文摘
The open-label, prospective study aimed to evaluate the efficacy and safety for standard intensive chemotherapy compared with attenuated therapy in elderly patients with acute myeloid leukemia (AML). A total of 297 patients between 65 and 82?years were enrolled in the study. The 141 patients received standard-dose therapy (daunorubicin 45?mg/m2?×?3?days with cytarabine 100?mg/m2?×?7?days for induction therapy, while post-induction therapy consisted of high-dose cytarabine 1.5?g/m2?×?4?days), and the attenuated treatment (daunorubicin 30?mg/m2?×?3?days with cytarabine 75?mg/m2?×?7?days for induction therapy, while post-induction therapy consisted of attenuated high-dose Ara-C 1.0?g/m2?×?3?days) was administered to the remaining 156 patients, based on a random number assigned. Total 168 patients (56.6?%) achieved complete remission with an incomplete blood recovery (CR)/CRi. No significant differences were observed between the two treatments (P?=?0.60). Attenuated chemotherapy improved overall survival (OS) and progression-free survival (PFS) compared to standard-dose therapy; 5-year OS values for these two groups were 39 and 24?months, respectively (P?<?0.001), and the PFS values for these two groups were 35 versus 23?months (P?<?0.001). In addition, the attenuated treatment with a poor risk profile overcame the negative impact and yielded OS and PFS values similar to those of the standard-dose chemotherapy with a better-to-intermediate risk profile. Five-year OS values for these two groups were 28 versus 28?months (P?=?0.89), and the 5-year PFS values were 27 and 28?months, respectively (P?=?0.89). The most common adverse drug effect for chemotherapy was agranulocytosis (98.3?%). There was a significant difference in early mortality between the attenuated and standard-dose treatment groups (0.64?% vs. 7.1?%, respectively, P?<?0.01). Standard intensive chemotherapy is less effective and far more toxic than attenuated induction and post-induction regimen in elderly patients with AML.