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Showing 2501 - 2550FDA Grants Approval to Lenvatinib/Pembrolizumab in Advanced Endometrial Cancer, Announces Project Orbis
The U.S. Food and Drug Administration (FDA) has announced Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE). Project Orbis provides a framework for concurrent submission and review of oncology drugs among its international partners. Under this project, the FDA, the...
Targeting an Important Tumor Vulnerability With Maintenance Olaparib in Germline BRCA-Mutated Pancreatic Cancer
In the POLO trial, which is discussed in this issue of The ASCO Post, Golan and colleagues evaluated the potential benefit of maintenance olaparib after disease stability or response to a minimum of 4 months of platinum-based chemotherapy in patients with metastatic pancreatic cancer and a...
ASTRO 2019: Machine-Learning Model May Accurately Predict Radiation Side Effects in Patients With Head and Neck Cancers
A study by Reddy et al investigating the use of a machine-learning model to predict which patients with head and neck cancer being treated with radiation may experience significant weight loss, feeding tube placement, and unplanned hospitalization has found that the model accurately identified the...
FDA Issues Drug Safety Communication on Lung Inflammation Due to Treatment With CDK4/6 Inhibitors
On September 13, the U.S. Food and Drug Administration (FDA) issued a drug safety communication warning that palbociclib, ribociclib, and abemaciclib—used to treat some patients with advanced breast cancer—may cause rare but severe inflammation of the lungs. The agency approved new warnings about...
Conundrums in Managing Cancer-Associated Thrombosis
Although there may be a clear role for prophylactic anticoagulation in hospitalized patients and those undergoing surgery, indication for prophylactic anticoagulation for patients with cancer seen in the ambulatory setting has yet to emerge. Until clinical trial data on prophylactic...
ASTRO 2019: Effect of Closure of Women’s Health Clinics From 2010 to 2013 on Cervical Cancer Screening and Detection
Following the closure of nearly 100 women’s health clinics across the United States from 2010 to 2013, fewer women were screened for cervical cancer; more women were diagnosed with advanced stages of the disease; and disease mortality rates rose. Findings from a new analysis combining several...
FDA Pipeline: Breakthrough Therapy Designation in Lung Cancer, Orphan Drug Designations in Myeloma and Soft-Tissue Sarcoma
Recently, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to tepotinib for metastatic non–small cell lung cancer harboring MET exon 14 skipping alterations, and Orphan Drug designations to novel chimeric antigen receptor T-cell therapies in both multiple myeloma ...
WCLC 2019: Selpercatinib in RET Fusion–Positive NSCLC
Patients with RET fusion–positive non–small cell lung cancer (NSCLC) comprise up to 2% of all NSCLC cases, but there are no targeted therapies currently approved for patients with this form of lung cancer. Selpercatinib (also known as LOXO-292) is an oral and highly selective investigational drug...
Oncology Communications Online: Pause and Think Before Hitting ‘Send’
The emergence of online technologies over the past few decades has fundamentally changed the way society communicates and shares information. This sea change has also had profound influence on the practice of medicine, from real-time information-sharing among colleagues, to having instant access...
Olaparib Monotherapy Improves Outcomes in BRCA-Mutated, Platinum-Sensitive Relapsed Ovarian Cancer
Compared with treatment with nonplatinum-based chemotherapy, monotherapy with the PARP (poly [ADP ribose] polymerase) inhibitor olaparib led to statistically significant and clinically relevant improvements in overall response rate and progression-free survival in women with germline...
Not for the Squeamish: Surgery in the 19th Century
Imagine undergoing major surgery in a grimy operating room without any form of antisepsis. That was the grim reality in the 1800s, when the ruling theory was that damage from “bad air” was responsible for infections in surgical wounds. Hospitals simply aired out the surgical wards at midday to...
Lenalidomide for Previously Treated Follicular and Marginal Zone Lymphomas
On May 28, 2019, lenalidomide was approved for use in combination with a rituximab product for previously treated follicular lymphoma and previously treated marginal zone lymphoma.1,2 Supporting Efficacy Data Approval was based on the findings of two clinical trials: AUGMENT (ClinicalTrials.gov...
Update on FDA-Approved CAR T-Cell Gene Therapy for B-Cell Lymphomas
On October 18, 2017, the U.S. Food and Drug Administration (FDA) granted approval to axicabtagene ciloleucel for the treatment of adult patients with relapsed or refractory large B-cell lymphoma. Specifically, this treatment can be used after two or more lines of systemic therapy for diffuse...
Hey Siri, Should I Get a Medical Degree?
I received a coffee mug from a physician colleague some years ago with the tag line: “Please do not confuse your Google search with my Medical Degree.” Physicians of all stripes and colors can relate to the agony of debunking a “Dr. Google” diagnosis. However, in a fast-evolving health-care...
WCLC 2019: First-Line Nivolumab/Ipilimumab in Special Populations With NSCLC
First-line therapy consisting of nivolumab plus ipilimumab showed a consistent safety profile in special populations with advanced non–small cell lung cancer (NSCLC), according to research presented by Fabrice Barlesi, MD, PhD, of Aix-Marseille University, Assistance Publique Hôpitaux de Marseille...
FDA Pipeline: Fast Track Designation in Myelodysplastic Syndrome and AML, Plus Multiple Breakthrough Designations
Recently, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to magrolimab in myelodysplastic syndrome and acute myeloid leukemia (AML). The agency also granted Breakthrough Therapy designations in lung cancer and desmoid tumors, as well as Breakthrough Device designations...
Avelumab for Mismatch Repair–Deficient and Mismatch Repair–Proficient Endometrial Cancer
In a phase II trial reported in the Journal of Clinical Oncology, Panagiotis A. Konstantinopoulos, MD, PhD, and colleagues found evidence of promising activity of the programmed cell death ligand 1 (PD-L1) inhibitor avelumab in mismatch repair–deficient (MMRD) recurrent or persistent endometrial...
ASCO and MASCC/ISOO Release a Clinical Practice Guideline on Medication-Related Osteonecrosis of the Jaw
ASCO and the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) have published a clinical practice guideline on medication-related osteonecrosis of the jaw in the Journal of Clinical Oncology.1 The guideline outlines the latest recommendations ...
Association Between Postdischarge Bleeding in Patients With Acute Coronary Syndrome and Subsequent Cancer Diagnosis
Bleeding during the first 6 months after discharge from the hospital for acute coronary syndrome may be linked to subsequent cancer diagnosis, according to research presented by Muñoz Pousa et al at the European Society of Cardiology Congress 2019 (Abstract P677). “Our results suggest that patients ...
2019 Quality Care: End-of-Life Care in Western Washington State vs Alberta, Canada
In a study to be presented by Khaki et al at the 2019 ASCO Quality Care Symposium, researchers found more aggressive end-of-life measures—including use of chemotherapy and admissions to the intensive care unit (ICU)—were employed in the last 30 days of life in Western Washington state vs Alberta,...
FDA Recommendation on Duodenoscopes With Disposable Components
The U.S. Food and Drug Administration (FDA) has recommended that duodenoscope manufacturers and health-care facilities transition to different types of duodenoscopes that may pose less risk to patient safety. Specifically, because of challenges with cleaning these devices for reuse and persistent...
Risk of Infections in Survivors of Childhood Leukemia
In a study reported in the Journal of Clinical Oncology, Pelland-Marcotte et al found that survivors of childhood leukemia remained at significantly increased risk of infection compared with matched controls during an extended period following completion of treatment. Study Details The...
Selinexor/Dexamethasone in Triple-Class Refractory Multiple Myeloma
In the phase IIb STORM Part 2 study reported in The New England Journal of Medicine, Chari et al found that the combination of oral selinexor and dexamethasone produced responses in patients with multiple myeloma refractory to prior treatment with an alkylating agent, immunomodulatory agent, and...
Virtual Reality May Improve Pain, Vision, Functioning in Patients With Cancer
Virtual reality can be used to improve functioning in patients with cancer, according to David Rhew, MD, Chief Medical Officer, Vice President and General Manager of Enterprise Healthcare, Samsung Electronics America. Research has shown that this technology can decrease pain and improve vision, as...
Polypharmacy Associated With Functional Decline in Older Patients With Advanced Cancer
Polypharmacy (ie, the concurrent use of eight or more medications) and potentially inappropriate medications may be associated with functional impairment in older adults with advanced cancer, according to research presented by Mostafa Mohamed, MBBCh, at the Multinational Association of Supportive...
CMS Finalizes Decision to Cover CAR T-Cell Therapy for Medicare Beneficiaries
ON AUGUST 7, the Centers for Medicare & Medicaid Services (CMS) finalized the decision to cover U.S. Food and Drug Administration (FDA)-approved chimeric antigen receptor (CAR) T-cell therapy among recipients of Medicare benefits. FDA-approved CAR T-cell therapies are approved to treat patients ...
Optimal First-Line Therapy for Stage IV Non–Small Cell Lung Cancer: Immunotherapy Alone or With Chemotherapy?
Recent studies in non–small cell lung cancer (NSCLC) have shown benefit for combining checkpoint inhibitors with chemotherapy. Should combinations, therefore, be the first choice for treating patients with newly diagnosed stage IV disease? Two lung cancer experts debated this point at the 2019...
All Oncologists Are Geriatric Oncologists...They Just Don’t Know It Yet
You don’t have to be a geriatrician to properly evaluate and manage older patients with cancer. The wave of older patients with cancer predicted over 30 years ago is now fully upon us. The oncology community finds itself ill-prepared to manage the increased number of older patients. It is not just...
Expert Point of View: Thomas Paul Slavin, Jr, MD
Thomas Paul Slavin, Jr, MD, of City of Hope National Medical Center, where he is Assistant Clinical Professor in the Department of Medical Oncology, Division of Clinical Cancer Genomics, and a Program Member of Cancer Control and Population Sciences, commented on these substudy findings. The...
Exploratory Analysis Shows DNA Methylation Assay Highly Specific for Cancer Detection
A cell-free DNA test based on the presence of DNA methylation has proven highly specific as a multicancer detection test and appears especially good at detecting high-risk malignancies. In most cases, it can also accurately pinpoint the tumor’s tissue of origin, researchers reported at the 2019...
Addition of Pemetrexed/Carboplatin to Gefitinib in Advanced EGFR-Mutant NSCLC
In an Indian single-center phase III trial reported in the Journal of Clinical Oncology, Noronha et al found that the addition of pemetrexed/carboplatin to gefitinib improved progression-free and overall survival in first-line treatment of advanced EGFR-mutant non–small cell lung cancer...
Swallowing-Related Quality of Life After Radiotherapy vs Surgery for Oropharyngeal Squamous Cell Carcinoma
In the phase II ORATOR trial reported in The Lancet Oncology, Nichols et al found a statistical but not clinically meaningful improvement in swallowing-related quality of life outcomes 1 year after treatment with radiotherapy vs transoral robotic surgery and neck dissection in patients with...
What Causes Liver Injury During Treatment With Pembrolizumab
Immunotherapy as a treatment for advanced solid cancers has rapidly evolved over the past decade—often yielding remarkable results. However, its use has also given way to new adverse effects, including drug-induced gastrointestinal and liver toxicities. “Checkpoint inhibitors are a game changer...
USPSTF Recommendation on Screening for Pancreatic Cancer in Asymptomatic Adults
As reported in JAMA, the U.S. Preventive Services Task Force (USPSTF), in a reaffirmation of its 2004 recommendation, has recommended against screening for pancreatic cancer in asymptomatic adults (a grade D recommendation).1 In developing the current recommendation, the USPSTF reviewed evidence on ...
Healthy Lifestyle for Young Adult Cancer Survivors
GUEST EDITOR Integrative Oncology is guest edited by Jun J. Mao, MD, MSCE, Laurance S. Rockefeller Chair in Integrative Medicine and Chief of Integrative Medicine Service at Memorial Sloan Kettering Cancer Center, New York. The survival rates of adolescent and young adults with cancer have risen ...
Almost 20 Years Later, Breast Fitness Is More Relevant Than Ever
BOOKMARK Title: Breast Fitness: An Optimal Exercise and Health Plan for Reducing Your Risk of Breast CancerAuthors: Anne McTiernan, MD, PhD; Julie Gralow, MD; and Lisa TalbottPublisher: St. Martin’s PressPublication Date: October 2000 (first edition)Price: $48.75, hardcover, 352 pages The...
Deintensified Chemoradiotherapy for HPV-Associated Oropharyngeal Squamous Cell Carcinoma
In a phase II trial reported in the Journal of Clinical Oncology, Chera et al found that deintensified chemoradiotherapy produced favorable outcomes in human papillomavirus (HPV)-associated oropharyngeal squamous cell carcinoma. Study Details In the multicenter trial, 114 patients were recruited...
What Causes Liver Injury During Treatment With Pembrolizumab
Immunotherapy as a treatment for advanced solid cancers has rapidly evolved over the past decade—often yielding remarkable results. However, its use has also given way to new adverse effects, including drug-induced gastrointestinal and liver toxicities. “Checkpoint inhibitors are a game changer...
An Early Decision to Become an Oncologist
GUEST EDITOR Dr. Abraham is the Director of the Breast Oncology Program at Taussig Cancer Institute, and Professor of Medicine, Lerner College of Medicine, Cleveland Clinic. For this installment of the Living a Full Life series, Guest Editor Jame Abraham, MD, FACP, spoke with Gilberto de Lima...
Surgical Resection Among Patients Receiving Primary Chemotherapy for Borderline Resectable and Locally Advanced Pancreatic Cancer
In an Italian prospective cohort study reported in JAMA Surgery, Maggino et al found that among patients receiving primary chemotherapy for newly diagnosed pancreatic ductal adenocarcinoma, conversion to surgical resection was achieved in 24% of those with borderline resectable disease and 9% of...
Single-Institution Study of Next-Generation Sequencing Outcomes in Patients With Cancer
In a single-institution retrospective study reported in the Journal of Oncology Practice, Davis and colleagues found that next-generation sequencing (NGS) tests resulted in changes in management in a small proportion of patients with cancer. Study Details The study involved retrospective review...
Olaparib/Temozolomide Shows Activity in Patients With Relapsed Small Cell Lung Cancer
Small cell lung cancer accounts for approximately 15% of all lung cancers and has high metastatic potential and poor clinical outcomes. While untreated small cell lung cancers are usually highly sensitive to cytotoxic chemotherapy—with response rates of between 50% and 70%—patients...
FDA Review Finds No Increased Risk of Prostate Cancer With Parkinson's Disease Treatments Containing Entacapone
A U.S. Food and Drug Administration (FDA) review of additional data found no increased risk of prostate cancer with the use of entacapone to treat Parkinson’s disease. The FDA conducted this review after an earlier trial—the Stalevo Reduction in Dyskinesia Evaluation–Parkinson's...
Addition of Cediranib to Cisplatin/Pemetrexed in Chemotherapy-Naive Unresectable Malignant Pleural Mesothelioma
In the phase II SWOG S0905 trial reported in the Journal of Clinical Oncology, Tsao et al found that the addition of the epidermal growth factor receptor and platelet-derived growth factor receptor inhibitor cediranib to cisplatin/pemetrexed was associated with limited benefit and greater toxicity...
USPSTF Recommendation on Screening for Pancreatic Cancer in Asymptomatic Adults
As reported in JAMA, the U.S. Preventive Services Task Force (USPSTF), in a reaffirmation of its 2004 recommendation, has recommended against screening for pancreatic cancer in asymptomatic adults (a grade D recommendation). In developing the current recommendation, the USPSTF reviewed...
Regorafenib Dose-Escalation Strategy vs Standard Dosing in Colorectal Cancer
In the phase II ReDOS trial reported in The Lancet Oncology, Tanios Bekaii-Saab, MD, and colleagues found that a regorafenib dose-escalation strategy compared favorably with standard dosing in regard to toxicity profile and activity in patients with refractory advanced colorectal cancer. Study...
Echinacea
The ASCO Post’s Integrative Oncology series is intended to facilitate the availability of evidence-based information on integrative and complementary therapies sometimes used by patients with cancer. In this installment, Yen Nien Hou, PharmD, DipIOM, LAc, explores the potential health benefits of...
The Role of Primary Care Physicians in Pediatric Cancer Survivorship
The symptoms related to childhood cancers that first prompt parents to seek medical care may be as nonspecific as those of the flu or a number of other common ailments. Therefore, a suspicion of cancer sometimes emerges during a visit to the child’s primary care physician. Although primary care...
Highlights in Geriatric Hematology From the ASH Annual Meeting & Exposition
GUEST EDITOR Geriatrics for the Oncologist is guest edited by Stuart M. Lichtman, MD, FACP, FASCO, and developed in collaboration with the International Society of Geriatric Oncology (SIOG). Dr. Lichtman is an Attending Physician at Memorial Sloan Kettering Cancer Center, Commack, New York, and...
CMS Finalizes Decision to Cover CAR T-Cell Therapy for Medicare Beneficiaries
On August 7, the Centers for Medicare & Medicaid Services (CMS) finalized the decision to cover U.S. Food and Drug Administration (FDA)-approved chimeric antigen receptor (CAR) T-cell therapy among recipients of Medicare benefits. FDA-approved CAR T-cell therapies are approved to...
