Efficacy and safety of sorafenib combined with Standard Chemotherapy in adult patients with Myeloid sarcoma: A multi-center, cohort study
Abstract
Background Currently, treatment for myeloid sarcoma (MS) primarily follows protocols of AML including standard chemotherapy and hematopoietic stem cell transplantation (HSCT), while most patients have a poor outcome. Sorafenib, a multitargeted tyrosine kinase inhibitor (TKI), has demonstrated promising antileukaemic activity in AML. We previously showed sorafenib combined with conventional therapies is effective and safe for refractory central nervous system leukemia (CNSL). Therefore, this study aims to evaluate the efficacy and safety of sorafenib combined with standard chemotherapy in adult patients diagnosed with MS.Methods In this multicenter, cohort study, the study population came from our three randomized controlled trial (NCT05404516, NCT02474290 and NCT03620955). Patients who met the following criteria were enrolled: (a) aged 18–65 years; (b) diagnosed with MS; (c) Eastern Cooperative Oncology Group Performance Status: 0-2. Patients were excluded from the study if they met any of the following criteria: (a) diagnosed with acute promyelocytic leukemia; (b) presence of significant uncontrolled or active cardiovascular, pulmonary, hepatic, or nephrotic disease. Patients who received standard chemotherapy were allocated to the control group, and those who received sorafenib combined with standard chemotherapy were allocated to the sorafenib group. For control group, patients received one cycle of induction therapy with idarubicin (12 mg/m² on days 1-3) plus cytarabine…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 71 participants or records.
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