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Showing 151 - 187SIDEBAR: 2013 New Drug/Indication Approvals*
1. September 30, 2013: Pertuzumab (Perjeta) Accelerated approval in combination with trastuzumab and docetaxel for the neoadjuvant treatment of HER2-positive, locally advanced, inflammatory, or early-stage breast cancer. 2. September 6, 2013: Paclitaxel protein-bound particles (albumin-bound)...
SIDEBAR: FDA Drug Approvals, 2013
Ibrutinib (Imbruvica) for mantle cell lymphoma Obinutuzumab (Gazyva) for chronic lymphocytic leukemia Pertuzumab (Perjeta) for breast cancer Paclitaxel protein-bound particles (Abraxane) for pancreatic adenocarcinoma Afatinib (Gilotrif) for non-small cell lung cancer, with Therascreen EGFR...
Leukemia Pioneer John M. Goldman, DM, Dies at 75
“He gave his honours to the world again,his blessed part to heaven, and slept in peace.” —William Shakespeare, Henry VIII In 1971, John M. Goldman, DM, FRCP, FRCPath, FMedSci, began research in chronic myeloid leukemia (CML), a uniformly fatal disease at the time. Over the ensuing decades, Dr....
Quest for Targeted Therapeutic ‘Cocktails’ Hits Roadblocks
The use of cutting-edge technology and bioinformatics to inform clinical decision-making in oncology is still a ways off, according to Mark Pegram, MD, the Susy Yuan-Huey Hung Professor of Oncology and Director of the Stanford Breast Oncology Program, Stanford University, Palo Alto, California. At...
In Advanced Lung Cancer, Targeted Combinations Are Still Works in Progress
For the treatment of advanced non–small cell lung cancer (NSCLC), combinations of targeted agents are of great research interest but have not yet been shown to improve outcomes. Single-agent treatment with tyrosine kinase inhibitors, therefore, remains the standard of care for patients with...
James Herman, MD, Named Co-Leader of UPCI Lung Cancer Program
A leader in the field of epigenetics whose work has led to important discoveries into how cancer develops and progresses has been named the co-leader of the Lung Cancer Program at the University of Pittsburgh Cancer Institute (UPCI), partner with UPMC CancerCenter. James Herman, MD, comes to...
Expert Point of View: William M. Sikov, MD
At the Breast Cancer Symposium, William M. Sikov, MD, Associate Professor of Medicine at the Warren Alpert Medical School of Brown University, Providence, Rhode Island, gave a talk on the use of pathologic complete response in the clinic and summarized the CTNeoBC findings for The ASCO Post. “The...
CTNeoBC Analysis: Response to Neoadjuvant Chemotherapy Varies by Breast Tumor Subtype
Women who achieve a pathologic complete response (pCR) to neoadjuvant chemotherapy rarely have local or regional recurrence of breast cancer, but this largely depends on tumor subtype, which remained an independent predictor of locoregional recurrence when pathologic response was taken into account ...
Pathologic Complete Response: Understanding the Subtleties
In the neoadjuvant treatment of breast cancer, the importance of achieving a pathologic complete response (pCR) varies substantially by breast cancer subtype. Patients are increasingly interested in this outcome, but it means different things to different patients, according to two breast cancer...
For Triple-Negative Breast Cancer, Adding Carboplatin to Anthracycline/Taxane Produces Benefit, but How Much?
Combination chemotherapy for triple-negative breast cancer is anthracycline- and taxane-based and has not really changed much in the past 10 years, but “we are starting to see emerging data with selective activity of platinum agents,” Priyanka Sharma, MD, told participants at the Best of ASCO...
ASCO Endorses Guideline for Molecular Testing for Selecting Lung Cancer Patients for EGFR and ALK Inhibitor Treatment
ASCO has endorsed the recently developed joint College of American Pathologists (CAP), International Association for the Study of Lung Cancer (IASLC), and Association for Molecular Pathology (AMP) guideline on molecular testing for selection of patients with lung cancer for EGFR and ALK inhibitor...
CD19-Directed CAR T Cells Produce Sustained Remission in Relapsed/Refractory Acute Lymphoblastic Leukemia
In a study reported in The New England Journal of Medicine, Shannon L. Maude, MD, PhD, of Children’s Hospital of Philadelphia, and Noelle Frey, MD, of the Perelman School of Medicine, University of Pennsylvania, and colleagues reported achieving sustained remissions in children and adults with...
FDA Guidance on the Use of Pathologic Complete Response in Development of New Treatments for High-Risk Early Breast Cancer Includes ASCO Suggestions
The U.S. Food and Drug Administration’s (FDA) final Guidance for Industry on Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer incorporates two changes that ASCO had proposed in comments submitted to the agency on a draft guidance issued in 2012. The...
Crizotinib in ROS1-Positive NSCLC: A Next Step Forward
Advances in the molecular characterization of non–small cell lung cancer (NSCLC) have led to the identification of molecularly defined distinct subsets of patients who derive benefit from targeted therapies. Currently, two such groups of agents have moved widely into clinical practice: epidermal...
New Choosing Wisely List, Leukemia Quick-Takes From ASH
Nearly 5,000 scientific abstracts were presented at the 2014 American Society of Hematology (ASH) Annual Meeting and Exhibition in San Francisco. Along with our targeted coverage of the meeting’s key newsmakers, The ASCO Post provides you with these brief reports of other interesting...
Expect Questions About Measles From Parents of Children With Cancer
With the large outbreak of measles that has spread to more than a dozen states, questions from parents of children with cancer should be expected and encouraged. Parents should “talk to their physician about what the level of risk may be for their child who is undergoing cancer treatment (or has...
Measles Presents Greater Risks in Children Being Treated for Cancer
Measles outbreaks in the United States during 2014 and early 2015 have yielded an unprecedented number of cases nationwide, raising concerns about the threat measles poses to cancer patients (especially children) who may be at risk for severe complications and even death due to measles infection....
Clinical Trials Actively Recruiting Patients With Esophageal Cancer
The information contained in this Clinical Trials Resource Guide includes actively recruiting observational, interventional, phase I, phase II, and phase III clinical studies for patients with newly diagnosed or recurrent esophageal cancer. All of the studies are listed on the National Institutes...
Clinical Trials Actively Recruiting Patients With Neuroblastoma
The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies for patients with newly diagnosed or relapsed or refractory neuroblastoma. The studies include pilot, observational, phase I, phase II, and phase III trials investigating single-agent and...
Cobas KRAS Mutation Test Receives FDA Approval
Roche announced that the U.S. Food and Drug Administration (FDA) has approved the cobas KRAS Mutation Test for diagnostic use. The real-time polymerase chain reaction (PCR) test is designed to identify KRAS mutations in tumor samples from patients with metastatic colorectal cancer and aid...
Gefitinib in EGFR-Mutant Metastatic NSCLC
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 July 13, 2015, gefitinib (Iressa) was approved for first-line ...
Answers: Primary Diffuse Large B-Cell Lymphoma of the Central Nervous System
Question 1: What is next best step in the management of this patient? Correct Answer: C. Ophthalmoscopy/slit lamp examination. Expert Perspective Ophthalmic involvement should be sought by noninvasive procedures such as slit lamp examination and ophthalmoscopy and abnormal findings must be...
FDA Oncology New Drug/New Indication Approvals for 2015
The following new hematology/oncology agents and expanded indications were approved by the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research in 2015: Alectinib (Alecensa), an ALK inhibitor, for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive...
SABCS 2015: Pathologic Complete Response to Presurgery Chemotherapy Improves Survival for Patients With Triple-Negative Breast Cancer
Patients with stage II or stage III triple-negative breast cancer who had a pathologic complete response (pCR) after presurgery chemotherapy had increased event-free and overall survival compared with those who had more than minimal residual invasive disease at surgery following presurgery...
SABCS 2015: ESR1 Gene Mutations Are Associated With Worse Overall Survival in Metastatic ER-Positive Breast Cancer
A study by Chandarlapaty et al investigating whether mutations in the estrogen receptor are common in patients with advanced breast cancer and how they affect patient outcomes has found that the D538G and Y537S mutations in the estrogen receptor 1 (ESR1) gene are prevalent in patients with advanced ...
Blood Test Detects Resistance to Aromatase Inhibitors in Breast Cancer Treatment
Scientists have developed a highly sensitive blood test that can spot when breast cancers become resistant to standard hormone treatment, and have demonstrated that this test could guide further treatment. The test gives an early warning of resistance to aromatase inhibitors, which are used to...
Biomarker miR-506 Helps Predict Survival Time in Gastric Cancer Patients
Gastric cancer is typically associated with late-stage diagnosis, as well as high mortality. A study by Li et al in The American Journal of Pathology points to a pivotal role played by the biomarker microRNA (miR)-506 in gastric cancer. Patients whose primary gastric cancer lesions express high...
New 'Mutation-Tracking' Blood Test Could Predict Breast Cancer Relapse
Scientists have developed a blood test for breast cancer that may be able to identify which patients will suffer a relapse after treatment, months before tumors are visible on hospital scans. The test may uncover small numbers of residual cancer cells that have resisted therapy by detecting cancer...
FDA Approves Gefitinib for EGFR-Mutated Metastatic Non–Small Cell Lung Cancer
The U.S. Food and Drug Administration (FDA) has approved gefitinib (Iressa) for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an...
Cobas KRAS Mutation Test Receives FDA Approval
Roche announced that the U.S. Food and Drug Administration (FDA) has approved the cobas KRAS Mutation Test for diagnostic use. The real-time polymerase chain reaction (PCR) test is designed to identify KRAS mutations in tumor samples from patients with metastatic colorectal cancer and aid...
CD19-Directed CAR T Cells Produce Sustained Remission in Relapsed/Refractory ALL
In a study reported in The New England Journal of Medicine, Maude et al reported achieving sustained remissions in children and adults with relapsed/refractory acute lymphoblastic leukemia (ALL) using autologous CD19-targeted chimeric antigen receptor (CAR)-modified T cells. Study Details In the...
ASCO Endorses Guideline for Molecular Testing to Select Lung Cancer Patients for EGFR and ALK Inhibitor Treatment
ASCO has endorsed the recently developed joint College of American Pathologists (CAP), International Association for the Study of Lung Cancer (IASLC), and Association of Molecular Pathologists (AMP) guideline on molecular testing for selection of patients with lung cancer for EGFR and ALK inhibitor ...
Multidimensional Analysis Provides More Accurate Prognostic Biomarkers in Colorectal Cancer
Using a multidimensional platform that combined nanofluidic technology for quantitative polymerase chain reaction (PCR) analysis and quantitative fluorescent immunohistochemistry for protein analysis, researchers at the Danbury Hospital Biomedical Research Institute were able to accurately predict...
Gene Signatures Identified by Meta-Analysis Predict Survival and Suboptimal Debulking in Late-Stage Ovarian Cancer
As reported in the Journal of the National Cancer Institute, Riester et al have identified gene-expression signatures predictive of survival and debulking status in late-stage ovarian cancer. Study Details The study involved meta-analytic techniques using integrated data from 13 publicly...
Study Compares Rituximab Maintenance to Observation After First-Line Treatment in Older Patients With Advanced Follicular Lymphoma
In an Italian study reported in the Journal of Clinical Oncology by Umberto Vitolo, MD, and colleagues in the Fondazione Italiana Linfomi, treatment-naive patients aged > 60 years with advanced follicular lymphoma were randomized to rituximab [Rituxan] maintenance or observation after brief ...
Digital PCR Technology Detects Brain Tumor–associated Mutation in Cerebrospinal Fluid
Researchers at Massachusetts General Hospital have used digital versions of a standard molecular biology tool to detect a common tumor-associated mutation in the cerebrospinal fluid of patients with brain tumors. In a report published in Molecular Therapy – Nucleic Acids, the...
FDA Approves Afatinib for EGFR-mutant Late-stage Non–Small Cell Lung Cancer
The U.S. Food and Drug Administration (FDA) today approved the tyrosine kinase inhibitor afatinib (Gilotrif) for the first-line treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors express epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21...
