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Better Radiation Toxicity Standards Needed in Both Clinical Trials and Practice

Better Radiation Toxicity Standards Needed in Both Clinical Trials and Practice

TAMPA, Florida—Standards for reporting toxicity related to
radiotherapy are at least 5 years behind those developed for chemotherapy
and need to be improved before the field can advance, according to Andy
Trotti, MD. "There is a need for a common late effects grading system
and a need for reporting standards," Dr. Trotti said. He is program
leader and director of clinical trials, Radiation Oncology, H. Lee Moffitt
Cancer Center and Research Institute, Tampa, Florida.

Barriers to progress in this area have included "doctor denial"
of toxicity in general and a lack of reporting standards, according to Dr.
Trotti. "Morbidity monitors are lacking in the routine clinical
practice of radiation therapy and quality assurance; this area is not
included in cancer outcomes; and there are no accepted reporting
requirements," he said. "Lack of infrastructure and funding for
toxicity research is also a part of the problem."

There are, however, several forces promoting standardized grading of
toxicity. As listed by Dr. Trotti these include:

  • clinical trials requirements;
  • advocacy groups;
  • government regulators;
  • outcomes research;
  • information technology;
  • toxicity intervention studies;
  • third parties such as insurance companies and HMOs;
  • the need to define clinically "acceptable" risk;
  • the need for quality assurance in routine practice; and
  • growing concern over medical errors.

Measuring Toxicity

"Toxicity criteria are crucial to the evaluation of radiation
protectors and toxicity modifiers," Dr. Trotti said. "Measuring
toxicity is more complex than measuring clinical efficacy and may involve
more than 300 kinds of toxic effects," he continued. "We need
valid and reliable scoring criteria that are widely applied so data can be
compared between trials."

The process of data collection also needs attention. "How do we make
sure we have reasonably complete and accurate toxicity data in clinical
trials or in routine practice? There are no standard tools to help us elicit
toxicity information from the patient," Dr. Trotti said.

Standardized systems for reporting radiation toxicity data are also
needed. Dr. Trotti said that there are few standards for how to report data
consistently between trials, which makes comparing toxicity of different
trials difficult.


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