Deviation from Radiation Protocols May Result in Treatment Failure and Even Death

The investigators presented their data in the first-of-its kind study November 1, 2012, during a plenary session at the American Society for Radiation Oncology (ASTRO) 54th annual meeting, held in Boston, MA, USA.

The findings, presented by Nitin Ohri, MD, who conducted the research while at Jefferson, but is currently at Albert Einstein/Montefiore Medical Center (New York, NY, USA) revealed that straying from protocols was linked with up to a 75% increased risk of treatment failure and overall mortality. This infers that implementing QA measures to ensure protocols are followed could improve outcomes for cancer patients, according to the authors.

It is widely accepted that deviating from a radiation therapy protocol in a clinical trial will more than likely result in adverse effects, as a result, significant QA measures have been taken over the last several decades to minimize such effects. However, while these measures have shown to decrease deviation, there is currently no data establishing the patient-outcome benefits of those measures. This is the first study, to the author’s knowledge, to examine the effects on those measures on risk of treatment failures and mortality.

Examples of radiation therapy deviation include insufficient targeting of high-risk lymph node regions or wrong dose calculation. The researchers studied two lung cancer trials, three trials for medulloblastoma, and trials for Ewing’s sarcoma, head and neck cancer, and pancreatic cancer, which in total included over 2,000 patients. They extracted information from the clinical trials, including number of patients included in QA analysis, definition of radiotherapy protocol deviation, and number of patients with and without radiotherapy deviations.

The investigators revealed that the frequency of radiation therapy deviations ranged from 8%-71%. Those deviations were also associated with a significant decrease in overall survival, and with an approximately 75% increase in the risk of treatment failure and mortality.

“The magnitude of these effect sizes demonstrates that delivery of high-quality radiation therapy and having a rigorous QA program is critical for the successful execution of clinical trials and for the effective treatment of all cancer patients,” said another author of the study, Adam P. Dicker, MD, PhD, chair of the department of radiation oncology at Jefferson and the Kimmel Cancer Center at Jefferson. “With such practices, deviations decrease and thus overall survival rates for cancer patients improve.”

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