[Antineoplastic effectiveness and toxicity of idarubicin (4-demethoxy-daunorubicin) in recurrent acute leukemias in childhood].
11 patients with refractory acute leukemia of childhood were treated with idarubicin per os. Bone marrow toxicity which was observed at a dose level of 60 mg/m2 p.o. (3 x 20 mg q 24 hrs p.o.) per 3 weeks was found to be the dose limiting factor. In contrast to the first phase I study of Tan et al. (16) the maximal tolerated dose in the present study was found to be lower at a level of 90 mg/m2 p.o. (3 x 30 mg/m2 p.o. q 24 hrs) per 3 weeks. Therefore, we recommend a dosage of 60 mg/m2 p.o. (3 x 20 mg/m2 p.o. q 24 hrs) per 3 weeks as a starting dose for phase II/III studies. 2 out of the 11 anthracycline pretreated patients (91-880 mg/m2) with acute leukemia reached a complete remission undergoing idarubicin p.o. as a single therapy.
Erttmann
R
R
Universitäts-Kinderklinik Hamburg.
Bode
U
U
Erb
N
N
Forcadell de Dios
P
P
Gutjahr
P
P
Haas
R
R
Kuhn
N
N
Siewert
H
H
Landbeck
G
G
D000293:Adolescent; D000903:Antibiotics, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use*; D001853:Bone Marrow / Q000187:drug effects; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D015255:Idarubicin / Q000009:adverse effects / Q000627:therapeutic use*; D007945:Leukemia, Lymphoid / Q000188:drug therapy*; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy*; D007958:Leukocyte Count / Q000187:drug effects; D008297:Male; D012074:Remission Induction
D000903:Antibiotics, Antineoplastic; D015255:Idarubicin
Antineoplastische Wirksamkeit und Toxizität von Idarubicin (4-Demethoxydaunorubicin) bei rezidivierten akuten Leukämien des Kindesalters.