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Radiation Therapy Protocol Deviations in Clinical Trials Associated with Treatment Failure and Increased Mortality

Study Results Underscore Need for Rigorous Quality Controls

New York City (October 29, 2012) – Radiation therapy protocol deviations in clinical trials are associated with increased risk of treatment failure and overall mortality, according to a study entitled, "Radiotherapy Protocol Deviations are Associated with Inferior Clinical Outcomes: A Meta-analysis of Cooperative Group Clinical Trials" to be presented today at the 54th annual meeting of the American Society for Radiation Oncology (ASTRO) in Boston, MA. The results underscore the need for rigorous quality assurance (QA) measures that could improve patient outcomes, according to the study's authors.

"Recent reports show that deviations from radiation protocols result in a 75 percent increase in disease progression and death among patients," said Nitin Ohri, MD, radiation oncologist at Montefiore Einstein Center for Cancer Care, Assistant Professor in the Department of Radiation Oncology at Albert Einstein College of Medicine, and first author of the study. "The results of our analysis demonstrate how important it is for cooperative groups to review the radiotherapy treatment plans before administering them to patients."

The meta-analysis included cooperative group trials for lung cancer trials, medulloblastoma or supratentorial primitive neuroectodermal tumor, Ewing's sarcoma, pancreatic cancer and head and neck cancer. The studies were conducted from the mid-1970s to 2005. The primary clinical outcome of interest was overall patient survival. Data for secondary outcomes, such as local control or event-free survival, were also recorded.

In the majority of cases, failure to meet radiotherapy QA measures was associated with inferior patient outcomes. The meta-analysis demonstrated that these deviations occurred in 8-71 percent of cases and were associated with significant increases in treatment failure and overall mortality.

"The magnitude of these outcomes demonstrates that the delivery of high-quality radiotherapy is critical for successful execution of clinical trials and for effective treatment of cancer patients," Dr. Ohri said. "Similar measures could benefit all cancer patients who are treated with radiotherapy."

The meta-analysis supports the use of real-time QA measures in clinical radiotherapy trials. However, since the vast majority of the studies included in the meta-analysis utilized two-dimensional RT, applicability of these findings to newer treatment technologies such as intensity modulated radiation therapy (IMRT) is unclear.

Dr. Ohri treats adult patients at Montefiore Einstein Center for Cancer Care, where his clinical interests include lung cancer, hepatocellular cancer, melanoma and sarcoma. His academic focus is immunologic manipulation to improve radiotherapy outcomes.