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Showing 851 - 900ASCO 2016: Liquid Biopsy May Help Guide Treatment Decisions for Patients With Advanced Solid Tumors
A large-scale genomic analysis found that patterns of genetic changes detected in blood samples (liquid biopsy) closely mirror those identified in traditional tumor biopsy. With blood samples from more than 15,000 patients and 50 different tumor types, this is one of the largest cancer genomics...
ASCO 2016: Precision Medicine Approach May Expand Therapeutic Options for Patients
Researchers reported encouraging early results from a phase II trial that matches patients with molecular abnormalities in the tumor to corresponding targeted treatments. Twenty-nine of 129 patients with 12 different types of advanced cancers responded to drugs outside of U.S. Food and Drug...
FDA Approves New Diagnostic Imaging Agent to Detect Rare Neuroendocrine Tumors
The U.S. Food and Drug Administration (FDA) today approved Netspot, the first kit for the preparation of Ga-68 dotatate injection, a radioactive diagnostic agent for positron-emission tomography (PET) imaging. This radioactive probe will help locate tumors in adult and pediatric patients with...
Eribulin Improves Overall Survival vs Dacarbazine in Previously Treated Advanced Liposarcoma or Leiomyosarcoma
In a phase III trial reported in The Lancet, Patrick Schöffski, MD, of University Hospitals Leuven, Leuven Cancer Institute, Belgium, and colleagues found that eribulin (Halaven) improved overall survival vs dacarbazine in patients with advanced or metastatic soft-tissue sarcoma who had received...
Venetoclax for Previously Treated Chronic Lymphocytic Leukemia With 17p Deletion
On April 11, 2016, venetoclax (Venclexta) was approved for treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by a U.S. Food and Drug Administration (FDA)-approved test, who have received at least one prior therapy.1,2 The accelerated approval was based...
Cabozantinib in Advanced Renal Cell Carcinoma
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. On April 25, 2016, a tablet formulation of cabozantinib...
CancerLinQ Completes Agreements With 36 ‘Vanguard’ Practices
CancerLinQ LLC announced on April 21 that it has completed agreements with 36 oncology practices from around the country to begin implementing CancerLinQ™, the groundbreaking health information technology platform that will harness big data analytics to help oncologists rapidly improve high-quality ...
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®): 2016 Guidelines
In 1996, the National Comprehensive Cancer Network (NCCN®) published its first set of Clinical Practice Guidelines in Oncology® (NCCN Guidelines®), covering eight tumor types. The NCCN Guidelines® are now published for more than 60 tumor types and topics. Some of the key updates for 2016 were...
Maximizing Cancer Cure: How Do We Get There?
Is cancer really “curable,” and if so, how? For a “Cancer Dialogue” held during the 2016 American Association of Cancer Research (AACR) Annual Meeting, half a dozen stellar participants from the research, industry, regulatory, and advocacy communities convened to debate the topic. The ASCO Post was ...
AUA 2016: IsoPSA, a Novel, Structure-Based Biomarker Test for Prostate Cancer, Explored in a Multicenter Prospective Trial
A promising new test is detecting prostate cancer more precisely than current tests by identifying molecular changes in the prostate-specific antigen (PSA) protein, according to Cleveland Clinic research presented at the 111th Annual Scientific Meeting of the American Urological Association (AUA)...
No Progression-Free Survival Benefit for First-Line Neratinib/Paclitaxel vs Trastuzumab/Paclitaxel in Metastatic HER2-Positive Breast Cancer
In the phase III NEfERT-T trial reported in JAMA Oncology, Awada et al found no progression-free survival benefit of neratinib/paclitaxel vs trastuzumab (Herceptin)/paclitaxel in previously untreated inoperable recurrent or metastatic HER2-positive breast cancer. A potential benefit of...
Defibrotide Sodium for Hepatic Veno-occlusive Disease After HSCT
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. On March 30, 2016, defibrotide sodium (Defitelio) was approved for...
Enzalutamide Produces Large Progression-Free Survival Benefit vs Bicalutamide in Two Trials in Castration-Resistant Prostate Cancer
In the randomized phase II TERRAIN trial reported in The Lancet Oncology, Neal D. Shore, MD, of Carolina Urologic Research Center, Myrtle Beach, and colleagues found that use of the androgen receptor inhibitor enzalutamide (Xtandi) more than doubled median progression-free survival vs bicalutamide...
Blue Ribbon Panel to Help Guide Cancer Moonshot Initiative
As described in the full report on page 39, the National Cancer Institute (NCI) announced a Blue Ribbon Panel of experts and advocates who will inform the scientific direction and goals at NCI of Vice President Joe Biden’s National Cancer Moonshot Initiative. Members of the research community and...
Friends of Cancer Research Encourages FDA to Modernize and Consolidate
“In order to take advantage of today’s advancements in science, drug development, and patient treatment, the U.S. Food and Drug Administration’s (FDA’s) structure needs reorganization to focus its resources and ensure the best outcomes for patients. Friends of Cancer Research (Friends) proposes...
Immunotherapy Could Be the Wave of the Future, but Problems and Challenges Cannot Be Ignored
Immunotherapy is on its way. A few agents have already been approved: ipilimumab (Yervoy) in 2011 for melanoma; nivolumab (Opdivo) in 2015 for non–small cell lung cancer (NSCLC) and then later that year for renal cell carcinoma; and pembrolizumab (Keytruda) for NSCLC. In addition, many clinical...
DigniCap Scalp-Cooling System Now Available for Women With Breast Cancer at 10 U.S. Cancer Treatment Centers
Dignitana Inc. recently announced that the DigniCap scalp cooling system, which was cleared by the U.S. Food and Drug Administration (FDA) in December 2015 to effectively reduce the likelihood of chemotherapy-induced hair loss in women with breast cancer, is now available at 10 cancer treatment...
Liquid Biopsies Predict Treatment Response and Survival in Gynecologic Cancers
A new study has demonstrated for the first time that personalized circulating tumor DNA (ctDNA) biomarkers in gynecologic cancers can detect the presence of residual tumor earlier than currently used serum and imaging studies.1,2 According to the data, undetectable levels of ctDNA at the completion ...
Higher EZH2 and Ki67 Expression May Be Associated With Aggressive Basal Cell Carcinoma
In a study reported in a research letter in JAMA Oncology, Rao et al found that high expression of EZH2 and Ki67 was associated with more-aggressive basal cell carcinoma.EZH2 is a histone methyltransferase of the polycomb repressive complex 2. EZH2 overexpression or gain of function mutations has...
Crizotinib in ROS1-Positive Metastatic Non–Small Cell Lung Cancer
On March 11, 2016, crizotinib (Xalkori) was approved for treatment of patients with metastatic non–small cell lung cancer (NSCLC) with ROS1 rearrangement–positive tumors.1,2 A U.S. Food and Drug Administration–approved test for the detection of ROS1 rearrangements in NSCLC is not currently...
Conquer Cancer Foundation Honors 74 Oncologists for Contributions to Genitourinary Cancer, Cancer Survivorship, Gastrointestinal Cancer, and Quality Care Research
The Conquer Cancer Foundation of ASCO is pleased to announce the recipients of its 2016 Conquer Cancer Foundation of ASCO Merit Awards in Gastrointestinal Cancer, Genitourinary Cancer, Cancer Survivorship, and Quality Care. The following 74 young investigators, recognized for the scientific merit...
NCI Announces Blue Ribbon Panel to Help Guide Vice President Biden’s National Cancer Moonshot Initiative
On April 4, 2016, The National Cancer Institute (NCI), part of the National Institutes of Health (NIH), announced a Blue Ribbon Panel of scientific experts, cancer leaders, and patient advocates that will inform the scientific direction and goals at NCI of Vice President Joe Biden’s National...
Atezolizumab Improves Survival vs Docetaxel in Previously Treated NSCLC: Increased Benefit With Increased PD-L1 Expression
In the phase II POPLAR trial reported in The Lancet, Louis Fehrenbacher, MD, of Kaiser Permanente Medical Center, and colleagues found that the investigational anti–programmed cell death ligand 1 (PD-L1) antibody atezolizumab improved overall survival vs docetaxel in patients with non–small cell...
DigniCap Scalp Cooling System Now Available for Women With Breast Cancer at 10 U.S. Cancer Treatment Centers
Dignitana Inc. announced today that the DigniCap scalp cooling system, which was cleared by the U.S. Food and Drug Administration (FDA) in December 2015 to effectively reduce the likelihood of chemotherapy-induced hair loss in women with breast cancer, is now available at 10 cancer treatment...
Introduction of New Diagnostic Devices in Oncology: New Is Not Necessarily Better
“New!” “Improved!” “Throw out that old [fill in the blank] and go buy a new [fill in the blank]!” Sound familiar? The key to marketing is to convince customers that they need a product without which they had previously been quite happy. All too often, this strategy is accompanied by a caveat emptor ...
Lauren Streicher, MD, Announced as Medical Director for Northwestern Medicine’s Upcoming Center for Sexual Health
Northwestern Medical Group recently announced that Lauren Streicher, MD, will be joining Northwestern Medicine in Chicago. Dr. Streicher is a clinical leader in gynecology, a published author, and a trusted medical contributor for many local and national media outlets. In her new role, Dr....
Obinutuzumab in Relapsed or Refractory Follicular Lymphoma
On February 26, 2016, obinutuzumab (Gazyva) was approved for use in combination with bendamustine (Bendeka, Treanda) followed by obinutuzumab monotherapy for treatment of patients with follicular lymphoma who have relapsed after or are refractory to a rituximab (Rituxan)-containing regimen.1,2...
Palbociclib Combined With Fulvestrant in Advanced Breast Cancer Progressing After Endocrine Therapy
On February 19, 2016, palbociclib (Ibrance) was approved for use in combination with fulvestrant (Faslodex) for treatment of hormone receptor–positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.1,2 In February 2015, palbociclib in...
Global Perspectives on the Integration of Biosimilars Into Oncology Practice
Dr. Robert Rifkin, Medical Director of Biosimilars at US Oncology Research, moderates a roundtable discussion on Global Perspectives on the Integration of Biosimilars into Oncology Practice, held in conjunction with the 2015 American Society of Hematology Annual Meeting in Orlando, Florida....
Atezolizumab Improves Survival vs Docetaxel in Advanced NSCLC in Relation to Increased PD-L1 Expression
In the phase II POPLAR trial reported in The Lancet, Fehrenbacher et al found that the anti–PD-L1 (programmed cell death ligand 1) antibody atezolizumab improved overall survival vs docetaxel in patients with non–small cell lung cancer (NSCLC) who had progressed on prior platinum-based...
An Increase for the National Institutes of Health Budget
The National Institutes of Health (NIH) received a nearly $2 billion funding increase—the first large increase for the agency in more than 12 years—in the federal omnibus spending bill Congress passed on December 18, 2015. And President Barack Obama signed the bill into law a day later. The 6.6%...
Eribulin Mesylate in Advanced Liposarcoma Previously Treated With an Anthracycline
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. On January 28, 2016, eribulin mesylate (Halaven) was approved for...
First-in-Class Drug ONC201 Shows Potential for Some Blood Cancers
ONC201, an investigational anticancer drug that triggers cell death in various tumor types, may have clinical potential for some blood cancers including mantle cell lymphoma and acute myeloid leukemia (AML), according to a recent clinical study. A research team led by Michael Andreeff, MD, PhD,...
Rolapitant Reduces Chemotherapy-Induced Nausea and Vomiting in Patients Receiving Moderately and Highly Emetogenic Chemotherapy
In three phase III studies reported in The Lancet Oncology, the addition of the neurokinin-1 (NK-1) receptor antagonist rolapitant to serotonin (5-HT3) receptor antagonist and dexamethasone treatment significantly improved complete response rates in the prevention of chemotherapy-induced nausea and ...
Study Finds Enzalutamide Increases Progression-Free Survival vs Bicalutamide in Metastatic Prostate Cancer
Use of the androgen receptor–inhibitor enzalutamide (Xtandi) more than doubled progression-free survival vs the nonsteroidal antiandrogen bicalutamide in patients with metastatic prostate cancer progressing on androgen-deprivation therapy, according to the randomized phase II TERRAIN trial...
Alectinib in ALK-Positive Metastatic NSCLC After Crizotinib
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. On December 11, 2015, alectinib (Alecensa) was granted...
Hospira Foundation Donates $5 Million to the University of Chicago Medicine
The Hospira Foundation has donated $5 million to the University of Chicago Medicine to create the Hospira Foundation Professorship in Oncology. The Hospira Foundation Professor will be a key leader in advancing the University of Chicago Medicine’s cancer research objectives, which include...
Fear’s Many Deleterious Consequences
Bookmark Title: The Fear Cure: Cultivating Courage as Medicine for the Body, Mind, and Soul Author: Lissa Rankin, MD Publisher: Hay House, Inc Publication date: February 23, 2015 Price: $25.99; hardcover, 336 pages Fear is a healthy survival mechanism, a fight-or-flight response designed to put...
Global Perspectives on the Integration of Biosimilars Into Oncology Practice
Dr. Robert Rifkin, Medical Director of Biosimilars at US Oncology Research, moderates a roundtable discussion on Global Perspectives on the Integration of Biosimilars into Oncology Practice, held in conjunction with the 2015 American Society of Hematology Annual Meeting in Orlando, Florida....
NCCN Awards Research Grants to Five Investigators to Study Effectiveness of Enzalutamide in Various Cancers
The National Comprehensive Cancer Network (NCCN) Oncology Research Program (ORP) has awarded five grants to investigators to evaluate and define the preclinical and clinical effectiveness of enzalutamide (Xtandi) in mantle cell lymphoma and endometrial, hepatocellular, and prostate cancers. These...
2016 GI Symposium: Irinotecan Liposome Injection in Metastatic Pancreatic Cancer: Updated Results of the Phase III NAPOLI-1 Study
Merrimack Pharmaceuticals, Inc, announced that an updated overall survival analysis of the phase III NAPOLI-1 study of irinotecan liposome injection (Onivyde) in combination with fluorouracil (5-FU) and leucovorin achieved a substantial improvement in 12-month overall survival compared to 5-FU and...
Phase I Trial Shows Injectable Agent Illuminates Cancer During Surgery
Doctors at the Duke University School of Medicine have tested a new injectable agent that causes cancer cells in a tumor to fluoresce, potentially increasing a surgeon’s ability to locate and remove all of a cancerous tumor on the first attempt. The imaging technology was developed through...
New Drug Application Submitted for Vemurafenib in Melanoma
Daiichi Sankyo announced that applications have been submitted for market approval for vemurafenib (PLX4032/RG7204) for the treatment of metastatic melanoma to the FDA and the European Medicines Agency (EMA). Additionally, a premarketing application for approval for a companion diagnostic test has...
Expert Point of View: Sunitinib/Prednisone Improves Progression-free Survival but not Overall Survival in Metastatic Castrate-resistant Prostate Cancer
Philip W. Kantoff, MD, of the Dana-Farber Cancer Institute, emphasized that this was essentially a negative study. “There is no evidence that VEGFR-targeted agents provide a survival benefit for men with advanced prostate cancer,” he indicated. “With shrinking resources and a rapidly improving...
Axitinib Improves Progression-free Survival over Sorafenib in Advanced Renal Cell Carcinoma
A randomized comparative effectiveness phase III trial demonstrated significantly superior efficacy for the tyrosine kinase inhibitor axitinib compared to sorafenib (Nexavar) in patients with advanced renal cell carcinoma (RCC). These data suggest that axitinib may become a new standard of care for ...
Are Clinical Pathways Inevitable in Oncology’s Future?
Our health-care system is undergoing a gradual but inevitable sea change, shifting from traditional fee-for-service to fee-for-value. A session at this year’s Association of Community Cancer Centers meeting in Washington, DC, shed light on how this trend will reshape incentives and the clinical...
ODAC Recommends Accelerated Approval for Brentuximab
Seattle Genetics, Inc, announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 10-0 to recommend that the agency grant accelerated approval of brentuximab vedotin (ADCETRIS) for the treatment of patients with Hodgkin lymphoma who relapse after autologous stem cell transplant...
Tissue of Origin Test Evaluated in Patients with Cancer of Unknown Primary
According to results of a study published in the Journal of Molecular Biomarkers and Diagnosis,1 the recently developed Tissue of Origin Test (Pathwork Diagnostics, Inc) aids in the diagnosis of challenging cancer cases such as those that are metastatic or that have a complex clinical history,...
Radium-223 Chloride Gets Fast Track Designation
Bayer HealthCare Pharmaceuticals, Inc, announced that its investigational compound radium-223 chloride, which is exclusively licensed from Algeta ASA, has been granted Fast Track designation by the FDA for the treatment of castration-resistant (hormone-refractory) prostate cancer in patients with...
FDA Grants Orphan Drug Status to MM-398, a Nanotherapeutic Encapsulation of Irinotecan, to Treat Pancreatic Cancer
Merrimack Pharmaceuticals, Inc, announced that the FDA has granted MM-398 orphan drug status for the treatment of pancreatic cancer. MM-398 is a novel, stable nanotherapeutic encapsulation of the marketed chemotherapy drug irinotecan. MM-398 is partnered with PharmaEngine, Inc, for development and...
