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Showing 4951 - 5000FDA Pilot Program Aims to Encourage Students to Pursue STEM Careers
When I was in high school, I spent summers working as a restaurant dishwasher, grocery store stock boy, and gardener in northwest Indiana. The idea of spending those weeks learning about science and medicine would not have been an option for me at that time. Yet it is precisely those students who...
Immune-Related Toxicity and Time to Treatment Failure With Nivolumab Plus Ipilimumab in Advanced Melanoma
As reported in JAMA Oncology by Shoushtari et al, a single-center experience has shown a very high rate of clinically significant immune-related adverse events with nivolumab (Opdivo) plus ipilimumab (Yervoy) for advanced melanoma. Their findings suggest that the full course of four doses of...
Expect Questions About Glioblastoma Symptoms
WITH THE MANY NEWS REPORTS about Senator John McCain being diagnosed with glioblastoma, patients may be asking if symptoms such as headaches and vision or speech problems should signal the need for screening or diagnostic tests. “There has never been any suggestion that doing routine screening,...
Control
Many Type A personalities deal with problems by controlling all aspects of the problem. Sometimes this works. Sometimes it works for a while. Sometimes it doesn’t work at all. The health-care system—hospitals, clinics, and doctors’ offices—have policies (specific office hours and strict...
To the Last Drop
It was 2:15 PM, and my afternoon clinic had not yet begun. The morning had been particularly trying as a result of disastrous clinical developments for two of my long-standing patients. Jessica had metastatic breast cancer, and I had been taking care of her for 7 years. Multiple lines of...
Midostaurin in FLT3 Mutation–Positive Acute Myeloid Leukemia and Systemic Mastocytosis
ON APRIL 28, 2017, midostaurin (Rydapt) was approved for treatment of adults with newly diagnosed acute myeloid leukemia (AML) who have FLT3 mutation–positive disease, as detected by a U.S. Food and Drug Administration (FDA)-approved test, in combination with standard cytarabine and daunorubicin...
Pembrolizumab in Classical Hodgkin Lymphoma
On March 14, 2017, pembrolizumab (Keytruda) was granted accelerated approval for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma or those who have relapsed after three or more prior lines of therapy.1,2 Supporting Efficacy Data APPROVAL WAS BASED on...
Shaping Real Careers With Virtual Mentorship
Institution: Postgraduate trainee and PhD candidate in medical oncology, Department of Clinical Oncology and Chemotherapy, Nagoya University Graduate School of MedicineMember since: 2014ASCO activities: Virtual Mentors, Journal of Global Oncology editorial fellow Of the many activities ASCO...
Emerging Global Leaders in Biosimilar Development: Regulatory Guidance and Cost Impact
BIOLOGICS PLAY A KEY ROLE in cancer treatment and are the principal components of many therapeutic regimens.1 However, they require complex manufacturing processes, resulting in high cost and occasional shortages in supply, limiting the accessibility of cancer treatment for many patients, more so ...
Atezolizumab in Patients With Advanced Urothelial Carcinoma Who Are Ineligible for Cisplatin
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 April 17, 2017, the programmed cell death ligand 1 (PD-L1)...
Journal of Clinical Oncology Literature Update
Staying up-to-date in the fast-paced world of oncology literature is a daunting task at best. To assist with that task, The ASCO Post has assembled an assortment of studies recently published in the Journal of Clinical Oncology. The topics range from therapy for stage IV non–small cell lung cancer...
Long-Term Follow-up in PIVOT Trial Shows No Significant Benefit of Surgery vs Observation for Overall or Prostate Cancer Mortality
After 19.5 years of follow-up in the PIVOT trial, radical prostatectomy was not associated with significantly improved all-cause or prostate cancer mortality vs observation among men with localized prostate cancer.1 The long-term follow-up was reported in The New England Journal of Medicine by...
Non–Small Cell Lung Cancer: Emerging Concepts for Checkpoint Inhibitors
With checkpoint inhibitors vitally important in the treatment of advanced non–small cell lung cancer (NSCLC), clinicians must become familiar with the nuances of their use. At the 2017 Debates and Didactics in Hematology and Oncology Conference in Sea Island, Georgia, Suresh S. Ramalingam, MD,...
‘Sidedness’ in Colon Cancer: Using the Data in the Clinic
The evidence from clinical trials has established that “side matters” when it comes to colorectal cancer outcomes. How do clinicians use this information in their practices? Christina Wu, MD, of Emory University, shared her thoughts with attendees at the 2017 Debates and Didactics in Hematology and ...
Targeted Treatments and Health-Related Quality of Life in Ovarian Cancer
Novel targeted treatment strategies and new trial endpoints in recurrent, platinum-sensitive ovarian cancer were highlighted in a gynecologic cancer session at the Best of ASCO New Orleans. At the meeting, Karen McLean, MD, PhD, of the University of Michigan Medical Center, Ann Arbor, presented...
For the Impoverished, Health Care Is a Luxury
Cancer is the second leading cause of death worldwide, and the global burden is on an inexorably upward trajectory. For the year 2012, there were 14.1 million new cancer cases and 8.2 million cancer-related deaths worldwide.1 It is predicted that by the year 2035, there will be 23.9 million new...
Update on Hematopoietic Cell Transplant Includes New Data in HIV-Infected and Follicular Lymphoma Patients
New hematology research, presented at the Best of ASCO New Orleans meeting, may help to guide the use of stem cell transplant in hematologic malignancies. At the meeting, Guillermo Garcia-Manero, MD, PhD, of The University of Texas MD Anderson Cancer Center, Houston, and Tycel Phillips, MD, of the...
FDA Clears Mammography Device With Option for Patient-Assisted Compression
On September 1, the U.S. Food and Drug Administration (FDA) cleared the first 2D digital mammography system that allows patients to increase or decrease the amount of compression applied to their own breast before the mammogram x-ray is taken. “Regular mammograms are an important tool in...
FDA Approves Gemtuzumab Ozogamicin for Treatment of Acute Myeloid Leukemia
The U.S. Food and Drug Administration (FDA) today approved gemtuzumab ozogamicin (Mylotarg) for the treatment of adults with newly diagnosed acute myeloid leukemia (AML) whose tumors express the CD33 antigen. The drug was also approved for the treatment of patients aged 2 years and older with...
FDA Statement Regarding Safety Concerns Related to Investigational Use of Pembrolizumab in Multiple Myeloma
On August 31, U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research Director Janet Woodcock, MD, issued the following statement: “Clinical trials play a critically important role in bringing to market innovative new therapies for patients facing life-threatening...
FDA Approves Fulvestrant as Monotherapy for Expanded Use in Breast Cancer
On August 28, the U.S. Food and Drug Administration (FDA) approved fulvestrant (Faslodex) at 500 mg as monotherapy for expanded use in women with hormone receptor–positive, human epidermal growth factor receptor 2 (HER2)–negative advanced breast cancer who have gone through menopause...
HPV Vaccination Rates Especially Low Among Childhood Cancer Survivors
The rate of human papillomavirus (HPV) vaccination in the United States is increasing, but remains lower than ideal. A new study suggests that survivors of childhood cancer receive the HPV vaccine at an even lower rate than their peers without cancer—24% vs 40%, respectively. Nearly...
Obinutuzumab vs Rituximab Plus CHOP in Previously Untreated Diffuse Large B-Cell Lymphoma
The phase III GOYA trial has shown no progression-free survival advantage with obinutuzumab (Gazyva) vs rituximab (Rituxan) plus CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) in previously untreated patients with advanced diffuse large B-cell lymphoma (DLBCL). The results were...
Treatment of Nonmetastatic Muscle-Invasive Bladder Cancer: AUA/ASCO/ASTRO/SUO Guideline
As reported in the Journal of Oncology Practice by Chang et al, for the first time for any type of malignancy, the American Urological Association (AUA), ASCO, American Society for Radiation Oncology (ASTRO), and Society of Urologic Oncology (SUO) have formulated an evidence-based guideline on...
Reduced-Dose Cabazitaxel After Docetaxel in Metastatic Castration-Resistant Prostate Cancer
In the phase III PROSELICA trial reported by Eisenberger et al in the Journal of Clinical Oncology, a cabazitaxel (Jevtana) dose of 20 mg/m2 (C20) was noninferior for overall survival vs the currently recommended dose of 25 mg/m2 (C25) after docetaxel treatment in metastatic castration-resistant...
Prolonged and Intensified Neoadjuvant Therapy for Esophageal Adenocarcinoma
A UK phase III trial (UK MRC OE05) has shown no significant survival benefit of extended and intensified neoadjuvant chemotherapy with epirubicin, cisplatin, and capecitabine vs standard cisplatin/fluorouracil followed by resection in patients with esophageal adenocarcinoma. The findings were...
Adjuvant Temozolomide in 1p/19q Non-Codeleted Anaplastic Glioma
Interim results of the phase III CATNON trial (EORTC study 26053-22054) indicate a survival benefit of adjuvant temozolomide in 1p/19q non-codeleted anaplastic glioma. These findings were reported in The Lancet by van den Bent et al. Study Details In the open-label 2 x 2 factorial trial, 745...
Early-Phase Study Finds Vitamin C May Activate TET2 Function
Vitamin C may “tell” faulty stem cells in the bone marrow to mature and die normally, instead of multiplying to cause blood cancers. This is the finding of a study led by researchers from Perlmutter Cancer Center at NYU Langone Health, and published by Cimmino et al in Cell....
International Consensus (or Not) on Management of Advanced Prostate Cancer
ALTHOUGH THE National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) strongly influence the management of advanced prostate cancer, they do not always reflect actual clinical practice. It turns out that in the real world, there are multiple areas ...
Updates of Key Trials in Metastatic Non–Small Cell Lung Cancer: KEYNOTE-024 and AvaALL
IMMUNOTHERAPY AND ANTIANGIOGENESIS were highlighted in a session on metastatic non–small cell lung cancer (NSCLC) at the Best of ASCO New Orleans meeting. Matthew Gubens, MD, MS, presented the selected abstracts from the ASCO Annual Meeting.1 Dr. Gubens is Associate Professor of Thoracic Medical...
Fighting Misinformation in HPV-Related Cancer Prevention
FAKE NEWS, junk science, and alternative facts seem pervasive in our current culture, to the detriment of important, verified scientific advancements. One area where this is quite evident is the vaccine against human papillomavirus (HPV). Although we have had a safe, effective vaccine since 2006...
A Personal Tribute to Angela H. Brodie, PhD, a Scientist Who Transformed Breast Cancer Treatment
Angela H. Brodie, PhD, a pioneer in breast cancer research, passed away on June 7, 2017, from complications of Parkinson’s disease and pancreatic cancer. An obituary for Dr. Brodie was published previously in the June 25, 2017, issue of The ASCO Post. Here, Dr. Balkees Abderrahman shares a...
FDA Accepts sBLA and Grants Priority Review for Brentuximab Vedotin in Cutaneous T-Cell Lymphoma
On August 16, the U.S. Food and Drug Administration (FDA) accepted a supplemental Biologics License Application (sBLA) and granted Priority Review for brentuximab vedotin (Adcetris) in patients with cutaneous T-cell lymphoma (CTCL). The sBLA and its acceptance is based on data from the phase III...
Unraveling the Complexities of Cellular Immunotherapy and Its Potential to Cure Some Cancers
This past fall, the Fred Hutchinson Cancer Research Center in Seattle opened an all-encompassing 9,222-square foot outpatient cellular immunotherapy clinic, specifically designed to serve patients participating in the center’s novel immunotherapy clinical trials, which mainly focus on chimeric...
Triple-Negative Breast Cancer: Practical Approach, Promising Research
Triple-negative breast cancer has a reputation for being a particularly challenging malignancy, but breast cancer specialist Nancy Davidson, MD, Senior Vice President of the Clinical Research Division at the Fred Hutchinson Cancer Research Center, Seattle, put this in perspective in a recent...
First-Line Cabazitaxel vs Docetaxel in Metastatic Castration-Resistant Prostate Cancer
The phase III FIRSTANA trial has shown no difference in overall survival with two dose regimens of cabazitaxel (Jevtana) vs docetaxel in the first-line treatment of metastatic castration-resistant prostate cancer. Results were reported by Oudard et al in the Journal of Clinical Oncology....
FDA to Expand Public Education Campaign to Focus on Prevention of Youth E-Cigarette Use
On August 8, the U.S. Food and Drug Administration (FDA) announced it would pursue a strategic, new public health education campaign aimed at discouraging the use of e-cigarettes and other electronic nicotine delivery systems (ENDS) by children. The agency plans to expand its “The Real...
Effect of Radiotherapy After Breast-Conserving Surgery Among Breast Cancer Subtypes
In an analysis of the Swedish Breast Cancer Group 91 Radiotherapy trial reported in the Journal of Clinical Oncology, Sjöström et al found that adjuvant radiotherapy vs no radiotherapy had an increased benefit in triple-negative disease and little effect on HER2-positive disease in a...
Final Overall Survival Results of GOG 240 Trial Adding Bevacizumab to Chemotherapy in Advanced Cervical Cancer
As reported in The Lancet by Tewari et al, the final overall survival results of the phase III Gynecologic Oncology Group (GOG) 240 trial show continued benefit of the addition of bevacizumab (Avastin) to chemotherapy in patients with metastatic, persistent, or recurrent cervical carcinoma. Study...
Health-Related Quality of Life With Immediate vs Delayed ADT in Prostate Cancer
In a health-related quality-of-life study among patients in the phase III TOAD trial, immediate vs delayed androgen-deprivation therapy was associated with early worsening of androgen-deprivation therapy–related symptoms but few other comparative adverse effects on functioning or quality of...
Higher Opioid Use Among Cancer Survivors
A new study found that opioid prescription use is more common in cancer survivors than in individuals without a history of cancer. This was true even among survivors who were 10 or more years past their cancer diagnosis. Published by Sutradhar et al in Cancer, the findings come at a time of rising...
Patients With Advanced Cancer Presenting to Emergency Departments With Delirium Likely to Die Earlier
According to a new study published by Elsayem et al in The Oncologist, patients with advanced cancer who are diagnosed with delirium when presenting to emergency departments are more likely to be hospitalized and more likely to die earlier than patients without delirium. This shows the importance...
Blinatumomab in Advanced Acute Lymphoblastic Leukemia: A Brighter Therapeutic Outlook
NEW DRUGS that will improve the outcome of adult patients who develop a deadly disease such as acute leukemia are badly needed; combinations of cytotoxic chemotherapeutic drugs may have reached an upper limit of utility. Agents that eradicate leukemia by alternative mechanisms would be of...
Improved Overall Survival With Blinatumomab vs Chemotherapy in Advanced Acute Lymphoblastic Leukemia
IN THE PHASE III TOWER TRIAL reported in The New England Journal of Medicine, Hagop Kantarjian, MD, of The University of Texas MD Anderson Cancer Center, and colleagues found that blinatumomab (Blincyto) treatment improved overall survival vs chemotherapy in heavily pretreated patients with B-cell ...
Alectinib: A New Standard for First-Line Therapy of ALK-Rearranged NSCLC?
ANAPLASTIC LYMPHOMA KINASE (ALK) was first identified in anaplastic large cell lymphoma. The ALK gene itself is not oncogenic, but it can become oncogenic by at least three mechanisms: by forming a fusion gene with a number of other partner genes, by copy number gain, or by mutations in the gene....
Are Thyroid Cancer Incidence and Mortality Rates Truly Increasing in the United States?
THYROID CANCER diagnoses are increasing at a rate faster than any other malignancy in the United States. In 2017, there will be 56,870 new cases, accounting for 3.4% of all cancers, and 2,010 people will die of thyroid cancer.1 This represents a more than 200% increase in incidence since the...
ASCO Tackles the Issue of the High Cost of Cancer Drugs
In July, ASCO issued a comprehensive set of recommendations to remedy the problem of escalating drug pricing on cancer therapies.1 ASCO’s position statement comes at a time when new cancer drugs are routinely priced at $100,000 a year or more—imatinib (Gleevec) costs up to $146,000 a year2—causing...
Sylvia
The following essay by Howard A. (Skip) Burris III, MD, is adapted from The Big Casino: America’s Best Cancer Doctors Share Their Most Powerful Stories, which was coedited by Stan Winokur, MD, and Vincent Coppola and published in May 2014. The book is available on Amazon.com and thebigcasino.org....
FDA Announces Comprehensive Regulatory Plan to Shift Trajectory of Tobacco-Related Disease, Death
On July 28, the U.S. Food and Drug Administration (FDA) announced a new comprehensive plan for tobacco and nicotine regulation that will serve as a multiyear roadmap to better protect children and significantly reduce tobacco-related disease and death. The approach places nicotine and the issue of...
A Deep and Incisive Look Into the Health-Care System
The seemingly impossible-to-cure maladies of our $3 trillion per year health-care system have been hyperanalyzed, fiercely debated, and voluminously written about by the country’s leading public health experts, opinionated doctors, and policymakers on Capitol Hill. The Affordable Care Act extended ...
