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Showing 8801 - 8850FDA Approves HPV Test for First-Line Cervical Cancer Screening
ON JULY 30, 2018, Roche announced approval by the U.S. Food and Drug Administration (FDA) of its cobas HPV Test in first-line screening for cervical cancer in women 25 years and older using cervical specimens collected in SurePath preservative fluid. The FDA first approved the cobas HPV test...
Meeting the Challenges of Immunotherapy-Related Toxicities
In 2011, the U.S. Food and Drug Administration (FDA) approved ipilimumab (Yervoy), an anticytotoxic T-lymphocyte– associated antigen 4 (CTLA-4), the first checkpoint inhibitor for the treatment of advanced melanoma.1 Since then, several more checkpoint inhibitors directed at both the programmed...
My Incidentally Discovered Cancer
In February 2015, there was no indication that my life was about to radically change. I was a practicing attorney and happily raising two young children with my husband. At 40 years old, I was healthy—or so I thought—and had no physical symptoms to alert me to the devastating news that was about to ...
Ensuring Quality With Patient-Reported Outcomes and Electronic Health Records
Accurately assessing the quality of cancer care over the continuum of treatment requires a special set of metrics and data-gathering methods. Moreover, with a growing number of cancer survivors, the post-treatment care involves primary care providers who are adept at managing the comorbidities...
ASCO Statement: Step Therapy Creates Barriers to Care for Medicare Advantage Beneficiaries With Cancer
Monica M. Bertagnolli, MD, FACS, FASCO, ASCO President, released the following statement today: “ASCO strongly opposes the Centers for Medicare & Medicaid Services (CMS) decision to allow Medicare Advantage plans to employ step therapy across physician-administered and self-administered...
Is Some DNA Worthless?
BOOKMARK Title: Junk DNA: A Journey Through the Dark Matter of the GenomeAuthor: Nessa CareyPublisher: Columbia University PressOriginal publication date: April 2015Price: $22.95, paperback, 360 pages When biologists first delved into the human wonder of genes in the 1970s, they eventually...
A Celebrity Gadfly’s Reflections on His Death and Other Things Meant to Irritate
BOOKMARK Title: MortalityAuthor: Christopher HitchensPublisher: Twelve: Hachette Book GroupOriginal Publication Date: May 13, 2014Price: $19.95, paperback, 128 pages “There are no atheists in foxholes” is an aphorism used to contend that in times of extreme fear, such as during war or facing a...
The Story of a Notorious Cluster of Childhood Cancers
BOOKMARK Title: Toms River: A Story of Science and SalvationAuthor: Dan FaginPublisher: Random HouseOriginal publication date: March 2013Price: $28.00, hardcover, 560 pages The Toms River emerges in the Pine Barrens of northern Ocean County, New Jersey, and zigzags through wetlands, emptying into...
NIH and Prostate Cancer Foundation Launch Large Study on Aggressive Prostate Cancer in African American Men
The largest coordinated research effort to study biologic and nonbiologic factors associated with aggressive prostate cancer in African American men has begun. The $26.5 million study is called RESPOND, or Research on Prostate Cancer in Men of African Ancestry: Defining the Roles of Genetics, Tumor ...
FDA Approves First Treatment for Rare Adrenal Tumors
On July 30, 2018, the U.S. Food and Drug Administration (FDA) approved iobenguane I 131 injection (Azedra) for intravenous use in the treatment of adults and adolescents aged 12 and older with unresectable pheochromocytoma or paraganglioma that have spread beyond the original tumor site and require ...
Is Universal Health Care a Human Right?
The Affordable Care Act (ACA) provided oncology services to people with cancer who had previously been denied coverage. And for that reason alone, many oncologists supported its passage. However, even though the U.S. health-care system remains in the crosshairs of partisan politics, parties on both ...
ASCO and Friends Submit Recommendations to FDA Aimed at Reducing Barriers to Clinical Trial Participation
ASCO and Friends of Cancer Research (Friends) have submitted recommended language to the U.S. Food and Drug Administration (FDA) for five guidance documents on ways to broaden eligibility criteria for cancer clinical trials. The recommendations are part of an ASCO...
Guidelines for Pediatric CAR T-Cell Therapy Developed
Almost 1 year after the U.S. Food and Drug Administration (FDA) approval of chimeric antigen receptor (CAR) T-cell therapy for children with acute lymphoblastic leukemia (ALL), researchers at The University of Texas MD Anderson Cancer Center and the Pediatric Acute Lung Injury and...
Utilization of Hypofractionated Radiation Therapy in Breast Cancer
Researchers at the Feinstein Institute for Medical Research and Northwell Health’s Department of Radiation Medicine have identified methods to increase use of the radiation therapy hypofractionation in patients with breast cancer. These findings, published by Gilbo et al...
Lung Cancer Screening Guidelines May Be Inadequate for High-Risk Minorities
Data from a lung cancer screening program at the University of Illinois at Chicago (UIC) provides evidence that national lung cancer screening guidelines, which were developed based on the National Lung Screening Trial (NLST) in 2011 and recommend screening based on age and smoking history, may be...
Cedars-Sinai Affiliate Announces New Cancer Center to Open in 2019
The Torrance Memorial Medical Center, a Cedars-Sinai Medical Center affiliate, recently announced the opening of a new cancer center. The new Hunt Cancer Center will provide patients with access to subspecialists who treat more than 60 types of common, rare, and complex cancers. As part of the...
FDA Expands Ribociclib Indication in Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer
On July 18, 2018, the U.S. Food and Drug Administration (FDA) expanded the indication for ribociclib (Kisqali), in combination with an aromatase inhibitor for pre/perimenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based...
NCCN Announces New Patient Guideline in Liver, Gallbladder, and Bile Duct Cancers
The National Comprehensive Cancer Network® (NCCN®) has released a new resource to help patients with liver, gallbladder, and bile duct cancers better understand their diagnosis and treatment options. This new edition of the NCCN Guidelines for Patients® takes the evidence-based, expert consensus...
ACS Commission on Cancer Announces Outstanding Achievement Awards
The Commission on Cancer of the American College of Surgeons (ACS) has granted its 2017 Outstanding Achievement Award to a select group of 16 accredited cancer programs throughout the United States. Award criteria were based on qualitative and quantitative surveys of cancer programs conducted...
Andrea M. Abbott, MD, Joins Fox Chase Cancer Center
The Fox Chase Cancer Center recently announced the addition of Andrea M. Abbott, MD, as Assistant Professor in the Department of Diagnostic Imaging. She joined the team that uses imaging technology to aid in cancer diagnosis, staging, and guidance of treatment. Dr. Abbott comes to Fox Chase after...
Researchers at Baylor Awarded Multiple Grants to Study Treatment Resistance in Breast Cancer
To better understand the causes of resistance to treatment in estrogen receptor–positive breast cancer, the Department of Defense has awarded researchers at Baylor College of Medicine multiple grants to study gene anomalies in estrogen receptor–positive breast cancer that are associated with...
St. Baldrick’s Foundation Announces 2018 Summer Grant Recipients
The St. Baldrick’s Foundation has announced its 2018 summer grant recipients, including seven from Baylor College of Medicine and Texas Children’s Cancer and Hematology Centers. 2018 Recipients Nmazou Ozuah, MD, Assistant Professor of Pediatrics, received an international scholar grant for...
FDA Approves Mogamulizumab-kpkc for Two Rare Types of Non-Hodgkin Lymphoma
Today, the U.S. Food and Drug Administration approved mogamulizumab-kpkc (Poteligeo) injection for intravenous use for the treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy. This approval provides a new...
FDA Warns of Increased Risk of Cancer Relapse With Long-Term Use of Azithromycin After Allogeneic Stem Cell Transplant
The U.S. Food and Drug Administration (FDA) is warning that the antibiotic azithromycin should not be given on a long-term basis to prevent the inflammatory lung condition bronchiolitis obliterans syndrome in patients with cancers of the blood or lymph nodes who undergo a donor stem cell...
Research Finds Failings in Some Apps Used for the Diagnosis of Skin Cancer
In the scramble to bring successful apps for the diagnosis of skin cancer to market, there is a concern that a lack of testing is risking public safety, according to research led by the University of Birmingham. The research, outlined at the British Association of Dermatologists Annual...
New Tool for Assessing Frailty in Patients With Newly Diagnosed Multiple Myeloma
A NEW “frailty index” may predict overall survival for patients newly diagnosed with multiple myeloma, according to a study published in JCO Clinical Cancer Informatics.1 Frailty is a critical factor in treatment decision-making for many patients with multiple myeloma, as many of these patients are ...
Expert Point of View: Rajesh Lalla, DDS, PhD
COMMENTING ON the results of this trial of GC4419, Rajesh V. Lalla, DDS, PhD, President of the Multinational Association of Supportive Care in Cancer, said, “This study demonstrated this agent’s strong potential for the management of oral mucositis in patients receiving head and neck radiation...
More Antibody-Drug Conjugates Expected to Impact Treatment of Lymphoma
FOR THE TREATMENT of lymphoma, antibody-drug conjugates (ADCs) are becoming an important class of drugs, as described at the 2018 Pan Pacific Lymphoma Conference by Brad Kahl, MD, Professor of Medicine at Washington University School of Medicine, St. Louis.1 “We have one ADC—brentuximab vedotin...
Rebecca Yang, MD, Joins Atlantic Health System
BREAST SURGEON Rebecca C. Yang, MD, has joined Atlantic Breast Associates at Overlook Medical Center and Carol G. Simon Cancer Center, part of Atlantic Health System Cancer Care, in New Jersey. Dr. Yang is a board-certified general surgeon and fellowship-trained breast surgeon. She joins Atlantic...
The US Oncology Network Promotes Marcus Neubauer, MD, to Chief Medical Officer
THE US ONCOLOGY Network recently announced the appointment of Marcus Neubauer, MD, as Chief Medical Officer, building on its mission of delivering a comprehensive approach to cancer care. Michael Seiden, MD, PhD, will continue to lead The US Oncology Network as its President. Dr. Neubauer has...
Medical Preparedness for Nuclear Disaster
ROBERT PETER GALE, MD, PhD, DSc (hc), was on the faculty of the University of California, Los Angeles, School of Medicine for 20 years and has served as Chairman of the Scientific Advisory Committee of the Center for International Blood and Marrow Transplant Research. In 1986, he was asked by the...
Why Oncologists Should Decline to Participate in the Right to Try Act
ON MAY 30, 2018, President Donald J. Trump signed into law the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017.1 This law creates an additional and alternative pathway for patients with a “life-threatening disease or condition” to access...
FDA Grants Breakthrough Therapy Designation to Quizartinib for Relapsed/Refractory FLT3-ITD AML
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to quizartinib, an investigational FLT3 inhibitor, for the treatment of adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML). Breakthrough Therapy designation is designed to...
Screening for Financial Issues in Adult Survivors of Childhood Cancer
Adult survivors of childhood cancer should be screened for financial problems that might cause them to delay or skip medical care or to suffer psychological distress. The recommendation from St. Jude Children’s Research Hospital researchers followed an analysis that found 65% of...
careHPV Test Receives WHO Prequalification Status for Cervical Cancer Screening
The careHPV Test, a molecular diagnostic for high-risk human papillomavirus (HPV) designed to screen women in low-resource settings, has been added to the World Health Organization (WHO) list of prequalified in vitro diagnostics (IVDs). HPV is the primary cause of cervical cancer, so ...
Immunosuppressants and Cutaneous Squamous Cell Carcinoma in Organ Transplant Recipients
Research published by Jung et al in OncoImmunology showed organ transplant recipients may reduce their risk of developing secondary skin cancer by changing their immunosuppressant medication. University of Queensland (UQ) researchers have studied the impact of such medications on the immune...
Phase III ASTRAL-1 Study of Guadecitabine in Patients With Treatment-Naive AML Ineligible to Receive Intensive Induction Chemotherapy
Results were recently announced from the ASTRAL-1 study evaluating the efficacy and safety of guadecitabine in adults with previously untreated acute myeloid leukemia (AML) who are not eligible for intensive induction chemotherapy. The study did not meet its co-primary endpoints: complete...
FDA Grants Breakthrough Therapy Designation to Lenvatinib Plus Pembrolizumab in Endometrial Carcinoma
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for lenvatinib (Lenvima) in combination with pembrolizumab (Keytruda) for the potential treatment of patients with advanced and/or metastatic non–microsatellite instability high (MSI-H)/proficient...
FDA Approves Ivosidenib for Relapsed or Refractory Acute Myeloid Leukemia
On July 20, 2018, the U.S. Food and Drug Administration approved ivosidenib (Tibsovo) for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test. Approval was based on an open-label, single-arm, multicenter...
American Cancer Society Outlines Blueprint for Cancer Control in the 21st Century
The American Cancer Society (ACS) is outlining its vision for cancer control in the decades ahead in a series of articles that began publishing in early July in CA: A Cancer Journal for Clinicians. The series of articles forms the basis of a national cancer control plan, with a blueprint toward the ...
FDA Grants Orphan Drug Designation to SRF231 for Treatment of Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to SRF231 for the treatment of patients with multiple myeloma. SRF231 is a fully human antibody that inhibits the activity of CD47, a protein overexpressed on many types of cancer cells, which prevents them from being...
Two Phase III Trials of KX2-391 in Actinic Keratosis Achieve Primary Endpoints
Two phase III studies—KX-AK-003 and KX-AK-004—achieved their primary endpoint of 100% clearance of actinic keratosis lesions at day 57 within the face or scalp treatment areas, with each study achieving statistical significance (P < .0001). Statistical significance (P < .001) ...
‘Super-Resolution’ MRI May Help Plan Radiotherapy Treatment in Lung Cancer
Physicists from The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust combined standard two-dimensional magnetic resonance imaging (MRI) images of the chests of healthy volunteers to create 'super-resolution' videos, showing the lungs expanding and contracting. The...
Dabrafenib/Trametinib Combination Receives CHMP Recommendation for the Adjuvant Treatment of BRAF V600 Mutation–Positive Melanoma
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of dabrafenib (Tafinlar) in combination with trametinib (Mekinist) for the adjuvant treatment of adult patients with stage III melanoma...
KEYNOTE-048: Pembrolizumab Monotherapy in Head and Neck Squamous Cell Carcinoma
The phase III KEYNOTE-048 trial, which is investigating pembrolizumab (Keytruda) for first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), met a primary endpoint of overall survival (OS) as monotherapy in patients whose tumors expressed programmed cell death ...
Forum of International Respiratory Societies Issues Statement on World Lung Cancer Day
On World Lung Cancer Day (August 1), the members of the Forum of International Respiratory Societies (FIRS) commemorate, celebrate, and support those impacted by lung cancer. FIRS continues to support the grassroots efforts of the lung cancer community to raise awareness about lung cancer and its...
European Commission Approves Trastuzumab Biosimilar
The European Commission (EC) has approved Trazimera, a biosimilar to trastuzumab (Herceptin), for the treatment of human epidermal growth factor (HER2)–overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. This approval...
New Tool for Assessing Frailty May Aid in Predicting Survival in Newly Diagnosed Multiple Myeloma
A new frailty index may aid in predicting overall survival for patients newly diagnosed with multiple myeloma, according to a study published by Mian et al in JCO Clinical Cancer Informatics. This tool is important because frailty is a critical factor in treatment decision-making for ...
ALTA-1L Trial of Brigatinib vs Crizotinib in ALK-Positive Advanced NSCLC Meets Primary Endpoint
The global, randomized, phase III ALTA-1L (ALK in Lung Cancer Trial of AP26113 in 1st Line) trial met its primary endpoint at the first prespecified interim analysis, with brigatinib (Alunbrig) demonstrating a statistically significant improvement in progression-free...
FDA Approves Lusutrombopag for Thrombocytopenia in Adults With Chronic Liver Disease
Today, the U.S. Food and Drug Administration (FDA) approved lusutrombopag (Mulpleta) for thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure. L-PLUS 1 and L-PLUS 2 Approval was based on two randomized, double-blind, placebo-controlled...
