Klin Onkol 2004; 17(2): 40-45.
Summary: Dosage of both methods of conservative antineoplastic therapy usually falters on/beyond the border of toxicity – therefore standardization of toxicity criteria/scoring is insistent. NCI in 1982 compiled The Common Toxicity Criteria (CTC) for chemotherapy and RTOG developed Acute Radiation Morbidity Scoring Criteria for radiation therapy. In 1993 RTOG, EORTC and NCI accepted The Late Effects of Normal Tissues (LENT) scoring system consisting of 4 key elements forming the scales and introducing by acronym „SOMA“ (S-Subjective, O-Objective, M-Medical Management, A-Analytic). The main difference from the previous morbidity scales is acceptance of patient’s attitude with regard to the „price of success“ (the cure of cancer) and the impact of morbidity on his quality of life (QoL). In 1997 NCI, RTOG, EORTC, representatives of pharmaceutical companies, and WHO revised and expanded the CTC and to merge systemic, radiation, and surgical criteria into one comprehensive and standardized system (CTC, version 2.0). Since October 1st. 2003 according to The Cancer Therapy Evaluation Program (CTEP) The Common Terminology Criteria for Adverse Events (CTCAE, version 3.0) have been valid for starting clinical trials. The effort for unambiquity and standarization of adverse events classification of multimodal anticancer treatment has to lead to the implementation and acceptance of The Consolidation of Standards for Reporting Trials (CONSORT) guidelines which have now been accepted by a large number of renowned medical journals. In regard towards a more prominent role of randomized controlled trials in parallel with the general trends in medicine (Evidence based medicine) the effort for methodological quality is fully warranted. Otherwise, the trial’s results are of little/no value or even misleading. It is also true for the extensive metaanalyses. It is a long but evidently right way to a higher reliability of treatment results evaluation.
