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Showing 6201 - 6250Recent Drug Approvals and Revisions in Prescribing Information
THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) issued the following approvals and prescribing information revisions in August 2018. Lenvatinib Approved for Unresectable Hepatocellular Carcinoma THE FDA approved lenvatinib (Lenvima) for the first-line treatment of patients with unresectable...
Adding Nimotuzumab to Chemoradiation Improved Survival in Locally Advanced Head and Neck Cancer
IN PATIENTS with locally advanced squamous cell carcinoma of the head and neck, nimotuzumab—a humanized monoclonal antibody against the epidermal growth factor receptor—in combination with cisplatin and radiotherapy was superior to cisplatin and radiotherapy alone in improving progression-free...
Relapsed or Refractory Hodgkin Lymphoma: Optimizing Salvage Therapy
As novel therapies come on board for treating relapsed or refractory Hodgkin lymphoma, the field is advancing toward more personalized therapy. The goal, even in the advanced-disease setting, is to increase the chances of complete response and negative positron-emission tomography (PET), while...
Every Day Is a Bonus
I have always been plagued with nagging headaches, so when they intensified in late 2010, I wasn’t too concerned. But when my eyes began involuntarily moving rapidly back and forth as I was writing Christmas cards, I knew the symptoms were a sign of something serious. A magnetic resonance imaging...
PDL1 Amplification in Solid Tumors
In a study reported in JAMA Oncology, Aaron M. Goodman, MD, of the University of California, San Diego Moores Center for Personalized Cancer Therapy, and colleagues found amplification of PDL1 genes in 0.7% of solid tumors, including more than 100 tumor types. Response to checkpoint inhibition was ...
Overall Survival Improved With Encorafenib/Binimetinib Combination in BRAF-Mutant Melanoma
IN PATIENTS with advanced BRAF V600–mutant melanoma, combining the BRAF inhibitor encorafenib (Braftovi) with the MEK inhibitor binimetinib (Mektovi) improved overall survival compared to vemurafenib (Zelboraf) or encorafenib as monotherapy, with a favorable toxicity profile, according to updated...
If It Isn’t Documented, Does It Count?
“The quality of mercy is not strained. It droppeth as the gentle rain from heaven Upon the place beneath.” —William Shakespeare THESE LINES from The Merchant of Venice suggest that mercy should be freely given. However, the metrics of quality is strained, pouring like a thunderous storm obscuring...
Prediction of Survival and Disease Control in HPV-Negative Head and Neck Cancer Using Molecular Markers
A new method may predict the course of human papillomavirus (HPV)-negative head and neck cancer after radiochemotherapy. According to findings published by Hess et al in Clinical Cancer Research, five microRNAs (miRNAs) may be able to provide the decisive data. Squamous cell carcinomas of the head ...
Protein-Metabolite Panel for Detection of Early-Stage Pancreatic Cancer
In a study reported in the Journal of the National Cancer Institute, Fahrmann et al developed and validated a plasma-derived metabolite panel that distinguished early-stage pancreatic ductal adenocarcinoma (PDAC) with high accuracy. Accuracy was further improved with the addition of a previously...
Love in the Time of Cancer
The ASCO Post is pleased to reproduce installments of the Art of Oncology as published previously in the Journal of Clinical Oncology. These articles focus on the experience of suffering from cancer or of caring for people diagnosed with cancer, and they include narratives, topical essays,...
First Large-Scale Survey of APPs in Oncology Shows Growing Role for Nurse Practitioners and Physician Assistants
Advanced practice providers (APPs) have increasingly become integral members of the oncology care delivery team, according to the first large-scale study of nurse practitioners (NPs) and physician assistants (PAs) in oncology. The study was conducted collaboratively by ASCO, the American Academy of ...
Improving the Lives of Patients With Cancer Is Richard L. Schilsky’s Lifelong Mission
In 2009, as Richard L. Schilsky, MD, FACP, FSCT, FASCO, was preparing his Presidential Address for that year’s ASCO Annual Meeting, he came across his 6th grade essay titled “My Ambition,” which foretold with eerie specificity the career path he would follow over the next 6 decades. In the paper,...
Statement From FDA Commissioner on Support for Exempting Coffee From California’s Cancer Warning Law
Scott Gottlieb, MD, Commissioner of the U.S. Food and Drug Administration, recently issued the following statement: “Ensuring that food is safe and truthfully labeled is one of our fundamental responsibilities at the FDA. Consumers deserve accurate information about the food they eat and how ...
Sex-Based Approaches to Oncology in the Era of Precision Oncology: Upcoming ESMO Workshop
Sex-based approaches to studying and treating disease have remained largely unexplored in medical oncology, despite the field’s growing interest in precision medicine and accumulating evidence that sex is a major factor in disease risk and response to treatment. At an upcoming European...
Near-Infrared Fluorescence With Indocyanine Green Dye vs Isosulfan Blue Dye for Detecting Sentinel Nodes in Gynecologic Cancers
In the phase III FILM study reported in The Lancet Oncology, Frumovitz et al found that near-infrared fluorescence imaging with indocyanine green dye identified more sentinel nodes vs isosulfan blue dye in women with clinical stage I endometrial or cervical cancer undergoing curative surgery. There ...
Medical Groups Release Letter on Proposed Changes to Medicare Physician Payment Rule
The American Medical Association and about 150 medical groups sent the following letter to Seema Verma, Administrator of the Centers for Medicare and Medicaid Services (CMS), regarding the administration’s proposals included in the 2019 Medicare physician payment rule. The full text of...
FDA Accepts sBLA for Elotuzumab Plus Pomalidomide and Low-Dose Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
The U.S. Food and Drug Administration (FDA) recently accepted a supplemental biologics license application (sBLA) for elotuzumab (Empliciti) in combination with pomalidomide (Pomalyst) and low-dose dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who...
ctDNA and Treatment Outcome in Diffuse Large B-Cell Lymphoma
In a study reported in the Journal of Clinical Oncology, Kurtz et al found that baseline circulating tumor DNA (ctDNA) and molecular response to treatment were independent predictors of treatment outcome in diffuse large B-cell lymphoma. Study Details The association of ctDNA with treatment...
CAR T-Cell Therapy in Europe: Differing Decisions on Approval of Two Agents
The European Commission (EC) recently approved the chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel (Kymriah) in the European Union (EU) for the treatment of pediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukemia (ALL) that is...
First Large-Scale Survey of Advanced Practice Providers in Oncology Shows Growing Role for Nurse Practitioners and Physician Assistants
Advanced practice providers (APPs) have increasingly become integral members of the oncology care delivery team, according to the first large-scale study of nurse practitioners (NPs) and physician assistants (PAs) in oncology published by Bruinooge et al in the Journal of Oncology Practice....
Dutch Quality-of-Life Study With One- vs Two-Stage Breast Reconstruction in Skin-Sparing Mastectomy
In a Dutch study reported in The Lancet Oncology, Negenborn et al found no differences in quality of life (QOL) between women receiving one-stage implant-based breast reconstruction (IBBR) with an acellular dermal matrix (ADM) vs standard two-stage IBBR. A previously reported safety analysis from...
Mogamulizumab vs Vorinostat in Previously Treated Cutaneous T-Cell Lymphoma
As reported by Kim and colleagues in The Lancet Oncology, the phase III MAVORIC trial showed that the anti-C-C chemokine receptor 4 (CCR4) monoclonal antibody mogamulizumab (Poteligeo) significantly improved progression-free survival vs vorinostat (Zolinza) among patients with previously treated...
Most Oncologists Have Discussed Medical Marijuana With Patients, Survey Finds
DATA FROM a new survey show that as many as 80% of oncologists have discussed medical marijuana use with their patients. According to the authors, this is the first nationally representative survey to examine oncologists’ practices and beliefs on the subject since the implementation of state...
Activity of T Cells in Metastatic Melanoma Resistant to Immune Checkpoint Inhibitor Treatment
In a study reported in the Annals of Oncology, Andersen et al found that tumor-infiltrating lymphocytes isolated from metastatic melanoma lesions in patients with disease progression after checkpoint inhibitor therapy remain functional. Moreover, they concluded these tumor-infiltrating lymphocytes...
Cutaneous Squamous Cell Carcinoma of the Lip and Risk of Nodal Metastasis
In a study reported in JAMA Dermatology, Wang et al found that the risk of nodal metastasis was higher for cutaneous squamous cell carcinoma of the lip with vermilion vs cutaneous location. Disease-specific and overall survival were similar for the two locations. Chrysalyne D. Schmults, MD, of the...
On Not Being Ready
The ASCO Post is pleased to reproduce installments of the Art of Oncology as published previously in the Journal of Clinical Oncology. These articles focus on the experience of suffering from cancer or of caring for people diagnosed with cancer, and they include narratives, topical essays,...
I Am Too Young for Breast Cancer
Two years ago, when I began having pain and bloody discharge in my left breast, I thought it was the return of a solitary intraductal papilloma I had had in that breast when I was a college student 6 years earlier, so the symptoms didn’t initially alarm me. It wasn’t until I noticed that the mass...
A Firsthand Account of Cancer and Mental Illness
Brain tumors are among the most challenging clinical scenarios faced by the oncology community. Along with devastating physiologic damage, brain tumors often have a dramatic effect on the patient’s cognitive, neurologic, and psychological functions. However, the body of literature focusing on...
FDA Grants Orphan Drug Designation to ASLAN003 in Acute Myeloid Leukemia
The U.S. Food and Drug Administration (FDA) has granted ASLAN003 Orphan Drug designation as a treatment for acute myeloid leukemia (AML). ASLAN003 is an orally active, potent inhibitor of human dihydroorotate dehydrogenase (DHODH) that has the potential to be a first-in-class drug in AML. The FDA...
Adding Sorafenib to Topotecan in Platinum-Resistant Ovarian Cancer
In a German phase II trial reported in The Lancet Oncology, Chekerov et al found that the addition of sorafenib (Nexavar) to topotecan improved progression-free survival in women with platinum-resistant ovarian cancer. Study Details In the multicenter investigator-initiated double-blind trial,...
FDA Updates Prescribing Information for Pembrolizumab and Atezolizumab in Urothelial Carcinoma
On August 16, 2018, the U.S. Food and Drug Administration (FDA) updated the prescribing information for pembrolizumab (Keytruda) and atezolizumab (Tecentriq) to require the use of an FDA-approved companion diagnostic test to determine programmed cell death ligand 1 (PD-L1) levels in tumor tissue...
Addition of Vincristine and Irinotecan to Vincristine, Dactinomycin, and Cyclophosphamide in Pediatric Intermediate-Risk Rhabdomyosarcoma
In a phase III Children’s Oncology Group study reported in the Journal of Clinical Oncology, Hawkins et al found that substituting vincristine and irinotecan (VI) for half of vincristine, dactinomycin, and cyclophosphamide (VAC) courses did not improve event-free survival in pediatric...
Bendamustine Followed by Obinutuzumab Plus Venetoclax in Treatment-Naive and Relapsed/Refractory CLL
In a German phase II trial reported in The Lancet Oncology, Cramer et al found promising response rates with bendamustine followed by obinutuzumab (Gazyva) plus venetoclax (Venclexta) in both treatment-naive and relapsed/refractory chronic lymphocytic leukemia (CLL). In the trial, patients with an ...
2019 Physician Fee Schedule and Quality Payment Program Proposed Rules Released
The Centers for Medicare & Medicaid Services (CMS) released its proposed rule for 2019 Medicare physician reimbursement. CMS estimates that in 2019, the overall impact for the hematology/oncology specialty will be a 4% reduction in reimbursement and a 2% reimbursement reduction for...
Breast Cancer Surgeon Hannah Hazard-Jenkins, MD, Deftly Balances Career and Family
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, spoke with breast cancer surgeon...
Obesity and Cancer: Complex Interplay of Multiple Factors
The evolving concept that dietary fat plays an important role in the etiology of human cancer emerged more than 50 years ago. Ernst Wynder, MD, whose seminal epidemiologic work led to identifying smoking as a contributory cause of lung cancer, presented a paper in 1967 showing a decided correlation ...
Be Prepared to Assist Patients to Make Informed Decisions About Breast Reconstruction Options
Two studies about postmastectomy breast reconstruction were recently published in JAMA Surgery. One study found overall complication rates of 32.9% at 2 years after reconstruction, with women having autologous reconstruction more likely to have complications than those having implant...
Breast Reconstruction: ‘A Process Not a Procedure’ With Potential Short- and Long-Term Complications
The complication rate among women who underwent postmastectomy breast reconstruction was 32.9% at 2 years postoperatively, and women undergoing autologous reconstruction “had significantly higher odds of developing any complication compared with those undergoing expander-implant reconstruction,”...
Navigating the ‘New Normal’: NCCN Summit Examines Access to High-Quality Cancer Care
It’s not just the leaps in development of precision medicines, the soaring costs, the new payment models, clinical trial designs, sources of data, and federal policies. It’s all of them plus the rapidity with which change is happening that makes this era of oncology exceptional. “I would say...
Cannabinoids for Cancer Pain: Dangerous or Beneficial?
Cannabis has been used in health care for millennia, and its use has been well documented, albeit never definitively integrated into clinical practice. Recent societal changes and the increasing acceptance and availability of cannabis have reignited the medical and public debate around its role in...
Therapeutic Applications for Cannabinoids in Oncology: The Debate Continues
In the early part of the 20th century, the U.S. government classified cannabis as a Schedule 1 drug: a dangerous substance with no medical value. For many years, that classification prevented systematic research in cannabinoid use in medicine. As a result of societal changes and an intense and...
FDA Approves Mogamulizumab-kpkc for Two Rare Types of Non-Hodgkin Lymphoma
On August 8, the U.S. Food and Drug Administration approved mogamulizumab-kpkc (Poteligeo) injection for intravenous use in the treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy. This approval provides a new...
Venetoclax and Beyond: Successfully Targeting BCL2
Although many agents have been able to successfully inhibit the proliferative capacity of cancer cells or disable mutations that spur cancer growth, one area that has proven elusive is the apoptotic pathway—the cell’s means of resisting death. That is until recently. Dysregulation of B-cell...
Unraveling the Mystery of What Gives Exceptional Responders Their Superpower
Once dismissed as rare medical miracles that overcame overwhelming odds to thwart cancer, exceptional responders to cancer treatment are now the subject of intense study. In 2015, the National Cancer Institute (NCI) announced the launch of its Exceptional Responders Initiative, with the goal of...
For Hodgkin Lymphoma, PD-1 Blockade Is Not the Final Answer
Although programmed cell death protein 1 (PD-1) blockade is highly effective in Hodgkin lymphoma, not all patients respond, and not all responses are durable. Stephen M. Ansell, MD, PhD, Chair of the Mayo Clinic Lymphoma Group and Professor of Medicine at the Mayo Clinic, Rochester, described...
VB4-845 Granted Fast Track Designation by FDA for Treatment of Non–Muscle Invasive Bladder Cancer
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to VB4-845 for the treatment of bacillus Calmette-Guérin (BCG)–unresponsive, high-grade, non–muscle invasive bladder cancer. VB4-845 is currently being evaluated in a phase III registration...
Drug Combination Design for Multiple Myeloma Using an AI Platform
A multidisciplinary team of researchers from the National University of Singapore (NUS) has developed an artificial intelligence (AI) technology platform that could potentially change the way drug combinations are being designed, hence enabling doctors to determine the most effective drug...
FDA Grants Breakthrough Therapy Designation for Encorafenib Plus Binimetinib and Cetuximab in BRAF V600E–Mutant Metastatic Colorectal Cancer
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for encorafenib (Braftovi) in combination with binimetinib (Mektovi) and cetuximab (Erbitux) for the treatment of patients with BRAF V600E–mutant metastatic colorectal cancer (mCRC), as detected by...
Apatinib and Oral Etoposide in Platinum-Resistant/Refractory Ovarian Cancer
In a Chinese single-center phase II study reported in The Lancet Oncology, Lan et al found a high response rate with oral apatinib plus oral etoposide in patients with platinum-resistant or refractory ovarian cancer. Study Details The study included 35 patients with progression within 6 months...
Cory Wiegert Named New CEO of CancerLinQ LLC
Cory Wiegert has been named Chief Executive Officer (CEO) of CancerLinQ LLC, a wholly owned nonprofit subsidiary of ASCO. Mr. Wiegert, a proven expert in building and successfully launching innovative technology solutions, began his new role today (August 13, 2018), overseeing the continued...
