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Showing 8201 - 8250Priority Review for Quizartinib in Relapsed or Refractory FLT3-ITD–Positive AML
THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) accepted a new drug application and granted Priority Review to quizartinib, a FLT3 inhibitor, for the treatment of adult patients with relapsed or refractory FLT3-ITD–positive acute myeloid leukemia (AML). The FDA is expected to make a decision on...
Welcome Questions About Cervical Cancer Treatment Options
TWO STUDIES reported in The New England Journal of Medicine1,2 showed that patients with early-stage cervical cancer had reduced disease-free and overall survival when treated with minimally invasive radical hysterectomy vs open or radical hysterectomy. The findings of these studies have been...
Comparing Survival Outcomes With Minimally Invasive and Open Surgical Approaches to Early-Stage Cervical Cancer
MINIMALLY INVASIVE radical hysterectomy for women with early-stage cervical cancer has been associated with reduced rates of disease-free and overall survival in the phase III LACC randomized noninferiority trial comparing minimally invasive and open abdominal radical hysterectomy. The results...
New Report Demonstrates Cost of Blood Cancer Care
THE COSTS to treat blood cancer are higher than the costs to treat other cancers, and the costs incurred by a patient diagnosed with a blood cancer do not return to precancer levels, according to a Milliman study commissioned by The Leukemia & Lymphoma Society (LLS). The study—The Cost Burden...
Illustrating Genius
FOUR AND A HALF YEARS AGO, author Neil Canavan attended a scientific conference to learn what he could about the then-emerging field of immunotherapy for cancer. After a presentation by Zelig Eshhar, PhD, principal investigator in the Department of Immunology at the Weizmann Institute of Science...
Clinician Survey to Explore Direct-Acting Oral Anticoagulants vs Low–Molecular-Weight Heparin in Cancer-Related VTE
Injectable low–molecular-weight heparin has long been considered the standard of care for treatment of venous thromboembolism (VTE) in patients with cancer. However, low–molecular-weight heparin is costly and often disliked by patients due to injection-related discomfort and bruising....
Improving Palliative Care in Low-Resource Settings
In 2016, ASCO published an update to its Clinical Practice Guideline, “Integration of Palliative Care Into Standard Oncology Care,” which provides evidence-based recommendations for symptom management, clarification of treatment goals, support of coping and distress management, and coordination of...
New Data Reported From International Studies of Lung Cancer Treatment
At the European Society for Medical Oncology (ESMO) 2018 Congress, important studies were presented for every cancer type. Here, The ASCO Post offers some snapshots of lung cancer studies that may inform approaches to treating this common cancer, which—despite the advances in recent years—remains...
FDA Approves Trastuzumab-pkrb for HER2-Overexpressing Breast Cancer
On December 14, the U.S. Food and Drug Administration (FDA) approved trastuzumab-pkrb (Herzuma), a HER2/neu receptor antagonist biosimilar to trastuzumab (Herceptin), for the following indications: Adjuvant breast cancer of HER2-overexpressing, node-positive or node-negative (estrogen...
FDA Approves Calaspargase Pegol-mknl for Pediatric and Young Adult Patients With ALL
On December 20, 2018, the U.S. Food and Drug Administration (FDA) approved calaspargase pegol-mknl (Asparlas), an asparagine-specific enzyme, as a component of a multiagent chemotherapeutic regimen for acute lymphoblastic leukemia (ALL) in pediatric and young adult patients aged 1 month to...
Statement From FDA Commissioner on In Vitro Companion Diagnostics
FDA Commissioner Scott Gottlieb, MD, recently issued the following statement on developing and class labeling of in vitro companion diagnostics for classes of oncology therapeutic products: “With a new draft guidance document that the FDA issued … our aim is to make it easier to get class labeling ...
Priority Review for Atezolizumab in Combination With Chemotherapy for Small Cell Lung Cancer
The U.S. Food and Drug Administration (FDA) accepted a supplemental biologics license application (sBLA) and granted Priority Review for atezolizumab (Tecentriq) in combination with carboplatin and etoposide for the first-line treatment of patients with extensive-stage small cell lung cancer. The...
Should I Have Lied?
The ASCO Post is pleased to reproduce installments of the Art of Oncology as published previously in the Journal of Clinical Oncology. These articles focus on the experience of suffering from cancer or of caring for people diagnosed with cancer, and they include narratives, topical essays,...
International Trials Present New Findings in Treatment of Breast Cancer
The European Society for Medical Oncology (ESMO) 2018 Congress featured an assortment of study findings, many with far-reaching clinical implications for the treatment of patients with various cancers. Many of these trials were covered in-depth in recent issues of The ASCO Post. Here, we present...
Overscreening for Prostate Cancer in Older Men Remains an Issue
Although most major cancer organizations agree on the guidelines for prostate cancer screening, there is still uneven application of the test, such as in the older patient population, resulting in overdiagnosis and waste in an already fiscally challenged health-care system. Researchers from the...
Researchers at The University of Texas at Dallas Receive Funding for Assorted Cancer Projects
MORE THAN $4.5 million in new funding from state and federal agencies will support cancer-related research over the next 5 years at The University of Texas at Dallas. Two projects related to brain cancer, each totaling $200,000 over 2 years, recently received High-Impact/High-Risk Research...
Update on Immune Checkpoint Inhibitors
Checkpoint inhibitors have moved the field of immuno-oncology to the forefront of cancer treatment and research. However, these agents come with the risk of serious adverse events. To shed light on the toxicities associated with checkpoint inhibitors and other timely issues in the field of...
New NCCN Member Institution: Abramson Cancer Center of the University of Pennsylvania
In November, the National Comprehensive Cancer Network® (NCCN) announced that Abramson Cancer Center (ACC) of the University of Pennsylvania will become the organization’s 28th Member Institution. The Abramson Cancer Center’s membership will include the Hospital of the University of Pennsylvania...
ESMO Immuno-Oncology 2018: Second-Line Nivolumab vs Chemotherapy in SCLC
Treatment with nivolumab (Opdivo) did not improve response rates or survival over standard chemotherapy in patients with metastatic small cell lung cancer (SCLC) who relapsed following first-line treatment, according to findings presented by Reck et al at the European Society for Medical...
AACR Remembers George H.W. Bush for Role in Cancer Research Support
The Board of Directors of the American Association for Cancer Research (AACR) released an announcement expressing sadness upon the passing of former President George H.W. Bush, on November 30 at the age of 94. Once elected, President Bush appointed Bernadine Healy, MD, in 1991 to lead the National ...
ESMO Immuno-Oncology 2018: OpACIN Trial: Neoadjuvant Ipilimumab Plus Nivolumab in Stage III Melanoma
Updated data of the OpACIN study, which studied combined ipilimumab (Yervoy) plus nivolumab (Opdivo) administered as neoadjuvant or adjuvant therapy in patients with high-risk stage III melanoma, demonstrated high response rates upon neoadjuvant therapy and promising long-term clinical outcome,...
ESMO Immuno-Oncology 2018: OAK Trial: Fast Progression in Patients With NSCLC Treated With Atezolizumab vs Chemotherapy
Overall survival (OS) was improved across all subgroups of patients with non–small cell lung cancer (NSCLC) who received atezolizumab (Tecentriq) compared with chemotherapy, including poor prognostic factors that were evaluated in an analysis of data from the OAK trial. Additionally, this...
Expert Point of View: Kenneth Shain, MD, PhD, and Vincent Rajkumar, MD
In interviews with The ASCO Post, Kenneth Shain, MD, PhD, Director of the Myeloma Working Group at Moffitt Cancer Center, Tampa, Florida, and Vincent Rajkumar, MD, Professor of Medicine at the Mayo Clinic in Rochester, Minnesota, commented on the findings of the MAIA trial. “The study shows that...
FDA Issues Guidance on Endpoints for Cancer Clinical Trials
This week, the U.S. Food and Drug Administration (FDA) issued a guidance titled Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics. The guidance provides recommendations to applicants on endpoints for cancer clinical trials submitted to the FDA to support effectiveness claims...
Front-Line Daratumumab Combination Regimen Improves Outcomes in Multiple Myeloma
In patients with newly diagnosed multiple myeloma who are not eligible for stem cell transplantation, the addition of daratumumab (Darzalex) to lenalidomide (Revlimid) and dexamethasone significantly reduced the risk of death or disease progression by 44%, according to a late-breaking abstract...
AI Technology for Digital Breast Tomosynthesis Receives FDA Clearance for Clinical Use
A deep-learning, cancer detection software built on artificial intelligence (AI) called ProFound AI received clearance by the U.S. Food and Drug Administration (FDA) for commercial sales and clinical use in the United States. The announcement was made in a news release from iCAD, Inc., a global...
Frederick National Laboratory Names Leonard P. Freedman, PhD, Chief Science Officer
Leonard P. Freedman, PhD, has been named Chief Science Officer at the Frederick National Laboratory for Cancer Research. He joins the Frederick National Laboratory after 6 years as Founding President of the Global Biological Standards Institute, a nonprofit organization dedicated to advancing life ...
FDA Approves Olaparib for Maintenance Treatment of BRCA-Mutated, Advanced Ovarian Cancer
On December 19, 2018, the U.S. Food and Drug Administration (FDA) approved olaparib (Lynparza) for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer...
Nuclear Excision Repair as a Possible Predictor of Early Relapse in Pediatric ALL
Researchers recently discovered that by testing the level of nucleotide excision repair (NER) gene expression, pediatric oncologists may be able to determine the likelihood of early relapse (less than 3 years) in patients with acute lymphoblastic leukemia (ALL). These findings were published by...
FDA Approves Pembrolizumab for Merkel Cell Carcinoma
Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma. The FDA’s approval was based on Cancer Immunotherapy Trials Network protocol 9...
Cornelis Melief, MD, PhD, Receives 2018 ESMO Immuno-Oncology Award
The European Society for Medical Oncology (ESMO) has selected Cornelis Melief, MD, PhD, to receive the ESMO 2018 Immuno-Oncology Award in recognition of his work studying the interactions of the immune system with cancer. Dr. Melief is Professor Emeritus in Tumor Immunology at the Leiden...
Nicholas J. Petrelli, MD, FACS, Receives Commendation for Excellence Award From Christiana Care Health System
Nicholas J. Petrelli, MD, FACS, Bank of America Endowed Medical Director of the Christiana Care Health System’s Helen F. Graham Cancer Center & Research Institute in Newark, Delaware, recently received the Annual Commendation for Excellence from Christiana Care’s Medical-Dental Staff. An expert ...
Grace Lu-Yao, PhD, Receives SIOG Nursing Award
Grace Lu-Yao, PhD, Associate Director of Population Science at the Sidney Kimmel Cancer Center–Jefferson Health (SKCC), has been honored with the International Society of Geriatric Oncology (SIOG) 2018 Nursing and Allied Health Investigator Award at the SIOG 2018 Annual Conference. Dr. Lu-Yao...
Jonathan Chernoff, MD, PhD, Receives Grant to Investigate RAC1-Mutant Melanoma
Jonathan Chernoff, MD, PhD, Chief Scientific Officer and Stanley P. Reimann Chair in Oncology Research at the Fox Chase Cancer Center, has received a grant from the Melanoma Research Foundation to support research on RAC1-mutant melanoma. The grant will provide $200,000 over 2 years. With this...
CDC Foundation Launches Virtual Tool to Prevent Infections in Patients With Cancer
The Centers for Disease Control and Prevention (CDC) Foundation recently launched an educational tool using virtual human technology to improve patient-provider conversations about neutropenia as a side effect of chemotherapy. This new resource is part of the Preventing Infections in Cancer...
Rishi Jain, MD, MS, DABOM, Joins Fox Chase GI Program
Rishi Jain, MD, MS, DABOM, has joined Fox Chase Cancer Center as Assistant Professor in the Gastrointestinal (GI) Medical Oncology Program. After graduating from Fox Chase/Temple University Fellowship Training Program, Dr. Jain moved on to the Gastrointestinal Medical Oncology Program at The Ohio...
Will the Trump Administration’s Plan to Reduce Cancer Drug Prices Work?
High drug prices are the number one health-care concern of many Americans. The average price of a cancer drug rose from less than $10,000/yr before 2000 to more than $170,000/yr in 2017.1-3 Between 1995 and 2013, the launch price of cancer drugs increased by 10% to 12% every year, and the average...
KATHERINE Trial: Adjuvant T-DM1 Reduces Invasive Disease Risk by 50% vs Trastuzumab in HER2-Positive Early Breast Cancer
In patients with HER2-positive early breast cancer and residual disease after neoadjuvant chemotherapy, adjuvant treatment with trastuzumab emtansine (T-DM1; Kadcyla) reduced the risk of invasive disease by 50% over trastuzumab (Herceptin).1 The phase III KATHERINE study was presented at the 2018...
ESMO Immuno-Oncology 2018: Does Proton Pump Inhibitor Therapy Impact the Efficacy of Nivolumab Plus Ipilimumab?
Patients with melanoma receiving proton pump inhibitors for comorbidities derived approximately half the clinical benefit from immunotherapy consisting of nivolumab (Opdivo) plus ipilimumab (Yervoy) as patients receiving the same combination but not treated with proton pump inhibitors, according to ...
ESMO Immuno-Oncology 2018: MYSTIC: First-Line Durvalumab With or Without Tremelimumab in Metastatic NSCLC
First-line immunotherapy with durvalumab (Imfinzi) or the combination of durvalumab and tremelimumab does not improve overall survival in unselected patients with lung cancer, according to late-breaking results from the MYSTIC trial presented by Rizvi et al at the European Society for Medical...
ESMO Immuno-Oncology 2018: KEYNOTE-010: Long-Term Treatment With Pembrolizumab in Previously Treated NSCLC
Patients with previously treated, advanced non–small cell lung cancer (NSCLC) who received pembrolizumab (Keytruda) showed significantly longer overall survival (OS) compared to those treated with docetaxel, Herbst et al reported at the ESMO Immuno-Oncology Congress 2018 in Geneva,...
FDA Approves Romiplostim for Pediatric Patients With Immune Thrombocytopenia
On December 14, 2018, the U.S. Food and Drug Administration (FDA) approved romiplostim (Nplate) for pediatric patients at least 1 year old with immune thrombocytopenia for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Approval was based ...
FDA Approves Trastuzumab-pkrb for HER2-Overexpressing Breast Cancer
On December 14, the U.S. Food and Drug Administration (FDA) approved trastuzumab-pkrb (Herzuma), a HER2/neu receptor antagonist biosimilar to trastuzumab (Herceptin), for the following indications: Adjuvant breast cancer of HER2 overexpressing node-positive or node-negative (estrogen...
Genetic Assay May Help Predict Disease Relapse in Patients With Gastroesophageal Cancer
A seven-gene assay could improve care for patients with gastroesophageal cancer by predicting their likelihood of relapse after chemotherapy and surgery. These findings were published by Smyth et al in Annals of Oncology. A team at The Institute of Cancer Research (ICR), London, and The Royal...
Does Tailored Lifestyle Feedback Given During Colorectal Cancer Screening Improve Disease-Preventive Behaviors?
A program that provided individually tailored lifestyle recommendations for patients undergoing screening for colorectal cancer helped encourage healthy behavior, according to results published by Knudsen et al in Cancer Epidemiology, Biomarkers & Prevention. “It is well known that...
Aggressive Squamous Cell Carcinoma in Solid Organ Transplant Recipients
Squamous cell carcinoma (SCC) is the most frequently diagnosed cancer in recipients of a solid organ transplant. When organ transplant recipients are diagnosed with SCC, they are also at higher risk for a more aggressive disease course, metastasis, and death than the general population. Researchers ...
CIMRA Assay for Detection of Gene Variants in Lynch Syndrome
An international team of researchers has developed, calibrated, and validated a novel tool for identifying the genetic changes in Lynch syndrome genes that are likely to be responsible for causing symptoms of the disease. The results were published by Drost et al in Genetics in Medicine. ...
Alexander B. Pine, MD, PhD, on Practices and Preferences for Anticoagulant Therapy in Treating VTE
Alexander B. Pine, MD, PhD, of Yale School of Medicine, discusses a survey gathering data on health-care providers’ practices and preferences in using direct oral anticoagulant therapy to treat venous thromboembolism. Readers of The ASCO Post are invited to participate in this research by...
RSNA 2018: Mammography Screening Beyond Age 75
Women aged 75 years and older may benefit from continued screening mammograms because of the comparatively high incidence of breast cancer found in this age group, according to a study presented at the Annual Meeting of the Radiological Society of North America (RSNA) (Abstract SSA01-04)....
RSNA 2018: Breast Cancer Risk-Based Mammography Screening in Younger Women
A new, large-scale study of more than 5 million mammograms found that annual mammography screening beginning at age 30 may benefit women with at least 1 of 3 specific risk factors: dense breasts, a personal history of breast cancer, or a family history of breast cancer. The study was presented at...
