Late effects toxicity scoring: the SOMA scale

The two large organizations that initiate and coordinate multicenter clinical trials in Europe and in North America, the EORTC and the RTOG, have recently formed specific subcommittees or working groups to update their systems for assessing the late injury to normal tissues. This is regarded as necessary in order to standardize and improve the recording so that there can be uniform reporting of toxicity, at agreed and regular intervals in different clinical studies. Many centres have devised their own scales for recording such injury, some of which record all the raw data as it is derived from the patient, while others give a single score on a scale of l-5 to indicate the severity of the overall response. With such a variability in detailed recording of the information on morbidity it is difficult, or even impossible, to compare the outcome of different clinical studies, separated either geographically or chronologically, and indeed there is even a risk of drift within a study in the long period from initiation through to its completion, In the European cooperative studies there is the further need to ensure that the recording of data is uniform against a background of many different languages being used in the consultation between the doctor and the patient By autumn 1993, the EORTC and RTOG working groups had each reached a quite advanced stage in their own organizations towards rationalizing the scoring of late injury. It was then recognized that there would be a great advantage if these two organizations could agree on a common scale, to enable direct comparison of the benefits emerging from the different therapeutic approaches that are being investigated by them.