Abnormalities 16q(22) and t(8;21) were considered favorable risk abnormalities, independent of whether other abnormalities were present or not.
Those with a normal karyotype or with –Y only were classified as intermediate risk.
Drug delivery was performed by each local center using locally developed patient friendly forms.
Details of the treatment and results of those pts receiving high-dose chemotherapy (BCNU (N, N-bis[2-chloroethyl]-N-nitrosourea), amsacrine, VP-16 and cytosine arabinoside (BAVC) conditioning regimen) with auto-PBSC support were presented in part elsewhere.
In view of the high relapse rate in older AML adults, we explored a non-infusional post-remission therapy.
Non-infusional treatment might enable treatment on an outpatient basis.
Prior treatment for secondary myelodysplasia with cytarabine (doses ) administered more than 6 weeks before registration was allowed.
Eligibility for second randomization included: first CR (CR1) after induction; WHO performance status of 0–2; absence of severe cardiac, pulmonary, neurologic and metabolic disease; adequate liver and renal function tests; absence of active infection; and HIV negativity.
It appeared that the CR rate was significantly higher in pts who received G-CSF during chemotherapy (58 vs 49%; P=0.009), whereas in terms of overall survival (OS) and DFS, no significant differences were observed between the various groups.
Pts received 1 or 2 remission–induction cycles of an i.v.
MICE regimen (mitoxantrone 7 mg/m) was supplied by Pfizer bv, Rivium Westlaan 142, LD Capelle a/d IJssel, The Netherlands.
Each patient signed an informed consent before randomization.
Pts 61–80 years of age with previously untreated de novo or secondary AML were randomized into four induction arms consisting of mitoxantrone, cytarabine and etoposide (MICE) given either alone or in combination with different schedules of G-CSF administration (Figure 1).