New precision medicine guidelines aimed at improving personalized cancer treatment plans
Tuesday, Jan 19th, 2016, Cleveland: A committee of national experts, led by a Cleveland Clinic researcher, has established first-of-its-kind guidelines to promote more accurate and individualized cancer predictions, guiding more precise treatment and leading to improved patient survival rates and outcomes.
These new guidelines are changing the traditional approach of cancer staging methods for cancer treatment. The new risk calculators – which will complement the existing staging system – will enable physicians to more accurately and precisely determine the best treatment for individual patients.
The American Joint Committee on Cancer (AJCC), which is responsible for periodically evaluating and updating the cancer stages, has acknowledged that cancer stages are imperfect, and it is committed to enhancing the system with more prognostic, statistically based risk calculators in 2016.
In preparation for these changes, the AJCC invited a group of top healthcare statistical experts from across the country to form the Precision Medicine Core (PMC). Led by Michael Kattan, Ph.D., MBA, chair of Cleveland Clinic's Department of Quantitative Health Sciences at Cleveland Clinic's Lerner Research Institute, the group discussed characteristics necessary for developing a quality risk model in cancer patients. The emphasis centered on performance metrics, implementation clarity, and clinical relevance.
"This represents a new paradigm shift for the future of cancer treatments," Kattan said.
The new guidelines will be published in the highly esteemed journal CA: A Cancer Journal for Clinicians on Tuesday, January 19th, 2016.
The Precision Medicine Core (PMC) was tasked with developing a criteria checklist to evaluate possible cancer risk calculators and determine which calculators will be endorsed by AJCC. The group identified 13 inclusion and 3 exclusion criteria for AJCC risk model endorsement in cancer. The following cancers will be the first to be evaluated for existing prediction models: breast, colon, prostate, lung, melanoma, and head and neck cancer, with the goal being to comprehensively include all cancers in the future. The PMC consists of researchers from Cleveland Clinic, The University of Texas MD Anderson Cancer Center, Cedars-Sinai Medical Center, Stanford University, UMC Utrecht, The Netherlands, University of Pennsylvania, Duke University, Sage Bionetworks, Queen's University, University of Illinois Hospital & Health Sciences System, Mayo Clinic, Memorial Sloan Kettering Cancer Center and Arizona State University.
The formulas must predict overall survival or death from a particular type of cancer and have to pass all 16 criteria. "Our checklist should open the door to a wave of statistical prediction models that get used clinically across many different cancers," said Kattan, a pioneer in the development of cancer risk calculators called nomograms. "It could potentially be applied outside cancer as well – anywhere statistical prediction models are being considered for widespread usage."
The current cancer staging system (stages I-IV), otherwise known as TNM, has been used for decades and is a simple way to universally assess cancer progression in patients around the world. However, many believe that the system is outdated, lumping all cancer patients into 4 stages, which do not account for individual differences in risk factors–such as genetics, age, gender, and lifestyle. As a result, a patient who is, for example, a "bad" stage 3, might be undertreated for a cancer that is likely to metastasize. On the other hand, a "good" stage 3 patient might receive more aggressive treatment than is necessary, which can lead to toxic side effects on the heart, kidneys or other organs.
Now that the guidelines have been established, researchers across the world will be invited to submit their cancer risk formulas for review by AJCC, with the potential of changing the face of cancer treatment for millions of people worldwide.
"When the models get into physicians' hands, the way patients are treated and managed and counseled will be forever changed for the better," Kattan said. "This is truly a great example of how precision medicine will help cancer patients in the not so distant future."
The next step will be distribution of this checklist, as well as the process, to authors of prediction models. They will then be invited to submit their models for consideration.
According to the American Cancer Society, in 2016 there will be an estimated 1,685,210 new cancer cases diagnosed and 595,690 cancer deaths in the U.S. Cancer is the second most common cause of death in the U.S., exceeded only by heart disease, and accounts for nearly 1 out of every 4 deaths.
About Cleveland Clinic
Cleveland Clinic is a nonprofit multispecialty academic medical center that integrates clinical and hospital care with research and education. Located in Cleveland, Ohio, it was founded in 1921 by four renowned physicians with a vision of providing outstanding patient care based upon the principles of cooperation, compassion and innovation. Cleveland Clinic has pioneered many medical breakthroughs, including coronary artery bypass surgery and the first face transplant in the United States. U.S.News & World Report consistently names Cleveland Clinic as one of the nation's best hospitals in its annual "America's Best Hospitals" survey. More than 3,000 full-time salaried physicians and researchers and 11,000 nurses represent 120 medical specialties and subspecialties. The Cleveland Clinic health system includes a main campus near downtown Cleveland, eight community hospitals, more than 75 Northern Ohio outpatient locations, including 16 full-service Family Health Centers, Cleveland Clinic Florida, the Lou Ruvo Center for Brain Health in Las Vegas, Cleveland Clinic Canada, and, scheduled to begin seeing patients in 2015, Cleveland Clinic Abu Dhabi. In 2012, there were 5.1 million outpatient visits throughout the Cleveland Clinic health system and 157,000 hospital admissions. Patients came for treatment from every state and from more than 130 countries. Visit us at http://www.clevelandclinic.org. Follow us at http://www.twitter.com/ClevelandClinic.
About the Lerner Research Institute
The Lerner Research Institute (LRI) is home to Cleveland Clinic's laboratory, translational and clinical research. Its mission is to promote human health by investigating in the laboratory and the clinic the causes of disease and discovering novel approaches to prevention and treatments; to train the next generation of biomedical researchers; and to foster productive collaborations with those providing clinical care. In 2014, LRI researchers published nearly 600 articles in high-impact biomedical journals (top 10% of all biomedical journals). LRI's total annual research expenditure was $255 million in 2014 (with $98 million in competitive federal funding). More than 2,000 people (including approximately 175 principal investigators, 200 postdoctoral fellows, and about 170 graduate students) in 13 departments work in research programs focusing on cardiovascular, cancer, neurologic, musculoskeletal, allergic and immunologic, eye, metabolic, and infectious diseases. The LRI has more than 700,000 square feet of lab, office, and scientific core services space. LRI faculty oversee the curriculum and teach students enrolled in the Cleveland Clinic Lerner College of Medicine (CCLCM) of Case Western Reserve University – training the next generation of physician-scientists. Institute faculty also participate in multiple doctoral programs, including the Molecular Medicine PhD Program, which integrates traditional graduate training with an emphasis on human diseases. The LRI is a significant source of commercial property, generating 66 invention disclosures, 4 licenses, and 50 patents in 2014.
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