Phase I Study Successfully Targets Metastatic Kidney Cancer

MedicalResearch.com Interview with:

Kevin D. Courtney, M.D., Ph.D.  Assistant Professor UT Southwestern Medical Cente

Dr. Courtney

Kevin D. Courtney, M.D., Ph.D. 
Assistant Professor
UT Southwestern Medical Center

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

Response: Clear cell renal cell carcinoma (ccRCC) is the most common form of kidney cancer. Metastatic ccRCC does not respond to traditional chemotherapy.

Current standard treatments for metastatic ccRCC include drugs called vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR TKIs) that block the growth of new blood vessels that feed the cancer, as well as drugs that inhibit an enzyme called mTOR that is involved in ccRCC growth and immune therapies that rev up the body’s immune response to try to fight the cancer. Each of these treatments can have significant side effects for patients that can make them difficult to tolerate.

Metastatic ccRCC is largely incurable, and we need novel and better-tolerated treatments. A central driver of ccRCC is a protein called hypoxia inducible factor 2alpha (HIF-2alpha). This protein has been very difficult to try to target with a drug. This study is the first to test a drug that targets HIF-2alpha in patients with metastatic ccRCC. The study results showed that the HIF-2alpha inhibitor, PT2385 (Peloton Therapeutics) was active in fighting metastatic ccRCC and was well-tolerated.

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Robotic-Assisted Radical Nephrectomy: No Difference in Outcomes But Takes Longer and Costs More

MedicalResearch.com Interview with:
In Gab Jeong, MD

Associate Professor
Department of Urology, Asan Medical Center
University of Ulsan College of Medicine
Seoul, Korea

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

Response: Use of robotic surgery has increased in urological practice over the last decade especially for the surgery that was difficult to perform with laparoscopic techniques such as radical prostatectomy for prostate cancer or partial resection of kidney cancer. However, the use, outcomes, and costs of robotic nephrectomy are unknown.

We examined the trend in use of robotic-assisted operations for radical nephrectomy in the United States and compared the perioperative outcomes and costs with laparoscopic radical nephrectomy. The proportion of radical nephrectomies using robotic-assisted operations increased from 1.5% in 2003 to 27.0% in 2015. Although there was no significant difference between robotic-assisted vs laparoscopic radical nephrectomy in major postoperative complications, robotic-assisted procedures were associated with longer operating time and higher direct hospital costs. The rate of prolonged operating time (>4 hours) for patients undergoing the robotic-assisted procedure was higher than for patients receiving the laparoscopic procedure (46.3% vs 25.8%; risk difference, 20.5%; 95% CI, 14.2% to 26.8%). Robotic-assisted radical nephrectomy was associated with higher mean 90-day direct hospital costs ($19530 vs $16851; difference, $2678; 95% CI, $838 to $4519).

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Factors Affecting Interest in Transplant Among ESRD Patients Receiving Dialysis

MedicalResearch.com Interview with:

Deborah Evans, MA, MSW, LCSW Manager, Social Work Services DaVita Kidney Care

Deborah Evans

Deborah Evans, MA, MSW, LCSW
Manager, Social Work Services
DaVita Kidney Care

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

Response: For patients with end-stage renal disease (ESRD) receiving dialysis, receipt of a transplant offers the best possible long-term treatment option. However, the process of becoming qualified to receive a transplant involves many steps, beginning with the patient’s statement of interest.

In this study, we sought to characterize transplant interest among patients in a large dialysis organization in the U.S. and to explore reasons identified by the patients for lack of interest in transplant when applicable.

As of November 2016, of the 182,906 patients with available transplant status information in the LDO database, 58,057 (31.7%) expressed that they were not interested in transplant. Among patients not interested in transplant, the most frequently identified reasons for lack of interest were:

  • Advanced age (25.7%)
  • Perceived poor health (12.0%)
  • Comfortable with current modality (12.0%)
  • Uninterested in further surgeries (11.9%)
  • 13.2% of patients not interested in transplant indicated that “other” factors were responsible for their lack of interest. At the time of the study, we didn’t have any further insight into what might account for these “other” factors.

Compared to patients with transplant status listed as active, those not interested in transplant were:

  • Older (21.4% < 60 years vs 64.6%)
  • More likely to be female (47.7% vs 36.6%)
  • More likely to be white (43.9% vs 30.4%) and less likely to be Hispanic (14.7% vs 22.2%)
  • More likely to be receiving in-center hemodialysis (92.0% vs 73.7%)
  • More likely to have Medicare/Medicaid as primary insurance (91.3% vs. 77.3%)

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CT Scan IV Contrast Not Linked With AKI or Emergent Dialysis, Even In Patients With Impaired Kidney Function

MedicalResearJennifer S. McDonald Ph.D Assistant Professor Department of Radiology Mayo Clinicch.com Interview with:
Jennifer S. McDonald Ph.D
Assistant Professor
Department of Radiology
Mayo Clinic

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

Dr. McDonald: Our research group is interested in studying contrast-induced nephropathy (CIN), which is the development of acute kidney injury following administration of iodinated contrast material. Iodinated contrast material is frequently administered during CT examinations. Recent publications, including those by our group, suggest that the incidence of contrast-induced nephropathy has been overestimated by prior, uncontrolled studies. The purpose of our study was to better evaluate the incidence and severity of CIN in patients with diminished renal function (eGFR < 60 ml/min/1.73m2). In the current article, we performed a controlled retrospective study comparing patients who received a contrast-enhanced CT scan at our institution to patients who received an unenhanced CT scan. We used propensity score analysis that incorporated numerous variables to match contrast recipients and control patients with similar clinical characteristics. After performing this analysis, we found that the rate of AKI, emergent dialysis, and short-term mortality was similar between contrast recipients and control patients.

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Over Half US Population Not Healthy Enough To Donate A Kidney

Anthony Bleyer, Jr.  Wake Forest University Class of 2015, Economics  President, Club Sports Union  Senior Captain, Wake Forest Men's Ultimate MedicalResearch.com Interview with:
Anthony Bleyer, Jr. 
Wake Forest University Class of 2015, Economics
President, Club Sports Union
Senior Captain, Wake Forest Men’s Ultimate

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

Response: There are over 100,000 individuals waiting for a kidney transplant, but each year only approximately 6,000 individuals have living donors who donate them a kidney; the rest of the individuals must remain on dialysis until they receive a kidney from an individual who has died and is a kidney donor.  A major limiting factor for kidney donation is that many individuals are not healthy enough to donate a kidney because they have  excessive obesity, diabetes mellitus, blood pressure that is too high, or they have other health conditions.  While it was known that obesity, hypertension, and other health conditions are contraindications to kidney transplant, there was no data about what percentage of the US population would be able to donate a kidney.  To study this, we (a team of kidney doctors and researchers at Wake Forest School of Medicine, Winston-Salem, NC) analyzed data from the National Health and Nutrition Survey. This study is a population-based sample that is representative of the US population.

Based on data from this study, we determined that 55.2% of the U.S. population would not have met eligibility criteria for kidney donation, often due to preventable health conditions.  19.2% of the population would have been unable to donate due to hypertension, 15% due to obesity, 11.6% due to excessive alcohol intake, and 11.5% due to diabetes.  60.1% of individuals with an adjusted family household income (AFHI) <$35,000 did not meet eligibility criteria vs. 49.3% for an AFHI > $100,000.   If one considers non-US citizenship and a family income below the poverty threshold as exclusion criteria, 68.5% of the US population would be unable to donate.
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Surveillance vs. Surgery For Small Kidney Masses?

MedicDavid C. Johnson, MD, MPH Department of Urology University of North Carolina School of MedicinealResearch.com Interview with:
David C. Johnson, MD, MPH
Department of Urology
University of North Carolina School of Medicine

 

Medical Research: What are the main findings of the study?

Dr. Johnson: The first main finding from this study is that the likelihood of benign pathology after surgical removal of a renal mass suspected to be malignant based on pre-operative is inversely proportionate to size. This concept is well-established, however we systematically reviewed the literature for surgical series that published rates of benign pathology stratified by size and combined these rates to determine a single pooled estimate of benign pathology of pre-operatively suspicious renal masses for each size strata. Using benign pathology rates from US studies only, we found that 40.4% of masses < 1 cm, 20.9% of masses 1-2 cm, 19.6% of masses 2-3 cm, 17.2% of masses 3-4 cm, 9.2% of masses 4-7 cm, and 6.4% of masses >7 cm are benign.

The more novel finding from this study was the quantification of a previously unmeasured burden of over treatment in kidney cancer. By combining the above mentioned rates of benign pathology with epidemiological data, we estimated that the overall burden of benign renal masses surgically removed in the US to approach 6,000 per year in 2009. This represented an 82% increase over the course of a decade. Most importantly, we found an overwhelmingly disproportionate rise in the surgical treatment of renal masses in the smallest size categories – those which were most likely to be benign. We found a 233%, 189% and 128% increase in surgically removed benign renal lesions < 1 cm, 1-2 cm, and 2-3 cm, respectively from 2000 – 2009 in the US.

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Small Changes Improve Geographic Disparity in Kidney Transplantation

Daniela P Ladner, MD, MPH, FACS Assistant Professor Transplant Surgery Department of Surgery, Division of Organ Transplantation Director Northwestern University Transplant Outcomes Research Collaborative (NUTORC) Comprehensive Transplant Center Feinberg School of Medicine, Northwestern UniversityMedicalResearch.com Interview with
Daniela P Ladner, MD, MPH, FACS
Assistant Professor Transplant Surgery
Department of Surgery, Division of Organ Transplantation
Director Northwestern University Transplant Outcomes Research Collaborative (NUTORC)
Comprehensive Transplant Center
Feinberg School of Medicine, Northwestern University

MedicalResearch: What are the main findings of the study?

Dr. Ladner: With the current kidney organ allocation system, there exists significant geographic disparity between the 58 Donor Services Areas (DSAs) in the US, which are distributed among 11 regions. This means that depending on where a patient lives it might take shorter or longer to receive a kidney organ for transplantation. Despite efforts, this has not improved over the course of 20 years and in most regions this has worsened. In 1991 and 1992 respectively, two states changed their kidney allocation system, such that kidneys would first be allocated with the DSA of procurement, then statewide, then regionally (which may include several states) and then nationally. Usually kidneys don’t get allocated statewide before regionally.

The main finding of this study is that in those two states (FL, TN), where a minor change to the kidney allocation was put into place, there was significant reduction in the geographic disparity between their Donor Services Areas. In other comparable states (equal numbers of DSAs within the state) the geographic disparity did not improve and in many the geographic disparity worsened. Continue reading

Rhabdomyolysis: Risk Prediction Score for Kidney Failure or Mortality

MedicalResearch.com Interview with:
Gearoid M. McMahon, MB, BCh
Renal Division, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston,
Massachusetts Framingham Heart Study, National Heart, Lung, and Blood Institute, and Center for Population Studies, Framingham, Massachusetts

MedicalResearch.com: What are the main findings of the study?

Answer: This study examined the incidence, causes and outcomes of rhabdomyolysis in two large University Teaching hospitals. Rhabdomyolysis is a characterized by an increase in serum creatine phosphokinase (CPK) and results from muscle damage from a variety of causes. The most important complication of rhabdomyolysis is acute kidney injury which can result in a need for dialysis. Using a series of laboratory and clinical variables that are readily available on admission, we constructed a risk score that can predict with some accuracy the likelihood that a patient with rhabdomyolysis might die or need dialysis during an admission. The final variables included in the model were age, gender, the cause of rhabdomyolysis and the admission CPK, creatinine, phosphate, bicarbonate and calcium. One of the advantages of this study was, because we had access to data from two institutions, we were able to derive the risk score in one hospital and confirm its accuracy in the second institution.

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