Little Cardiac Toxicity with Sunitinib, Sorafenib - Renal and Urology News |
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CHICAGO—Sunitinib (SU) and sorafenib (SO) for adjuvant therapy will likely not cause significant cardiac toxicity in patients with resected renal cell carcinoma (RCC), according to a study presented at the American Society of Clinical Oncology 2012 annual meeting
The study, by Naomi B. Haas, MD, Associate Professor of Medicine at the University of Pennsylvania in Philadelphia, Robert G. Uzzo, MD, Professor of Surgery at Temple University, and colleagues, involved a cardiac analysis of 1,943 patients with resected high-risk RCC and normal left ventricular ejection fraction (LVEF).
“This study is the first to demonstrate that in the adjuvant setting these two drugs do not cause increased risk of cardiac events,” said Dr. Uzzo, Chief of Surgery at Fox Chase Cancer Center in Philadelphia. “This is the largest adjuvant kidney cancer trial ever done. It is also the first in the targeted therapy era.”
Study patients had participated in E2805, a randomized, double-blind study in which patients were randomized to one of three treatment arms. Arm A included patients who received oral SU once daily for four weeks followed by rest for two weeks and oral placebo in place of SO twice daily for six weeks. Arm B included patients who received oral SO twice daily for six weeks and oral placebo in place of SU once daily for four weeks followed by rest for two weeks. Arm C included patients who received oral placebo in place of both drugs.
Tumor tissue was collected prior to or during nephrectomy. Blood and urine samples were collected at baseline and periodically during study for biomarker correlative studies.
The objectives of the study were to determine if patients treated with sunitinib (SU) or sorafenib (SO) experienced clinically significant decreases in LVEF and to describe the frequency of clinically significant heart failure (HF).
Dr. Haas' group evaluated heart function using multiple gated acquisition (MUGA) scans at baseline and at three, six, and 12 months, and at the end of treatment. They also obtained MUGA scans if symptoms developed and at three months after the last abnormal assessment.
Post-baseline MUGA scans were available for 1,589 of 1,943 patients; 1,293 patients had MUGA assessment at six months or later, including 397 in the SU arm, 394 in the SO arm, and 502 in the placebo group.
The researchers defined the primary cardiac endpoint as an LVEF decline below the institutional lower limit of normal (ILN)—a 16% or greater decline from baseline occurring within six months of the start of therapy. The primary cardiac endpoint occurred in nine patients (2.3%) in the SU arm, seven (1.8%) in the SO arm, and five (1%) in the placebo arm.
Clinically significant HF, which was defined as grade 3 or higher LV systolic or diastolic dysfunction, occurred in 11 patients: five SU recipients (1.2%)], four SO recipients (1%), and two placebo recipients (0.4%).
Eight patients had cardiac ischemia possibly or probably from treatment. Only one grade 4 event followed a primary LVEF event.
The researchers concluded that cardiac function in patients starting with normal EF was not impaired significantly in patients receiving SU and SO compared with placebo. Ischemic events were uncommon and not clearly associated with treatment.
“It is important to note therefore that although we don't know the efficacy of these drugs in the adjuvant setting this is important information regarding their safety,” Dr. Uzzo told Renal & Urology News. “The most important information to take home is that the drugs are safe in the adjuvant setting and that cardiac events are rarely the cause of stopping drug. We await the results to see if they are efficacious.”
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Ontario's first renal plan to improve the quality of care and treatment for ... - Canada NewsWire (press release) |
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Ontario Renal Plan will drive change in health, accountability and value for money in chronic kidney disease care
TORONTO, June 5, 2012 /CNW/ - Cancer Care Ontario's (CCO) Ontario Renal Network (ORN) has released Ontario's first-ever renal plan, a three year plan focused on improving care for patients with chronic kidney disease (CKD).
"The number of people living with chronic kidney disease risk factors in Ontario is rising," said Deb Matthews, Minister of Health and Long-Term Care. "This plan will work to keep Ontarians healthy by helping to slow the progression of CKD, while improving the quality of care and treatment for current and future patients."
Areas targeted in the Ontario Renal Plan include: slowing the progression of CKD, improving patient experience to have more control over care; increasing healthy, functioning vascular access for hemodialysis; and ensuring that capacity plans are adequate to meet current and future needs.
"The Ontario Renal Plan was developed collaboratively with healthcare providers across the province. It's based on input provided by clinicians, policy experts, regional planners, and most importantly, the people who use Ontario's CKD system," said Michael Sherar, President and CEO, Cancer Care Ontario. "The plan will guide us in improving the life of every person with kidney disease in Ontario by supporting excellent, evidence-based CKD patient care."
By 2015, the plan seeks to guide improvements in:
- The experiences of CKD patients and their families at every stage of their journey with knowledge and tools to manage their health in collaboration with their care providers.
- Early detection and prevention through appropriate screening, improved partnerships between primary and specialty care providers and the utilization of effective clinical tools.
- Appropriate body access for peritoneal dialysis and hemodialysis.
- CKD infrastructure, which includes the needs for equipment, physical space and human resources.
- Research and innovation.
- Patient-based funding that ensures better patient care throughout the full patient journey and provides greater value for money for the health system.
The Ontario Renal Plan provides provincial guidance to Ontario's healthcare system: its implementation is regionally directed. CKD programs will be showcasing the relationship between the provincial plan and local implementation stories at a series of local events throughout 2012. The first event is Thursday, June 7, 2012 at The Scarborough Hospital.
Read the full report at www.renalnetwork.on.ca
Cancer Care Ontario - an Ontario government agency - drives quality and continuous improvement in disease prevention and screening, the delivery of care and the patient experience, for cancer, chronic kidney disease and access to care for key health services. Known for its innovation and results-driven approaches, CCO leads multi-year system planning, contracts for services with hospitals and providers, develops and deploys information systems, establishes guidelines and standards and tracks performance targets to ensure system-wide improvements in cancer, chronic kidney disease and access to care.
The Ontario Renal Network (ORN), part of Cancer Care Ontario, provides overall leadership and strategic direction to effectively organize and manage the delivery of renal services in Ontario in a consistent and coordinated manner. Priorities include establishing consistent standards and guidelines for renal care, planning for service delivery, and putting in place information systems to measure performance.
Backgrounder - http://www.renalnetwork.on.ca/common/pages/UserFile.aspx?fileId=134287
For further information:
Media contacts:
Marko Perovic, Senior Public Affairs Advisor
Cancer Care Ontario
Phone: 1-855-460-2646
Email:
This e-mail address is being protected from spambots. You need JavaScript enabled to view it
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Ontario's first renal plan to improve the quality of care and treatment for ... - DigitalJournal.com (press release) |
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Ontario Renal Plan will drive change in health, accountability and value for money in chronic kidney disease care
TORONTO, June 5, 2012 /CNW/ - Cancer Care Ontario's (CCO) Ontario Renal Network (ORN) has released Ontario's first-ever renal plan, a three year plan focused on improving care for patients with chronic kidney disease (CKD).
"The number of people living with chronic kidney disease risk factors in Ontario is rising," said Deb Matthews, Minister of Health and Long-Term Care. "This plan will work to keep Ontarians healthy by helping to slow the progression of CKD, while improving the quality of care and treatment for current and future patients."
Areas targeted in the Ontario Renal Plan include: slowing the progression of CKD, improving patient experience to have more control over care; increasing healthy, functioning vascular access for hemodialysis; and ensuring that capacity plans are adequate to meet current and future needs.
"The Ontario Renal Plan was developed collaboratively with healthcare providers across the province. It's based on input provided by clinicians, policy experts, regional planners, and most importantly, the people who use Ontario's CKD system," said Michael Sherar, President and CEO, Cancer Care Ontario. "The plan will guide us in improving the life of every person with kidney disease in Ontario by supporting excellent, evidence-based CKD patient care."
By 2015, the plan seeks to guide improvements in:
- The experiences of CKD patients and their families at every stage of their journey with knowledge and tools to manage their health in collaboration with their care providers.
- Early detection and prevention through appropriate screening, improved partnerships between primary and specialty care providers and the utilization of effective clinical tools.
- Appropriate body access for peritoneal dialysis and hemodialysis.
- CKD infrastructure, which includes the needs for equipment, physical space and human resources.
- Research and innovation.
- Patient-based funding that ensures better patient care throughout the full patient journey and provides greater value for money for the health system.
The Ontario Renal Plan provides provincial guidance to Ontario's healthcare system: its implementation is regionally directed. CKD programs will be showcasing the relationship between the provincial plan and local implementation stories at a series of local events throughout 2012. The first event is Thursday, June 7, 2012 at The Scarborough Hospital.
Read the full report at www.renalnetwork.on.ca
Cancer Care Ontario - an Ontario government agency - drives quality and continuous improvement in disease prevention and screening, the delivery of care and the patient experience, for cancer, chronic kidney disease and access to care for key health services. Known for its innovation and results-driven approaches, CCO leads multi-year system planning, contracts for services with hospitals and providers, develops and deploys information systems, establishes guidelines and standards and tracks performance targets to ensure system-wide improvements in cancer, chronic kidney disease and access to care.
The Ontario Renal Network (ORN), part of Cancer Care Ontario, provides overall leadership and strategic direction to effectively organize and manage the delivery of renal services in Ontario in a consistent and coordinated manner. Priorities include establishing consistent standards and guidelines for renal care, planning for service delivery, and putting in place information systems to measure performance.
Backgrounder - http://www.renalnetwork.on.ca/common/pages/UserFile.aspx?fileId=134287
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Sepsis Outbreak at LA County Dialysis Center Prompts Public Health Investigation - Infection Control Today |
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Three patients with chronic kidney failure treated at a dialysis center in Los Angeles County, California contracted sepsis caused by improper cleaning and disinfection of a dialyzer.
Described in a poster presented at the 39th Annual Educational Conference and International Meeting of the Association for Professionals in Infection Control and Epidemiology (APIC), the County of Los Angeles Department of Public Health, conducted an investigation led by public health nurse L’Tanya English, RN, MPH, who found that the bacteria infecting the three patients were genetically linked. These patients were infected with Stenotrophomonas maltophilia (S. maltophilia), a rare type of Gram-negative bacteria.
Two of these patients were also positive for Candida parapsilosis (C. parapsilosis), a fungus that can cause sepsis in immune-compromised patients. One of these patients was positive for C. parapsilosis in the dialyzer only, and one patient was positive for Candida in the blood and in the dialyzer, which was genetically traced back to the same fungus in a faucet in the reprocessing room, where the dialyzers are disinfected and sanitized. The infections were reported to the health department in August 2011.
Two patients developed fevers and were hospitalized. One patient was assessed and treated as an outpatient; all patients later recovered.
The County of Los Angeles Department of Public Health became aware of the situation when a hospital in southern California reported an outbreak of sepsis tied to one dialysis center. During the course of their investigation, they discovered that all of the cases used the same type of dialyzer with a removable component – an O-ring header. These three patients were the only ones in the facility to use this type of dialyzer. In response to this outbreak, the facility decided to discontinue use of multi-use dialyzers with O-ring headers.
“Hemodialysis technology is life-saving, but carries a high risk of infection, regardless of the type of dialyzer used,” says English. “Dialysis centers must work to reduce the risk of infection for their patients by ensuring proper cleaning and disinfection procedures are being followed throughout the facility. If multi-use dialyzers with removable headers and O-rings are used, processes to ensure proper disinfection must be in place.”
The County of Los Angeles Department of Public Health is working with state and federal partners to conduct outreach to dialysis centers to decrease dialysis-associated infections and will discuss lessons learned from the investigation at the APIC Annual Conference.
“Contaminated O-rings have been previously implicated in dialysis-associated infection outbreaks. This report underscores the need for adequate infection prevention training in dialysis settings, as well as the critical partnership between public health departments and infection preventionists in hospitals and outpatient settings,” says Michelle Farber, RN, CIC, APIC's 2012 president. “Collaboration with public health is essential to pinpoint the cause of infection outbreaks and improve infection prevention practices across all healthcare settings.”
Hemodialysis is a life-saving procedure that uses an artificial kidney, or dialyzer, to remove waste from the blood when the kidneys no longer work. It is most often the treatment for end-stage renal disease. Following cardiovascular disease, infection is the second highest cause of death for hemodialysis patients.
The most recent draft of the U.S. Department of Health and Human Services’ National Action Plan to Prevent Healthcare-associated Infections: Roadmap to Elimination includes a revised chapter on efforts to prevent and reduce healthcare-associated infections in end-stage renal disease patients.
In an effort to establish best practices for protecting patients undergoing hemodialysis, APIC published a Guide to the Elimination of Infections in Hemodialysis and has an archived webinar on dialysis event surveillance and reporting.
Poster Presentation #9-136 – Outbreak investigation at a dialysis center associated with a multi-use dialyzer with removable headers and O-rings, Los Angeles County.
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