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.
