Real-world effectiveness of mitoxantrone hydrochloride liposome containing regimens in acute myeloid leukemia.
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BACKGROUND: Mitoxantrone hydrochloride liposome (Lipo-MIT) exhibits encouraging efficacy in treating multiple hematologic malignancies. This study evaluated the real-world efficacy and safety of Lipo-MIT-containing regimens in the treatment of acute myeloid leukemia (AML). METHODS: This noninterventional, ambispective cohort study was conducted at 42 centers in China. Patients with newly diagnosed or relapsed/refractory AML who received Lipo-MIT-containing regimens were included. The primary endpoint was the composite complete remission (CRc) rate. RESULTS: Between January 2022 and December 2023, 117 patients with newly diagnosed AML and 122 patients with relapsed/refractory AML were included. The CRc and objective response rates were 84.6% (95% confidence interval [CI], 76.8-90.6) and 91.5% (95% CI, 84.8-95.8), respectively, in the newly diagnosed AML, and 45.1% (95% CI, 36.1-54.3) and 55.7% (95% CI, 46.5-64.7), respectively, in relapsed/refractory AML. The 2-year-event-free survival and overall survival rates for newly diagnosed AML were 67.0% (95% CI, 54.4-76.8) and 77.8% (95% CI, 63.8-86.9), respectively, while the rates for relapsed/refractory AML were 23.9% (95% CI, 12.5-37.3) and 56.9% (95% CI, 39.6-70.9), respectively. Univariate and multivariate analyses suggested age and the number of prior failed induction therapy cycles as independent prognostic factors for CRc in relapsed/refractory AML (all P < .05). Treatment-related adverse events (AEs) were reported in 216 patients (90.4%). Thrombocytopenia (64.4%), leukopenia (63.6%), and neutropenia (60.7%) were the most common AEs of grade 3-4. No treatment-related deaths occurred. CONCLUSIONS: Lipo-MIT-containing regimens were effective and well-tolerated in AML under real-world circumstances. TRIAL REGISTRATION ID: ChiCTR2200067172.