| Introduction:Treatment of relapsing, refractory and senile acute myeloid leukemia is a very difficult problem. For the cure of these diseases, an intensive therapy aimed to kill all leukemia cells is required, but this usually results in a high degree of myelosuppression and infectious complications . Granulocyte colony-stimulating factor (G-CSF) has been proved useful for the recovery of severe neutropenia after intensive chemotherapy. Additionally, G-CSF can be used for "priming". Priming here is defined as driving of quiescent leukemia cells into chemotherapy-sensitive proliferating stages, and therefore may increase their response to chemotherapy and improve treatment outcomes in patients with AML. Several investigators have attempted to use the growth factor before and/or during remission induction chemotherapy. The first such successful attempt was reported by Austrianinvestigators who observed 83% CR in 18 newly diagnosed AML, higher than that of their historical control group receiving no G-CSF. After that, Japanese investigators conducted a preliminary double-blind controlled study to assess whether G-CSF stimulates the growth of AML cells and increases the remission rate in 58 adult patients with relapsed or refractory AML. 50% of patients in the G-CSF group and 37% in the placebo group had CR. The rate was higher in the G-CSF group, although the difference was not statistically significant (p-0306). Based on these investigations, we used G-CSF priming regimen to treat refractory, relapsing and senile acute myeloid leukemia, and obtained a preferable clinical outcome.1. Objective:To evaluate the clinical outcome of G-CSF priming regimen in treatment of refractory, relapsing and senile aute myeloid leukemia.2. Materials and Methods: 2.1 Patients:16 patients, 10 men and 6 women ranged in age from 15 to 78 years (median 48), with refractory, relapsing or senile acute myeloid leukemia were entered to our study between March 2002 and January 2004. All patients were diagnosed with MIC (Morphologic, immunologic, cytogenetic) classification.The control group consists of 18 patients (12 men and 6 women,median age 48) with refractory, relapsing or senile acute myeloid leukemia treated in our hospital between 1999 and 2002. All of them were also diagnosed with MIC.2.2 Methods:All patients enrolled were treated with G-CSF priming regimen consisting of low-dose cytosine arabinoside (Ara-C 1 Omg.m-2.12h-1, subcutaneously, day 1-14), aclarubicin (Acla 5-7mg.m-2.d-1,continuous intravenous infusion, day 1-8; or 10-14mg.m-2.d-1, continuous intravenous infusion, day 1-4) or homoharringtonine (HHT lmg.m-2.d-1, continuous intravenous infusion, day 1-14), and concurrent use of granulocyte colony-stimulating factor (G-CSF 1 OOug.m-2.12h-1, subcutaneously, day 1-14). In the course of chemo, blood routine examinations were made every other day, and the G-CSF was suspended while WBC> 20xl0~9/L. Chemotherapy intermission was 14-21 days. If two courses were of no effect, then the investigation was terminated.Patients in the control group received intensive chemotherapy with medium /high dosed Ara-C (1 -3g.m-2.12h-1 x 3-5d), combined with mitoxantrone or DNR or vp-16.2.3 StatisticsEnumeration data was analyzed by Chi-square test. 3. Results:All patients accomplished the chemotherapy, with no treatment related death. 9 of 16 patients achieved complete remission , the CR rate was 56.25%, compared with 22.2% of the control group (X2 = 4.15, P < 0.05). However, the total effective rate ( 68.75%) was not statistically higher than the control group (44.4%) (X2=2.03, P>0.05).Therapy related mortality (0.0%) was apparently decreased in priming group than in control group (38.9%)(X2 = 7.84, P<0.01). 4.ConcIusions:Our study shows that the priming regimen is effective and safe to refractory, relapsing, secondary or senile acute myeloid leukemia. Further studies are necessary to evaluate the long-term effects of this new therapeutic concept in AML.
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