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Scientists Identify Biomarker to Predict Immune Response Risk After Stem Cell Transplants

Researchers from Indiana University, the University of Michigan, the Fred Hutchinson Cancer Research Center and the Dana-Farber Cancer Institute have identified and validated a biomarker accessible in blood tests that could be used to predict which stem cell transplant patients are at highest risk for a potentially fatal immune response called graft-versus-host disease.

Although transplant specialists have been able to reduce its impact, graft-versus-host disease remains a leading cause of death among patients who receive a stem cell transplant from another person, known as an allogeneic transplant. Such transplants are used to treat blood and bone marrow cancers such as leukemia and multiple myeloma, often as a last resort. Graft-versus-host disease occurs when immune cells from the transplant see the patient’s body as foreign and attack it.

Approximately 20,000 allogeneic stem cell transplants were performed worldwide in 2012. Thirty to 40 percent of stem cell transplant recipients whose donor is related will experience graft-versus-host disease. The percentage could rise to 60 to 80 percent if the patient and donor are not related.

The researchers found that patients with a high level of a protein named ST2 were more than twice as likely to have graft-versus-host disease that resisted standard treatment with steroids; and nearly four times as likely to die within six months of the transplant. Their findings were reported in the Aug. 8 edition of the New England Journal of Medicine.

“What we found particularly significant was that this marker was a better predictor than the clinical severity of the disease when it was diagnosed,” said Sophie Paczesny, M.D., Ph.D., associate professor of medicine at the IU School of Medicine and senior author of the study.

Thus, patients with low ST2 levels were more likely to respond to treatment regardless of how serious their graft-versus-host disease was graded, while patients with high ST2 levels were less likely to respond to treatment, whether their disease was graded less serious or more serious.

“This blood test, which is currently available to clinicians, will make informed treatment possible as the clinicians will now be able to adjust therapy to the degree of risk rather than treating every patient the same way,” Dr. Paczesny said.

In addition, while the disease most commonly appears about 30 days after the transplant, higher ST2 levels in blood samples taken as early as 14 days after transplant — far before the clinical signs of graft-versus-host disease are apparent — were associated with an increased risk of death from the toxicity of the transplant.

Therefore, the authors noted, early identification of patients who likely won’t respond to standard treatments is important and would allow physicians to consider additional therapies and early intervention. On the other hand, patients with low risk will not need to have additional medicine further suppressing their immune system. But, they cautioned, additional large prospective studies are needed to better define the levels of risk predicted by the ST2 marker.

Study: ST2 as a marker for risk of therapy-resistant graft-versus-host disease and death. [New England Journal of Medicine]

Source: Indiana University School of Medicine

A Roadblock to Personalized Cancer Care?

There’s a major roadblock to creating personalized cancer care.

Doctors need a way to target treatments to patients most likely to benefit and avoid treating those who will not. Tumor biomarker tests can help do this.

The problem, according to a new commentary paper, is that, unlike drugs or other therapies, cancer biomarker tests are undervalued by doctors and patients. The authors say that inconsistent regulatory rules, inadequate payment and underfunded tumor biomarker research has left us in a vicious cycle that prevents development and testing of reliable biomarker tests that could be used to personalize clinical care of patients with cancer.

“Right now biomarkers are not valued nearly to the extent that we see with therapeutics. But if a tumor biomarker test is being used to decide whether a patient should receive a certain treatment, then it is as critical for patient care as a therapeutic agent. A bad test is as dangerous as a bad drug,” says Daniel F. Hayes, M.D., clinical director of the breast oncology program at the University of Michigan Comprehensive Cancer Center.

Hayes led a blue-ribbon panel of experts from universities, corporations, insurance and advocacy organizations to outline the issues in a commentary published recently in Science Translational Medicine.

Tumor biomarker tests look at the genetic or molecular make-up of a tumor to determine whether the cancer is likely to progress, and if so, if it is likely to respond to treatment. If the test is good, it can help doctors decide when a patient can safely skip further therapy, or it can be used to direct which drug might be most likely to help. The result: “personalized medicine,” which means patients get treatments that benefit them specifically and they avoid treatments – including their costs and side effects – that are not likely to make a difference for them.

The regulatory process, the research funding, the reimbursement, even the standards for journal publications for tumor biomarker tests are all meager compared to the robust support for drug development, the authors say.

This creates a vicious cycle in which researchers and drug companies don’t invest in tumor biomarker research, tests are not fully evaluated in clinical trials, and tests with uncertain value in terms of predicting the success of treatment are published. This in turn means that few of these tests are included in evidence-based care guidelines, leaving health care professionals unsure of whether or how to use the test, and third-party payers unsure of how much to pay for them.

The authors outline five recommendations and suggest that all five must be addressed to break the vicious cycle:

  1. Reform regulatory review of tumor biomarker tests
  2. Increase reimbursement for tumor biomarker tests that are proven to help determine which therapies will or are working
  3. Increase investment for tumor biomarker research so it’s comparable to new drug research
  4. Increase the rigor for peer review of tumor biomarker publications
  5. Include only proven biomarker tests in evidence-based care guidelines

“These recommendations are not about creating more regulation; they are about creating an even playing field that allows tumor biomarker tests to be developed and proven clinically relevant. We want to stimulate innovation yet hold investigators and clinicians to the highest scientific standards – as we now do for therapeutics,” Hayes says. “We need to change the way we value tumor biomarkers in this country.”

Study: Breaking a Vicious Cycle [Science Translational Medicine]

Source: University of Michigan Health System

Life Technologies Launches Compendia Oncomine NGS Power Tools for Cancer Researchers, Discovers Novel Gene Fusions

Life Technologies Corporation (NASDAQ: LIFE) recently announced the introduction of Oncomine® Next Gen Sequencing Power Tools, an analytics offering that will allow cancer researchers to explore results from in-depth analysis of next generation sequencing (NGS) data, including data from The Cancer Genome Atlas. In total, more than 4,500 paired tumor and samples have been analyzed to date.

How the Era of Personalized Medicine is Bearing Fruit

The Personalized Medicine World Conference, PMWC 2013, to be held on January 28-29, 2013 in Silicon Valley, is a two-day business and educational conference that provides real-world insights into personalized medicine and allows participants to join the discussion, interacting with key opinion leaders who are framing and forming the future of this rapidly changing industry. PMWC 2013 is co-hosted by Stanford Hospital & Clinics, SAP and Oracle.

Creating a Future of Personalized Medicine: U-M Forms Nonprofit Joint Venture for Advanced DNA Diagnostics

As a key step toward providing patients with treatments based on their own DNA profiles, the University of Michigan and the International Genomics Consortium (IGC) have launched a new joint venture that will help usher in an age of personalized medicine.