[Therapy realization and complications in the BFM-83 therapy study of acute myelogenous leukemia]

Data on the realization of therapy are available for 159 out of 173 (92%) protocol patients included in the study AML-BFM-83. The induction therapy could be carried out according to protocol in almost 80% of patients, with a dose compliance (= actual dose/prescribed dose) of greater than or equal to 80% for all substances. During the second therapy phase (consolidation) considerable deviations from the recommended therapy occurred in all nonresponders and in 34% of the patients who had achieved remission. The maintenance therapy had to be reduced in one third of the patients, mainly due to thrombopenias. Lethal complications caused by therapy-induced toxicity, occurred in 7 out of 173 cases (4%), and followed severe infections (mycoses), or other complications such as cardiotoxicity. The proportion of severe complications decreased from the induction through the first to the second consolidation phase. They were rare during maintenance therapy, but markedly more frequent in nonresponders and in children with early relapse (within 12 months). In view of the small differences in dose compliance, it is difficult to determine the prognostic significance of the realization to therapy. With the application of the COX regression and special life table analyses the dose compliance decreases in significance after including the known initial prognostic factors.(ABSTRACT TRUNCATED AT 250 WORDS)