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Showing 26101 - 26150FDA Hears Proposals on Codevelopment of Companion Diagnostics for Breakthrough Therapies
A companion diagnostic developed for use with a drug that has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) should automatically be eligible for priority review, according to an expert panel that presented this proposal and four others to the FDA in...
NIH Awards $17 Million in Grants to Augment Genomics Research in Africa
The National Institutes of Health has awarded 10 new grants totaling up to $17 million over the next 4 years to support genomics research in Africa, as part of the Human Heredity and Health in Africa (H3Africa) program. This set of grants is the second disbursement of H3Africa awards and brings the ...
FDA Approves Transducer Array Layout System for Use in Patients With Recurrent Glioblastoma Multiforme
Novocure recently announced that it has received FDA approval for its NovoTAL (Transducer Array Layout) System through a Premarket Approval supplement. The NovoTAL System allows certified physicians to use the individual magnetic resonance imaging data of recurrent glioblastoma multiforme patients...
IOM Presents 2013 Lienhard Award to Leader of Smoking Cessation and Tobacco Prevention Efforts
The Institute of Medicine has (IOM) presented the 2013 Gustav O. Lienhard Award to Steven A. Schroeder, MD, whose pioneering efforts to control tobacco use have helped save millions from premature, smoking-related deaths. The award also recognizes Dr. Schroeder’s leadership in general medicine as...
Focus on the Texas Society of Clinical Oncology
The second largest state in the nation (after Alaska), Texas covers a total area of 268,581 square miles and has a diverse population of over 26 million people. In 1987, the Texas Society of Medical Oncology, now the Texas Society of Clinical Oncology (TxSCO), was formed to address the oncology...
Yoga to Manage Sleep Disruption in Cancer Survivors: A Low-Risk Intervention With High Potential for Benefit
Impaired sleep quality is a concerning problem for many patients with cancer, and pharmacologic treatments come with many negative effects. Several small studies indicate that yoga improves persistent fatigue, sleep disturbance, anxiety, and quality of life, in addition to reducing the need for...
Yoga Improves Sleep Quality in Patients With Cancer Suffering From Sleep Disruption
It is estimated that 30% to 90% of patients with cancer experience impairment of sleep quality post-treatment, and such impairment can be severe enough to increase morbidity and mortality. Preliminary evidence indicates that yoga may improve sleep in cancer patients. In a study reported in the...
Focal Adhesion Kinase Regulates YB-1–Mediated Paclitaxel Resistance in Ovarian Cancer
It has been found that focal adhesion kinase (FAK) inhibition sensitizes ovarian cancer to the effects of taxanes. In a study reported in the Journal of the National Cancer Institute, Kang and colleagues evaluated the response of taxane-resistant and taxane-sensitive ovarian cancer models to a...
Fatty Acid Network Exerts Growth Inhibitory Effects in Pancreatic Cancer
In a study reported in Clinical Cancer Research, Zhang and colleagues used integrated metabolomics and transcriptomics to investigate gene-metabolic networks and identify metabolic pathways that are perturbed in pancreatic ductal adenocarcinoma. A global metabolite profiling analysis was performed ...
Tumor-Infiltrating Lymphocytes in Glioblastoma Are Related to Specific Genomic Alterations
The role of tumor-infiltrating lymphocytes in glioblastoma has not been fully defined. In a study reported in Clinical Cancer Research, Rutledge and colleagues assessed the association between tumor-infiltrating lymphocytes and molecular alterations, histologies, and survival in glioblastoma. In...
No Progression-Free Survival Difference for Cediranib or Cediranib/Lomustine vs Lomustine in Recurrent Glioblastoma
In a phase III study (REGAL trial) reported in the Journal of Clinical Oncology, Tracy T. Batchelor, MD, MPH, of the Massachusetts General Hospital Cancer Center, and colleagues compared oral monotherapy with the investigational pan–vascular endothelial growth factor (VEGF) receptor tyrosine kinase ...
In International Study, Patients Prefer Subcutaneous Over Intravenous Trastuzumab for Breast Cancer
Subcutaneous trastuzumab (not available in the United States) has been shown to have noninferior efficacy and similar pharmacokinetic and safety profiles compared with intravenous trastuzumab (Herceptin) in patients with early-stage HER2-positive breast cancer. In the PrefHer trial reported in...
Evidence-Based Opportunity to Personalize Breast Cancer Risk: The Data Are Building
The worldwide data from prospective studies of the relationship between levels of endogenous sex hormones and breast cancer risk in postmenopausal women show multiple and complex relationships.1 Nine prospective studies (different from those reported here) of women not taking exogenous sex hormones ...
Circulating Estrogens and Androgens Associated With Breast Cancer Risk in Premenopausal Women
In a study reported in The Lancet Oncology, Timothy Key, DPhil, of Oxford University, and colleagues in the Endogenous Hormones and Breast Cancer Collaborative Group analyzed data from seven prospective studies to determine associations between sex hormones and risk of breast cancer in...
Advancing Psychosocial Oncology Care Over the Next Decade
A psychiatrist for more than 40 years, Jimmie C. Holland, MD, Attending Psychiatrist and Wayne E. Chapman Chair at Memorial Sloan-Kettering Cancer Center and Professor of Psychiatry, Weill Medical College of Cornell University in New York, is internationally recognized as the founder of the...
NIH Announces 15 Clinical and Translational Science Awards
Translating basic discoveries into new treatments that tangibly improve human health requires innovative collaborations and resources, as well as a diverse, highly trained workforce. To help meet these needs, the National Institutes of Health recently announced more than $79 million in fiscal year...
High-Dose Spinal Stereotactic Body Radiotherapy Associated With Increased Risk of Vertebral Compression Fracture
As reviewed in this issue of The ASCO Post, Sahgal et al reported a multi-institutional analysis aimed at clarifying the risk of developing either new or progressive vertebral body compression fractures following high-dose spinal stereotactic body radiation therapy. In the period studied, they...
Vertebral Compression Fracture Risk Increased After Spinal Stereotactic Body Radiotherapy
In a study reported in Journal of Clinical Oncology, Arjun Sahgal, MD, of Princess Margaret Cancer Centre in Toronto, and colleagues evaluated the occurrence of vertebral compression fractures in patients undergoing spinal stereotactic body radiotherapy.1 Vertebral compression fractures occurred in ...
Two Patients in One, Mom and Baby: Managing Coincident Pregnancy and Lymphoma
The news that she is both pregnant and has been found to have a potentially lethal malignancy is one of the most emotionally wrenching events any young woman ever faces. Understandably, the patient, her partner, their families, and even their caregivers find this experience fraught with anxiety and ...
Multicenter Analysis of Outcomes of Lymphoma in Pregnancy
Lymphoma is the fourth most frequent cancer to occur in pregnant women. In a multicenter retrospective analysis reported in Journal of Clinical Oncology, Andrew M. Evens, DO, MSc, Chief of Hematology/Oncology at Tufts University Medical Center, Boston, and colleagues examined treatment,...
New Report Examines Trends in End-of-Life Care
Although fewer Medicare patients with cancer died in the hospital in 2010 than in the years 2003–2007, aggressive treatment continues at the end of life, according to a new report from the Dartmouth Atlas Project.1 The findings also show that a significant number of patients were likely to receive...
Illness Is Personal!
For clinicians and health service researchers striving to improve care for people living with life-threatening conditions, September was a sobering month. The Dartmouth Atlas group released a brief report on Trends in Cancer Care Near the End of Life1 showing that while the proportion of patients...
Breast Cancer Index Assay Prognostic for Distant Recurrence in Estrogen Receptor–Positive, Node-Negative Breast Cancer
In a study reported in The Lancet Oncology, Dennis C. Sgroi, MD, of Massachusetts General Hospital, and colleagues compared the ability of the breast-cancer index (BCI) assay, 21-gene recurrence score (Oncotype DX), and an immunohistochemical prognostic model (IHC4) to predict early and late...
ASCO Receives Additional Funding for Virtual Learning Collaborative From California HealthCare Foundation
ASCO is pleased to announce grant funding from the California HealthCare Foundation to support the Virtual Learning Collaborative (VLC). This pilot project will use the VLC to improve the quality of palliative care in routine medical oncology practice. ASCO is also collaborating with the American...
ASCO Announces Inaugural Class for Quality Training Program
For oncologists, continuous quality improvement is a key goal. We measure and assess the quality of care we deliver and constantly look for areas where we can do better,” said ASCO President Clifford A. Hudis, MD, FACP. “ASCO’s Quality Training Program will guide oncology care providers in...
Celebrating 30 Years of Mentorship That Makes a Difference
The Conquer Cancer Foundation (CCF) Grants and Awards Program has been instrumental in helping launch the careers of hundreds of aspiring cancer researchers around the world over the past 30 years. Since the first grant provided in 1984, Conquer Cancer Foundation–funded scientists have become some...
New Recommendations on HER2 Testing and Colorectal Cancer Follow-up Care
The latest additions to Cancer.Net’s patient-friendly versions of ASCO’s Clinical Practice Guidelines include guidance on HER2 testing, as well as an endorsement of colorectal cancer follow-up care recommendations from Cancer Care Ontario. ASCO Care and Treatment Recommendations (formerly called...
ASCO Reconfirms Commitment to Choosing Wisely® Campaign
In collaboration with the American Board of Internal Medicine (ABIM) Foundation’s Choosing Wisely® campaign, ASCO recently released a second “Top Five” opportunities list of common practices or procedures in oncology whose clinical value is not supported by available evidence and if eliminated, can ...
Interim Data Reported From Phase IB Study of Investigational Anti-PD-1 Immunotherapy for NSCLC
Interim data from a Phase IB trial evaluating the investigational anti-PD-1 immunotherapy, MK-3475, in patients with previously treated non-small cell lung cancer (NSCLC) were presented recently at the 15th World Conference on Lung Cancer in Sydney, Australia. Edward Garon, MD, Director of Thoracic ...
Pertuzumab in Neoadjuvant Treatment of HER2-Positive Early Breast Cancer
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication On September 30, 2013, pertuzumab injection (Perjeta)...
FDA Announces Strategic Plan to Prevent Drug Shortages
The U.S. Food and Drug Administration (FDA) is taking two actions to further enhance the agency’s ongoing efforts to prevent and resolve drug shortages. The FDA has released a strategic plan called for in the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 to improve the...
Finasteride for Prostate Cancer Prevention: Long-Term Results Disappointing but Reassuring
All medical care should seek to achieve one or more of three goals: to relieve suffering, to prevent future suffering, or to prolong life. Care for cancer is no exception, and minimizing suffering from cancer and prolonging life has primarily resulted from advances in treatment. Although there are...
No Difference in Long-Term Survival With Finasteride or Placebo in the Prostate Cancer Prevention Trial
In the Prostate Cancer Prevention Trial (PCPT), initially reported in 2003, finasteride significantly reduced the risk of prostate cancer by 24.8% but was associated with a relative 26.9% increase in risk of high-grade disease compared with placebo. In a study reported in The New England Journal of ...
Technologic Innovations Are Likely to Transform Oncology Care
Oncology and medicine as a whole are likely to benefit from a variety of technologic innovations recently showcased at the third annual The Atlantic Meets the Pacific symposium, according to Peter P. Yu, MD, President-Elect of the American Society of Clinical Oncology, and medical oncologist and...
Neoadjuvant Treatment of Early Breast Cancer
INSIDE THE BLACK BOX is an occasional column providing insight into the FDA and its policies and procedures. In this first installment, FDA Clinical Reviewers Laleh Amiri-Kordestani, MD, and Suparna Wedam, MD, discuss FDA’s recent approval of pertuzumab (Perjeta) for the neoadjuvant treatment of...
SIDEBAR: Brian J. Druker, MD, Discusses Ponatinib
In an interview with The ASCO Post following FDA’s recommendation that sales of ponatinib (Iclusig) be suspended, (see here) Brian J. Druker, MD, Director of Oregon Health & Science University Knight Cancer Institute and JELD-WEN Chair of Leukemia Research, had concerns about obtaining the drug ...
Brivanib Fails to Live Up to the Promise of Early Studies
Hepatocellular carcinoma is a devastating disease worldwide. Although advances in liver transplantation, surgery, and locoregional therapies have made tumor control or even cure possible for a minority of patients, the majority of patients diagnosed with hepatocellular carcinoma will develop...
Brivanib Studied in First- and Second-Line Therapy for Advanced Hepatocellular Carcinoma
The investigational drug brivanib is a dual inhibitor of vascular endothelial growth factor and fibroblast growth factor signaling, both implicated in hepatocellular carcinoma. The agent was recently evaluated in two phase III trials, one comparing first-line brivanib with sorafenib (Nexavar) in...
Pemetrexed Improves Progression-Free Survival vs Gefitinib in Second-Line Setting for EGFR Wild-Type Nonsquamous NSCLC
Both pemetrexed (Alimta) and gefitinib (Iressa) are standard second-line treatments for advanced nonsquamous non–small cell lung cancer (NSCLC) in East Asia. In a phase II trial (CTONG 0806) reported at the International Association for the Study of Lung Cancer’s 15th World Conference on Lung...
Investigational ALK Inhibitor Shows Promise in Patients With Crizotinib-Refractory, ALK-Positive NSCLC
Patients with non–small cell lung cancer (NSCLC) whose tumors have the ALK gene rearrangement usually respond to the drug crizotinib (Xalkori), with a median duration of response of approximately 10 months. In a study reported by Shirish Gadgeel, MD, of Karmanos Cancer Institute in Detroit, and...
Oncogene Addiction and the Rationale for Molecular Targeted Therapy in Lung Cancer
Over the past decade, Fadlo R. Khuri, MD, Professor and Roberto C. Goizueta Distinguished Chair of Hematology and Medical Oncology, and Deputy Director of the Winship Cancer Institute of Emory University, Atlanta, has focused his research and clinical career on investigating novel approaches in the ...
FDA Grants Priority Review to Ramucirumab as a Potential Single-Agent Treatment for Advanced Gastric Cancer
The FDA has assigned Priority Review to the regulatory submission for ramucirumab as a single-agent treatment for advanced gastric cancer following disease progression after initial chemotherapy. Ramucirumab is a human monoclonal antibody that specifically blocks the vascular endothelial growth...
Sale of Ponatinib Suspended Due to Risk of Life-Threatening Blood Clots
The U.S. Food and Drug Administration (FDA) has asked the manufacturer of the tyrosine kinase inhibitor ponatinib (Iclusig) to suspend marketing and sales of the drug because of the risk of life-threatening blood clots and severe narrowing of blood vessels. Ariad Pharmaceuticals has agreed to...
FDA Approves First Extended-Release, Single-Entity Hydrocodone Product
The U.S. Food and Drug Administration (FDA) today approved hydrocodone bitartrate extended-release capsules (Zohydro ER) for the management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate. The drug, a Schedule...
Long-Term Colorectal Cancer Incidence and Mortality After Lower Endoscopy
Colonoscopy and sigmoidoscopy have been shown to provide protection against colorectal cancer, but the magnitude and duration of protection, particularly against proximal colon cancer, remain undefined. A study of long-term colorectal cancer incidence and mortality after lower endoscopy reported in ...
One Dose of HPV 16/18 Vaccine Produces Durable Response, Study Finds
Results from the Costa Rica HPV 16/18 Vaccine Trial indicate that 4-year efficacy against 12-month HPV 16/18 persistent infection was similarly high among women who received one, two, or the recommended three doses of the bivalent HPV16/18 L1 virus-like particle vaccine (Cervarix). The findings...
In Mismatch Repair–Deficient Colon Cancer, Side Matters
In general, we have come to think of mismatch repair–deficient colon cancer as having a more favorable prognosis, being less likely to metastasize to regional nodes or distant sites, and being resistant to fluoropyrimidines. Much of our data, however, come from trials combining stage II and III...
Impact of Deficient DNA Mismatch Repair on Disease-Free Survival in Stage III Colon Cancer
In an analysis reported in the Journal of Clinical Oncology, Frank A. Sinicrope, MD, of the Mayo Clinic and North Central Cancer Treatment Group (NCCTG), and colleagues investigated the association of deficient DNA mismatch repair with prognosis in patients with stage III colon cancer treated with...
Important News Briefs: New Data Reported in Breast, Renal Cell, Head and Neck, and Lung Cancer
The 2013 European Cancer Congress (ECC), held September 27 to October 1 in Amsterdam, was jointly sponsored by the European Society of Medical Oncology, the European Cancer Organization, and the European Society of Radiation Oncology. With the Congress theme being “Reinforcing Multidisciplinarity,” ...
Institute of Medicine Elects New Members, Foreign Associates
The Institute of Medicine (IOM) recently announced the names of 70 new members and 10 foreign associates during its 43rd Annual Meeting. “It is an honor to welcome our highly distinguished colleagues to the Institute of Medicine,” said IOM President Harvey V. Fineberg. “These individuals have...
