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Showing 6251 - 6300FDA Announces Comprehensive Regenerative Medicine Policy Framework
On November 16, the U.S. Food and Drug Administration (FDA) announced a comprehensive policy framework for the development and oversight of regenerative medicine products, including novel cellular therapies. The framework—outlined in a suite of four guidance documents—builds upon the...
ESMO Publishes Precision Medicine Glossary
The European Society for Medical Oncology (ESMO) has published its ESMO Precision Medicine Glossary in Annals of Oncology. The glossary’s 43 definitions are set to pave the way for consistent communication on precision medicine between oncologists, researchers, and patients by standardizing...
Hospital Groups File Lawsuit to Stop Significant Payment Cuts for 340B Hospitals
The American Hospital Association (AHA), the Association of American Medical Colleges (AAMC), and America’s Essential Hospitals have filed a lawsuit against the U.S. Department of Health and Human Services (HHS) in the U.S. District Court for the District of Columbia to prevent significant...
ASCO Endorses ASTRO Guideline on Stereotactic Body Radiotherapy for Early-Stage NSCLC
As reported in the Journal of Clinical Oncologyby Bryan J. Schneider, MD, of the University of Michigan, Ann Arbor, and colleagues, ASCO has endorsed the recently released American Society for Radiation Oncology (ASTRO) evidence-based guideline on stereotactic body radiotherapy in early-stage...
Are African American Women With Type 2 Diabetes at Increased Risk for ER-Negative Breast Cancer?
A prospective study by Palmer et al assessing the relationship of type 2 diabetes and the incidence of estrogen receptor–negative and estrogen receptor–positive breast cancer among African American women has found statistically significant evidence of an increased risk of estrogen...
FDA Approves Fulvestrant in Combination With Abemaciclib in Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer
Today, the U.S. Food and Drug Administration (FDA) approved a new indication for fulvestrant (Faslodex), expanding the drug's approved use to include combined therapy with abemaciclib (Verzenio), a cyclin-dependent kinase (CDK) 4/6 inhibitor, for the treatment of hormone receptor–positive,...
FDA Authorizes MSK-IMPACT Tumor Profiling Assay
Today, the U.S. Food and Drug Administration (FDA) authorized Memorial Sloan Kettering Cancer Center’s MSK-IMPACT tumor profiling assay, an in vitro diagnostic test that can identify more biomarkers that may be found in various cancers than any test previously reviewed by the...
Ventana MMR IHC Panel for Patients Diagnosed With Colorectal Cancer Receives FDA Clearance
On November 14, the U.S. Food & Drug Administration (FDA) granted clearance to the Ventana MMR IHC Panel, which provides clinicians with a comprehensive group of immunohistochemistry (IHC) tests for patients diagnosed with colorectal cancer. The tests detect proteins associated with the DNA...
Adding Targeted Agent to Chemotherapy in Second-Line Treatment of Advanced Gastric Cancer
In the Asian phase III GOLD trial reported in The Lancet Oncology, Bang et al found that the addition of olaparib (Lynparza) to paclitaxel did not significantly improve overall survival among patients with previously treated advanced gastric cancer, including those with...
Chronic Stress Hormones May Promote Resistance to EGFR Inhibitors in Patients With Lung Cancer
Elevated levels of chronic stress hormones, such as those produced by psychological distress, may promote resistance to drugs commonly used to treat lung cancer patients with EGFR mutations, according to new research from The University of Texas MD Anderson Cancer Center. Retrospective analysis of...
Study Finds HPV Screening May Be More Sensitive Than Pap Test for Detecting Cervical Cancer
The main goal of cervical screening programs is to detect and treat precancer before the cancer develops. Human papillomavirus (HPV) testing is more sensitive than cytology for detecting precancer. However, reports of rare HPV-negative, cytology-positive cancers are motivating the continued use of...
FDA Approves Letermovir for Prophylaxis of Cytomegalovirus Infection and Disease in Allogeneic Stem Cell Transplant Patients
Today, the U.S. Food and Drug Administration (FDA) approved letermovir (Prevymis) once-daily tablets for oral use and injection for intravenous infusion. Letermovir is indicated for prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients of an allogeneic...
A Revolutionary Technology Offers Hope and Ethical Concern
Aldous Huxley’s classic 1932 dystopian novel Brave New World pictures an eerie future where humans are genetically bred, altered to create worthy citizens. Welcome back to the future. First there was the astounding feat of sequencing the entire human genome; now, thanks to a revolutionary...
Barrie Cassileth, PhD: A Pioneer in Integrative Oncology
Integrative oncology is an evolving evidence-based specialty providing whole-person care by combining conventional approved cancer treatments with integrative and complementary therapies that best serve the needs of patients based on their diagnosis, prognosis, treatment history, and individual...
National Cancer Institute Awards Dr. Ruth Etzioni 5-Year Grant to Fill Gaps in Cancer-Recurrence Data
RUTH ETZIONI, PhD, a Biostatistician at Fred Hutchinson Cancer Research Center’s Public Health Sciences Division, has received a 5–year National Institutes of Health grant to advance the science of cancer surveillance by developing, validating, and deploying a scalable and automated approach for...
Clinical Trials Actively Recruiting Patients With Lung Cancer
THE INFORMATION contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies focused on patients with lung cancer. These studies highlight combinations of chemotherapy, mutation-specific treatments, stereotactic body radiation therapy, metastatic control, cancer...
Fox Chase Cancer Center Receives Historic Gift to Establish Pancreatic Cancer Institute
PHILADELPHIA PHILANTHROPIST Concetta “Chet” Greenberg has made a transformational gift to create The Marvin and Concetta Greenberg Pancreatic Cancer Institute at Fox Chase Cancer Center. This multimillion-dollar commitment will significantly accelerate the pace of pancreatic cancer research, and...
FDA Approves Intravenous Rolapitant for Prevention of Delayed Chemotherapy-Induced Nausea and Vomiting
ON OCTOBER 25, the U.S. Food and Drug Administration (FDA) approved intravenous (IV) rolapitant (Varubi) in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including...
Balancing Immune-Related Adverse Events With Efficacy of Dual Checkpoint Inhibitor Therapy in Melanoma
MUCH PROGRESS has been made in the past decade in the treatment of patients with newly diagnosed metastatic melanoma. In the front-line setting, programmed cell death protein 1 (PD-1) monotherapy (nivolumab [Opdivo] and pembrolizumab [Keytruda]) and combined PD-1 plus cytotoxic...
EXPERT POINT OF VIEW: Geraldine M. Jacobson, MD, MPH, MBA
GERALDINE M. JACOBSON, MD, MPH, MBA, ASTRO Secretary/Treasurer, Professor and Chair of Radiation Oncology at the West Virginia University School of Medicine, Morgantown, went into more detail about the importance of this study. “The study directly compared brachytherapy/chemotherapy, which we use...
Pelvic Radiation Therapy Preferred Over Brachytherapy Plus Chemotherapy in Treatment of High-Risk Endometrial Cancer
VAGINAL CUFF BRACHYTHERAPY plus chemotherapy failed to show superiority over pelvic radiation therapy for women with high-risk stage I–II endometrial cancer in a phase III trial.1 Furthermore, vaginal cuff brachytherapy plus chemotherapy led to more pelvic and para-aortic nodal recurrences and...
ASCO Cites Evidence That Alcohol Is Linked to Cancer, Calls for Reduced Alcohol Consumption
Alcohol use—whether light, moderate, or heavy—is linked with increasing the risk of several leading cancers, including those of the breast, colon, esophagus, and head and neck, according to evidence gathered by ASCO. In a statement released November 7 identifying alcohol as a definite...
Long-Term Follow-up of Cardiac Function After Adjuvant Therapy With Trastuzumab in Early Breast Cancer
As reported by Ganz et al in the Journal of Clinical Oncology, long-term follow-up of patients in the National Surgical Adjuvant Breast and Bowel Project (NSABP) Protocol B-31/NRG Oncology trial showed no worsening of cardiac function or quality of life with the addition of adjuvant trastuzumab...
FDA Approves Vemurafenib for Certain Patients With Erdheim-Chester Disease
On November 6, the U.S. Food and Drug Administration (FDA) expanded the approval of vemurafenib (Zelboraf) to include the treatment of certain adult patients with Erdheim-Chester disease (ECD), a rare cancer of the blood. Vemurafenib is indicated to treat patients whose cancer cells have a specific ...
FDA Accepts sBLA for Bevacizumab as a Front-Line Treatment for Advanced Ovarian Cancer
On October 25, Genentech announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) for bevacizumab (Avastin) in combination with chemotherapy (carboplatin and paclitaxel), followed by bevacizumab alone, for the front-line ...
Hospital Emergency Department Practices for Treating Older Adults With Cancer
A new study published by Lipitz-Snyderman et al in JNCCN–Journal of the National Comprehensive Cancer Network found that among patients presenting to the emergency department, those with cancer, especially those aged 75 years or older, are more likely to be admitted to the hospital—and...
Life After Treatment: Managing Lymphoma Survivors
According to Surveillance, Epidemiology, and End Results (SEER) data, patients with Hodgkin lymphoma and non-Hodgkin lymphoma (NHL) have 5-year survival rates of 86% and 71%, respectively.1 Although the increased number of survivors is welcome proof of the success of new treatment regimens, it also ...
Management of Newly Diagnosed Multiple Myeloma in Transplant-Eligible Patients
The treatment paradigm for multiple myeloma has changed dramatically in the past decade with the availability of several efficacious agents in various drug classes. At the National Comprehensive Cancer Network® (NCCN®) 13th Annual Congress: Hematologic Malignancies™, Shaji K. Kumar, MD, Professor...
How Effective Communication Is Integral to Patient-Centered Care
Communicating effectively with patients with advanced cancer not only helps patients and their family members successfully transition to palliative and end-of-life care, it can prevent physicians from experiencing professional burnout, according to Robert M. Arnold, MD, Distinguished Service...
Quick Takes on Studies in Noncolorectal Gastrointestinal Cancers
In this roundup, The ASCO Post offers a glance at key findings from studies in noncolorectal gastrointestinal malignancies presented at the European Society for Medical Oncology (ESMO) 2017 Congress from investigators around the world. Docetaxel-Based Triplet in Gastric Cancer The superiority of...
FDA Approves Novel Therapies for Lymphoma Indications
IN OCTOBER, the U.S. Food and Drug Administration (FDA) approved two novel agents for lymphoma indications: -acalabrutinib (Calquence), a kinase inhibitor, for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy; and axicabtagene ciloleucel (Yescarta), a...
EXPERT POINT OF VIEW: Eric Van Cutsem, MD, PhD
Invited discussant Eric Van Cutsem, MD, PhD, of University Hospitals Leuven, Belgium, commented that both ATTRACTION-02 and KEYNOTE-059 suggest that anti-PD [programmed cell death protein] antibodies have activity in advanced gastric cancer, but their findings differed with regard to the impact of ...
In Patients With Non–Small Cell Lung Cancer, Tumor Mutation Load Emerging as Biomarker for Immunotherapy
Tumor mutation burden is emerging as a biomarker for selecting non–small cell lung cancer (NSCLC) patients for immunotherapy, according to Naiyer Rizvi, MD, the Price Family Chair of Clinical Translational Medicine, Professor of Medicine, and Director of Thoracic Oncology at Columbia University,...
ENDEAVOR Trial Endeavors to Make Case for Carfilzomib: Despite Survival Advantage, Should We Be Surprised?
LOCATION! LOCATION! LOCATION! That’s what home buyers are frequently cautioned about before purchasing a property. For trialists, and more importantly, practicing oncologists, a study’s design, akin to a property’s location, must be taken into account prior to buying into the results and changing ...
Treatment Based on BRCA1 Expression Did Not Improve Survival in NSCLC
IN PATIENTS with early-stage non–small cell lung cancer (NSCLC), the use of expression of BRCA1 failed as an approach to customize chemotherapy, investigators from the Spanish Lung Cancer Cooperative Group reported at the 2017 International Association for the Study of Lung Cancer (IASLC) World...
New Persistent Opioid Use After Curative-Intent Cancer Surgery
A study reported by Lee et al in the Journal of Clinical Oncology indicates that approximately 10% of patients undergoing curative-intent surgery for cancer become new persistent opioid users. Study Details The study involved data from 68,463 patients from a national data set of insurance claims...
The Liver Meeting: Daily Aspirin May Reduce Risk for Hepatitis B Virus–Related Liver Cancer
A new study presented at The Liver Meeting, held by the American Association for the Study of Liver Diseases, found that daily aspirin therapy was significantly associated with a reduced risk in hepatitis B virus (HBV)–related liver cancer (Abstract 223). According to AASLD’s...
ASCO/CCO Focused Guideline Update on Role of Bone-Modifying Agents in Metastatic Breast Cancer
As reported by Catherine Van Poznak, MD, of the University of Michigan, Ann Arbor, and colleagues in the Journal of Clinical Oncology, ASCO and Cancer Care Ontario (CCO) have collaborated in providing a focused update for the ASCO clinical practice guideline on the role of bone-modifying agents in...
Jacob J. Strand, MD, on Dealing With Opioid Use Disorders
Jacob J. Strand, MD, of the Mayo Clinic, discusses tips and tools that clinicians can use to develop universal precautions for prescribing opioids in oncology and palliative care practice.
AACR-NCI-EORTC: Noninvasive Computational Imaging Approach May Help Predict Response to Immunotherapy
A computational imaging-based signature of immune-cell infiltration in and around a tumor could predict patients’ responses to treatment with anti–programmed cell death protein 1/programmed death-ligand 1 (PD-1/PD-L1) immunotherapies, according to data from a study presented by Sun et...
AACR-NCI-EORTC: Colorectal Cancer Test Could Detect Early Cancer-Causing Genetic Biomarkers With High Degree of Sensitivity
An investigational test that screens for colorectal cancer could detect genetic mutations that are indicative of the disease with a high degree of sensitivity and specificity, according to results of a study presented by Powell et al at the AACR-NCI-EORTC International Conference on Molecular...
Charles F. von Gunten, MD, PhD, on Palliative Care in Oncology: A Fellows Curriculum
Charles F. von Gunten, MD, PhD, of OhioHealth, discusses an online curriculum that changed younger physicians’ use of palliative medicine in practice during the year after fellowship training (Abstract 202).
Gary Gilliland, MD, PhD, Testifies Before Congress on NIH Funding System
Gary Gilliland, MD, PhD, President and Director of Fred Hutchinson Cancer Research Center, recently delivered the following testimony and answered questions from members of the House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies. His remarks...
AACR-NCI-EORTC: Tazemetostat as Treatment for Certain Pediatric Relapsed or Refractory Solid Tumors
Children with relapsed or refractory malignant rhabdoid tumors, epithelioid sarcomas, or poorly differentiated chordomas with a particular genetic defect tolerated treatment with the investigational drug tazemetostat well, and some had objective and durable responses, according to data from a phase ...
AACR-NCI-EORTC: Colorectal Cancers May Mutate to Escape Immune System Detection
Whole-exome sequencing revealed that colorectal cancers with high mutational load (microsatellite instability–high, or MSI-H) predominantly use “immunoediting” to escape immune surveillance, while colorectal cancers with low mutational load (microsatellite stable, or MSS) use...
Combination Therapy for Docetaxel-Pretreated Metastatic Castration-Resistant Prostate Cancer
The phase III AFFINITY trial has shown no survival benefit with the addition of the antisense oligonucleotide custirsen to cabazitaxel (Jevtana)/prednisone in patients with metastatic prostate cancer previously treated with docetaxel. These findings were reported in The Lancet Oncology by Beer et...
FDA Approves Intravenous Rolapitant for Delayed Chemotherapy-Induced Nausea and Vomiting
On October 25, the U.S. Food and Drug Administration (FDA) approved intravenous (IV) rolapitant (Varubi) in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including,...
Changes in Opioid Prescription for Cancer Patients Referred to Outpatient Palliative Care
In a study reported in the Journal of Oncology Practice, Haider et al found that the median morphine equivalent daily dose decreased significantly among cancer patients seen at MD Anderson Cancer Center’s outpatient palliative care clinic between 2010 and 2015. Use of hydrocodone decreased...
Extended Aromatase Inhibitor Therapy After Sequential Endocrine Therapy
In the Dutch phase III DATA trial reported in The Lancet Oncology by Tjan-Heinjen et al, a nonsignificant disease-free survival advantage was found for 6 vs 3 years of adjuvant aromatase inhibitor therapy after 2 to 3 years of tamoxifen in hormone receptor–positive early breast cancer....
FDA Grants Priority Review for Olaparib in Metastatic Breast Cancer
On October 18, AstraZeneca and Merck & Co announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to a supplemental New Drug Application (sNDA) for the use of olaparib (Lynparza) tablets in patients with germline BRCA-mutated, HER2-negative...
