Ergebnisse der Studie BFM 76/79 zur Behandlung der akuten lymphoblastischen Leukämie bei Kindern und Jugendlichen

Abstract Between October, 1976, and March, 1979, 158 children and adolescents were treated for acute lymphoblastic leukemia in 9 pediatric oncology centers of the Federal Republic of Germany and West-Berlin. The goal was to determine, whether prognosis could be markedly improved for patients with high risk for relapse factors at diagnosis by adaptation of therapy. The results were compared with those of a historical control group (study BFM 70/76). The risk for relapse was estimated by a risk index (RI) based upon findings at diagnosis (high risk: RI > = 3). Induction therapy consisted of an 8 week multidrug regimen (Protocol I). In patients with RI < 3 (limb A), Protocol I was followed by maintenance therapy with oral 6-mercaptopurine and methotrexate as well as prednisone/vincristine reinduction pulses up to a total duration of 2 years after diagnosis. Patients with RI > = 3 were randomly allocated to receive a 6 week reinforced reinduction therapy (Protocol II) either 4 or 20 weeks after completion of Protocol I (limbs B1 and B2). Maintenance therapy consisted of the same drugs as in limb A and was discontinued after a total duration of 2 œ years after diagnosis. The life-table analysis after 51 months showed a 70% disease free survival for the total group of patients. Compared with the control group, therapeutic results were identical for patients with RI < 3, whereas prognosis was improved by 30% for patients with RI > = 3 with no demonstrable difference when compared with patients of limb A. There was also no difference between limbs B1 and B2. Cox Regression revealed the initial peripheral blast cell count to be a predictor of poor outcome only in the historical control group. In contrast, liver and spleen enlargement at diagnosis were prognostic in both studies. Age > 10 years did significantly influence prognosis of patients in study BFM 76/79. Undoubtedly, the results for high-risk patients were markedly improved by intensification of therapy.