Checkpoint Inhibitors Rapidly Being Incorporated Into Routine Cancer Care

MedicalResearch.com Interview with:

Jeremy O'Connor, MD Section of General Internal Medicine Department of Internal Medicine Postdoctoral Fellow, National Clinician Scholars Program Yale University

Dr. O’Connor

Jeremy O’Connor, MD
Section of General Internal Medicine
Department of Internal Medicine
Postdoctoral Fellow, National Clinician Scholars Program
Yale University

MedicalResearch.com: What is the background for this study?  

Response: There has been a lot of enthusiasm for the use of novel therapies in cancer care, and in particular for novel anticancer agents known as immune checkpoint inhibitors. But very little is known about how quickly providers have adopted immune checkpoint inhibitors into clinical practice. Existing studies suggest, in fact, that the process of clinical adoption is slow, with conventional wisdom holding that it takes an average of 17 years for new evidence to change practice.

Our study evaluated whether the adoption of novel therapies might be much faster in certain contexts with the early use of immune checkpoint inhibitors as a notable example.

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First Signs of Psychotic Disorder May Appear in Childhood With Drop in IQ

MedicalResearch.com Interview with:
Josephine Mollon PhD
Department of Psychosis Studies, Institute of Psychiatry, Psychology, and Neuroscience
King’s College London, London, England
Currently with the Department of Psychiatry
Yale University School of Medicine
New Haven, Connecticut

MedicalResearch.com: What is the background for this study?

Response: Psychotic disorders, such as schizophrenia, are severe mental disorders that cause a range of abnormalities in perception and thinking. Individuals with psychotic disorders also experience severe impairments in IQ and there is evidence that these impairments begin many years before hallucinations and delusions first appear. Understanding how and when individuals with psychotic disorder experience a drop in IQ scores will help us better predict and treat poor cognition in these individuals, and perhaps even the disorder itself.

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Improving Adjuvant Clinical Trials By Including Only Patients For Whom Current Therapies Do Not Work Well

MedicalResearch.com Interview with:

Lajos Pusztai, M.D, D.Phil. Professor of Medicine Director of Breast Cancer Translational Research Co-Director of the Yale Cancer Center Genetics, Genomics and Epigenetics Program Yale School of Medicine New Haven, CT  06511

Dr. Pusztai

Lajos Pusztai, M.D, D.Phil.
Professor of Medicine
Director of Breast Cancer Translational Research
Co-Director of the Yale Cancer Center Genetics, Genomics and Epigenetics Program
Yale School of Medicine
New Haven, CT  06511

MedicalResearch.com: What is the background for this study?

Response: Overall, about 85% of newly diagnosed stage I-III breast cancer patients will not die of their disease, and this roughly equates to an 85% cure rate. Of course cure rates are higher for stage I cancers and lower for stage III cancers. An 85% overall cure rate is good but not good enough, we continuously try to develop new therapies hoping to push these rates to 90%…,95%…etc. However, it is not possible to cure a patient twice over. For example, if surgery plus endocrine therapy cures all patients, the addition of chemotherapy cannot improve on it no matter how effective it is. If surgery plus endocrine therapy cures 95%, adding the perfect chemo to this treatment can only bring about a 5% improvement, and very good chemo that would push cure from 95% to 97%, would require a very large trial including many thousands of patients.

This is an increasingly common scenario in modern breast cancer adjuvant trials (where the goal is to improve survival and cure); the control arm that receives the current standard of care invariably does better than expected and the experimental arm only improves outcome by 1-3% that does not reach statistical significance.  The painful conclusion from these trials is that we do not know if the new drug actually works or not because there were not enough events to demonstrate an effect.

Of course, a lot of patients in the study were also exposed to a new drug with all of its associated toxicities who could not possibly benefit from it.

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Genetic Cause and Clinical Cure Found For Rare Skin Disorder

MedicalResearch.com Interview with:

Keith Adam Choate, MD, PhD, FAAD Associate Professor of Dermatology, of Genetics and of Pathology Director of Research, Dermatology Yale University School of Medicine New Haven, CT

Dr Choate

Keith Adam Choate, MD, PhD, FAAD
Associate Professor of Dermatology,
Genetics and Pathology
Director of Research, Dermatology
Yale University School of Medicine
New Haven, CT

MedicalResearch.com: What is the background for this study? What are the main findings?

Response:  Over the last 10 years, we have systematically been examining patients with ichthyosis to identify new genetic causes of this group of disorders.  We found that autosomal recessive mutations in KDSR cause ichthyosis and that the resulting skin disease is effectively treated with isotretinoin.

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Phase 3 Studies Demonstrate Reduce Endometriosis-Associated Pain with Elagolix

MedicalResearch.com Interview with:

Hugh S. Taylor, M.D. Anitta O’keeffe Young Professor and Chair Departemnt of Obstetrics, Gynecology and Reproductive Sciences Yale School of Medicine Chief of Obstetrics and Gynecology Yale-New Haven Hospital

Dr. Taylor

Hugh S. Taylor, M.D.
Anitta O’keeffe Young Professor and Chair
Departemnt of Obstetrics, Gynecology and Reproductive Sciences
Yale School of Medicine
Chief of Obstetrics and Gynecology
Yale-New Haven Hospital

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Elagolix is an investigational, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that blocks endogenous GnRH signaling by binding competitively to GnRH receptors. Administration results in rapid, reversible, dose-dependent inhibition of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) secretion, leading to reduced ovarian production of the sex hormones, estradiol and progesterone, while on therapy.

Data from two replicate Phase 3 studies evaluating the efficacy and safety of elagolix were published in the New England Journal of Medicine. Elagolix demonstrated dose-dependent superiority in reducing daily menstrual and non-menstrual pelvic pain associated with endometriosis compared to placebo. At month three and month six, patients treated with elagolix reported statistically significant reductions in scores for menstrual pain (dysmenorrhea, DYS) and non-menstrual pelvic pain (NMPP) associated with endometriosis as measured by the Daily Assessment of Endometriosis Pain scale. The safety profile of elagolix was consistent across both Phase 3 trials and also consistent with prior elagolix studies.

Ultimately, the studies showed that both elagolix doses (150 mg QD and 200 mg BID) were effective in improving dysmenorrhea, non-menstrual pelvic pain and quality of life over 6 months in women with endometriosis-associated pain. The elagolix safety/tolerability profile was consistent with the mechanism of action.

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Fewer Heart Attacks and Strokes After Trans-Fat Restriction Laws in New York

MedicalResearch.com Interview with:

Eric J. Brandt, MD Yale University Cardiovascular Disease Fellow

Dr. Eric Brandt

Eric J. Brandt, MD
Yale University
Cardiovascular Disease Fellow

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: From previous studies we know that industrial trans fatty acid (trans fat) consumption is linked to elevated risk for cardiovascular disease. Even small amounts of consumption can be deleterious to cardiovascular health. In New York state, there were 11 counties that restricted the use of trans fatty acids in eateries. We compared hospitalization for heart attacks and stroke from 2002 through 2013 in counties that did and did not have restrictions.

Our study found that when comparing populations within New York state that restricted the use of trans fat, compared to those that did not, there was an associated additional decline beyond temporal trends for heart attacks and stroke events combined by 6.2%.

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End-of-Life Care Transition Patterns of Medicare Beneficiaries

MedicalResearch.com Interview with:
Shi-Yi Wang MD, PhD.

Department of Chronic Disease Epidemiology
Yale School of Public Health
New Haven, CT

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Care at the end of life is often fragmented and poorly coordinated across different health providers. Multiple transitions in care settings can be burdensome to patients and their families as well as costly to society. Despite these concerns about care transitions in the end of life, we lack contemporary data on the number, timing, and overall pattern of healthcare transitions in the last 6 months of life.

This study adds to the extant literature by understanding transition trajectories, national variation of the transitions, and factors associated with transitions. We found that more than 80% of Medicare fee-for-service decedents had at least one health care transition and approximately one-third had ≥ 4 transitions in the last 6 months of life. We produced Sankey diagrams to visualize the sequences of healthcare transitions. The most frequent transition pattern involving at least four transitions: home-hospital-home (or skilled nursing facility)-hospital-healthcare setting other than hospital. There was substantial geographic variation in healthcare transitions in the United States. We found that several factors were associated with a significantly increased risk of having multiple transitions, including female gender, blacks, residence in lower income areas, presence of heart disease or kidney disease.

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Gene Expression-based Breast Cancer Index Can Improve Decision Making For ER+ Patients

MedicalResearch.com Interview with:

Tara Sanft, MD Assistant Professor of Medicine (Medical Oncology) Medical Director of Adult Survivorship Yale Cancer Center Survivorship Clinic

Dr. Tara Sanft

Tara Sanft, MD
Assistant Professor of Medicine (Medical Oncology)
Medical Director of Adult Survivorship
Yale Cancer Center Survivorship Clinic 

MedicalResearch.com: What is the background for this study?

Response: Previous studies have demonstrated the benefit of extended endocrine therapy (EET) for hormone receptor-positive (HR+) breast cancer in preventing late relapse, however that benefit is limited to 3-5% of women where late recurrence was prevented or staved off. However, EET has become common practice and as a result we are exposing many patients to risks of side effects and toxicities associated with anti-estrogen therapies when they may not be benefitting, and, conversely may not be treating the patients that might actually benefit. There is a real need to better identify the patients who are both at most risk of late distant recurrence, and most likely to benefit from EET.

This prospective study included 141 patients with a mean age of 62. In the study, 83% of patients were postmenopausal, 73% were stage I.

Breast Cancer Index (BCI) is a gene expression-based test and is the only currently available validated biomarker that is both prognostic for late distant recurrence and predictive for likelihood of benefit from EET. The purpose of this prospective study was to assess the impact of BCI on: physician EET recommendations; physician confidence; patient satisfaction, anxiety, and decision-conflict; and the cost impact of BCI.

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Racial Disparities in Genetic Testing of Women With Breast Cancer

MedicalResearch.com Interview with:

Cary P. Gross, MD Section of General Internal Medicine Yale University School of Medicine New Haven, CT

Dr. Cary Gross

Cary P. Gross, MD
Section of General Internal Medicine
Yale University School of Medicine
New Haven, CT

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Prior work has demonstrated racial and socioeconomic disparities in breast cancer diagnosis, treatment, and outcomes.  As the oncology field has progressed over the past decade, the use of genetic testing to guide treatment decisions is one of the most exciting new developments.

Our team was concerned that these new gene tests, which can offer important benefits, may have the potential to exacerbate disparities further.  That is, if there is unequal access to gene testing among patients for whom it is recommended, then our progress against cancer will not be equitably shared among people of all races and ethnicities.

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Membership In Medical Schools’ Honor Society Skews Toward White Students

MedicalResearch.com Interview with:

Dowin Boatright, MD, MBA</strong> Department of Emergency Medicine Yale School of Medicine New Haven, Connecticut Fellow, Robert Wood Johnson Clinical Scholars Program Veterans Affairs Scholar

Dr. Dowin Boatright

Dowin Boatright, MD, MBA
Department of Emergency Medicine
Yale School of Medicine
New Haven, Connecticut
Fellow, Robert Wood Johnson Clinical Scholars Program
Veterans Affairs Scholar

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Studies have demonstrated racial and ethnic inequities in medicine, including disparities in the receipt of awards, research funding, and promotions. Yet few studies have examined the link between race and ethnicity and opportunities for medical school students.

Our results show that black and Asian medical school students are less likely to be selected for membership in a prestigious medical honor society, Alpha Omega Alpha (AΩA), than white medical school students.

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