Author Interviews, Biomarkers, Cancer Research, Infections, Technology, University of Pittsburgh / 13.06.2016
‘Epi-Chip’ Aims To Reconstruct Entire Infection Exposure History From Drop of Blood
MedicalResearch.com Interview with:
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Dr. Donald Burke[/caption]
Donald S. Burke, M.D.
Dean of the University of Pittsburgh Graduate School of Public Health
Director of the University of Pittsburgh Center for Vaccine Research
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Burke: At the University of Pittsburgh we developed a unique method for detecting antibodies in the blood of patients in a proof-of-principle study that opens the door to development of simple diagnostic tests for diseases for which no microbial cause is known, including auto-immune diseases, cancers and other conditions.
We used a technique pioneered by co-author Thomas Kodadek, Ph.D., of the Scripps Research Institute, that synthesizes random molecular shapes called “peptoids” hooked onto microscopic plastic beads. The technique can produce millions of molecular shapes. The peptoids are not organic, but if they match to the corresponding shape on an antibody, that antibody will connect to them, allowing the scientist to pull out that bead and examine that peptoid and its corresponding antibody.
My team chemically generated a huge library of random molecular shapes. Then, using blood from HIV-infected patients and from non-infected people, we screened a million of these random molecular shapes to find the ones that bound only to antibodies present in the blood of HIV-infected patients, but not the healthy controls. No HIV proteins or structures were used to construct or select the peptoids, but the approach, nonetheless, successfully led to selection of the best molecular shapes to use in screening for HIV antibodies.
We then resynthesized that HIV-antibody-targeting peptoid in mass and tested it by screening hundreds of samples from the Multicenter AIDS Cohort Study (MACS), a confidential research study of the natural history of treated and untreated HIV/AIDS in men who have sex with men (supported by the National Institutes of Health). Study co-author Charles Rinaldo, Ph.D., chair of Pitt Public Health’s Department of Infectious Diseases and Microbiology and director of the Pittsburgh arm of the MACS, selected the samples, but blinded the testers to which samples were HIV-positive or -negative. The test distinguished between the samples of HIV-positive blood and HIV-negative blood with a high degree of accuracy.
Dr. Donald Burke[/caption]
Donald S. Burke, M.D.
Dean of the University of Pittsburgh Graduate School of Public Health
Director of the University of Pittsburgh Center for Vaccine Research
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Burke: At the University of Pittsburgh we developed a unique method for detecting antibodies in the blood of patients in a proof-of-principle study that opens the door to development of simple diagnostic tests for diseases for which no microbial cause is known, including auto-immune diseases, cancers and other conditions.
We used a technique pioneered by co-author Thomas Kodadek, Ph.D., of the Scripps Research Institute, that synthesizes random molecular shapes called “peptoids” hooked onto microscopic plastic beads. The technique can produce millions of molecular shapes. The peptoids are not organic, but if they match to the corresponding shape on an antibody, that antibody will connect to them, allowing the scientist to pull out that bead and examine that peptoid and its corresponding antibody.
My team chemically generated a huge library of random molecular shapes. Then, using blood from HIV-infected patients and from non-infected people, we screened a million of these random molecular shapes to find the ones that bound only to antibodies present in the blood of HIV-infected patients, but not the healthy controls. No HIV proteins or structures were used to construct or select the peptoids, but the approach, nonetheless, successfully led to selection of the best molecular shapes to use in screening for HIV antibodies.
We then resynthesized that HIV-antibody-targeting peptoid in mass and tested it by screening hundreds of samples from the Multicenter AIDS Cohort Study (MACS), a confidential research study of the natural history of treated and untreated HIV/AIDS in men who have sex with men (supported by the National Institutes of Health). Study co-author Charles Rinaldo, Ph.D., chair of Pitt Public Health’s Department of Infectious Diseases and Microbiology and director of the Pittsburgh arm of the MACS, selected the samples, but blinded the testers to which samples were HIV-positive or -negative. The test distinguished between the samples of HIV-positive blood and HIV-negative blood with a high degree of accuracy.
Dr. Heerspink[/caption]
Doctor Hiddo Lambers Heerspink
Department of Clinical Pharmacy and Pharmacology
University Medical Center Groningen
the Netherlands
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: SGLT2 inhibitors, including canagliflozin, have beneficial effects on multiple cardiovascular and renal risk parameters. This suggests that SGLT2 inhibitors may confer cardiovascular and renal protection. A recent large clinical trial with the SGLT2 inhibitor empagliflozin demonstrated marked reductions in cardiovascular morbidity and mortality and suggested possible renoprotective effects. Whether SGLT2 inhibition slows the progression of kidney function decline independent of its glucose-lowering effect, however, is unknown. We therefore assessed whether canagliflozin slows the progression of kidney function decline by comparing the effects of canagliflozin versus glimepiride on eGFR and albuminuria.
Dr. Gretchen Tietjen[/caption]
Dr. Gretchen Tietjen MD
Professor and Chair of Neurology
Director of UTMC Headache Treatment and Research Program
Director of the UTMC Stroke Program
MedicalResearch.com: What is the background for this study?
Dr. Tietjen : C-reactive protein (CRP) is a well-established biomarker of inflammation. Elevated levels of CRP predict future cardiovascular events, such as myocardial infarction (heart attack) and stroke. Evidence linking higher CRP levels with migraine is limited and results from large population-based studies are conflicting. The National Health and Nutrition Examination Survey (NHANES) data for children and adolescents linked elevated CRP to headache, particularly in girls, and the Women’s Health Study showed an association of CRP with migraine in women over 45 years of age. In the Reykjavik study, CRP levels in persons with migraine were similar to levels in those without migraine. The aim of our study was to examine the relationship of CRP and migraine in a large population-based sample of over 9,000 young adults (24 to 32 years old) from The National Longitudinal Study of Adolescent to Adult Health (Add Health).
Dr. Katri Korpela[/caption]
Dr. Katri Korpela, PhD
University of Helsinki
Helsinki
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Korpela: Previous studies have shown that breastfeeding reduces the frequency of infections in the child and is associated with lower risk of childhood overweight. Conversely, antibiotic use in early life is associated with increased BMI. Both antibiotic use and breastfeeding are known to influence the infant's microbiota. However, these two factors have not been studied together and it was not known whether antibiotic use could modify the beneficial effects of breastfeeding. We collected data on lifetime antibiotic use, breastfeeding duration, and BMI in a group of daycare-attending children aged 2-6 years. We found that the beneficial effects on long breastfeeding, particularly as regards BMI development, were evident only in the children who did not get antibiotics in early life. Antibiotic use before or soon after weaning seemed to eliminate the protection against elevated BMI in preschool age and weaken the protection against infections after weaning.
Dr. Richard Schwab[/caption]
Richard J. Schwab, MD
Professor, Department of Medicine
Division of Sleep Medicine
Pulmonary, Allergy and Critical Care Division
Co-Director, Penn Sleep Center
University of Pennsylvania Medical Center
Philadelphia, PA 19104
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Schwab: Hypoglossal nerve stimulation is a pacemaker (a tiny generator and a sensing lead) placed in the right side of the chest, but instead of using electrical pulses to control the heart, the device stimulates the hypoglossal nerve which is the nerve that controls the motion of the tongue. Patients use a remote control to turn on the device before going to sleep and turn it off upon waking up. Stimulation of the tongue moves the tongue forward which enlarges the upper airway.
Dr. Stefania Papatheodorou[/caption]
Stefania I. Papatheodorou, MD, PhD
Cyprus International Institute for Environmental and Public Health
Limassol, Cyprus
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Marijuana is the most commonly used illicit drug in the United States. Despite increasing use and acceptance of marijuana, both medically and recreationally, gaps remain in our knowledge regarding potential health effects.
In this study, we aimed to evaluate associations between recent marijuana use, exhaled Nitric Oxide (eNO) and pulmonary function. We performed a cross-sectional study of 10,327 US adults participating in the National Health and Nutrition Examination Survey (NHANES) in the years 2007 to 2012.
Exhaled Nitric Oxide was lower among participants who used marijuana in the past 0 to 4 days and those who last used marijuana 5 to 30 days before the examination compared with the never users. FEV1 was higher among participants who used marijuana within 0 to 4 days before the examination compared with those who never used marijuana, while FVC was higher in both past and current marijuana users compared with never users. The FEV1/FVC ratio was significantly lower among those who used marijuana in the 0 to 4 days before the examination compared with never users.
Dr. Marko Mornar Jelavic[/caption]
Marko Mornar Jelavic, MD, PhD
Department for Internal Medicine and Dialysis
Health Center Zagreb
Zagreb, Croatia
MedicalResearch.com: What is the background for this study?
Response: Zagreb is the capital and the largest city of the Republic of Croatia which is placed in South-Eastern Europe. The wider Zagreb metropolitan area has the total population of up to 1.2 million (20% of the total Croatia’s population). The climate of Zagreb is classified as a humid continental. The average daily mean temperature in winter is around +1 °C (from December to February) and the average temperature in summer is 22.0 °C.
For the first time, we wanted to investigate whether particles of dimensions ≤10 micrometers (PM10) nitrogen dioxide (NO2) and ozone (O3), as well as certain meteorological conditions (air temperature, humidity and pressure) have any impact on appearance of myocardial infarction (MI) in the region with a humid continental climate.
Dr. Hannah Carliner[/caption]
Hannah Carliner, ScD MPH
Post Doctoral Fellow in Substance Abuse Epidemiology
Mailman School of Public Health
Columbia University
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Carliner: We know from previous research that traumatic experiences in childhood can have far-reaching effects on the mental and physical health of adults, including increasing the risk for substance use disorders. There is a particularly strong body of evidence about this concerning exposure to child abuse and various other forms of family dysfunction and violence.
However, no previous studies have examined a wider range of traumatic childhood experiences and their link to experimentation with different kinds of drugs in adolescence. While some studies have interviewed adults about initiation of drug use at this age, those results are not as reliable as interviewing teens directly.
Using a nationally-representative sample of almost 10,000 non-institutionalized U.S. adolescents, we therefore determined that childhood trauma was associated with lifetime drug use in teens-- not only with clinically-significant disordered drug use, but even with just trying drugs one time.
Dr. Katya Rubia[/caption]
Katya Rubia, PhD
Department of Child and Adolescent Psychiatry
Institute of Psychiatry, Psychology, and Neuroscience
King’s College London
London, England
MedicalResearch.com: What are the main findings?
Dr. Rubia: ADHD and OCD patients both suffer from poor inhibitory control and in both disorders this has been associated with structural and functional deficits in fronto-striatal networks. However, it is not clear to what extent the two disorders differ in their underlying neural substrates. This study therefore conducted a meta-analysis of all published whole brain structural and functional MRI studies of inhibitory control in both disorders.
MedicalResearch.com: What are the main findings?
Dr. Rubia: The main findings are that ADHD and OCD patients differ quite fundamentally in their structural and functional brain abnormalities. OCD patients have enlarged volume in basal ganglia and insula, while ADHD patients have reduced volumes in these regions. In fMRI, in the left hemisphere this was also observed for the left insula and putamen, which were increased in OCD and reduced in ADHD. In addition both disorders have different frontal deficits. OCD patients have deficits in rostro-dorsal medial frontal regions that are important for top-down control of affect while ADHD patients had reduced activation in lateral inferior frontal cortex, a key area of attention and cognitive control. The findings fit into the notion of fronto-striatal dysregulation in OCD where basal ganglia are overactive and poorly controlled by medial frontal regions and a delayed fronto-striatal maturation in ADHD where both lateral frontal regions and the basal ganglia/insula are smaller, and presumably less developed in structure and in function in ADHD.
Dr. Jesper Smit[/caption]
Jesper Smit, MD
Department of Clinical Microbiology
Aalborg University Hospital
Aalborg, Denmark
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Smit: Use of glucocorticoids have been suggested to be associated with increased risk of blood infections by Staphylococcus aureus, but the existing evidence is sparse. Therefore, we conducted a large case-control study to investigate this topic in detail.
We found that the risk of staphylococcal blood infections was more than doubled in users of systemic glucocorticoids compared with non-users and that the risk of infection escalated with increasing dose.
Dr. Andrea Cipriani[/caption]
Andrea Cipriani, MD PhD
Associate Professor
Department of Psychiatry
University of Oxford
Warneford Hospital
Oxford UK
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Cipriani: Major depressive disorder is common in young people, with a prevalence of about 3% in school-age children (aged 6–12 years) and 6% in adolescents (aged 13–18 years). Compared with adults, children and adolescents with major depressive disorder are still underdiagnosed and undertreated, possibly because they tend to present with rather undifferentiated depressive symptoms—eg, irritability, aggressive behaviours, and school refusal. Consequences of depressive episodes in these patients include serious impairments in social functioning, and suicidal ideation and attempts. Our analysis represents the most comprehensive synthesis of data for currently available pharmacological treatments for children and adolescents with acute major depressive disorder (5620 participants, recruited in 34 trials).
Among all antidepressants, we found that only fluoxetine was significantly better than placebo. According to our results, fluoxetine should be considered the best evidence-based option among antidepressants when a pharmacological treatment is indicated for children and adolescents with moderate to severe depression. Other antidepressants do not seem to be suitable as routine treatment options.
Dr. Laura Kann[/caption]
Laura Kann, PhD
Chief, School-Based Surveillance Branch Division of Adolescent and School Health
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP)
Centers for Disease Control and Prevention (CDC)
MedicalResearch.com: What is YRBSS?
Dr. Kann: The Youth Risk Behavior Surveillance System (YRBSS) is the only surveillance system designed to measure the major health risk behaviors among our nation's high school students and to track those behaviors over time at the national, state, and local levels. Reports from this surveillance system have been released every two years since 1991. More information is available at: www.cdc.gov/yrbs.
Adam Glassman[/caption]
MedicalResearch.com Interview with:
Adam Glassman, M.S.
Director, DRCRnet Coordinating Center
Jaeb Center for Health Research
Tampa, FL 33647
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Diabetic macular edema (DME) is the most common cause of vision loss in patients with diabetes, impairing the vision of approximately 750,000 people in the United States. The most common treatment involves the injection into the eye of one of 3 drugs that inhibit vascular endothelial growth factor (VEGF). The Diabetic Retinopathy Clinical Research Network, funded by the National Institutes of Health, conducted a randomized clinical trial on the comparative effectiveness of the 3 anti-VEGF drugs EYLEA®, Avastin®, or Lucentis® for eyes with decreased vision from diabetic macular edema. There are substantial cost differences between the three drugs. In the United States, EYLEA® costs approximately $1850, repackaged (compounded) Avastin® $60, and Lucentis® $1170 per injection. In eyes with relatively good starting vision, there were no differences in vision outcomes; all three groups, on average, had improved vision. In eyes with starting vision of 20/50 or worse, EYLEA® had better vision outcomes at 1 year than either Avastin® or Lucentis®, and better vision outcomes at 2 years than Avastin®. However, given that, on average, eyes will receive 9 to 10 injections within the first year of treatment and 5 injections in the second year, neither EYLEA® nor Lucentis® would be considered cost effective by standard benchmarks compared with Avastin® unless their prices decrease substantially.
Dr. Alexander Egeberg[/caption]
Alexander Egeberg, MD PhD
Gentofte Hospital
Department of Dermatology and Allergy
Denmark
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Egeberg: While psoriasis has been associated with an increased risk of cardiovascular disease (CVD), studies have generally neglected to adjust for family history of CVD which is a well-established cardiovascular risk factor.
In a population-based study of young patients with psoriasis, we found an increased risk of CVD only in patients with a positive family history of CVD but not in those patients that did not have a positive family history.
Dr. Mathew Jankowich[/caption]
Matthew D. Jankowich, MD
Assistant Professor of Medicine
Alpert Medical School of Brown University
Staff physician at the Providence VA Medical Center
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Jankowich: For some time, endothelin-1 has been known to cause vasoconstriction in the pulmonary circulation, and elevated endothelin-1 levels have been noted in patients with pulmonary arterial hypertension and decompensated congestive heart failure, as well as other advanced disease states. However, endothelin-1 has not been well studied in members of the general population. In our study, we examined plasma endothelin-1 levels in participants in the Jackson Heart Study and the relationship of plasma endothelin-1 levels to pulmonary hypertension, mortality and heart failure. We found increased odds of having pulmonary hypertension, defined as an echocardiography estimation of the pulmonary artery systolic pressure>40mmHg, in those participants with higher plasma endothelin-1 levels. Having higher endothelin-1 levels was also associated with an increased risk of both mortality and heart failure. Those participant with both high endothelin-1 levels (a level in the top 25%) and pulmonary hypertension were at the highest risk of mortality.
David Beversdorf, M.D.
Associate professor in the departments of radiology, neurology and psychological sciences
University of Missouri and
Missouri University Thompson Center for Autism and Neurodevelopmental Disorders
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Beversdorf: Our previous work had demonstrated in retrospective surveys a higher incidence of prenatal psychosocial stress exposure during the late 2nd and early 3rd trimester in pregnancies where the offspring had developed autism spectrum disorder (ASD). This had been confirmed in other studies, including a study examining the timing of exposure to tropical storms during pregnancy. However, not everyone exposed to stress during pregnancy has a child with ASD, so we began to look at genetic risk for augmented stress reactivity. This initial exploration involved examination of the interaction between stress exposure during ASD-associated pregnancies and the maternal presence of variations in one gene well known to affect stress reactivity. Variations in this gene were also targeted as they have been associated with ASD in some studies. We found in two independent groups of patients (one in Missouri, one in Ontario, Canada) that maternal presence of at least one copy of the stress-susceptible variant of this gene is associated with the link between maternal stress exposure during this time window of pregnancy and subsequent development of ASD in the offspring.
Nate Miersma[/caption]
MedicalResearch.com: What is the background of the Stryker Surgicount Safety-Sponge System?
Mr. Miersma: Retained surgical sponges are the number one reported surgical never event, occurring roughly a dozen times per day in the United States. SurgiCount helps hospitals eliminate retained sponges by supplementing and verifying the manual count of sponges using a unique bar code for each sponge.
• The traditional manual sponge-counting method expects nurses and surgical technicians to track sponges with extreme precision using only a whiteboard and dry-erase marker. Though the majority of nurses and surgical technicians are experienced and thorough, the fast-paced, high-pressure environment of an operating room creates the risk for false-correct counts caused by distraction, exhaustion or personnel changes. At a rate of 11 times per day, the ‘white board while multi-tasking’ method clearly isn’t sufficient.
• When using SurgiCount, a nurse or surgical technician scans the barcodes to enter them into the computer’s backup count. During the closing count at the end of the procedure, a nurse or surgical technician scans each bar code again, while the computer tracks which sponges have been counted out and which remain. If the counts do not match, the SurgiCount scanner identifies which sponge or sponges are still unaccounted for, and directs staff to resolve the count by locating the outstanding sponge or sponges. Numerous clinical studies indicate that the primary cause of retained surgical sponges is false-correct counts. SurgiCount ensures that these false-correct counts no longer occur during the busy closing process.
• The scanner never gets tired or distracted, and can’t accidentally count the same sponge out twice, or count out a sponge which was accidentally introduced to the case possibly from another room, or from a sponge which was hidden and left over from a previous case.
Dr. Arjun Balar[/caption]
Dr. Arjun Balar MD
Assistant Professor, Department of Medicine
Co-Leader Genitourinary Cancers Program
NYU Langone Medical Center
Laura and Isaac Perlmutter Cancer Center
MedicalResearch.com: What is the background for this study?
Dr. Balar: Standard treatment for advanced urothelial cancer includes cisplatin chemotherapy. But more than half of patients are not expected to tolerate
it well and alternative treatment is inferior to cisplatin. The average survival for these patients is in the range of 9-10 months with carboplatin-based treatment, which is the most commonly used alternative
to cisplatin. Atezolizumab is a PD-L1 blocking antibody that reactivates
the body¹s immune system to fight bladder cancer and has been recently
FDA approved in the management of advanced urothelial cancer in the
second-line setting after failure of platinum-based chemotherapy.
Dr. Addolorata Pisconti[/caption]
Dr Addolorata Pisconti Ph.D.
Department of Biochemistry
Institute of Integrative Biology
University of Liverpool
Liverpool United Kingdom
MedicalResearch.com: What is the background for this study?
Dr. Pisconti: Duchenne muscular dystrophy (DMD) is a genetic disorder caused by lack of the cytoskeletal protein dystrophin which, under normal conditions, protects the muscle fibres during the stress of contraction. In the absence of dystrophin, muscle fibres are more fragile and are easily damaged leading to progressive loss of muscle mass and strength, loss of ambulation, difficulties breathing, cardiomyopathy and eventually premature death. There is no cure for DMD.
In Duchenne muscular dystrophy the resident muscle stem cells are impaired and therefore regeneration of damaged muscle fibres is also impaired. Some of the mechanisms leading to impaired muscle stem cell function have been hypothesised, however this remains to date an elusive topic. Chronic inflammation and fibrosis are a hallmark of dystrophic muscle but how they affect muscle stem cells and their regenerative potential remains largely unknown.
Dr. Cynthia Ogden[/caption]
Cynthia L Ogden PhD, MRP
Public Health, Nutrition and Dietetics
CDC Atlanta
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Ogden: Monitoring trends in obesity prevalence is important because of the health risks associated with obesity and because obesity often tracks from childhood to adulthood. The most recent data before this point showed no increases overall in youth, men or women over the previous decade.
We used the most recent nationally representative data with measured weights and heights from the National Health and Nutrition Examination Survey to look at trends in obesity prevalence.
Dr. Lena S. Sun[/caption]
Lena S. Sun, MD
E. M. Papper Professor of Pediatric Anesthesiology
Professor of Anesthesiology and Pediatrics
Executive Vice Chairman, Department of Anesthesiology
Chief, Division of Pediatric Anesthesiology
Columbia University Medical Center
New York, New York 10032
MedicalResearch.com: What is the background for this study?
Dr. Sun: The background for the study is as follow: There is robust evidence in both rodent and non-human primate studies that exposure of the developing brain leads to impairment in cognitive function and behavior later in life. The evidence from human studies derives mostly from retrospective studies and the results have been mixed. Some have demonstrated anesthesia in early childhood was associated with impaired neurocognitive function, while others have found no such association. Our study is the first to specifically designed to address the question of effects of general anesthesia exposure on cognitive function, comparing exposure with no exposure.
Dr. Robert Ferris[/caption]
Robert L. Ferris, M.D., Ph.D.
Robert L. Ferris, M.D., Ph.D.
UPMC Endowed Professor and Vice-Chair
Associate Director for Translational Research
Co-Leader, Cancer Immunology Program
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Ferris: Investigators at the University of Pittsburgh Cancer Institute<http://upci.upmc.edu/> (UPCI) co-led CheckMate-141<https://clinicaltrials.gov/ct2/show/NCT02105636> a large, randomized international phase III clinical trial that enrolled 361 patients with recurrent or metastatic head and neck squamous cell carcinoma who had not responded to platinum-based chemotherapy, a rapidly progressing form of the disease with an especially poor prognosis. Patients were randomized to receive either nivolumab or a single type of standard chemotherapy until tumor progression was observed.
Nivolumab, which belongs to a class of drugs known as immunotherapeutics, enables the body’s immune system to destroy cancer cells. It currently is approved to treat certain types of cancers, including melanoma and lung cancer. The nivolumab group achieved better outcomes than the standard chemotherapy group by all accounts. After 12 months, 36 percent of the nivolumab group was alive, compared to just 17 percent of the standard chemotherapy group.
Nivolumab treatment also doubled the number of patients whose tumors shrunk, and the number whose disease had not progressed after six months of treatment. Importantly, these benefits were achieved with just one-third the rate of serious adverse events reported in the standard chemotherapy group. In addition, on average, patients receiving nivolumab reported that their quality of life remained stable or improved throughout the study, while those in the chemotherapy group reported a decline. The new trial was considered so successful that it was stopped early to allow patients in the comparison group to receive the new drug.