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Blood, 15 September 2000, Vol. 96, No. 6, pp. 2049-2054
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Immunosuppressive therapy using antithymocyte globulin,
cyclosporine, and danazol with or without human granulocyte
colony-stimulating factor in children with acquired aplastic
anemia
Seiji Kojima,
Shigeyoshi Hibi,
Yoshiyuki Kosaka,
Masuji Yamamoto,
Masahiro Tsuchida,
Hideo Mugishima,
Kanji Sugita,
Hiromasa Yabe,
Akira Ohara, and
Ichiro Tsukimoto for the
Japan Childhood Aplastic Anemia Study Group
From the Japan Childhood Aplastic Anemia Study Group (Nagoya,
Japan).
A prospective multicenter trial of 119 children 1 to 18 years
of age with newly diagnosed aplastic anemia (AA) was conducted, comparing treatment using antithymocyte globulin (ATG), cyclosporine (CyA), and danazol (DAN) with or without rhG-CSF (400 µg/m2, day on days 1-90). All children with very severe
AA received rhG-CSF (VSAA group, n = 50). The other children were
randomized to receive ATG, CyA, DAN, and rhG-CSF (G-CSF+ group,
n = 35) or ATG, CyA, and DAN without rhG-CSF (G-CSF group,
n = 34). After 6 months, the hematologic response rate was 71%,
55%, and 77% in the VSAA group, G-CSF+ group, and G-CSF group,
respectively. There was no difference in the incidence of febrile
episodes and documented infections between the G-CSF+ and G-CSF
groups. Bone marrow transplantation (BMT) was attempted in 22 patients
in whom initial immunosuppressive therapy (IST; n = 18) failed or in
whom a relapse occurred after an initial response (n = 4). Nineteen of the 22 patients are alive and well after a median follow-up of 18 months (range, 3 to 66 months) since BMT. The probability of survival
at 4 years was 83% ± 7% in the VSAA group, 91% ± 5% in the
G-CSF+ group, and 93% ± 6% in the G-CSF group. Myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) developed in one patient in
each of the three groups; the overall risk for MDS/AML was 3% ± 2%
at 4 years. Because the results of IST were encouraging, it is
suggested that children with AA receive IST as first-line therapy if there is no human leukocyte antigen-matched sibling donor.
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