This study was aimed to investigate the efficacy of moderate intensity regimen, CHG (
homoharringtonine,
cytarabine and
granulocyte colony-stimulating factor (
G-CSF)) on the patients with high-risk MDS or MDS-transformed
acute myeloid leukemia. 30 newly diagnosed adult patients with high-risk MDS or MDS-transformed AML were enrolled in this clinical trial to evaluate the efficacy of sequential low-dose
homoharringtonine/
cytarabine chemotherapy combined with
G-CSF priming.
Homoharringtonine and
Ara-C were injected intravenously at doses of 1 mg and 25 mg daily for 14 consecutive days respectively,
G-CSF was injected subcutaneously once daily at a dose of 300 microg on 12 hours prior to
chemotherapy and continued given until the end of
chemotherapy or when the peripheral WBC count reached > 20 x 10(9)/L. This regimen was given only for one course, and followed by conventional
chemotherapy as maintenance or consolidation
therapy when CR achieved. 33 patients with high- risk MDS and MDS-transformed AML were injected
aclarubicin/
Ara-C intravenously at doses of 10 mg and 25 mg for 8 and 14 consecutive days respectively,
G-CSF was used at the same dose and the same way as the CHG regimen. 33 patients with high-risk MDS and MDS-transformed AML were treated with HHT/
Ara-C intravenously at doses of 2 - 3 mg and 100 - 150 mg daily for 7 consecutive days respectively,
G-CSF was injected when WBC count was below 4 x 10(9)/L, and it was stopped to be used when WBC count was > 4 x 10(9)/L. The results showed that (1) 14 patients achieved complete remission (CR) (46.67 %) and 7 patients achieved partial remission (PR) (23.33 %) with one course of CHG regimen, total effective rate was 70%; 14 patient achieved CR (42.4%) and 9 patients achieved PR (27.3%) with one course of
CAG regimen, total effective rate was 69.7%; 7 patient achieved CR (33.3%) and 3 patients achieved PR (9.1%) with one course of HA regimen, total effective rate was 42.4%. There was no statistical difference between the effective rate of CHG and CAG, but difference was significant between CHG and HA. (2)
Agranulocytosis (neutrophil < 0.5 x 10(9)/L) occurred in 12 cases (40%) of CHG-treated patients with a mean 8 days of agranulocytic period, so the infectious complications were less serious and tolerable without treatment-related death. (3) Among 14 out of 30 patients with CR, 9 relapsed, the mean duration from CR to replace was 8.2 months. All relapsed patients reusing CHG regimen did not achieved CR again. (4) Among 13 cases with
CR, 6 patients just received HA or DA regimens as consolidatory and intensive
chemotherapy after CR have relapsed, the mean CR time was only 6.1 months. Otherwise, the mean CR time of 7 CR patients received alternative succeeded
chemotherapy containing
mitoxantrone/
idarubicin/THP/
homoharringtonine/
daunorubicin/
aclarubicin after CR was 10.6 months; and among them 4 are still in continuous CR. It is concluded that the CHG
chemotherapy regimen has a similar effect with CAG but better than HA, and in a saft
chemotherapy regimen with slight myelosuppression in clinical application, strong and alternative succeeded
chemotherapy is necessary for CR patients to keep longer CR and survival.