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Showing 3451 - 3500NCI-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...
FDA Expands Approval of Ipilimumab to Include Pediatric Patients 12 Years and Older With Unresectable or Metastatic Melanoma
Today, the U.S. Food and Drug Administration (FDA) expanded the indication for ipilimumab (Yervoy) injection for intravenous use to now include the treatment of unresectable or metastatic melanoma in pediatric patients 12 years of age and older. Ipilimumab was evaluated in 2 trials of pediatric...
Concurrent Chemotherapy, Proton Therapy May Improve Survival in Patients With Advanced Lung Cancer
For patients with advanced, inoperable stage III lung cancer, concurrent chemotherapy and proton-beam radiotherapy offers improved survival compared to historical data for standard of care, according to a new study from The University of Texas MD Anderson Cancer Center. The research, published by...
Social Interaction May Affect Patients’ Response to Chemotherapy
How well patients with cancer fared after chemotherapy was affected by their social interaction with other patients during treatment, according to a new study by researchers at the National Human Genome Research Institute (NHGRI), part of the National Institutes of Health, and the University of...
ASCO-AACI’s Best Practices in Cancer Clinical Trials Initiative: Streamlining Adverse Events Reporting and Research Community Forum Activities
Research sites and investigators face an ever-increasing number of challenges in the conduct and management of cancer clinical trials. Many of these challenges stem from the multitude of requirements for clinical trials that sponsors and regulatory and administrative agencies have set. In...
Pembrolizumab and Cetuximab-Treated Head and Neck Cancer: Activity Confirmed But No Surprises
WITH THE RECENT efficacy findings, improvements in survival, and resultant U.S. Food and Drug Administration (FDA) approvals of programmed cell death protein 1 (PD-1) immune checkpoint inhibitors across multiple solid tumor indications, the publication of yet another positive trial adds to the...
Pembrolizumab in Second-Line Therapy for Advanced Urothelial Carcinoma
THE TREATMENT OF metastatic urothelial carcinoma experienced a long period of stagnation until the recognition that targeting the programmed cell death protein 1 (PD-1) pathway could yield deep and durable responses.1-3 Cisplatin-based combination chemotherapy has been the reference standard for...
Insurance Approval Rates for Enrollment in Oncology Clinical Trials Increased Under Affordable Care Act
The Patient Protection and Affordable Care Act (ACA) of 2010 was the first federal law to mandate that group health insurance plans and state-licensed insurance issuers provide coverage of standard-of-care costs for patients enrolled in approved clinical trials, effective on January 1, 2014. Under...
Tumor ‘Sidedness’ in Colon Cancer: Studies Look for Explanations
TUMOR “SIDEDNESS” in colon cancer has become a topic of great interest, after right-sided tumors were shown to have a worse prognosis than left-sided ones and biologics were found to differ in efficacy based on side. At the 2017 ASCO Annual Meeting, studies explored why this might be so. Three...
Maintaining Predictable Increases in NIH Funding for Cancer Research
CONGRESS RECENTLY passed its fiscal year (FY) 2017 spending bill, which contains an additional $2 billion for the National Institutes of Health (NIH). This marks the first time in more than a dozen years that Congress funded back-to-back increases for the NIH, demonstrating the bipartisan...
ASCO Offers Path to Addressing Affordability of Cancer Drugs in New Position Statement
Today, ASCO issued a position statement aimed at contributing to the national dialogue on rising cancer drug prices. The statement, which asserts that any solutions must also preserve patients' access to care and foster innovation, analyzes a wide array of options and recommends that a panel of...
FDA Approves Three-Drug Combination Tablet for Hepatitis C
On July 18, the U.S. Food and Drug Administration (FDA) approved a combination tablet (Vosevi) to treat adults with chronic hepatitis C virus genotypes 1–6 without cirrhosis or with mild cirrhosis. This fixed-dose, combination tablet contains two previously approved drugs—sofosbuvir and ...
Educating Young People on Sun-Safe Behaviors and Reducing the Risk of Melanoma
“If minors don’t tan, then they may never become adult tanners,” Jeffrey E. Gershenwald, MD, said in explaining the emphasis on teaching sun safety behaviors to young children as part of the Melanoma Moon Shot Program at The University of Texas MD Anderson Cancer Center, Houston. Dr. Gershenwald is ...
Music Therapy: Relevance in Oncology
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, authors Karen Popkin, LCAT, MT-BC, and Jyothirmai Gubili, MS, present the case ...
Ensuring Advance Directives Are Followed and Lawsuits Are Avoided
Thaddeus Mason Pope, JD, PhD, has focused his legal career on improving medical care decision-making and protecting patients’ rights at the end of life. His specific areas of legal expertise include patients’ rights, informed consent, and end-of-life medicine. Dr. Pope is the coauthor of The Right ...
Advance Care Planning: Ensuring Patients’ End-of-Life Wishes Are Honored
When Amy Berman, BSN, LHD (aged 58), stood in front of the mirror to perform a routine breast self-exam and saw redness and dimpling on her right breast, she feared they were the telltale signs of inflammatory breast cancer. “I have never self-diagnosed myself before, but I had recently read an...
Adding Pravastatin to Chemotherapy in Small Cell Lung Cancer
Following early reports associating favorable outcomes in cancer patients with the use of statins,1,2 further observational studies in this area have provided mixed findings.3 As recently reported in the Journal of Clinical Oncology, and reviewed in this issue of The ASCO Post, Seckl and colleagues ...
Effect of Methotrexate and Corticosteroid Strategies on Neurocognitive Function in Patients With B-Lineage ALL
In a Children’s Oncology Group (COG) study (AALL06N1) reported in the Journal of Clinical Oncology, Hardy et al found that age < 10 years at diagnosis was associated with poorer neurocognitive function in patients with high-risk B-lineage acute lymphoblastic leukemia regardless of...
Appropriate Distress Screening and Follow-up Leads to Fewer ER Visits and Hospitalizations in Patients With Cancer
Following a cancer diagnosis, all patients experience some level of distress—regardless of disease stage. When severe and left untreated, distress can have a significant impact on health outcomes, lead to greater mortality and morbidity, affect immune function, and result in higher...
Nivolumab Treatment Beyond Disease Progression in Advanced Melanoma
In a retrospective analysis reported in JAMA Oncology, Long et al found that a substantial proportion of patients with advanced melanoma derived benefit from continued nivolumab (Opdivo) treatment after Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1–defined disease...
CD33 Splicing Polymorphism and Response to Gemtuzumab Ozogamicin in AML
In an analysis of the phase III Children’s Oncology Group AAML0531 trial, published by Lambda et al in the Journal of Clinical Oncology, the CD33-targeted immunoconjugate gemtuzumab ozogamicin was shown to have benefit among patients with de novo acute myeloid leukemia (AML) who carry the CC...
Study Demonstrates Potential for Artificial Intelligence and Whole-Genome Sequencing to Scale Access to Precision Medicine
In a study published by Wrzeszczynski et al in Neurology: Genetics, researchers at the New York Genome Center (NYGC), The Rockefeller University, and IBM illustrated the potential of IBM Watson for Genomics to analyze complex genomic data from state-of-the-art sequencing of whole genomes. The study ...
New CDC Report Shows Cancer Death Rates Are Higher in Rural America
Despite decreases in cancer death rates nationwide, a new report from the Centers for Disease Control and Prevention (CDC) shows slower reduction in cancer death rates in rural America (a decrease of 1.0% per year) compared with urban America (a decrease of 1.6% per year), according to data...
Impact of Health Insurance and Sociodemographic Status on Survival for AYAs With Cancer
According to the National Cancer Institute, cancer is the leading cause of disease-related death among adolescents and young adults (AYAs) between the ages of 15 and 39. And although cancer survival among this age group is more than 80%, AYAs have not experienced the same improvements in relative...
Priority Review Granted for Abemaciclib in the Treatment of Advanced Breast Cancer
On July 10, the U.S. Food and Drug Administration (FDA) accepted a new drug application (NDA) for abemaciclib, a cyclin-dependent kinase (CDK) 4/6 inhibitor, and gave the NDA a Priority Review designation. The NDA includes Eli Lilly and Company’s submission of abemaciclib for two indications: ...
Overall Survival With Nivolumab vs Chemotherapy in Ipilimumab-Refractory Advanced Melanoma
As reported in the Journal of Clinical Oncology by Larkin et al, the phase III CheckMate 037 trial has shown no difference in overall survival with nivolumab (Opdivo) vs investigator’s choice of chemotherapy in ipilimumab (Yervoy)-refractory advanced melanoma. More chemotherapy patients never ...
Narrow Network Insurance Plans More Likely to Exclude Doctors at NCI-Designated and NCCN Member Cancer Centers
Patients with cancer in the United States may be unable to access care at the nation’s top hospitals due to narrow insurance plan coverage—leaving patients to choose between lower premiums or access to higher-quality cancer care. A new study from the Perelman School of Medicine at the...
Current Performance Measures for Cervical Cancer Screening
Health-care systems use performance measures for cervical cancer screening based on guidelines from such organizations as the American College of Obstetricians and Gynecologists to monitor the appropriateness of cervical cancer screening. According to the performance measure in the Healthcare...
FDA Places Clinical Hold on Three Studies Evaluating Pembrolizumab in Multiple Myeloma
On July 5, Merck announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on KEYNOTE-183, KEYNOTE-185, and KEYNOTE-023, three combination studies of pembrolizumab (Keytruda), an anti–programmed cell death protein 1 (PD-1) therapy, in multiple myeloma. This...
Has a New Standard Really Been Established for the Adjuvant Treatment of Pancreatic Cancer?
THE PAST YEAR has undoubtedly been a disappointing one as far as clinical advances in pancreatic cancer go. No fewer than five high-profile randomized phase II or III trials in this setting reported negative results in 2016, ranging from next-generation cytotoxic agents1 to novel immunotherapeutic ...
Encouraging Results With Pembrolizumab in Relapsed/Refractory Classical Hodgkin Lymphoma
AN EFFECTIVE antitumor immune response relies on cytotoxic T cells that are activated and able to target the malignant clone. As T cells become activated, they upregulate suppressive receptors including programmed cell death protein 1 (PD-1). Upregulation of inhibitory signals is important to...
Preparing for Future Challenges in Geriatric Surgical Oncology
In the past decade, advances in surgical oncology have been echoed in the field of geriatric oncology. The current literature regarding older people with cancer includes mainly retrospective cohort studies, focusing on alternatives to radical surgery in comorbid patients. More recently, work has...
ASCO’s New MACRA Decision Tree Tool Helps Determine Which QPP Reporting Requirements Apply to Your Practice
Believe it or not, we’re halfway through the 1st year of the Quality Payment Program (QPP). ASCO, the Centers for Medicare & Medicaid Services (CMS), and other stakeholders have released guidance on successfully complying with QPP, but tailored information addressing a practice’s specific...
Autologous and Allogeneic Hematopoietic Cell Transplantation
HERE ARE SEVERAL ABSTRACTS selected from the proceedings of the 2016 American Society of Hematology (ASH) Annual Meeting & Exposition, highlighting clinical trials on autologous and allogeneic hematopoietic cell transplantation for various hematologic malignancies. Additional selected...
Blinatumomab in B-Precursor Acute Lymphoblastic Leukemia
In a phase II trial reported in the Journal of Clinical Oncology, Giovanni Martinelli, MD, of S. Orsola University Hospital, Bologna, and colleagues found that blinatumomab (Blincyto) produced complete responses in patients with relapsed/refractory Philadelphia chromosome–positive B-precursor...
Fat Grafting and Patient-Reported Outcomes in Postmastectomy Breast Reconstruction
The use of fat grafting as a tool for breast reconstruction following a mastectomy may improve breast satisfaction, psychosocial well-being, and sexual well-being in patients, according to a study published by Bennett et al in JAMA Surgery. Fat grafting as an adjunct to breast reconstruction...
FDA Grants Marketing Approval to the Praxis Extended RAS Panel
On June 29, the U.S. Food and Drug Administration (FDA) granted marketing approval to the Praxis Extended RAS Panel, a next-generation sequencing test to detect certain genetic mutations in RAS genes in tumor samples of patients with metastatic colorectal cancer. The test is used to aid in the...
Expert Point of View: Michael S. Sabel, MD; Marcela Maus, MD, PhD; and Carl June, MD
"We are now seeing the merger of immunotherapy with precision medicine. This is the epitome of personalized medicine,” said ASCO-invited expert Michael S. Sabel, MD, Chief of the Division of Surgical Oncology at University of Michigan Health Systems, Ann Arbor. He called the effort to target...
Overcoming Sexism in Academic Medicine
The troubling results from a survey1 investigating the sexual harassment and discrimination experiences of academic medical faculty show that such incidents continue to happen with unexpected frequency despite increasing awareness of the problem. The study by Reshma Jagsi, MD, DPhil, and...
The Emperor’s New Clothes: Biosimilars and Cost in Oncology
Biosimilars are biologic products similar to the parent (branded) molecule in structure and function—such as erythropoietin and filgrastim (Neupogen).1 To truly bend the cost curve, we want to see a dramatic economic savings achieved as oncology biosimilars for rituximab (Rituxan), trastuzumab...
High-Risk Mutations Predict Poor Outcomes for Patients With Myelodysplastic Syndromes Undergoing Transplantation
Although several treatment options are available for patients with myelodysplastic syndromes (MDS), hematopoietic stem cell transplantation (HSCT) remains the only curative therapy.1 The risks of complications and death from transplantation can be substantial. Determining which patients may...
Pembrolizumab Moving Forward in Triple-Negative Breast Cancer
In the treatment of triple-negative breast cancer, checkpoint inhibition is making inroads in both early- and late-stage disease, and the line of treatment and expression of the programmed cell death ligand 1 (PD-L1) could be important in determining outcomes, according to studies reported at the...
FDA Approves Panitumumab for Use in Wild-Type RAS Metastatic Colorectal Cancer
On June 30, 2017, the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for panitumumab (Vectibix) for patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) metastatic...
Two Studies Show Scalp Cooling Reduces Hair Loss in Women Receiving Chemotherapy for Breast Cancer
An interim analysis of the SCALP trial, reported in JAMA by Julie Nangia, MD, of Baylor College of Medicine, and colleagues, showed that use of a scalp-cooling device significantly reduced hair loss in women receiving chemotherapy for stage I or II breast cancer compared with no scalp cooling.1 The ...
ESMO World GI 2017: Right-Sided Colorectal Tumors: An Internal Radiation Advantage
For patients with colorectal cancer that has metastasized to the liver, having a primary tumor on the left side as opposed to the right side of the colon is known to be a significant advantage in terms of treatment response. But a new study, presented by van Hazel et al at the European Society for...
FDA Clears Expanded Use of Cooling Cap to Reduce Hair Loss During Chemotherapy
On July 3, the U.S. Food and Drug Administration (FDA) cleared the expanded use of a cooling cap, DigniCap Cooling System, to reduce hair loss during chemotherapy. This is the first cooling cap cleared by the agency for use in cancer patients with solid tumors. “We are pleased to expand the...
ESMO World GI 2017: Study Explores Association of Mediterranean Diet Components With Advanced Colorectal Polyps
The benefits of a Mediterranean diet are well known when it comes to colorectal protection, but it’s hard to know specifically what elements of the diet are the healthiest. Now a new study, presented by Fliss Isakov et al at the ESMO 19th World Congress on Gastrointestinal Cancer, suggests...
FDA Allows Marketing of Test to Aid in the Detection of Certain Leukemias and Lymphomas
On June 29, the U.S. Food and Drug Administration (FDA) allowed marketing of ClearLLab Reagents (T1, T2, B1, B2, M), the first agency-authorized test for use with flow cytometry to aid in the detection of several leukemias and lymphomas, including chronic leukemia, acute leukemia, non-Hodgkin...
European Commission Expands Use of Ceritinib for First-Line Use in ALK-Positive Advanced NSCLC
On June 29, the European Commission approved expanding the use of ceritinib (Zykadia) to include the first-line treatment of patients with advanced non–small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)–positive. Approval follows a positive opinion granted...
FDA Unveils Plan to Eliminate Orphan Designation Backlog
Today, the U.S. Food and Drug Administration (FDA) unveiled a strategic plan to eliminate the agency’s existing Orphan Drug designation request backlog and ensure continued timely response to all new requests for designation with firm deadlines. The agency’s Orphan Drug Modernization...
