The cardiovascular fitness level of cancer survivors is not affected by many standard cancer therapies, say researchers from Georgetown University Medical Cancer. That is the finding of a new observational study to be presented today at the American College of Sports Medicine in Seattle.

“We know physical activity is a critical component of cancer survivorship, both during and after cancer treatment,” says Jennifer LeMoine, Ph.D., a post-doctoral research fellow with training in exercise physiology at GUMC’s Lombardi Comprehensive Cancer Center. “In order to prescribe an exercise program, it’s critical that we understand our patient’s fitness level and whether or not treatment has had an impact on their cardiovascular health.”

For the study, the researchers conducted a chart review of 49 women who attended a physician-directed fitness clinic for cancer survivors, founded and run by Priscilla Furth, MD, the study’s co-author. The data included demographics, physical activity levels and cancer treatment type, duration and time since their treatment. Fitness assessments were conducted using a three-minute step test during a clinic visit. The purpose of the study was to assess the step test as a way of determining a patient’s current cardiovascular fitness level.

LeMoine says, “Often, what people think they are physically capable of doing and what they can actually do are two very different things. Many have a better fitness level than they expect while some find they’re not as fit as they thought. The step test gives us a better idea of their exercise tolerance and cardiovascular fitness.”

All the patients in the study were women and were diverse by age and body mass index. Their cancer diagnoses and treatments varied. Overall, 33 percent of the survivors were sedentary and 67 percent reported being physically active. Thirty-five (71 percent) of the participants completed the step test. Test completion and heart rate recovery were not affected by treatment, BMI, or age.

“What’s really exciting to us was that we found that cardiovascular fitness was not affected by the expected culprits — cancer treatment, type, duration or time since treatment,” LeMoine explains. “That isn’t to say there aren’t side effects of some treatments that may hinder physical activity, but when it comes to actual cardiovascular fitness as measured in our clinic, many of the standard treatments didn’t have a role.”

“We’ve modified an in-clinic cardiovascular assessment tool, the three-minute step test, with the goal of finding a test that can easily and quickly be performed in a physician’s office,” explains Priscilla A. Furth, MD, a professor of oncology and medicine at Lombardi. “Having this kind of evaluation tool is critical for physicians, like me, who are interested in prescribing physical activity for this population.”

LeMoine and Furth report no related financial interests. There was no external funding for this research.

About Lombardi Comprehensive Cancer Center

The Lombardi Comprehensive Cancer Center, part of Georgetown University Medical Center and Georgetown University Hospital, seeks to improve the diagnosis, treatment, and prevention of cancer through innovative basic and clinical research, patient care, community education and outreach, and the training of cancer specialists of the future. Lombardi is one of only 41 comprehensive cancer centers in the nation, as designated by the National Cancer Institute, and the only one in the Washington, D.C., area.

About Georgetown University Medical Center

Georgetown University Medical Center is an internationally recognized academic medical center with a three-part mission of research, teaching and patient care (through Georgetown’s affiliation with MedStar Health). GUMC’s mission is carried out with a strong emphasis on public service and a dedication to the Catholic, Jesuit principle of cura personalis — or “care of the whole person.” The Medical Center includes the School of Medicine and the School of Nursing and Health Studies, both nationally ranked, the world-renowned Lombardi Comprehensive Cancer Center and the Biomedical Graduate Research Organization (BGRO), home to 60 percent of the university’s sponsored research funding.

Source: Georgetown University Medical Center

Celladon Corporation presented today Phase 1 data from the Calcium Up-Regulation by Percutaneous Administration of Gene Therapy in Cardiac Disease (CUPID), a First-in-Human Phase 1/2 Clinical Trial, in a scientific symposium at the 12th Annual American Society of Gene Therapy Meeting.

The Phase 1 data showed that MYDICAR(R) had an acceptable safety profile in twelve patients, as determined by study investigators and an independent safety committee. In addition, improvements from baseline to six months were observed across a number of key efficacy parameters important in assessing heart failure status. Efficacy was defined as the mean improvement in at least 2 of 5 domains without any worsening in the remaining domains, including a functional six-minute walk test, oxygen consumption, quality of life questionnaire, biomarker activity and left ventricular size and function.

“We are encouraged by the meaningful improvements in cardiac function and overall condition of patients, findings that we believe demonstrate the return toward normal intracellular calcium cycling and contractility in some of the heart muscle cells of these very sick patients,” said Krisztina M. Zsebo, Ph.D., president and chief executive officer. “Our extensive preclinical and clinical investigation to understand the molecular basis of myocardial dysfunction, together with the evolution of safe and efficient gene transfer technology, has placed gene-based therapy for heart failure within reach and yielded valuable insights for the entire field of study.”

The Phase 1 open-label, sequential dose escalation, multi-center phase of the trial was designed to investigate safety and biological effects of restoring SERCA2a enzyme activity in heart muscle cells. The enzyme levels are decreased in late stages of heart failure, and extensive research shows loss of SERCA2a levels represents a common pathway resulting in a defect in the ability of the heart to contract properly. Replacing the enzyme may restore function and reverse heart failure.

The Phase 2 randomized, double-blind, placebo-controlled, parallel-group, dose ranging portion of the study is designed to evaluate the use of MYDICAR at two or three dose levels compared to placebo in 37 patients. CUPID is currently enrolling patients with advanced heart failure at 17 U.S. medical centers.

Zsebo adds, “We anticipate completion of Phase 2 enrollment late this summer and plan to report results in the first half of 2010. In addition, we have adequate MYDICAR product manufactured to complete Phase 3 and recently acquired exclusive license to utilize Adeno-Associated Viral (AAV) vector technology in heart failure, which bodes well for commercial product development of MYDICAR and important to potential strategic partners. “

Celladon scientists, led by company co-founder Roger J. Hajjar, M.D., Director of the Cardiovascular Research Center at Mount Sinai School of Medicine, New York, developed MYDICAR for restoring the SERCA2a calcium transporter in heart failure and validated the overall beneficial effects on cardiac function. MYDICAR is a recombinant adeno-associated viral (rAAV) vector that transfers the SERCA2a gene into heart muscle cells. MYDICAR is delivered in a single dose directly to the heart muscle during a short outpatient procedure, performed in a standard cardiac catheterization laboratory via a small incision in the upper leg.

Of the twelve patients treated, two with low levels of pre-existing antibodies to the AAV vector did not show improvement in these parameters. The data are consistent with safety established for other rAAV vectors, which has been demonstrated in clinical studies of more than 500 patients. AAV vectors are the product of decades of research focused on the safety of gene transfer agents, and are derived from components of a non-replicating, non-pathogenic, commonly occurring human virus. AAV vectors do not integrate into the chromosome and are considered non-mutagenic. In addition, they have not been associated with the types of inflammatory reactions observed in trials involving adenoviral vectors, which are known to induce acute inflammation of tissues due to activation of the body’s immune system.

Source: Celladon Corporation

Sequel Systems says the Electronic Prescribe (E-Prescribe) program, in which paper-based health records would be converted to electronic health records (EHRs), would be beneficial to hospital-based and managed services organizations. This not only reduces medical errors made in the reading of written prescriptions - which results in increased liability - but also offers financial incentives by receiving increases in Medicare reimbursements to those organizations that adopt the program.

An Institute of Medicine report showed that 100,000 people die each year from medical errors in hospitals, and more than 1.5 million people are injured. As a result, these medical errors have cost U.S. taxpayers $17-$29 billion annually. E-Prescriptions improve quality safety and quality of care, reduce the amount of time spent communicating back and forth with pharmacies, provide more accuracy and efficiency and reduce health care costs by preventing adverse drug events and substituting generics or less expensive medications for brand-name drugs.

On February 17, President Barack Obama signed the 2009 American Recovery and Reinvestment Act (ARRA) into law that qualifies hospitals and physicians for $17 billion worth of incentive payments from Medicaid and Medicare over a five-year period. Under ARRA’s Health Information Technology for Economic and Clinical Health (HITECH) Act, each physician is eligible for $40,000-$60,000, providing they can prove “meaningful use” of an EHR. A draft outline of such “meaningful use” standards is expected to be released by the Secretary of Health and Human Services on June 1.

While the exact definition of “meaningful use” has yet to be determined, the legislation outlines three criteria for EHRs: it must include e-prescribing, it must provide electronic exchange of health information and it must allow submission of clinical quality measures.

“We support the president’s plan to have all medical records digitized,” said Irfan Iqbal, Director of Medical Informatics, Sequel Systems. “The grant money, along with the increased reimbursements, should provide enough financial incentives for hospitals and medical service groups to make the conversion to EHRs.”

The Centers for Medicare & Medicaid Services (CMS) defines e-prescribing as “a prescriber’s ability to electronically send an accurate, error-free and understandable prescription directly to a pharmacy from the point-of-care,” and calls it “an important element in improving the quality of patient care.” On April 7, 2008, the CMS adopted “Standards for E-Prescribing Under Medicare Part D” and the Medicare Prescription Drug Program.

Physicians who switch to EHRs by the end of 2009 will receive $18,000 a year in Medicaid incentives starting in 2011. If they start using EHRs in 2011, they can receive a total of $44,000. While physicians have five years to make the transition to EHRs, the financial incentives decrease each year. Those who do not use EHRs by 2015 will be penalized.

“I encourage all doctors to take advantage of the E-prescribe program as soon as possible,” Mr. Iqbal said. “This innovative program provides financial incentives for these doctors, and greatly reduces the number of injuries and deaths that are caused by medical errors because of written prescriptions that are illegible or inaccurate. This also means a reduction in liability on the hospital’s part. Because these prescriptions are filled out electronically, the patient no longer has to wait to pick up their medications, saving the patient time at the check-out counter.”

Source
Sequel Systems