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Showing 6801 - 6850FDA Pipeline: Designations for Treatments of Graft-vs-Host-Disease, Colorectal Cancer, Pancreatic Cancer, and More
The U.S. Food and Drug Administration (FDA) recently issued the following new designations and clearances: Fast Track Designation for Itolizumab for the Treatment of Acute Graft-vs-Host Disease The FDA granted Fast Track designation to itolizumab for the treatment of acute graft-vs-host ...
BRCA Exchange: Resource Aggregates Data on BRCA Variants
A global resource that includes data on thousands of inherited variants in the BRCA1 and BRCA2 genes is available to the public. The BRCA Exchange was created through the BRCA Challenge, a long-term demonstration project initiated by the Global Alliance for Genomics and...
Study Identifies Prognostic Biomarker in HPV-Related Head and Neck Cancers
A study investigating how to identify and treat patients with high- and low-risk human papillomavirus (HPV)-related oropharyngeal squamous cell carcinoma has demonstrated variations in HPV-related molecules among HPV-positive cases of the disease. Using their findings, the investigators developed a ...
27% Drop in Overall U.S. Cancer Mortality Rate From 1991 to 2016
A steady 25-year decline has resulted in a 27% drop in the overall cancer death rate in the United States between 1991 and 2016. The data come from “Cancer Statistics, 2019,” the American Cancer Society’s annual report on cancer rates and trends. The report was published in CA: A...
Higher Incidence of Brain and CNS Tumors Among People Living in Appalachia
A recent study published by Ostrom et al in the Journal of Neuro-Oncology showed that compared to the rest of the United States, the Appalachian region has a 5% higher incidence of malignant primary brain tumors and other central nervous system (CNS) tumors, a higher mortality rate due to ...
Gleason 6 Score May Underestimate Prostate Cancer Mortality Risk in Black Men
Black men diagnosed with prostate cancer classified as low risk may actually have a more aggressive form of the disease that is more likely to be fatal than in nonblack men placed in the same prognostic category, according to results from a new study published as a research letter by Mahal et al in ...
Quality of Life and Patient- and Clinician-Reported Cumulative Toxicity
New research has found that quality of life for people with cancer is reduced by an accumulation of low-level toxicities just as much as it is from high-level adverse events. Additionally, patient-reported outcomes were more likely to reflect the impact on a patient’s physical well-being than ...
New Study Examines Orphan Drug Exclusivity and Pricing
A new report commissioned by the National Organization for Rare Disorders (NORD) and published by the IQVIA Institute demonstrates that the 7-year market exclusivity granted to drugs designated under the Orphan Drug Act of 1983 for rare diseases is working as intended. In nearly every case, orphan...
Transformation of EGFR-Mutant NSCLC to SCLC
In a study reported in the Journal of Clinical Oncology, Marcoux et al provided further evidence that EGFR-mutant non–small cell lung cancer (NSCLC) can undergo transformation to small cell lung cancer (SCLC) and identified factors associated with such transformation. It has been estimated...
Study Assesses Impact of Digital Mammography on Breast Cancer Detection and Recall Rates
The shift from film to digital mammography increased the detection of breast cancer overall in the United Kingdom—without increasing the recall rate—according to a study published by Blanks et al in Radiology. “Image quality with digital mammography is improved over that of...
High Long-Term Risk of Solid Cancers in Survivors of Childhood Hodgkin Lymphoma
A new study may bolster existing evidence that survivors of childhood Hodgkin lymphoma face an elevated risk of developing various types of solid tumors many years later. The study showed that certain subgroups of patients have an especially high risk. Published by Holmqvist et al in the journal...
FDA Approves Tagraxofusp-ezrs for Blastic Plasmacytoid Dendritic Cell Neoplasm
On December 21, the U.S. Food and Drug Administration (FDA) approved tagraxofusp-erzs (Elzonris) infusion for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients aged 2 years and older. “Prior to [this] approval, there had been no...
ASCO and ESMO Publish Joint Assessment of Their Value Frameworks
TO BETTER UNDERSTAND the performance characteristics of ASCO’s Value Framework Net Health Benefit Score version 2 (ASCO-NHB v2)1 and the European Society for Medical Oncology’s (ESMO’s) Magnitude of Clinical Benefit Scale version 1.1 (ESMO-MCBS v1.1),2 ASCO and ESMO undertook a joint project to...
I Welcome Being the Face of Multiple Myeloma
Thirteen years ago, at age 34, I was healthy and enjoying life. I went to the gym almost daily, and when I wasn’t at the gym, I was shooting hoops with my friends. During a gym workout while on a family vacation, I suddenly felt excruciating pain in my left shoulder and thought I must have strained ...
For Maria Papaleontiou, MD, Research Holds the Key to Improving Care of Patients With Thyroid Cancer
Maria Papaleontiou, MD, whose research interests focus on the complex issues surrounding the management of thyroid cancer and thyroid disease in general, was born on Cyprus, a small island nestled in the azure waters of the Mediterranean Sea. She recently spoke with The ASCO Post about her life and ...
Stories of the Scientists Behind Immunotherapy
As the field of immunotherapy accelerates, so does the literature reporting on the path ahead. One of the newer books on the topic is A Cure Within: Scientists Unleashing the Immune System to Kill Cancer. It has a top-notch pedigree: the author, Neil Canavan, is a seasoned journalist with more than ...
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...
Pembrolizumab in Sorafenib-Pretreated Hepatocellular Carcinoma
ON NOVEMBER 9, 2018, pembrolizumab (Keytruda) was granted accelerated approval for treatment of patients with hepatocellular carcinoma previously treated with sorafenib (Nexavar).1,2 Supporting Efficacy Data APPROVAL WAS BASED on durable responses in the phase II KEYNOTE-224 trial...
Venetoclax in Combination Regimens for Older Patients With AML or Those With Comorbidities Precluding Intensive Induction
On November 21, 2018, venetoclax (Venclexta) was granted accelerated approval for use in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in patients aged ≥ 75 years or who have comorbidities that preclude the use of ...
Managing the Cost of Cancer Care
A cancer diagnosis is often overwhelming. Adding financial burden to the mix can sometimes feel unmanageable. Provide your patients with practical guidelines with the Managing the Cost of Cancer Care booklet from ASCO. It covers health insurance benefits, information about the Affordable Care Act,...
Breakthroughs Save Lives: ASCO’s Conquer Cancer Foundation Launches National Awareness Campaign
“I realized I just couldn’t wait for a new treatment option,” a determined Breelyn Wilky, MD, says, staring into the camera. “I had to find one.” If you missed the debut of the “Breakthroughs Save Lives” video during the 2018 ASCO Annual Meeting, look for it on television and online as part of a...
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...
Global Oncology Education and Professional Development: ASCO International’s Impact
ASCO is such a misnomer: the American Society of Clinical Oncology is far more than simply “American.” Over the past several years, I (a Canadian-born breast surgical oncologist, with an Indian-born mother and a Tanzanian-born father) have traveled to Zimbabwe, Bhutan, and the Philippines with this ...
FDA Announces New Updates to Expanded Access Program
The U.S. Food and Drug Administration (FDA) recently announced new changes to expand and update the Expanded Access (EA) program, which allows very ill patients access to experimental treatments outside of clinical trials. The most recent updates include: Clarifications on Safety Data: The FDA...
Apply to Join ASCO’s Education Council by January 31
ASCO is seeking leaders in education to join its Education Council. The Council consists of ASCO members who are committed to advancing ASCO’s educational mission. Specific responsibilities of the Council include prioritizing programs to address educational gaps, advising on the latest in...
Check Out the Top Five Most Popular ASCO University Courses of 2018
New to ASCO University’s e-learning offerings and not sure where to start? With a comprehensive course catalog that spans tumor types, practice information, and other aspects of cancer care, choosing a course can be a challenge. To help get you started, here is a list of the most popular courses of ...
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...
Study Findings on Myeloproliferative Neoplasms Including Systemic Mastocytosis
HERE IS AN UPDATE on six different studies featured at the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition. Topics focused on novel treatments for myelofibrosis, polycythemia vera and essential thrombocythemia, as well as systemic mastocytosis. Myelofibrosis ABSTRACT...
Lorlatinib in Second- or Third-Line Treatment of ALK-Positive Metastatic Non–Small Cell Lung Cancer
On November 2, 2018, lorlatinib (Lorbrena) was granted accelerated approval for the treatment of patients with ALK-positive metastatic non–small cell lung cancer (NSCLC) whose disease has progressed on crizotinib (Xalkori) and at least one other ALK inhibitor for metastatic disease or whose disease ...
How to Build a Clinical Trial Infrastructure in the Community Oncology Setting
HISTORICALLY, CLINICAL research has been viewed as an entity belonging to academic settings alone. With the advent of the Community Clinical Oncology Program (CCOP) in the 1980s and later with the Cancer Trials Support Unit, cancer clinical trials have begun to emerge in the community setting....
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...
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 ...
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...
Optimal Duration of Checkpoint Inhibition in Melanoma Is No More Than 2 Years
For patients with advanced melanoma, the concept of treating to disease progression does not always apply. With many patients responding to checkpoint inhibition for years, when can treatment be safely discontinued? This important clinical question was addressed at the European Society for Medical...
Pembrolizumab Plus Chemoradiotherapy in HPV-Positive Head and Neck Cancer
The addition of pembrolizumab (Keytruda) to a chemoradiotherapy regimen yielded complete response rates of 85% in patients with human papillomavirus (HPV)-positive advanced squamous cell carcinoma of the head and neck. These findings from a phase Ib study were presented at the 2018 Society for...
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...
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...
The Great Opioid Debate: Treating Cancer Pain Safely
As the number of opioid-related deaths continues to rise in the United States, stakeholders are struggling to make sense of the crisis. At the 2018 Palliative and Supportive Care in Oncology Symposium, two experts in the field, Charles F. von Gunten, MD, PhD, and Leslie J. Blackhall, MD,...
Immunotherapy-Related Toxicities May Be More Common Than Originally Reported
Immunotherapy has significantly improved the overall survival of patients with non–small cell lung cancer (NSCLC) and is generally better tolerated than traditional chemotherapies, but the results of a retrospective study suggested that immunotherapy side effects may be more common than initially...
Has Scalp Cooling Reached the Level of Standard of Care?
Does evidence of the effectiveness and safety of scalp cooling to reduce hair loss among women being treated for breast cancer mean that scalp cooling is a new standard of care? “I would suggest that it is,” stated Mikel Ross, MSN, RN, AGNP-BC, of the Breast Medicine Service, Memorial Sloan...
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...
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...
Expert Point of View: Joseph C. Alvarnas, MD
“When people don’t respond [to chimeric antigen receptor (CAR) T-cell therapy] as well as they should, it may be that the T cells are depleted and functionally exhausted. The mechanism of exhaustion is in part mediated by checkpoint-related killing. By thwarting that process with pembrolizumab...
Combining a Checkpoint Inhibitor With CAR T-Cell Therapy May Augment Immune Response
Chimeric antigen receptor (CAR) T-cell therapy is a revolutionary approach to treating hematologic malignancies. As experience with this strategy is gained, researchers are learning more about how to optimize responses, especially in patients with “immune exhaustion,” who have a suboptimal initial...
Expert Point of View: Joseph C. Alvarnas, MD, and Henry Fung, MD
Commenting on the ibrutinib (Imbruvica)/chimeric antigen receptor (CAR) T-cell approach at a press conference, Joseph C. Alvarnas, MD, said: “Patients with CLL do not do as well on CAR T-cell therapy as those with B-cell acute lymphoblastic leukemia, and by combining ibrutinib with CAR T cells,...
Early Studies of Ibrutinib Plus CAR T-Cell Combination in Chronic Lymphocytic Leukemia
Researchers are combining chimeric antigen receptor (CAR) T-cell therapy with ibrutinib (Imbruvica) as a means of augmenting and deepening responses in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). Two pilot studies presented at the 2018 American Society of Hematology...
Larotrectinib for Solid Tumors With NTRK Gene Fusions
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On November 26, 2018, larotrectinib (Vitrakvi) was...
