Patients Prefer Doctors Who Face Them Rather Than Computer Screen

MedicalResearch.com Interview with:
Dr. Ali Haider, MBBS MD

Assistant Professor, Department of Palliative Care and Rehabilitation Medicine
Division of Cancer Medicine
The University of Texas MD Anderson Cancer Center
Houston, TX 

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

Response: Patients with chronic and serious illnesses such as cancer often experience high physical and psychosocial symptoms. Recent studies have reported association of physicians’ examination room computer use with less face to face interactions and eye contact. It’s important for the clinicians to look for certain physical cues to better understand the well being of their patients. Therefore we conducted this randomized clinical trial to understand patients perception of physicians compassion, communication skills and professionalism with and without the use of examination room computer.

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One Year Follow Up of Kisqali® (ribociclib) plus Letrozole in HR+, HER2- Advanced Breast Cancer Demonstrates Continued Efficacy

MedicalResearch.com Interview with:

Gabriel N. Hortobagyi, MD, FACP Professor of Medicine, Department of Breast Medical Oncology, Division of Cancer Medicine, UTMDACC, Nellie B. Connally Chair in Breast Cancer, Department of Breast Medical Oncology, Division of Cancer Medicine Program Director, Department of Breast Medical Oncology Susan G. Komen Interdisciplinary Breast Fellowship Program The University of Texas MD Anderson Cancer Center Houston, TX

Dr. Hortobagyi

Gabriel N. Hortobagyi, MD, FACP
Professor of Medicine, Department of Breast Medical Oncology,
Division of Cancer Medicine, UTMDACC,
Nellie B. Connally Chair in Breast Cancer, Department of Breast Medical Oncology, Division of Cancer Medicine
Program Director, Department of Breast Medical Oncology
Susan G. Komen Interdisciplinary Breast Fellowship Program
The University of Texas MD Anderson Cancer Center
Houston, TX

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

Response: The MONALEESA-2 trial is a double-blind, randomized, Phase III trial that evaluated efficacy and safety of Kisqali plus letrozole compared to letrozole alone in postmenopausal women with HR+/HER2- advanced breast cancer who had not previously been treated for their advanced disease.

MedicalResearch.com: What are the main findings?

o Updated findings from the Phase III MONALEESA-2 trial confirm the efficacy and safety of Kisqali® (ribociclib) plus letrozole as a treatment option for HR+/HER2- advanced or metastatic breast cancer:
• After nearly one year of additional follow-up, Kisqali plus letrozole demonstrated median progression-free survival (PFS) of 25.3 months (95% CI: 23.0-30.3) compared to 16.0 months (95% CI: 13.4-18.2) for letrozole alone.
• The progression-free survival rate at two years was 54.7% in the Kisqali plus letrozole arm compared to 35.9% in patients treated with letrozole alone.
• In women with measurable disease, 55% of patients saw their tumor size shrink by at least 30% (overall response rate (ORR)) compared to 39% of patients with letrozole plus placebo.
• Treatment benefit remained consistent across all patient subgroups regardless of demographics or disease characteristics, including women with visceral disease and those diagnosed de novo.

o The safety profile of Kisqali plus letrozole remained consistent and the incidence of laboratory and electrocardiogram (ECG) irregularities were similar to that observed at the first interim analysis.

• The most common grade 3/4 laboratory abnormalities for Kisqali plus letrozole compared to letrozole alone were decreased neutrophils (62.6% vs 1.5%), decreased leukocytes (36.8% vs 1.5%), decreased lymphocytes (16.2% vs 3.9%) and elevated alanine aminotransferase (11.4% vs 1.2%).

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Clinical Trial Uses Patient’s Own Tumor To Manufacture Anti-Cancer Vaccine

MedicalResearch.com Interview with:
Chrisann Kyi, MD
Fellow, Division of Hematology and Medical Oncology
Icahn School of Medicine at Mount Sinai
One Gustave L. Levy Place, Box 1079
New York, NY 10029

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

Response: Mutation-derived tumor antigens (MTAs or neoantigens) arise as a direct result of somatic mutations, including nucleotide substitutions, insertions, and deletions that occur during carcinogenesis. These somatic variations can be characterized via genetic sequencing and used to identify MTAs with predictive computational genomics and algorithms. To be a good candidate for a cancer vaccine, a mutated cancer protein must be visible and recognized by T cells, the soldiers of the immune system, so that they in turn can be educated to seek out and destroy cancer cells that bear the mutated protein.

At annual ASCO conference this year, we are presenting an exciting clinical trial investigating the feasibility, safety, and immunogenicity of a personalized MTA-based multi-peptide vaccine in the adjuvant treatment for multiple solid tumors.

In this trial, the patient’s own tumor is used to manufacture a cancer vaccine according to the mutations in their individual tumor. This vaccine is then given back to the patient in the adjuvant setting. The clinical trial is currently open and accruing at Tisch Cancer Center at Mount Sinai Hospital, NY

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Pembrolizumab – Keytruda- Shows Promise in Subset of Triple Negative Breast Cancer

MedicalResearch.com Interview with:

Sylvia Adams, MD Associate Professor of Medicine Breast Cancer and Cancer Immunotherapy Programs NYU Langone Medical Center Cancer Institute/Clinical Cancer Center New York, NY 10016

Dr. Adams

Sylvia Adams, MD
Associate Professor of Medicine
Breast Cancer and Cancer Immunotherapy Programs
NYU Langone Medical Center
Cancer Institute/Clinical Cancer Center
New York, NY 10016

 

MedicalResearch.com: What is the background for the Keynote-086 trial ? What are the main findings?

Response: This study is the largest immunotherapy study to date presented in metastatic triple negative breast cancer. This phase 2 trial studied the efficacy and safety of pembrolizumab (P) as single agent in a very aggressive disease and had two cohorts, a cohort of previously untreated patients (Cohort B) and a cohort with patients who had received prior chemotherapy lines in the metastatic setting (Cohort A).

The study showed that single agent pembrolizumab can elicit durable responses in a subset of patients. This was found regardless of tumoral PD-L1 expression but appeared to be much more frequent in women without prior chemotherapy treatments in the metastatic setting. Survival is especially promising for patients responding to therapy.

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Healthy Diet and Exercise Reduce Colon Cancer Recurrence

MedicalResearch.com Interview with:
Dr. Erin Van Blarigan, ScD
Assistant Professor, Department of Epidemiology and Biostatistics
UC San Francisco

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

Response: There are over 1.3 million colorectal cancer survivors in the United States. Cancer survivors often seek guidance on what they can do to lower their risk of cancer recurrence and death. In response to patient interest and the need for improved survivorship care, the American Cancer Society (ACS) published guidelines on nutrition and physical activity for cancer survivors.

The guidelines are to:
1) achieve and maintain a healthy body weight;
2) engage in regular physical activity; and
3) achieve a dietary pattern that is high in vegetables, fruits, and whole grains.

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Merkel Cell Carcinoma: Promising Treatment With Combination of T cells and PD-1 Blockade

MedicalResearch.com Interview with:
Dr. Kelly Garneski Paulson, MD, PHD
Fred Hutchinson Cancer Research Center
Seattle, WA  

MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Merkel cell carcinoma (MCC) is an aggressive skin cancer with increasing impact. Currently, there are more than 2000 new cases of MCC diagnosed each year in the US. Over one third of patients will develop metastatic disease.

Most cases of Merkel cell carcinoma are caused by a virus (Merkel cell polyomavirus). In these cancers, the viral oncoproteins (cancer causing proteins) are highly expressed (exclusively on tumor tissue), immunogenic and are necessary for cancer growth.  These oncoproteins are thus ideal targets for cancer immunotherapy, making MCC a great cancer in which to study and develop immunotherapy.  Indeed, immunotherapies are effective in MCC, with observed response to checkpoint inhibitor mono therapy on the order of 35-55%, although complete responses remain rare.

In our first trial, we treated four patients with metastatic Merkel cell carcinoma with endogenous T cell therapy (ex vivo expanded polyclonal T cells recognizing Merkel cell polyomavirus). One patient developed a complete response, but three patients rapidly progressed. Interestingly, we observed that the patient with the complete response had low levels of PD-1 expression on the virus specific transferred T cells. We thus hypothesized adding adding an immune checkpoint inhibitor (avelumab, anti-PD-L1) to the transferred T cells would be acceptably safe and potentially improve clinical effectiveness.

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Herceptin Biosimilar CT-P6 Found Safe and Effective in Early Breast Cancer

MedicalResearch.com Interview with:

Prof Francisco J Esteva MD PhD</strong> Director of the breast medical oncology program at Perlmutter Cancer Center. NYU Langone Medical Center

Prof. Esteva

Prof Francisco J Esteva MD PhD
Director of the breast medical oncology program at Perlmutter Cancer Center.
NYU Langone Medical Center

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

Response: Trastuzumab is a monoclonal antibody directed against the human epidermal growth factor receptor 2 (HER-2). Trastuzumab therapy has been shown to improve survival in patients with early-stage and metastatic her-2 positive breast cancer.

In this study, we compared the safety and efficacy of the trastuzumab originator (Herceptin) to a trastuzumab biosimilar (CT-P6) in patients with stage I-III HER-2 positive breast cancer receiving neoadjuvant chemotherapy. The study was a randomized phase III trial.

We found the pathological complete response rates were similar in both groups. Both antibodies were safe. Pharmacokinetic studies showed similar plasma concentrations for the trastuzumab originator and the proposed biosimilar.

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Malignancies More Common In Men With BRCA Germline Mutations

MedicalResearch.com Interview with:
Roy Mano, MD and
David Margel, MD, PhD
Department of Urology, Rabin Medical Center
Petach Tikva, Israel

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

Response: According to previous reports, male BRCA mutation carriers have a higher risk of developing malignancies of the prostate, pancreas, breast, colon and melanoma. While malignancy screening protocols for female BRCA carriers are well established and widely implemented, little is known about the optimal screening protocol for male BRCA carriers, and current screening protocols focus on malignancies of the breast and prostate rather than offer a comprehensive screening protocol for all BRCA associated malignancies.

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Taking Testosterone Doesn’t Increase Prostate Cancer Risk

MedicalResearch.com Interview with:

Dr. Stacy Loeb, MD, MScDepartment of Urology, Population Health, and Laura and Isaac Perlmutter Cancer CenterNew York University, New York

Dr. Stacy Loeb

Dr. Stacy Loeb MD Msc
Assistant Professor of Urology and Population Health
New York University Langone Medical Center

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

Response: The association between exposure to testosterone replacement therapy and prostate cancer risk is controversial.  The purpose of our study was to examine this issue using national registries from Sweden, with complete records on prescription medications and prostate cancer diagnoses.  Overall, we found no association between testosterone use and overall prostate cancer risk. There was an early increase in favorable cancers which is likely due to a detection bias, but long-term users actually had a significantly reduced risk of aggressive disease.

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Regional Variation in Chemotherapy Prescriptions For Metastatic Prostate Cancer

MedicalResearch.com Interview with:

Megan Elizabeth Veresh Caram MD Clinical Lecturer Internal Medicine, Hematology & Oncology University of Michigan

Dr. Caram

Megan Elizabeth Veresh Caram MD
Clinical Lecturer
Internal Medicine, Hematology & Oncology
University of Michigan

 

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

Response: Abiraterone and enzalutamide are oral medications that were approved by the Food & Drug Administration in 2011 and 2012 to treat men with metastatic castration-resistant prostate cancer. Most men with advanced prostate cancer are over age 65 and thus eligible for Medicare Part D. We conducted a study to better understand the early dissemination of these drugs across the United States using national Medicare Part D and Dartmouth Atlas data.

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Using a Spacer During Prostate Radiation May Help Preserve Sexual Function

MedicalResearch.com Interview with:

Daniel A. Hamstra, MD PhD The Texas Center for Proton Therapy Irving, TX

Dr. Hamstra

Daniel A. Hamstra, MD PhD
Radiation Oncologist
Beaumont Hospital
Dearborn Michigan

MedicalResearch.com: What is the background for the The SpaceOAR phase 3 trial study and the hydrogel spacer?

Response: External beam radiation therapy is commonly used to treat men with prostate cancer. As part of this treatment, side effects can occur involving bowel, urinary, and sexual symptoms.

This study was performed to test if an absorbable hydrogel placed between the prostate and rectum (using a simple outpatient procedure) could move the rectum away from the prostate and thus result in sparing of the rectum and decreased bowel toxicity. The study randomized 222 men and the three-year data were just published (The International Journal of Radiation Oncology Biology and Physics). With three years of follow-up, we saw that the spacer did improve the radiation plans and decreased both rectal toxicity and urinary toxicity.

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Prostate Cancer: No Association Between Androgen Deprivation Therapy and Dementia

MedicalResearch.com Interview with:
Farzin Khosrow-Khavar, M.Sc. Ph.D. Candidate
Department of Epidemiology, Biostatistics and Occupational Health, McGill University
Center for Clinical Epidemiology – Jewish General Hospital
Montreal, QC 

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

Response: Previous studies have shown an association between androgen deprivation therapy (ADT) and risk of dementia and Alzheimer’s disease. However, these studies had methodological limitations that may account for this positive association. Using appropriate study design and methodology, we found no association between androgen deprivation therapy and risk of dementia (including Alzheimer’s disease) in patients with prostate cancer. These results were consistent by cumulative duration of  androgen deprivation therapy use and by ADT modality.

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Cancer Susceptibility Gene Mutations in Individuals With Colorectal Cancer

MedicalResearch.com Interview with:
Matthew B Yurgelun, M.D

Instructor in Medicine, Harvard Medical School
Dana-Farber Cancer Institute

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

Response: It has long been known that hereditary factors play a key role in colorectal cancer risk. It is currently well-established that approximately 3% of all colorectal cancers arise in the setting of Lynch syndrome, a relatively common inherited syndrome that markedly increases one’s lifetime risk of colorectal cancer, as well as cancers of the uterus, ovaries, stomach, small intestine, urinary tract, pancreas, and other malignancies. Current standard-of-care in the field is to test all colorectal cancer specimens for mismatch repair deficiency, which is a very reliable means of screening for Lynch syndrome. The prevalence of other hereditary syndromes among patients with colorectal cancer has not been known, though other such factors have been presumed to be quite rare.

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Physical Activity Linked to Improved Survival from Metastatic Colon Cancer

MedicalResearch.com Interview with:

Brendan John Guercio, M.D. Clinical Fellow in Medicine (EXT) Brigham and Women's Hospital

Dr. Brendan Guercio

Brendan John Guercio, M.D.
Clinical Fellow in Medicine (EXT)
Brigham and Women’s Hospital

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

Response: Sedentary lifestyle is a known risk factor for the development of colon cancer and has been associated with increased disease recurrence and mortality in patients with early stage colorectal cancer. This is the first study to our knowledge to show an association between increased physical activity (i.e. non-sedentary lifestyle) and improved survival and progression-free survival in patients with metastatic colorectal cancer.

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Genetic Determinants of Cisplatin Resistance in Patients With Advanced Germ Cell Tumors

MedicalResearch.com Interview with:

Darren R. Feldman, MD Medical Oncologist Memorial Sloan Kettering Cancer Center

Dr. Darren Feldman

Darren R. Feldman, MD
Medical Oncologist
Memorial Sloan Kettering Cancer Center

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

Response: There is limited knowledge as to why a minority of patients with advanced germ cell tumors are resistant to chemotherapy while the majority achieve complete responses. Patients with cisplatin-resistant disease require intensive salvage treatment and are at high risk of dying from their disease. We sought to determine whether certain genomic alterations within tumors might be associated with cisplatin-resistance in GCT. We also wanted to identify the spectrum of genomic alterations in this population which might represent novel targets for existing or new drug development in this disease.

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One Size Fits All Strategy No Longer Works For Treatment of Ovarian Cancer

MedicalResearch.com Interview with:

Larissa A. Meyer, MD MPH F.A.C.O.G. Assistant Professor Dept of Gynecologic Oncology and Reproductive Medicine Houston, TX 77030-1362

Dr. Larissa Meyer

Larissa A. Meyer, MD MPH F.A.C.O.G.
Assistant Professor
Dept of Gynecologic Oncology and Reproductive Medicine
Houston, TX 77030-1362

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

Response: Despite the completion of two randomized controlled trials, controversy regarding the optimal approach for the treatment of advanced ovarian cancer remains. Our observational study highlights the importance of thoughtful selection of individuals for primary cytoreductive surgery for advanced ovarian cancer. Our results suggest that primary cytoreductive surgery may improve survival for patients with stage IIIC ovarian cancer who are likely to achieve an optimal cytoreduction, while neoadjuvant chemotherapy may be the preferred option for many women with stage IV ovarian cancer.

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Cancer Caregivers Report More Stress Than For Non-Cancer Conditions

MedicalResearch.com Interview with:

Erin Kent, PhD, MS Program Director Outcomes Research Branch of the Healthcare Delivery Research Program National Cancer Institute

Dr. Erin Kent

Erin Kent, PhD, MS
Program Director
Outcomes Research Branch of the Healthcare Delivery Research Program
National Cancer Institute

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

Response: Informal or family caregivers assist loved ones by providing care which is typically uncompensated, takes place typically at home, and often involves significant efforts for an extended period of time. Caregiving can require the performance of demanding tasks, which include managing symptom burden, monitoring for side effects from treatment, coordinating care, administering medication, and managing a care recipient’s financial and social obligations. In addition, there are many unique aspects of cancer that can place unique demands on caregivers, including sometimes a rapid deterioration of health, the receipt of multi-modal therapy (eg. surgery, chemotherapy, and radiation), and the possibility of cancer recurrence.

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With Some Exceptions, Care at Veterans’ Hospitals Comparable to Other Health Systems

MedicalResearch.com Interview with:
Claire O’Hanlon, MPP
Pardee RAND Graduate School and
Courtney Gidengil, MD, MPH
RAND Corporation

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

Response: Providing high-quality health care is central to our nation’s commitment to veterans, but the quality of care provided in Veterans Affairs health care system (VA) is a longstanding area of concern. Part of the 2014 Veterans Access, Choice and Accountability Act (VACAA) mandated an independent assessment of VA’s health care capabilities and resources of the Veterans Health Administration, including a comprehensive evaluation of health care quality. As part of this evaluation we conducted this systematic review of journal articles that compare quality of care at the VA to other settings as an update to a 2009 review on this subject.
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Adding Plinabulin To Chemotherapy Reduces Toxicity, Improves Efficacy

MedicalResearch.com Interview with:

Dr. Lan Huang PhD Co-founder and Chief Executive Officer BeyondSpring Pharmaceuticals, Inc

Dr. Lan Huang

Dr. Lan Huang PhD
Co-founder, Chairman and CEO
BeyondSpring Pharmaceuticals, Inc

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

Response: The background for this study is the toxicity of Docetaxel chemotherapy causes inadequate dosing with Docetaxel due to dose delay, reduction or discontinuation, thus leaving the patient with inadequate chemotherapy treatment.

A main finding is a statistically significant p value of 0.002 in lower rates of grade 3 and 4 Neutropenia for patients dosed with a combination of BeyondSpring’s Plinabulin and Docetaxel compared to those patients dosed with Docetaxel alone. As a result, approximately 14 percent more patients stayed on the adequate (dense) dose of Docetaxel in the Docetaxel + Plinabulin arm as compared to Docetaxel alone.

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Older Breast Cancer Patients Much Less Likely to Receive 21-Gene Recurrence Score Testing

MedicalResearch.com Interview with:

Valentina Petkov, MD, MPH Health Scientist/Program Officer NIH/NCI/DCCPS/Surveillance Research Program

Dr. Petkov

Valentina Petkov, MD, MPH
Health Scientist/Program Officer
NIH/NCI/DCCPS/Surveillance Research Program

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

Dr. Petkov: The number of breast cancer diagnoses is increasing in older patients because of increasing life expectancy and changing population demographics. Despite high incidence, little is known about breast cancer biology and outcomes in patients older than 70, which are often under-represented in clinical trials. The 21-gene Oncotype DX Breast Recurrence Score assay has been used in clinical practice to predict distant recurrence risk and chemotherapy benefit in lymph node negative, hormonal receptor positive (estrogen and/or progesterone receptor positive) invasive breast cancer since 2004. The goal of our study was to evaluate the role of the 21 gene assay in older patients at population level.

We used Surveillance Epidemiology and End Results (SEER) data. We included in the analysis 40,134 patients who were diagnosed with invasive breast cancer between 2004 and 2011, had negative nodes and their tumors were hormonal receptor positive and HER2 negative. Breast Cancer Specific Mortality (BCSM) was assessed at 5 years after diagnosis in patients with low risk (Recurrence Score <18), intermediate risk (Recurrence Score 18-30) and high risk (Recurrence Score >30).

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PD-L1 Agent Atezolizumab Effective in 25% of Metastatic Urothelial Cancers

MedicalResearch.com Interview with:

Dr. Arjun Balar MD Assistant Professor, Department of Medicine Co-Leader Genitourinary Cancers Program NYU Langone Medical Center Laura and Isaac Perlmutter Cancer Center

Dr. Arjun Balar

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.

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Nivolumab Extended Life in Subset of Head and Neck Cancer Patients

MedicalResearch.com Interview with:

Robert L. Ferris, M.D., Ph.D. UPMC Endowed Professor and Vice-Chair Chief, Division of Head and Neck Surgery University of Pittsburgh

Dr. Robert Ferris

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.

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Primary Care Screening Detects Melanoma at Earlier Stage

Laura Ferris, M.D., Ph.D. Associate professor, Department of Dermatology University of Pittsburgh School of Medicine and Member of the Melanoma Program University of Pittsburgh Cancer Institute

Dr. Laura Ferris

MedicalResearch.com Interview with:
Laura Ferris, M.D., Ph.D.
Associate professor, Department of Dermatology
University of Pittsburgh School of Medicine and
Member of the Melanoma Program
University of Pittsburgh Cancer Institute

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

Dr. Ferris: Rates of melanoma, the most dangerous form of skin cancer, are on the rise, and skin cancer screenings are one of the most important steps for early detection and treatment. Typically, patients receive skin checks by setting up an appointment with a dermatologist. UPMC instituted a new screening initiative, which was modeled after a promising German program, the goal being to improve the detection of melanomas by making it easier for patients to get screened during routine office visits with their primary care physicians (PCPs). PCPs completed training on how to recognize melanomas and were asked to offer annual screening during office visits to all patients aged 35 and older. In 2014, during the first year of the program, 15 percent of the 333,788 eligible UPMC patients were screened in this fashion.

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Potentially Inappropriate Medications Linked to Decreased Survival in Elderly Lymphoma Patients

MedicalResearch.com Interview with:

Dr. Catherine S. M. Diefenbach MD Assistant Professor of Medicine NYU Cancer Center New York, NY 10016

Dr. Catherine Diefenbach

Dr. Catherine S. M. Diefenbach MD
Assistant Professor of Medicine
NYU Cancer Center
New York, NY 10016

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

Dr. Diefenbach: It is well known that age is important prognostic factor in non-Hodgkin’s lymphoma (NHL). Multiple studies have illustrated that elderly lymphoma patients have inferior survival outcomes as compared to their younger counterpart. While the tumor biology is often different in these two groups, and may play a role in this discordancy, elderly patients are often frail or have multiple medical comorbidities. These include geriatric syndromes, such as: cognitive impairment, falls, polypharmacy, and potentially inappropriate medication (PIM) use. All of these may contribute to poor outcomes for elderly patients. In addition, elderly patients are often under-treated for their aggressive lymphoma out of concern for toxicity or side effects, even though the data clearly demonstrates that elderly patients can still benefit from curative intent chemotherapy.

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Chemotherapy and Toxicities of Immune Checkpoint Inhibitors May Be Prohibitively Expensive

MedicalResearch.com Interview with:
Neil T. Mason, MBA
Personalized Medicine Strategist
Personalized Cancer Medicine
Division of Population Science
Moffitt Cancer Center

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

Response: Immune checkpoint inhibitors targeting PD-1 (nivolumab and pembrolizumab) and CTLA-4 (ipilimumab) have revolutionized the treatment of metastatic disease in melanoma and non-small cell lung cancer with additional indications showing positive results. These drugs have elicited profound and durable responses in a significant number of patients, but have been criticized for their high cost. Though the price of the drugs themselves can reach over $100,000 per year, they can also cause severe, life threatening toxicities that are difficult and expensive manage.

This model utilizes patient data from a large, NCI-designated cancer center to estimate the average cost of treatment with immune checkpoint inhibitors based on average duration of treatment and reported incidence of major toxicities. Based on the model, PD-1 inhibitor therapies are less costly than ipilimumab due to the significantly higher cost per dose of ipilimumab and average treatment duration of less than a year for PD-1 inhibitors. Managing drug-related toxicities were estimated to contribute between $8,200 and $9,600 to the cost of therapy with nivolumab adding the most cost.

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Biomarker Based Chemotherapy Approach Improved Outcomes

MedicalResearch.com Interview with:

Maria Schwaederle PharmD Clinical Research Scientist Center for Personalized Cancer Therapy UCSD Moores Cancer Center La Jolla, CA 92093

Dr. Maria Schwaederle

Maria Schwaederle PharmD
Clinical Research Scientist
Center for Personalized Cancer Therapy
UCSD Moores Cancer Center
La Jolla, CA 92093

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

Dr. Schwaederle: We performed this analysis with experts in the field, including but not limited to Drs Schilsky, Lee, Mendelsohn and Kurzrock, all known for their experience in the area of precision/personalized medicine.
Historically, phase I trials (which are often first in human or highly experimental in other ways) were believed to be examining only toxicity. Our meta-analysis of 13,203 patients shows that in the era of precision medicine, this historical belief needs to be discarded. Second, it is the use of precision medicine that makes this belief outdated.
Indeed, Phase I trials that utilized a biomarker-driven approach that is the essence of precision medicine had a median response rate of about 31%, which is higher than many FDA approved drugs, and this is in spite of the fact that phase I patients are a highly refractory group having failed multiple lines of conventional therapy.

Importantly, however, it was not the use of targeted agents alone that was important. It was the biomarker-based approach where patients are matched to drugs. Without matching, response rates were dismal—about 5%.

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Risk Factors of Chemotherapy Induced Peripheral Neuropathy Identified

MedicalResearch.com Interview with:

Dawn L. Hershman, MD MS Professor of Medicine and Epidemiology Leader, Breast Cancer Program Herbert Irving Comprehensive Cancer Center Columbia University NY NY

Dr. Dawn Hershman

Dawn L. Hershman, MD MS
Professor of Medicine and Epidemiology
Leader, Breast Cancer Program
Herbert Irving Comprehensive Cancer Center
Columbia University
NY NY

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

Dr. Hershman: Chemotherapy induced peripheral neuropathy is a common side effect of anti cancer therapy and there are currently no ways to prevent it. We used a large clinical trials database, SWOG, and linked it to Medicare claims for patients over the age of 65. We found that age and type of taxane were associated with the development of CIPN. We also found a significant increase when a taxane was given along with a platinum agent. We found a doubling of risk among patients with a prior history of diabetes. No other chronic condition was associated with an increased risk of CIPN. We found a suggestion of a decreased risk among patients with a prior history of auto-immune disease.

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Parents of Childhood Cancer Survivors Often Unaware of Future Physical, Intelligence and Quality of Life Limitations

MedicalResearch.com Interview with:

Katie Greenzang, MD Dana-Farber/Boston Children’s Cancer and Blood Disorders Center

Dr. Katie Greenzang

Katie Greenzang, MD
Dana-Farber/Boston Children’s Cancer and Blood Disorders Center

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

Dr. Greenzang: Advances made over the last several decades mean that more than 80 percent of children diagnosed with cancer will become long-term survivors. However, many of these survivors experience physical and cognitive late effects of the treatment that cured them. We surveyed 352 parents of children recently diagnosed with cancer to assess how well they understood their children’s risk of future limitations in physical abilities, intelligence, and quality of life. We found that an overwhelming majority of parents (92 percent) are very interested in learning about possible late effects, and most (86 percent) seek detailed information. Yet, parent and physician predictions of a child’s risk of experiencing late effects of treatment often don’t match. Among children identified by their oncologists as being at high risk for such challenges, only 38 percent of parents recognized this risk in physical abilities, 21 percent in intelligence, and 5 percent in quality of life.

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Multiplex Gene Panel Can Reveal Unexpected Clinically Relevant Genes

MedicalResearch.com Interview with:

Gregory Idos MD Division of Gastroenterology and Hepatology Keck School of Medicine University of Southern California Los Angeles, CA 90033

Dr. Gregory Idos

Gregory Idos MD
Division of Gastroenterology and Hepatology
Keck School of Medicine
University of Southern California
Los Angeles, CA 90033

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

Dr. Idos: Identifying individuals at increased risk for hereditary cancer prompts enhanced cancer surveillance as early detection mitigates disease specific morbidity and mortality. This justifies germ line genetic testing for specific cancer risk alleles. In recent years, the field of cancer genetics has moved from a gene by gene sequencing approach to now having the ability to examine multiple genes concurrently. Multiplex gene panel (MGP) testing allows simultaneous analysis of multiple high- and moderate- penetrance genes. As a result, more pathogenic mutations and variants of uncertain significance (VUS) are discovered. MGP tests are increasingly being used by cancer genetic clinics, but questions remain about the clinical utility and complexities of these tests.

We are conducting a multi center prospective trial to measure the added yield of detecting pathogenic mutations using the MGP approach. In our interim analysis of the first 1000 participants, we found that multiplex gene panel testing increased the yield of detection of pathogenic mutations by 26%. In some cases, we found patient’s who had a mutation in the BRCA gene, but their family history did not indicate a history of breast or ovarian cancer.

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Radical Prostatectomies: Referral to High Volume Centers Saves Money

MedicalResearch.com Interview with:

Sarmad Sadeghi MD, MS, PhD Assistant Professor of Medicine Norris Comprehensive Cancer Center University of Southern California

Dr. Sarmad Sadeghi

Sarmad Sadeghi MD, MS, PhD
Assistant Professor of Medicine
Norris Comprehensive Cancer Center
University of Southern California

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

Dr. Sadeghi: Several years ago analyses of outcomes for radical prostatectomy highlighted the significant impact of surgical experience on the oncological outcome for the patients. In this case experience was measured by the number of radical prostatectomies performed by the surgeon, and oncological outcome was measured by treatment failure rates (rising PSA). Despite this data, the move for redirecting patients to “high volume centers” where more experienced surgeons perform the operation has been sluggish. There was insufficient data on what is involved in referring patients to high volume centers and whether or not such action is cost effective.

In a previous study we demonstrated that for every referral to a high volume center, there would be an average of $1,800 over a follow-up period of 20 years in societal cost savings. The main source of these savings is fewer treatment failures.
The next question was who is a good candidate for referral and whether these savings can offset the referral costs.

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Multiple Myeloma: Thalidomide Derivative Lenalidomide Improved Survival After Chemo and Stem Cell Transplant

MedicalResearch.com Interview with:

Philip McCarthy, BA, MD Professor of Oncology Director, Blood and Marrow Transplant Program Roswell Park Cancer Institute Associate Professor of Medicine Jacobs School of Medicine and Biomedical Sciences State University of New York at Buffalo Buffalo, NY 14263

Dr. Philip McCarthy

Philip McCarthy, BA, MD
Professor of Oncology
Director, Blood and Marrow Transplant Program
Roswell Park Cancer Institute
Associate Professor of Medicine
Jacobs School of Medicine and Biomedical Sciences
State University of New York at Buffalo
Buffalo, NY 14263

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

Dr. McCarthy: There have been three Phase III studies that examined the role of maintenance lenalidomide after autologous stem cell transplant (ASCT) for newly diagnosed multiple myeloma patients. IFM 2005-02 (France), CALGB 100104 (Alliance, USA), GIMEMA-RVMM-PI-209 (Italy). All three studies had progression free survival (PFS) as their primary endpoint and all demonstrated a superior PFS when compared to placebo or no therapy after ASCT. However only the CALGB 100104 study demonstrated a statistically superior overall survival (OS). Thus, a meta-analysis was necessary to assess the effect of post-ASCT lenalidomide maintenance on overall survival. This study utilized a pooled analysis of updated primary-source patient data from all three studies after the primary efficacy analyses had been conducted. The meta-analysis demonstrated that there is a statistically superior OS (P value=0.001, HR=0.74 (0.62-0.89)), Median OS for no maintenance or placebo was 86 months and the median OS for lenalidomide had not been reached. The median OS for lenalidomide treatment arm was extrapolated to be 116 months based on median of the control arm and HR (median, 86 months; HR = 0.74). Thus, there is a 26% reduction in the risk of death which is an estimated 2.5 year increase in median OS. There is an increased incidence of second primary malignancies with lenalidomide maintenance when compared to placebo but this risk is less than the risk of dying when not receiving lenalidomide.

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Neuroblastoma: Adding Novel Monoclonal Antibody To Chemotherapy Shrunk More Tumors

MedicalResearch.com Interview with:

Wayne L. Furman, MD Department of Oncology Jude Children's Research Hospital Memphis, TN 38105-3678

Dr. Wayne Furman

Wayne L. Furman, MD
Department of Oncology
Jude Children’s Research Hospital
Memphis, TN 38105-3678

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

Dr. Furman: Despite improvement in 2-yr EFS from 46% to 66% with the inclusion of dinutuximab, a monoclonal antibody that recognizes a glycoprotein on neuroblasts called ‘GD2’ (disialoganglioside), more than one-third of children with high-risk neuroblastoma still are not cured. Therefore novel therapeutic approaches are needed for this subset of patients. The clinical evaluation of various anti-GD 2 monoclonal antibodies in children with neuroblastoma has been exclusively focused on treatment of patients after recovery from consolidation, in a state of ‘minimal residual disease’. This is because traditionally chemotherapy has been thought to be too immunosuppressive to combine with monoclonal antibodies. However recent studies suggest, even in the setting of “bulky” solid tumors, the combination of chemotherapy with monoclonal antibodies can enhance the effectiveness of the antibodies. First, chemotherapy can increase the efficacy of antibodies by depleting cells of the immune system that suppress immune function. Also chemotherapy-induced tumor cell death can trigger tumor antigen release, uptake by antigen processing cells and an enhanced antitumor immune response. There is also data that anti-GD2 monoclonal antibodies can suppress tumor cell growth independent of immune system involvement. Furthermore anti-GD2 monoclonal antibodies and chemotherapy have non-overlapping toxicities. All of these reasons were good reasons to evaluate the addition of a novel anti-GD2 monoclonal antibody, called hu14.18K322A, to chemotherapy, outside the setting of minimal residual disease, in children with newly diagnosed children with high-risk neuroblastoma.

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Genetic Assay Oncotype Dx Helps Clarify Chemotherapy Decisions in HER2 Negative Breast Cancer

MedicalResearch.com Interview with:

Oleg Gluz, MD West German Study Group Breast Center Niederrhein Evangelical Hospital Bethesda Moenchengladbach, Germany

Dr. Oleg Gluz

Oleg Gluz, MD
West German Study Group
Breast Center Niederrhein
Evangelical Hospital Bethesda
Moenchengladbach, Germany

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

Dr. Gluz: PlanB trial is a Phase III chemotherapy study performed in patients with clinically high risk HER2 negative breast cancer. After early amendement, Recurrence Score (Oncotype Dx) as a selection criterion for or against chemotherapy together with central pathology review were included into the study. Patients with very low RS of below 12 and up to 3 positive lymph nodes were recommended to omit chemotherapy based on the low genomic recurrence risk. Chemotherapy was omitted in about 15% of all patients.

For the first time we present prospective data comparing a genomical tool (Oncotype Dx) and an independent central pathology review for grade, ER, PR, and Ki-67 from a large phase III study combined with an exploratory analysis on early relapse risk.

MedicalResearch.com: What are the main findings?

Dr. Gluz: The study has two major findings:

We have found a significant discordance in risk assessment between prognostic tools (grade by local and central lab, Oncotype Dx, Ki-67).

Patients treated by endocrine therapy alone based on very low Recurrence Score had an excellent disease free survival of 97% after 3 years of follow up.

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Many Breast Cancer Patients Overestimate Risk of Recurrence and Spread

MedicalResearch.com Interview with:

Sarah T. Hawley PhD MPH Professor of Medicine University of Michigan

Dr. Sarah Hawley

Sarah T. Hawley PhD MPH
Professor of Medicine
University of Michigan

Medical Research: What is the background for this study? What are the main findings?

Dr. Hawley: Research has shown that breast cancer patients do not have a good understanding of their risk of distant recurrence, and and that the fear of cancer spreading is one of the biggest concerns that patients have. The research that has been done shows that most patients over-esimate this risk, and think they have a bigger chance of the cancer coming back than they actually have. There has been relatively little done to investigate the association between patient over-estimation of risk and patient reported outcomes, specifically their quality of life. We therefore conducted our study to understand the extent of overestimation of risk in a population-based sample of breast cancer patients with very favorable prognosis (DCIS, low risk invasive breast cancer) using a numeric (number based) and descriptive (general understanding) measure, and to understand the association between over-estimation and quality of life.

The main findings are that almost 40% of our sample of patients over-estimated their risk; 33% using a numeric measure and 15% using a descriptive measure. There was no clear “type” of patient who overestimated her risk of distant recurrence, though women with lower education more over overestimated numerically than those with higher education.

Both numeric and descriptive over-estimation was associated with reduced quality of life outcomes, especially with frequency of worry about recurrence, however over estimating descriptively mattered the most. Women who overestimated their risk both numerically and descriptively had a nearly 10 fold odds of frequent worry compared to women who understood their risk.

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Childhood Cancer Survivors Need Better Long Term Care Follow up

More Cancer Research on MedicalResearch.com

Erin E. Hahn, PhD, MPH Research Scientist Southern California Permanente Medical Group Kaiser Permanente Research Department of Research & Evaluation Pasadena, CA 91101

Dr. Erin Hahn

MedicalResearch.com Interview with:
Erin E. Hahn, PhD, MPH

Research Scientist
Southern California Permanente Medical Group
Kaiser Permanente Research
Department of Research & Evaluation
Pasadena, CA 91101

Medical Research: What is the background for this study?

Dr. Hahn:  Adolescent and young adults, or AYAs, who are diagnosed and treated for Hodgkin lymphoma have very high overall survival rates. However, these patients are at high risk for short and long term health issues related to their cancer treatment, including cancer recurrence, cardiac and pulmonary problems, and developing new primary cancers. Some of these issues arise during treatment and persist over time, called long-term effects, and some develop years later, called late effects.

Evidence and consensus based guidelines are available from organizations like the National Comprehensive Cancer Network and the Children’s Oncology Group to help manage the post treatment care of  Adolescent and young adults Hodgkin lymphoma survivors. Examining adherence to guidelines is an important part of high quality care, and can help us find and address gaps in care.

Guideline recommended care for these patients includes: oncology visits, imaging and labs, preventive care, counseling and education, risk based screening for late effects. Risk-based screening is based on a patient’s treatment. The type of health screening a patient needs is determined by the treatment exposure they had, such as certain types of chemotherapy or high-dose radiation that have known late effects 

Medical Research: What are the main findings?

Dr. Hahn: For this pilot study, I was interested to see if post-treatment  Adolescent and young adults Hodgkin lymphoma patients in an integrated health care system received recommended short and long term care. The study setting is Kaiser Permanente Southern California (KPSC). KPSC provides care for almost 4 million members with 14 medical centers, and they have a long-standing electronic medical record.

For our population, we included AYA patients diagnosed with classical Hodgkin lymphoma between 15 and 39 years of age, diagnosed between 2000 and 2010. We wanted to find patients who were diagnosed, treated, and followed for at least 2 years within this single system. We have a sample of 354 patients, which is great. It has been traditionally difficult to find and follow these patients/obtain accurate medical information that isn’t only self-report data. We were able to extract chemotherapy, radiation, and other care details from the electronic medical record.

We first looked at receipt of short term recommended care, within the first year after treatment had ended. We looked specifically at oncology visits, use of recommended CT scan and lab tests, and preventive care, such as the flu vaccine. The great majority of patients had the recommended oncology visits, CT scan, and lab tests. However, receipt of the flu vaccine was lower, at 20%. When we looked at a composite measure of all 4 recommended services, only about half of the patients received all four recommended services within the first year after treatment.

We also looked at use of a longer term recommended service for cardiac issues. Cardiac screening is recommended for patients who are 10 years out from their treatment and who received high-dose anthracyclines, plus radiation to the chest. This is the highest risk group for cardiac damage. Almost everyone received annual blood pressure screening, but only about 30% received screening with an electrocardiogram, echocardiogram, or MUGA scan.

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Nivolumab Has Potential Activity Against Platinum Resistant Ovarian Cancer

Junzo Hamanishi M.D., Ph.D. Department of Gynecology and Obstetrics, Kyoto University Graduate School of Medicine Assistant Professor Kyoto Japan

Dr. Hamanishi

MedicalResearch.com Interview with:
Junzo Hamanishi  M.D., Ph.D.
Department of Gynecology and Obstetrics,
Kyoto University Graduate School of Medicine
Assistant Professor
Kyoto Japan

Medical Research: What is the background for this study?

Dr. Hamanishi: More than 70% of patients with advanced ovarian cancer who achieve remission ultimately relapse and there are few effective treatments for these patients. Because the development of new treatment strategies for these patients is urgently required, we have focused on and studied the potential of cancer cells to escape from host immunity with PD-1/PD-L1 immunosuppressive signal in the tumor microenvironment to find new treatment strategies to overcome this phenomenon, collaborating with Professor Honjo who discovered PD-1 since 2006. Therefore, we conducted a phase II clinical trial in 20 platinum-resistant, recurrent ovarian cancer patients to evaluate the safety and anti-tumor efficacy of anti-PD-1 antibody (nivolumab) with 2 cohort at a dose of 1 or 3 mg/kg (constituting two 10-patient cohorts).

Medical Research: What are the main findings?

Dr. Hamanishi: This study is the first investigator-initiated phase II clinical trial testing the safety and efficacy of nivolumab against platinum-resistant ovarian cancer. In the 20 patients in whom responses could be evaluated, the best overall response was 15%, including two patients with a durable complete response (3mg/kg cohort). The disease control rate in all 20 patients was 45%. The median progression-free survival was 3.5 months, with a median overall survival of 20.0 months. Especially in the 3 mg/kg cohort, two patients achieved a complete response, and disease stabilized in another two patients. The objective response rate in 3mg/kg cohort cohort was 20% and disease was controlled in 40% of the higher-dose group. In the four patients who demonstrated an antitumor response, responses were durable and evident. Grade 3 or 4 treatment-related adverse events (AE) occurred in eight out of 20 patients or 40% overall. However, the frequency of AEs were not different in 2 cohorts.

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HRD Score Can Help Predict Response To Some Chemotherapeutic Agents

MedicalResearch.com Interview with:
Dr. Kirsten Timms, PhD
Program Director
VP Biomarker Discovery at Myriad Genetics Inc

Medical Research: What is the background for this study? What are the main findings?

Dr. Timms: The Homologous Recombination Deficiency (HRD) score is a tumor biomarker which quantitates genomic rearrangements associated with defects in DNA damage repair. It has been shown in multiple studies that HRD score can identify tumors sensitive to DNA damaging agents such as platinum salts or PARP inhibitors. Many tumors are spatially heterogeneous: different parts of a tumor show variation at both the genomic level, and in their appearance. This tumor heterogeneity has the potential to negatively impact the accuracy of biomarker tests. This study assessed the consistency of the HRD score in multiple biopsies obtained from the same cancer to understand the impact of tumor heterogeneity on the HRD score. The main finding of this study is that the HRD score is highly conserved between different biopsies of the same tumor.

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Individualized Sunitinib Dosing Improved Response Rate in Renal Cell Cancer

MedicalResearch.com Interview with:
Georg A. Bjarnason, MD, FRCP(C)
The Anna-Liisa Farquharson Chair in Renal Cell Cancer Research
Associate Professor, Faculty of Medicine, University of Toronto
Division of Medical Oncology, Sunnybrook Odette Cancer Centre
Toronto, ONT, Canada

Medical Research: What is the background for this study?

Dr. Bjarnason: Higher sunitinib drug exposure is associated with better response (RR), progression free (PFS) and overall survival (OS). Retrospective data show poorer PFS and OS in patients with minimum toxicity on the 28 day (d)/14 d schedule vs patients needing dose/schedule changes. We hypothesized that toxicity-driven dose/schedule changes would optimize drug exposure.

Medical Research: What are the main findings?

Dr. Bjarnason: The main findings of this report include:

  1. Individualized Sunitinib therapy is safe and feasible in a multicenter setting (13 study canters).
  2. Response rates (CR+PR+ SD rate of 89.2%) are among the best for any tyrosine-kinase inhibitor (TKI) in renal cell cancer with implications for dosing of sunitinib in other indications and for the dosing of other TKI’s. Only 10% of patients were refractory to Sunitinib. This has been around 20% in other studies.3. Dose intensity was improved in 65% of patients vs. the standard dosing schema for Sunitinib. 20% of patients were dose escalated, and much fewer patients needed dose reductions or stopped due to toxicity.
  3. The primary endpoint is PFS and the data are too early for this but: 37/102 (36.3%) patients have been on therapy longer than the 8.5 Mo PFS in the EFFECT comparator trial and 25/83 (30.1%) of these patients are still on therapy.  For 49 patients with CR+PR the median time on therapy is 14.3 months (29 patients (59%) still on treatment). For 42 patients with standard treatment the median time in therapy is 6.8 months (15 patients (34%) still on treatment).

Medical Research: What should clinicians and patients take away from your report?

Dr. Bjarnason: Many oncologists are already using alternate schedules for sunitinib because of the toxicity associated with the standard 4/2 schedule. These data provide them with an algorithm for individualized sunitinib therapy that is safe and associated with a very good response rate and time on therapy.

Medical Research: What recommendations do you have for future research as a result of this study?

Dr. Bjarnason: The safety and activity of other targeted drugs might be optimized by individualizing therapy based on toxicity.

Citation:

Presented at 2015 ASCO Meeting:

Phase II study of individualized sunitinib as first-line therapy for metastatic renal cell cancer

J Clin Oncol 33, 2015 (suppl; abstr 4555)

Author(s):

Georg A. Bjarnason, Jennifer J. Knox, Christian K. Kollmannsberger, Denis Soulieres, D. Scott Ernst, Christina M. Canil, Eric Winquist, Pawel Zalewski, Sebastien J. Hotte, Scott A. North, Daniel Yick Chin Heng, Robyn Jane Macfarlane, Peter M. Venner, Ian Tannock, Anil Kapoor, Bernhard J. Eigl, Aaron Richard Hansen, Piotr Czaykowski, Ben Boyd, Naveen S. Basappa; Sunnybrook Odette Cancer Centre, University of Toronto, Toronto, ON, Canada; Princess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto, ON, Canada; BC Cancer Agency, Vancouver Cancer Centre, Vancouver, BC, Canada; Centre Hospitalier de l’Université de Montréal, Montreal, QC, Canada; London Regional Cancer Centre, London, ON, Canada; Ottawa Reg Cancer Centre, Manotick, ON, Canada; London Health Sciences Centre, London, ON, Canada; Lakeridge Health, Oshawa, ON, Canada; Juravinski Cancer Centre, Hamilton, ON, Canada; Cross Cancer Institute, Edmonton, AB, Canada; Tom Baker Cancer Center, University of Calgary, Calgary, AB, Canada; Queen Elizabeth II Health Sciences Centre, Halifax, NS, Canada; Cross Cancer Inst, Edmonton, AB, Canada; Princess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada; BC Cancer Agency, Vancouver, BC, Canada; Princess Margaret Hospital, Toronto, ON, Canada; CancerCare Manitoba, Winnipeg, MB, Canada; Ozmosis Research Inc, Toronto, ON, Canada

 

MedicalResearch.com Interview with: Georg A. Bjarnason, MD, FRCP(C) (2015). Individualized Sunitinib Dosing Improved Response Rate in Renal Cell Cancer 

Treatment With Eribulin Is Step Forward for Advanced Soft Tissue Sarcomas

Professor Patrick Schöffski Head, Department of General Medical Oncology and the Laboratory of Experimental Oncology at the University Hospital Leuven, KU Leuven, BelgiumMedicalResearch.com Interview with:
Professor Patrick Schöffski
Head, Department of General Medical Oncology and the Laboratory of Experimental Oncology at the University Hospital
Leuven, KU Leuven, Belgium

MedicalResearch: What are the key points of the study?

Professor Schöffski: This is the first and only randomised controlled trial of a single agent systemic therapy to demonstrate an improvement in overall survival in people previously treated for advanced soft tissue sarcomas. The study met its primary objective for overall survival benefit (OS) for investigational use in patients treated with eribulin compared to dacarbazine. Median OS for eribulin was 13.5 months versus 11.5 months for dacarbazine representing a significant benefit, meaning that patients treated with eribulin may have a 23% reduction in the risk of death. Furthermore, an additional study endpoint included progression-free survival (PFS) at 12 weeks.  While there was a numerical difference between arms favouring eribulin versus dacarbazine (33% vs 29%) this was not statistically significant. Median PFS was 2.6 months in both arms.

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Myriad Presents Data on Expanded Cancer Genetics and Chemotherapy Susceptibility Testing

MedicalResearch.com spoke with Dr. Jonathan Lancaster, MD, Ph.D. at the 2015 ASCO meeting in Chicago.  Dr. Lancaster is the new Vice President of Medical Affairs for Oncology, Myriad Genetic Laboratories, at Myriad. Dr. Lancaster jointed Myriad in February 2015 after twelve years at the Moffitt Cancer Center. Prior to Moffitt, Dr. Lancaster was medical director of the Gynecologic Dysplasia Clinic at Duke University Medical Center in Durham, NC, where he also completed his residency and fellowship training.MedicalResearch.com spoke with
Dr. Johnathan Lancaster, MD, Ph.D. at the 2015 ASCO meeting in Chicago.
Dr. Lancaster is the new Vice President of Medical Affairs for Oncology, Myriad Genetic Laboratories, at Myriad. Dr. Lancaster jointed Myriad in February 2015 after twelve years at the Moffitt Cancer Center. Prior to Moffitt, Dr. Lancaster was medical director of the Gynecologic Dysplasia Clinic at Duke University Medical Center in Durham, NC, where he also completed his residency and fellowship training.

MedicalResearch.com: Can you tell us a little more about your background? How did you come to work at Myriad?

Dr. Lancaster: My background and interests lie at the intersection of patient care and the molecular and genetic understanding of cancer. I completed my MD and Ph.D. in molecular genetics at the University of Wales, and then came to Duke for a research fellowship and residency training in Obstetrics & Gynecology. I spent twelve years as a gynecology-oncology surgeon.

At the Moffitt Cancer Center, I ran a research lab attempting to understand the molecular and genetic underpinnings of ovarian cancer development and progression. Our translation research attempted to identify markers, or microRNAs, that help predict ovarian tumors’ response to chemotherapeutic agents.

I also have experience in the management and financial issues facing medicine and health care. While at Moffitt, I was president of the 350-member Moffitt Medical Group, deputy physician-in-chief and director of the Center for Women’s Oncology.

The opportunity at Myriad Genetics allows me to utilize my experience in all three interests, clinical care, research and management, to contribute to a broader mission of cancer treatment and prevention.

MedicalResearch.com: What studies are being presented at ASCO this year by Myriad associated researchers?

Dr. Lancaster: There are 19 abstracts presented by Myriad at ASCO 2015, which is a testament to the emphasis Myriad places on basic and translational research (Myriad reinvests $300-400 of the proceeds from every clinical test performed into research). The studies center around two main themes:

1: An enhanced panel of genes, called MyRisk, to test for increased risk of hereditary cancers.

2: The use of Homologous Recombination Deficiency (HRD) testing and score, called MyChoice, which helps clinicians determine which patients may respond best to some chemotherapeutic agents.

MedicalResearch.com: What does the MyRisk panel offer over and above the information learned from BRAC1/2 testing? Why should a patient or clinician want this testing performed?

Dr. Lancaster: The MyRisk panel tests for 25 state-of-the-art genes with the goal of determining who may be at increased risk for certain malignancies even if they are BRAC1/2 negative. The typical patient is one who has a family history of cancer but may have been told she doesn’t have the ‘breast cancer gene’ because she is BRAC1/2 negative. We now know that up to 50% of these patients may carry other genes that make them more susceptible to cancer. Panel testing allows clinicians to identify many more patients at risk for cancer who would have been missed with more traditional BRAC1/2 testing alone.

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Melanoma Survival Improved By Cancer-Killing Virus

Howard L. Kaufman, MD, FACS Rutgers Cancer Institute of New Jersey New Brunswick, NJMedicalResearch.com Interview with:
Howard L. Kaufman, MD, FACS
Rutgers Cancer Institute of New Jersey
New Brunswick, NJ

Medical Research: What is the background for this study? What are the main findings?

Response: The study clearly demonstrated that advanced melanoma patients achieved a significant improvement in both response rate and durable response rate with Talimogene laherparepvec, or T-VEC. T-VEC is the first oncolytic virus to show a clinical benefit in a randomized phase 3 clinical trial for the treatment of cancer. Patients who received T-VEC also had an improved progress-free and overall survival with nearly 11% obtaining a complete response. T-VEC is an oncolytic virus that mediates anti-tumor activity by directly killing injected tumor cells and by initiating a systemic immune response. Treatment was also associated with few side effects, which were mostly low grade fever, fatigue, chills, nausea and pain at the injection site.

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Taking A Little More Tissue After Breast Cancer Removal May Save Reduce Need For Further Surgery

Anees B. Chagpar, MD, MSc, MPH, MA, MBA, FRCS(C), FACSAssociate Professor, Department of Surgery Director, The Breast Center -- Smilow Cancer Hospital at Yale-New Haven Assistant Director -- Global Oncology, Yale Comprehensive Cancer Center Program Director, Yale Interdisciplinary Breast Fellowship Yale University School of Medicine Breast Centerm New Haven, CT 06510MedicalResearch.com Interview with:
Anees B. Chagpar, MD, MSc, MPH, MA, MBA, FRCS(C), FACS, Associate Professor, Department of Surgery
Director, The Breast Center — Smilow Cancer Hospital at Yale-New Haven, Assistant Director — Global Oncology, Yale Comprehensive Cancer Center
Program Director, Yale Interdisciplinary Breast Fellowship
Yale University School of Medicine Breast Centerm
New Haven, CT,

Medical Research: What is the background for this study? What are the main findings?

Response: Every year in the US, nearly 300,000 women are diagnosed with breast cancer — the majority of these will have early stage breast cancer, and will opt for breast conserving surgery to remove their disease.  The goal of this operation is to remove the cancer with a rim of normal tissue all the way around it (i.e., a margin), but sadly, 20-40% of women will have cancer cells at the edge of the tissue that is removed, often mandating a return trip to the operating room to remove more tissue to ensure that no further disease is left behind.  No one likes to go back to the operating room — so we asked the question, “How can we do better?”.  Surgeons have debated various means of obtaining clear margins.  Some have advocated taking routine cavity shave margins — a little bit more tissue all the way around the cavity after the tumor is removed at the first operation.  Others have argued that this may not be necessary; that one could use intraoperative imaging of the specimen and gross evaluation to define where more tissue may need to be removed (if at all) — i.e., selective margins.  We conducted a randomized controlled trial to answer this question.  We told surgeons to do their best operation, using intraoperative imaging and gross evaluation, and removing selective margins as they saw fit.  After they were happy with the procedure they had performed and were ready to close, we opened a randomization envelope intraoperatively, and surgeons were either instructed to close as they normally would (“NO SHAVE”), or take a bit more tissue all the way around the cavity (“SHAVE”).

Patients in both groups were evenly matched in terms of baseline characteristics.  The key finding was that patients who were randomized to the “SHAVE” group half as likely to have positive final margins and require a re-operation than patients in the “NO SHAVE” group.  On their postoperative visit, we asked patients, before they knew which group they had been randomized to, what they thought of their cosmetic results.  While the volume of tissue excised in the “SHAVE” group was higher than in the “NO SHAVE” group, the distribution of patient-perceived cosmetic outcomes were identical in both groups.  Complication rate was also no different between the two groups.  We will be following patients for five years for long-term cosmetic and recurrence outcomes. Continue reading

Immunotherapy Shows Promise In Advanced Head and Neck Squamous Cell Cancer

Tanguy Seiwert, MD Assistant Professor, Dept. of Medicine Associate Director, Head and Neck Cancer Program Section of Hematology/Oncology Fellow, Institute for Genomics and Systems Biology Speciality Chief Editor, Frontiers in Head and Neck Cancer University of Chicago Chicago, IL 60637MedicalResearch.com Interview with:
Tanguy Seiwert, MD
Assistant Professor, Dept. of Medicine
Associate Director, Head and Neck Cancer Program
Section of Hematology/Oncology
Fellow, Institute for Genomics and Systems Biology
Speciality Chief Editor
Frontiers in Head and Neck Cancer
University of Chicago Chicago, IL 60637

Medical Research: What is the background for this study?

Dr. Seiwert: Recurrent/metastatic Head and Neck Squamous Cell Cancer (HNSCC) remains poorly treatable with a median OS of 10-13 months

There is evidence of a  prominent immune escape observed in squamous cell carcinoma of the head and neck (SCCHN) suggesting that anti-PD1 agents (similar to e.g. melanoma) may be active.

Medical Research: What are the main findings?

Dr. Seiwert:

  • One in four patients with Head/Neck cancer treated with pembrolizumab showed marked tumor shrinkage (so called – partial/complete responses), and 57% of patients experienced any decrease in the size of their tumors.
  • Pembrolizumab is broadly active in both HPV(-) and HPV(+) types of squamous cell carcinoma of the head and neck.
  • Pemborliuzmab treatment is active in heavily pretreated squamous cell carcinoma of the head and neck patients.
  • Responses seem to be durable è 86% of responding patients remain in response.

Treatment overall was well tolerated with less than 10% of patients experiencing severe side effects (≥Grade 3).

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Pacritinib Improved Disease Control In Myelofibrosis and Reduced Need For Blood Transfusions

Ruben A. Mesa, MD, FACP Consultant Hematologist Chair, Division of Hematology & Medical Oncology Deputy Director, Mayo Clinic Cancer Center Professor of Medicine Mayo Clinic Cancer Center NCI Designated Comprehensive Cancer Center Scottsdale, AZMedicalResearch.com Interview with:
Ruben A. Mesa, MD, FACP
Consultant Hematologist
Chair, Division of Hematology & Medical Oncology
Deputy Director, Mayo Clinic Cancer Center
Professor of Medicine Mayo Clinic Cancer Center
NCI Designated Comprehensive Cancer Center
Scottsdale, AZ

Medical Research: What is the background for this study? What are the main findings?

Dr. Mesa: Myelofibrosis is a rare and chronic blood cancer associated with significantly reduced quality of life and shortened survival. In patients with this disease, spleen enlargement (splenomegaly) is a very common and debilitating symptom – and as the disease progresses, the body slows production of important blood cells.

The results presented at ASCO were from the PERSIST-1 study, which is a Phase 3 registration-directed trial designed to compare pacritinib — an investigational oral multikinase inhibitor with specificity for JAK2 and FLT3 – to best available therapy (exclusive of a JAK inhibitor) in patients with myelofibrosis — regardless of their platelet counts.  Data from this study showed that compared to best available therapy, pacritinib resulted in a significantly higher proportion of patients with spleen volume reduction and control of disease-related symptoms, regardless of platelet levels at the time of enrollment.

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