) was first identified in anaplastic large cell lymphoma. The ALK gene itself is not oncogenic, but it can become oncogenic by at least three mechanisms: by forming a fusion gene with a number of other partner genes, by copy number gain, or by mutations in the gene....
U.S. Preventive Services Task Force Recommends Against Screening for Thyroid Cancer in Asymptomatic Individuals
AS REPORTED in JAMA, the U.S. Preventive Services Task Force (USPSTF) has recommended against thyroid cancer screening in asymptomatic individuals.1 The current USPSTF statement is an update of a 1996 USPSTF recommendation statement. The recommendation was based on Task Force review of evidence on ...
ASCO Tackles the Issue of the High Cost of Cancer Drugs
In July, ASCO issued a comprehensive set of recommendations to remedy the problem of escalating drug pricing on cancer therapies.1 ASCO’s position statement comes at a time when new cancer drugs are routinely priced at $100,000 a year or more—imatinib (Gleevec) costs up to $146,000 a year2—causing...
FDA Announces Comprehensive Regulatory Plan to Shift Trajectory of Tobacco-Related Disease, Death
On July 28, the U.S. Food and Drug Administration (FDA) announced a new comprehensive plan for tobacco and nicotine regulation that will serve as a multiyear roadmap to better protect children and significantly reduce tobacco-related disease and death. The approach places nicotine and the issue of...
Trastuzumab-Based Regimens in Older Women With Early Breast Cancer
A comparative analysis of outcomes with two different trastuzumab (Herceptin)-based adjuvant regimens in older women with early HER2-positive breast cancer found little difference in safety and efficacy between treatments. The study was reported by Reeder-Hayes et al in the Journal of Clinical...
Searching for Happiness
This is the story, told through their own photographs, of a group of adolescent patients with cancer in their search for happiness. Their images relay their hopes and fears, their desire to be normal, and their urge to escape. These photographs are the outcome of a creative arts–based support...
How to Help Young Patients Preserve Their Fertility
GUEST EDITOR Adolescent and Young Adult Oncology explores the unique physical, psychosocial, social, emotional, sexual, and financial challenges adolescents and young adults with cancer face. The column is guest edited by Brandon Hayes-Lattin, MD, FACP, Professor of Medicine and Medical Director...
Breast Cancer Surveillance Consortium Receives $17 Million NCI Grant
INVESTIGATORS AT Breast Cancer Surveillance Consortium (BCSC) have received a $17 million program project grant renewal from the National Cancer Institute to study the effectiveness of different breast cancer screening and surveillance strategies using digital mammography, digital breast...
One Size May Not Fit All: Thoughts on the New Adjuvant Bisphosphonate Guideline for Early-Stage Breast Cancer
The oncology community has now conducted several prospectively designed, hypothesis-driven randomized clinical trials among women with breast cancer to address this question: Do adjuvant bisphosphonates decrease the risk of breast cancer bone metastases and other recurrence? A meta-analysis1 by...
Cancer Care Ontario and ASCO Clinical Practice Guideline: Use of Adjuvant Bisphosphonates and Other Bone-Modifying Agents in Breast Cancer
As reported in the Journal of Clinical Oncology by Sukhbinder Dhesy-Thind, MD, MSc, FRCPC, of Juravinski Cancer Centre, Hamilton Health Sciences, and colleagues, Cancer Care Ontario and ASCO have issued a clinical practice guideline on the use of adjuvant bisphosphonates and other bone-modifying...
Advances in the Treatment of Triple-Negative Breast Cancer
WITHIN THE SPECTRUM of breast cancer subtypes, triple-negative disease is “particularly troubling,” but better scientific understanding of this malignancy is leading to advances in its treatment, according to breast cancer expert Nancy Davidson, MD. Triple-negative breast cancer does not express...
Financial Toxicity: Cancer Supportive Care Professionals Consider the Side Effects of Soaring Costs
IS IT POSSIBLE to identify patients with cancer who are at risk for financial stress and intervene to reduce that risk? And could reducing financial stress—or financial toxicity, as it is often called in the context of cancer care—improve both health-related quality of life and physical health?...
Convergence of Precision Medicine and Immuno-oncology
“THE CONVERGENCE of two very hot and interesting topics—precision medicine and immuno-oncology”—is being advanced by next-generation sequencing, Douglas B. Johnson, MD, MSCI, made clear at the inaugural OncoSET Symposium: Emerging Approaches to Precision Medicine,” sponsored by the Robert H. Lurie ...
New Data Reported on Vemurafenib, Vitamin D, Selective Internal Radiotherapy, and Circulating Tumor DNA in Colorectal Cancer
RESULTS OF the IDEA trial, which showed that some patients with stage III low-risk colon cancer may require less oxaliplatin therapy (see the June 25 issue of The ASCO Post), were among the findings highlighted at the 2017 ASCO Annual Meeting Plenary Session. Other studies of interest in colorectal ...
Expert Point of View: Frank Sinicrope, MD
FRANK SINICROPE, MD, Professor of Oncology and Co-Leader of the GI Cancer Program at the Mayo Clinic, Rochester, said CHARTA addressed whether patient outcomes can be improved with a triplet regimen plus bevacizumab (Avastin) vs a standard doublet plus bevacizumab. This was based upon the finding...
FDA Actions Yield Extended Approvals of Novel Agents, Advisory Committee Votes Favorably on Two Biosimilars and Pediatric Indication for CAR T-Cell Therapy
DURING JULY, the U.S. Food and Drug Administration (FDA) and its Oncologic Drugs Advisory Committee (ODAC) made a number of approvals and recommendations on a variety of oncology products. Neratinib ON JULY 1 7, the FDA approved neratinib (Nerlynx) for the extended adjuvant treatment of adult...
A New Triumvirate in Estrogen Receptor–Positive Metastatic Breast Cancer
THE BODY OF EVIDENCE supporting the use of cell-cycle inhibitors in combination with endocrine therapy for estrogen receptor–positive metastatic breast cancer now has another agent in the spotlight. The phase III MONARCH 2 trial—reported at the 2017 ASCO Annual Meeting and by Sledge et al in the...
An Educational Program for Safe Handling of Opioids
Improper storage, use, and disposal of prescribed opioids can lead to diversion or accidental overdose. Given that opioids are the mainstay of cancer pain treatment, this issue is particularly germane in the oncology community. The ASCO Post recently spoke with Akhila Reddy, MD, and Maxine de la...
MammaPrint Test Addressed in ASCO Breast Cancer Guideline Update
New recommendations on the use of the MammaPrint genomic test issued on July 10 will help guide decisions on adjuvant systemic therapy for women with early breast cancer. The recommendations update the ASCO 2016 clinical practice guideline on the use of biomarkers in these patients. The guideline ...
First Oncologist Elected AMA President, Barbara L. McAneny, MD, Advocates for Access to Health Care for Everyone
Since the founding of the American Medical Association (AMA) in 1847, Barbara L. McAneny, MD, is the fourth woman and first oncologist to be elected President of the venerable medical association. “I’m a generic Midwesterner. I was born in Missouri and raised in Madison County, Illinois, and went...
Launch of Watson-Powered Genomic Sequencing Service to Help Physicians Bring Precision Cancer Treatments to Patients Nationwide
On July 27, IBM Watson Health and Quest Diagnostics announced the launch of IBM Watson Genomics from Quest Diagnostics, a new service that helps advance precision medicine by combining cognitive computing with genomic tumor sequencing. Memorial Sloan Kettering Cancer Center (MSK) will...
NETRF Commits $4 Million for Neuroendocrine Tumor Research
The Neuroendocrine Tumor Research Foundation (NETRF) has announced its largest research commitment ever—$4 million in collaborative grants—most from its new Accelerator Grants program to study neuroendocrine tumors, a widely misunderstood, commonly misdiagnosed cancer type without adequately...
Effect of BRAF V600E Mutation on Outcome in Pediatric Low-Grade Gliomas
An analysis reported by Lassaletta et al in the Journal of Clinical Oncology showed that BRAF V600E mutation is associated with a poor outcome in pediatric low-grade gliomas treated with standard adjuvant therapy. Study Details The study involved patients with low-grade gliomas with long-term...
FDA Approves Enasidenib in Relapsed or Refractory Acute Myeloid Leukemia
Today, the U.S. Food and Drug Administration (FDA) approved enasidenib (Idhifa) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. The drug is approved for use with a companion diagnostic, the RealTime IDH2 Assay, which ...
FDA Approves Nivolumab in MSI-H or dMMR Metastatic Colorectal Cancer
Today, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) injection for intravenous use for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer...
New ASCO Recommendations for Controlling Nausea and Vomiting Related to Cancer Treatment
An update of the ASCO Clinical Practice Guideline covers new medicines for nausea and vomiting related to cancer treatment. The update, issued by Hesketh et al in the Journal of Clinical Oncology today, provides new evidence-based information on the appropriate use of olanzapine, neurokinin 1...
Fulvestrant Receives EC Approval as First-Line Therapy for Advanced Breast Cancer
On July 26, the European Commission (EC) approved fulvestrant (Falsodex) for the treatment of estrogen receptor–positive, locally advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy. The EC approval is based on pivotal data from the...
Association of Bisphosphonate Use and Breast Cancer Risk in Postmenopausal Women
A study in postmenopausal women in the French E3N prospective cohort indicated bisphosphonate use was not associated with a reduced risk of breast cancer. These findings were reported by Fournier et al in the Journal of Clinical Oncology. Study Details The study included 64,438 postmenopausal...
Study Finds HER2 Mutations in 3% of Lung Cancers
The Lung Cancer Mutation Consortium at the University of Colorado Cancer Center reported that 24 of 920 patients (3%) with advanced-stage lung cancer in a recent study had mutations in the gene HER2. According to the study, published by Pillai et al in Cancer, 71% of these patients were...
Association Between Vasectomy and Prostate Cancer
A systematic review and meta-analysis has found no association between vasectomy and high-grade, advanced, or fatal prostate cancer but a weak association with any prostate cancer. These findings were reported in JAMA Oncology by Bhindi et al. Study Details The analysis involved 53 studies,...
National Cancer Groups Release Joint Statement to Chart the Future of Cancer Health Disparities Research
Several national cancer organizations have released a joint position statement to guide the future of cancer health disparities research. The statement, which was published by Polite et al in Cancer Research, represents a unified strategy by the American Association for Cancer Research (AACR), the...
NCI-COG Pediatric MATCH Trial to Test Targeted Drugs in Childhood Cancers
Today, investigators at the National Cancer Institute (NCI) and the Children’s Oncology Group (COG) announced the opening of enrollment for a unique precision medicine clinical trial. NCI-COG Pediatric Molecular Analysis for Therapy Choice (Pediatric MATCH) is a nationwide trial to explore...
