[Results of treatment of children with acute lymphatic leukemia (ALL) according to the ALL V protocol of the Netherlands Working Group on Leukemia in Children].
The Dutch Childhood Leukemia Study Group performed a phase III study (Study ALL V) to evaluate the effectiveness of addition of rubidomycin to induction treatment with vincristine, prednisone and L-asparaginase in children (0-15 years) with standard risk acute lymphoblastic leukemia: WBC less than 50.10(9)/l, absence of mediastinal mass and/or cerebromeningeal leukemia. Furthermore, the influence of some initial patient- en disease-characteristics on the outcome was analysed. Between May 1979 and December 1982 240 patients entered into the study and were randomized into 2 groups: group A (n = 122) received induction treatment with vincristine, prednisone and L-asparaginase; group B (n = 118) received induction treatment with vincristine, prednisone, L-asparaginase and rubidomycin. All patients received cranial irradiation (doses adjusted to age) and intrathecal methotrexate, followed by maintenance treatment with 6-mercaptopurine and methotrexate for 5 weeks, alternated with vincristine and prednisone for 2 weeks, up to 24 months. Complete remission rate was 94% in both groups. Event-free survival at 5 years after diagnosis was higher in group B (62% +/- 4.6%) than in group A (54.2% +/- 4.6%) but the difference was not significant. A higher initial WBC, age greater than or equal to 10 years and a positive acid phosphatase reaction of the leukemic cells were unfavorable prognostic factors (p less than 0.01). Sex, FAB-morphology, immunophenotype and place of treatment (center or general hospital) were not significant factors.
van der Does-van den Berg
A
A
Stichting Nederlandse Werkgroep Leukemie bij Kinderen (SNWLK), Den Haag.
van Wering
E R
ER
Suciu
S
S
Solbu
G
G
Rammeloo
J A
JA
de Koning
J
J
van Zanen
G E
GE
D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001215:Asparaginase / Q000008:administration & dosage; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D003630:Daunorubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007223:Infant; D007945:Leukemia, Lymphoid / Q000188:drug therapy*; D008297:Male; D011241:Prednisone / Q000008:administration & dosage; D011897:Random Allocation; D014750:Vincristine / Q000008:administration & dosage
D014750:Vincristine; D001215:Asparaginase; D011241:Prednisone; D003630:Daunorubicin
Resultaten van behandeling van kinderen met acute lymfatische leukemie (ALL) volgens SNWLK protocol ALL V.