We conducted this phase Ⅱ trial to assess the efficacy and clinical cross-resistance of
the combination of mitoxantrone and etoposide in patients with refractory acute leukemia
to other induction chemotherapy.
The regimen were as follows; """"5-3"""" schedule consisted of mitoxantrone, 12mg/m²
/day, in a 1-hour infusion on day 1 to 3 and etoposide, 200mg/m²/day, in a 30-minute
infusion on day 1 to 5. """"5-5"""" schedule consisted of mitoxantrone, 10mg/m²/day, in a
1-hour infusion and etoposide, 100mg/m²/day, in a 30-minute infusion, both on day 1
to 5.
Between Jan. 1989 and April 1990, nineteen patients were entered and evaluable. Eight
were primarily resistant to other induction chemotherapy and eleven had first relapse.
Morphologic diognosis were seven ALL and twelve AML.
Four patients attained a complete remission(21%) with a median duration of 11.7
weeks (range 8-42 + weeks). The median survials were not significantly
different(P>0.05) ; 10.3 weeks for overall patients, 22 weeks for responders, and 9.9
weeks for non-responders.
The predictive factors associated with complete remission or survival were analized
for age, sex, morphologic diagnosis(ALL vs AML), salvage status(primary resistant vs
relapsed), duration of first complect remission, type of schedule, bone marrow cellularity,
percent blood blast plus promyelocyte, WBC count, alkaline phosphatase, bilirubin value.
No significant variables were demonstrated. (P>0.05)
Severe myelosuppression was observed in all patients, with a median time to complete
remission of 41.5 days. Five died of sepsis during granulocytopenic period. Nine suffered
from hepatotoxicity, including cholestatic jaundice in five. In conclusion, the mitoxantrone
and etoposide salvage chemotherapy showed some activity in patients with highly
reractory acute leukemia to other induction chemotherapy but serious toxicity was a
major problem.

Keywords: Mitoxantrone,Etoposide,Refractory Acute Leukemia