Efficacy and safety analysis of different treatment regimens in newly diagnosed acute promyelocytic leukemia.

Abstract

This retrospective study analyzed the clinical data of 151 newly diagnosed adult acute promyelocytic leukemia (APL) patients during induction therapy at Qilu Hospital of Shandong University to compare the efficacy and complications of different treatment regimens in low-to-intermediate-risk (WBC < 10 × 10⁹/L) and high-risk (WBC ≥ 10 × 10⁹/L) patients. Low-to-intermediate-risk patients were divided into three groups: ATRA + ATO dual induction (n = 18), ATRA + ATO + single-agent chemotherapy (n = 63), and ATRA + ATO + dual-agent chemotherapy (n = 18). High-risk patients were divided into two groups: ATRA + chemotherapy (n = 11) and ATRA + ATO + chemotherapy (n = 41). Results showed no significant differences in early mortality (0% vs. 3.17% vs. 5.56%), complete remission rates (94.44% vs. 96.83%), or molecular remission rates (94.44% vs. 100%) among low-to-intermediate-risk groups (P > 0.05). However, the dual induction group demonstrated superior relapse-free survival (100% vs. 93.65% vs. 88.89%) and lower rates of infection (66.67%) and hepatic dysfunction (22.22%), whereas the dual-agent chemotherapy group exhibited the highest infection (100%) and liver injury rates (61.11%) (P < 0.05). In high-risk patients, the ATRA + ATO + chemotherapy group showed significantly lower relapse rates (4.88% vs. 27.27%, P = 0.025) and higher overall survival (87.80% vs. 81.81%) compared to the ATRA + chemotherapy group. Complications analysis revealed myelosuppression (78.81%) and infections (83.44%) as the most common adverse events in low-to-intermediate-risk patients, with infections reaching 95.12% in high-risk patients. The dual induction group had a higher incidence of differentiation syndrome (5.56%) but lower risks of severe bleeding and DIC. For low-to-intermediate-risk APL patients during induction therapy, ATRA + ATO dual induction reduces relapse and hepatic toxicity but requires vigilance for differentiation syndrome. High-risk patients benefit from ATRA + ATO combined with chemotherapy to improve survival. Treatment should be individualized to balance efficacy and complications, with supportive care critical for mitigating infections and bleeding. This study provides clinical evidence for optimizing APL regimens in the chemotherapy-free era.