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Showing 5301 - 5350Statement 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and class labeling of in vitro companion diagnostics for classes of oncology therapeutic products: “With a new draft guidance document that the FDA issued … our aim is to make it easier to get class labeling ...
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...
Minimally Invasive vs Open Abdominal Radical Hysterectomy in Early-Stage Cervical Cancer
TWO STUDIES recently reported in The New England Journal of Medicine indicate that minimally invasive radical hysterectomy is associated with poorer survival outcomes than open abdominal radical hysterectomy in women with early-stage cervical cancer. As reported by Pedro T. Ramirez, MD, of 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...
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...
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...
Fixed-Duration Venetoclax Plus Rituximab in Relapsed or Refractory CLL
In patients with relapsed or refractory chronic lymphocytic leukemia (CLL), fixed-duration venetoclax -(Venclexta) combined with rituximab (Rituxan) reduced the risk of disease progression or death compared with standard-of-care bendamustine/rituximab, according to longer-term follow-up of the...
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...
Disease-Free Survival With Letrozole vs Placebo After Aromatase Inhibitor–Based Therapy in Postmenopausal Breast Cancer
As reported by Mamounas et al in The Lancet Oncology, the phase III NRG Oncology/NSABP B-42 trial has shown no disease-free survival benefit with 5 years of letrozole (Femara) vs placebo after 5 years of aromatase inhibitor–based therapy in women with hormone receptor–positive...
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...
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...
Controlling the Global Burden of Liver Cancer
The burden of mortality related to liver cancer is increasing worldwide. Prevention and control of viral hepatitis will be vital in combating this burden, but curbing the growing epidemic of obesity must also be seen as a key part of liver cancer prevention, according to Rosmawati Mohamed, MD, of...
Low-Dose CT Lung Screening: New Developments Support Increased Quality, More Data, Deep Learning
Two years ago, Rick Avila, MS, Chief Executive Officer (CEO) of Accumetra, LLC, was using rolls of Scotch tape as a research tool. The Scotch tape was a phantom, or reference object, and his company was working with computed tomography (CT) lung screening sites around the world to determine the...
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...
Expert Point of View: Carlos L. Arteaga, MD, Laura J. Esserman, MD, MBA, and Joseph Sparano, MD
“This study supports the use of neoadjuvant chemotherapy,” commented press conference moderator Carlos L. Arteaga, MD, of the Simmons Cancer Center at UTSouthwestern Medical Center in Dallas. “It did not matter whether patients received adjuvant therapy, as long as they had achieved a pathologic...
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...
Expert Point of View: Aaron T. Gerds, MD, MS
At a press conference where the ECOG-ACRIN E1912 presentation and related issues were discussed, session moderator Aaron T. Gerds, MD, MS, of the Cleveland Clinic Taussig Cancer Center, was quite enthusiastic about these results. “I believe these results should change clinical practice....
Expert Point of View: Eric P. Winer, MD, and Jame Abraham, MD
Commenting on the findings of the KATHERINE trial were Eric P. Winer, MD, Director of the Breast Oncology Program in the Susan F. Smith Center for Women’s Cancers at Dana-Farber Cancer Institute and the Thompson Senior Investigator in Breast Cancer Research andProfessor of Medicine at Harvard...
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: 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...
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. ...
Reducing Infections in Patients With AML Receiving Induction and Reinduction Chemotherapy
In a report in the Journal of Oncology Practice, Morris et al described an initiative that has been successful in reducing the incidence of invasive fungal infections in patients with acute myeloid leukemia (AML) receiving induction and reinduction therapy at the University of Virginia Health...
Eicosapentaenoic Acid and Aspirin in Preventing Colorectal Adenomas
In a UK trial (seAFOod Polyp Prevention) reported in The Lancet by Hull et al, no differences in adenoma prevention were found after treatment with omega-3 polyunsaturated fatty acid eicosapentaenoic acid (EPA), aspirin, both, or placebo in patients with high-risk findings on colonoscopy. On the...
ASCO and Friends of Cancer Research Applaud NCI’s Expansion of Clinical Trial Eligibility Criteria
ASCO and Friends of Cancer Research (Friends) applaud the National Cancer Institute's (NCI) recent revision of its clinical trial protocol template to broaden eligibility criteria for cancer clinical trials. The protocol template was expanded to help increase the opportunity for ...
FDA Pipeline: New Priority Reviews, Designations, and Clearances, Plus Statements on Genetic Testing and Class Labeling
The U.S. Food and Drug Administration (FDA) recently issued the following new approvals and designations: Priority Review for Atezolizumab in Combination With Chemotherapy for the Initial Treatment of Extensive-Stage SCLC The FDA accepted a supplemental biologics license application...
Every Cancer Treatment Plan Is Different—Help Your Patients Learn About What to Expect
YOUR PATIENTS can be active partners in their treatment. Address patient concerns and questions about core types of treatment with affordable printed materials from ASCO Answers. Topics include oral chemotherapy, understanding immunotherapy, understanding blood test results, and much more. Many of ...
2019 Medicare Physician Fee Schedule and Quality Payment Program Final Rule Released
AT THE BEGINNING of November, the Centers for Medicare & Medicaid Services (CMS) released the final rule for the Medicare Physician Fee Schedule and Quality Payment Program (QPP) outlining reimbursement changes for 2019. CMS estimates that the overall impact will be a 1% reimbursement cut for...
Oncology Care Team Reduces Opioid Use After Surgery by Using Quality Improvement Approach
IN A QUALITY improvement project that was featured in the Quality Care Symposium press program,1 members of an oncology care team achieved a 46% reduction in opioid use among patients who underwent a range of urologic surgeries. They did this by using a systemic approach that identified multiple...
Role of Genomic Profiling in Younger Patients With Cancer
Although overall cancer survival rates continue to improve among all age groups in the United States—there are currently an estimated 15.5 million cancer survivors, and that number is expected to increase to 20.3 million by 20261—survival rates for adolescents and young adults with cancer (AYAs)...
Oncology Researcher Catherine J. Wu, MD, Always Knew She Wanted to Be a Doctor
Catherine J. Wu, MD, Professor at Dana-Farber Cancer Institute, was reared in a medical environment, which shaped her career path as a physician-scientist. “Both of my parents are physicians and were trained in internal medicine. Medicine was always part of my life as I grew up, and it seemed like...
Moxetumomab Pasudotox-tdfk for Relapsed or Refractory Hairy Cell Leukemia
ON SEPTEMBER 13, 2018, moxetumomab pasudotox-tdfk (Lumoxiti), a CD22-directed cytotoxin, was approved for the treatment of adult patients with relapsed or refractory hairy cell leukemia who received at least two prior systemic therapies, including with a purine nucleoside analog.1,2 Supporting...
Encorafenib and Binimetinib: A New Benchmark in Metastatic Melanoma Therapy?
IN JULY 2018, the U.S. Food and Drug Administration (FDA) approved the combination of the oral BRAF inhibitor encorafenib (Braftovi) and the oral MEK inhibitor binimetinib (Mektovi) for BRAF V600E– or V600K– positive metastatic melanoma. The FDA approval was based on the results of the COLUMBUS...
Duvelisib for Relapsed or Refractory CLL/SLL and for Relapsed or Refractory Follicular Lymphoma
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 September 24, 2018, duvelisib (Copiktra) was granted...
Shedding Light on Mechanisms of Resistance to Treatment of Metastatic Castration-Resistant Prostate Cancer
ONE OF the pressing issues in metastatic castration-resistant prostate cancer is the development of resistance to therapies directed at the androgen receptor (AR), such as enzalutamide (Xtandi) and abiraterone acetate (Zytiga). Research is ongoing to identify mechanisms of resistance in the hope of ...
Management of HER2-Positive Breast Cancer: Business as Usual?
MANAGEMENT OF HER2-positive breast cancer changed after the introduction of trastuzumab (Herceptin), the first anti-HER2 therapy to be approved by the U.S. Food and Drug Administration (FDA) for this type of cancer. Recent studies have more clearly defined the role of pertuzumab (Perjeta) and...
PARP Inhibitor Active in BRCA1/2-Mutated Metastatic Castration-Resistant Prostate Cancer
THE SEARCH for biomarkers in prostate cancer has proved frustrating, partly due to the complexity of the disease and its heterogeneity. A preliminary analysis of a phase II (TRITON2) study suggests that rucaparib (Rubraca), a poly (ADP-ribose) polymerase (PARP) inhibitor, may be active in men with...
Expert Point of View: Laurie H. Sehn, MD
LAURIE H. SEHN, MD, Chair, Lymphoma Tumour Group, BC Cancer Agency, Vancouver, British Columbia, Canada, said these results are not unexpected and support de-escalation in selected patients. “The FLYER trial evaluates treatment with four cycles compared with six cycles of cyclophosphamide,...
Should Oncologists Recommend Cannabis?
A RECENT survey of 400 clinical oncologists found that 80% discuss the use of medical cannabis with their patients, and although nearly 50% recommend it, fewer than 30% consider themselves knowledgeable enough to make such recommendations.1 Oncologists are perhaps among the most evidence-demanding ...
Expert Point of View: Susan M. O’Brien, MD
THE STUDY’S discussant, Susan M. O’Brien, MD, Associate Director for Clinical Science, Chao Family Comprehensive Cancer Center, University of California Irvine Health, said the results of the Alliance North American Intergroup Study A041202—demonstrating that ibrutinib (Imbruvica) is more...
Ibrutinib vs Standard of Care in Front-Line Treatment of Older Patients With Chronic Lymphocytic Leukemia
IBRUTINIB (IMBRUVICA) as a front-line agent proved superior to standard-of-care chemoimmunotherapy for chronic lymphocytic leukemia (CLL) in older patients in A041202, an Alliance-led National Clinical Trials Network study.1 At a follow-up of 38 months, the median progression-free survival was not ...
SABCS 2018: Oxybutynin for the Management of Hot Flashes in Women Unable to Receive Hormone Replacement Treatment
Treatment with oxybutynin helped reduce the frequency and intensity of hot flashes for women who could not take hormone replacement therapy, including breast cancer survivors, according to the results of a trial presented at the 2018 San Antonio Breast Cancer Symposium by Leon-Ferre et al (Abstract ...
SABCS 2018: TAILORx Results Show Association Between Clinical Outcomes in Breast Cancer and Race
An analysis of the association between clinical outcomes and race in participants enrolled in the TAILORx trial found that even with equivalent treatments among women with hormone receptor–positive, HER2-negative breast cancer, black women had worse clinical outcomes than white women, despite ...
Neurologic Knowledge to Enhance Well-Being and Happiness
BOOKMARK Title: Your Happy Brain: Why and How to Hug ItAuthors: Philomena Lawrence, BA, BEd, and Gilbert Lawrence, MD, FRCRPublisher: CreateSpace Independent Publishing PlatformPublication date: June 2018Price: $16.00, paperback, 390 pages Some 2,400 years ago, the ancient Greeks were among the...
SABCS 2018: AMAROS Trial: 10-Year Follow-up of Axillary Radiotherapy or Surgery in Early-Stage Breast Cancer
Patients with early-stage breast cancer who had cancer detected in a sentinel lymph node biopsy had comparable 10-year recurrence and survival rates following either axillary radiotherapy or axillary lymph node dissection, according to data from the randomized, phase III AMAROS clinical trial...
Denial’s Many Faces
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,...
University Collaboration Aims to Tackle Cancer Health Disparities
The National Cancer Institute has provided a grant to develop a joint cancer drug discovery/development and research education program to focus on cancers that have an increased risk of incidence and/or mortality among underserved communities, namely African Americans, Hispanics, and Native...
