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Showing 1101 - 1150Oncotype DX Ductal Carcinoma in Situ Score Reliably Predicts Tumor Recurrence
Ductal carcinoma in situ, which accounts for 30% of all newly diagnosed breast cancers, does not always evolve into a lesion with metastatic potential. Only a proportion of these cases will progress to invasive breast cancer, but up until recently, it has not been possible to identify reliably...
Palliative Care in the Middle East
While some seek peace in the Middle East through political means, others are looking to help patients with cancer find peace through palliative care. This endeavor is bringing oncology professionals together across the region’s national borders and cultural boundaries to implement solutions and...
Supplemental New Drug Application for Carfilzomib
Amgen and its subsidiary Onyx Pharmaceuticals, Inc, announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) carfilzomib (Kyprolis) to seek approval for the treatment of patients with relapsed multiple myeloma who have received at least...
Blinatumomab in Philadelphia Chromosome–Negative Relapsed/Refractory B-Cell Precursor ALL
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 3, 2014, blinatumomab (Blincyto) was granted...
Ibrutinib for Waldenström’s Macroglobulinemia
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 29, 2015, the U.S. Food and Drug Administration (FDA)...
Pharmacokinetics and Exposure Response in Drug Development
INSIDE THE BLACK BOX is an occasional column offering insight into the U.S. Food and Drug Administration (FDA) and its policies and procedures. In this installment, former clinical pharmacology team leader Julie Bullock, PharmD, and current team leader Nitin Mehrotra, PhD, discuss how...
Palbociclib as Initial Endocrine-Based Therapy in Postmenopausal Women With Metastatic 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. On February 3, 2015, palbociclib (Ibrance) was granted...
Lenvatinib in Advanced Radioiodine-Refractory Differentiated Thyroid 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. On February 13, 2015, lenvatinib (Lenvima) was approved for the...
Targeting Biliary Tract Cancers Through Genomic Profiling
Biliary tract cancers are challenging, but a large genomic profiling study has identified potentially clinically relevant genomic alterations in up to two-thirds of patients.1 “The diverse landscape of clinically relevant genomic alterations in biliary tract cancers can serve as targets for...
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...
Global Oncology Launches Global Cancer Project Map With NCI
Nonprofit Global Oncology, Inc (GO) announced the launch of the Global Cancer Project Map, a novel online resource and virtual information exchange connecting the global cancer community. Developed by Global Oncology in collaboration with the National Cancer Institute (NCI) Center for Global...
Biosimilar Filgrastim-sndz in Filgrastim Indications
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 6, 2015, the granulocyte colony-stimulating factor...
Evidence Mounts for Clinical Utility of AR-V7 in Treatment Selection for Advanced Prostate Cancer
The search is on in prostate cancer to identify predictive and prognostic biologic and genomic markers that go beyond traditional ones. Several groups are working in this area. One marker that has received much attention is a splice abnormality in the androgen receptor (AR) called AR-V7. Two...
Scalp Cooling Caps Offer Option to Prevent Hair Loss During Chemotherapy
Hair loss remains one of the most dreaded side effects of chemotherapy, particularly for women. Scalp cooling caps worn by patients during chemotherapy infusion and for brief periods of time before and after offer these patients an option to preserve 50% or more of the hair on their heads. Although ...
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...
FDA Grants Fast Track Designation to Evofosfamide for Advanced Pancreatic Cancer
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of evofosfamide (TH-302), administered in combination with gemcitabine, for previously untreated patients with metastatic or locally advanced unresectable pancreatic cancer. Evofosfamide is an...
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®): 2015 Updates
For 2 decades, the NCCN Guidelines® have been recognized as the standard of cancer care in the United States, combining evidence, experience, and choice, so that multidisciplinary cancer treatment teams—including patients—are empowered to make informed decisions about cancer care,” said Robert W....
Andrew C. von Eschenbach, MD, Went From the Front Lines of Cancer Care to a Bird’s-Eye View of the Changing Oncology Landscape
At the end of the day, I’m still a kid from South Philly,” Andrew C. von Eschenbach, MD, former Director of the National Cancer Institute (NCI) and Commissioner of the U.S. Food and Drug Administration (FDA), told The ASCO Post. Dr. von Eschenbach is the product of a closely knit yet culturally...
Merck Chairman and CEO Kenneth C. Frazier Becomes PhRMA Board Chairman
Kenneth C. Frazier, JD, Chairman and CEO of Merck & Co., Inc., was elected Chairman of the Board of the Pharmaceutical Research and Manufacturers of America (PhRMA). Mr. Frazier formerly held the position of Chairman-Elect and succeeds Ian C. Read, Chairman and CEO of Pfizer, Inc. New Officers ...
What Is the Future of Intraperitoneal Treatment in Advanced Ovarian Cancer?
An analysis of Gynecologic Oncology Group (GOG) studies recently reported in the Journal of Clinical Oncology by Tewari and colleagues and reviewed in this issue of The ASCO Post showed a survival benefit of intraperitoneal chemotherapy vs intravenous chemotherapy over long-term follow-up in women...
Clinically Meaningful Preliminary Results With Pembrolizumab in Recurrent Head and Neck Cancer
Pembrolizumab (Keytruda) is making inroads into head and neck cancer, with encouraging results in heavily pre-treated patients with recurrent or metastatic squamous cell carcinoma of the head and neck, according to a report on the expansion-cohort KEYNOTE-012 study presented at the 2015 ASCO...
16-Gene Assay Recurrence Score Predicts Recurrence After Surgery for Localized Renal Cell Carcinoma
In a study reported in The Lancet Oncology, Brian Rini, MD, of the Cleveland Clinic Taussig Cancer Institute, and colleagues developed a 16-gene assay and recurrence score that predicted postoperative outcome in patients with stage I to III clear cell renal cell carcinoma.1 Development Phase In the ...
ASCO, Conquer Cancer Foundation Congratulate 2015 Grant and Award Recipients
The Conquer Cancer Foundation of ASCO presented more than $6.7 million in grants and awards to more than 200 promising oncology researchers at the 2015 ASCO Annual Meeting. The Conquer Cancer Foundation and ASCO congratulate the recipients on their contributions to the field of oncology and offer...
Daratumumab Expanded Access Program Open to Eligible U.S. Patients With Heavily Pretreated Multiple Myeloma
Janssen Biotech, Inc, announced the opening of a daratumumab expanded access program for eligible patients in the United States. Daratumumab is an investigational human anti-CD38 monoclonal antibody being evaluated in clinical trials as a treatment for patients with multiple myeloma. The...
The Value Proposition in Oncology: ASCO Session Weighs Points of View
The value proposition in health care is often represented with the following equation: Value = Outcomes/Cost. The simplicity of this equation, however, belies the complexity of its parts, which are the contributions of multiple stakeholders with unique perspectives. A session presented at the 2015...
Microangiopathic Hemolytic Anemia and Thrombocytopenia: Answers From Hematology Expert Review Questions
Question 1: What is the best first step in management of this patient? Correct Answer: C. Start plasma exchange. Expert Perspective Although distinguishing among thrombotic thrombocytopenic purpura, typical hemolytic uremic syndrome, and atypical hemolytic uremic syndrome (see Table 1 in the...
Carfilzomib in Combination With Lenalidomide and Dexamethasone in Relapsed Multiple Myeloma
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 24, 2015, carfilzomib (Kyprolis) was approved for use in...
Joxel Garcia, MD, to Direct MD Anderson Moon Shots Program Prevention Efforts
The University of Texas MD Anderson Cancer Center has appointed former United States Public Health Service four-star Admiral Joxel Garcia, MD, as the inaugural Executive Director of the Cancer Prevention and Control Platform, part of MD Anderson’s Moon Shots Program. He joined MD Anderson on August ...
‘Share the Journey’ Mobile App Aims to Understand the Different Experiences of Breast Cancer Survivors
In March 2015, Sage Bionetworks and Apple released “Share the Journey: Mind, Body, and Wellness After Breast Cancer,” a patient-centered iPhone app that tracks five common consequences of breast cancer treatment, including fatigue, cognitive function, sleep disturbances, mood changes, and a...
Brentuximab Vedotin for Consolidation Therapy in High-Risk Hodgkin Lymphoma
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 August 17, 2015, brentuximab vedotin (Adcetris) was approved...
Rolapitant for Prevention of Delayed Chemotherapy-Induced Nausea and Vomiting
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 September 2, 2015, rolapitant (Varubi) was approved for use in...
Older Patients With Cancer: A Growing Population in Need of Evidence-Based Care
The 2013 Institute of Medicine (IOM) report Delivering High Quality Cancer Care: Charting a New Course for a System in Crisis1 identified the dearth of evidence on older adults as a major quality-of-care issue. The U.S. population is aging at a rapid rate, and cancer is a disease that primarily...
NCCN Turns 20: Value-Based Care Has Arrived
Twenty years ago, the National Comprehensive Cancer Network (NCCN) began as a cooperative effort of 12 prestigious cancer centers, working to define and promote national guidelines for the care of patients with cancer. A major goal was to encourage uniformity in the management of malignant...
Mayo Clinic Receives Federal Grant to Fund Clinical Test of Triple-Negative Breast Cancer Vaccine
Researchers on Mayo Clinic’s Florida campus have been awarded a $13.3 million, 5-year federal grant to test a vaccine designed to prevent the recurrence of triple-negative breast cancer. This Breakthrough Award from the U.S. Department of Defense’s Breast Cancer Research Program will fund a...
Trifluridine/Tipiracil in Previously Treated Metastatic Colorectal 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. On September 22, 2015, trifluridine/tipiracil (Lonsurf) was...
Irinotecan Liposome Injection Plus Fluorouracil/Leucovorin to Treat Patients With Metastatic Pancreatic 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. On October 22, 2015, irinotecan liposome injection (Onivyde)...
Talimogene Laherparepvec for Treatment of Unresectable Cutaneous, Subcutaneous, and Nodal Melanoma Lesions
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 October 27, 2015, talimogene laherparepvec (Imlygic) was...
Ixazomib in Previously Treated Multiple Myeloma
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 November 20, 2015, ixazomib (Ninlaro) was approved by the U.S....
A Blueprint for Drug/Diagnostic Development: Expansion and Use of Curated Genetic Databases
In a continuation of a 2014 conference that explored regulatory considerations and strategies for next-generation sequencing, the Friends of Cancer Research, with support from Alexandria Real Estate Equities, Inc, Pasadena, California, met to discuss the issues and problems of coordinating drug and ...
NCCN Names Robert C. Young, MD, Interim Vice President of Oncology Research Program
The National Comprehensive Cancer Network (NCCN) has appointed Robert C. Young, MD, as Interim Vice President of the NCCN Oncology Research Program. Dr. Young brings to NCCN more than 45 years of oncology experience. He is President of RCY Medicine, a consulting service focused on cancer center...
Cobimetinib in BRAF-Mutant Unresectable or Metastatic Melanoma in Combination With Vemurafenib
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 November 10, 2015, the U.S. Food and Drug Administration...
Breast Care Services at Henry Ford Health System Gains New Director, Three New Surgeons
Internationally renowned breast cancer surgeon Lisa A. Newman, MD, MPH, has joined Henry Ford Health System to lead its metro Detroit breast cancer program and new international breast cancer research center. She begins work in December as the Director of the Breast Cancer Program at Henry Ford....
ASH Announces 2016 Scholar Award Recipients
The American Society of Hematology (ASH) has announced the recipients of its 2016 Scholar Awards. One of ASH’s most prestigious award programs, the ASH Scholar Award program financially supports fellows and junior faculty dedicated to careers in hematology research as they transition from training...
UnitedHealthcare Signs Agreement With Foundation Medicine for Genomic Profiling Assay for Non–Small Cell Lung Cancer
Foundation Medicine, Inc. recently announced that it has signed a national agreement for the company’s comprehensive genomic profiling assay for solid tumors, called FoundationOne, with UnitedHealthcare. The agreement, which became effective December 15, 2015, covers the assay for patients with...
Researcher Spotlight: Conquering Cancer With Dr. Heske
Sometimes, cancer treatments that initially appear promising begin to lose their effectiveness. This is due to the ability diseases like cancer have to develop resistance to treatments over time and, essentially, outsmart them. But what if there were ways to ensure this didn’t happen? What if...
FDA Allows Marketing of Cooling Cap to Reduce Hair Loss During Chemotherapy
The U.S. Food and Drug Administration has cleared the first cooling cap to reduce hair loss in female breast cancer patients undergoing chemotherapy for marketing in the United States. Hair loss is a common side effect of certain types of chemotherapy, commonly associated with the treatment of...
SABCS 2015: Resistance of Estrogen Receptor–Positive Breast Cancer to Tamoxifen Therapy May Be Driven by APOBEC3B
Responses to tamoxifen were significantly prolonged by reducing levels of the enzyme APOBEC3B in preclinical models of estrogen receptor–positive breast cancer and significantly shortened by increasing levels of APOBEC3B, suggesting that APOBEC3B drives resistance to tamoxifen, according to...
ASH 2015: Test Creates Simulations That May Help Predict Drug Responses, Drive Personalized Treatment
Researchers at the University of Iowa College of Dentistry are partnering with a private company to develop computer simulations that can help personalize cancer care by predicting how a patient will respond to a drug treatment. Their findings were presented by Brogden et al at the 57th American...
Investigational NAE Inhibitor Pevonedistat Shows Potential Activity in Patients With Relapsed/Refractory Lymphoma
A phase I study evaluating the safety, pharmacokinetic profile, pharmacodynamic effects, and antitumor activity of the first-in-class investigational NEDD8-activating enzyme (NAE) inhibitor pevonedistat (TAK-924/MLN4924) in patients with relapsed/refractory lymphoma or multiple myeloma has found...
Most Women Undergoing BRCA Genetic Testing Do Not Receive Pretest Genetic Counseling
In the ABOUT study reported in JAMA Oncology, Armstrong et al found that the majority of BRCA-tested women in a commercially insured population responding to a questionnaire about their experience had not received genetic counseling from a genetics clinician prior to testing. The study was...
