Efficacy and safety of flumatinib as frontline treatment in elderly patients with newly diagnosed chronic myeloid leukemia in real-world

Objective To investigate efficacy and safety of flumatinib as frontline treatment in elderly patients with newly diagnosed chronic myeloid leukemia in real-world，providing a basis for clinical medication. Methods A total of 48 elderly patients with newly diagnosed chronic myeloid leukemia admitted to Affiliated Hospital of Anhui University of Science and Technology from June 2020 to June 2024 were selected as the study subjects，with the age of（72.61±5.03）years. Among them，44 cases（91.67%）had non-hematological comorbidities. All patients received oral flumatinib at a dose of 600 mg once daily. Hematological，cytogenetic and molecular responses（MR），as well as safety indicators，were collected at 3，6，12，and 18 months after treatment. Follow-up was conducted until September 30，2024，and event - free survival（EFS）and overall survival（OS）rates were calculated. Results At 3 months of treatrnent，95.83%（46/48）of patients reached complete hematologic response（CHR）and 100%（43/43）reached CHR at 6 months. The early molecular response（EMR）rates were 82.61%（38/46），92.86%（39/42）and 100%（34/34），respectively at 3，6 and 12 months .The major molecular response（MMR）rates were 21.74%（10/46），54.76%（23/42），73.53%（25/34）and 82.76%（24/29），respectively at 3，6，12，and 18 months. The MR4.0 rates at 3，6，12 and 18 months were 6.52%（3/46），19.05%（8/42），38.24%（13/34）and 48.28%（14/29），respectively. The MR4.5 rates were 0，14.29%（6/42），35.29%（12/34）and 34.48%（10/29）at 3，6，12 and 18 months. The deep MR（DMR）rate was 48.28%（14/29）at 18 months. All patients were started at the standard dose，and by the end of follow - up 40 patients（83.33%）maintained the standard dose flumatinib（600 mg/d）. The median follow-up duration was（20.89±10.98）months，with a 3-year EFS rate of 78.9% and an OS rate of 94.5%. Hematological adverse reactions were thrombocytopenia in 6 cases（12.50%），anemia in 5 cases（10.42%）and leukopenia in 4 cases（8.33%）. Non-hematologic adversereactions were diarrhea in 8 cases（16.67%），rash in 5 cases（10.42%），abdominal distension in 4 cases（8.33%），liver function damage in 4 cases（8.33%），renal impairment in 3 cases（6.25%），and hyperbilirubinemia in 2 cases（4.17%）. Conclusion In the real-world，flumatinib as first-line treatment of elderly CML patients improves EMR，predicting DMR and the possibility of obtaining treatment-free remission，with a good safety profile.