Retrospective analysis of sorafenib combined with interferon α-1b, interleukin-2, and thalidomide as maintenance therapy in FLT3-ITD-positive acute myeloid leukemia.

OBJECTIVE

To evaluate the clinical efficacy of maintenance therapy with sorafenib combined with interferon α-1b, interleukin-2, and thalidomide (the ITI regimen) in patients with FLT3-ITD-positive acute myeloid leukemia (AML).

METHODS

19 FLT3-ITD(+) AML patients were retrospectively analyzed, who received the sorafenib combined with ITI regimen as maintenance therapy after achieving remission at Affiliated Cancer Hospital of Zhengzhou University (January 2014-December 2024). Minimal residual disease (MRD) levels were monitored, and clinical outcomes, including survival duration, were assessed.

RESULTS

This study included 19 patients (9 males, 10 females) with a median age at diagnosis of 59 years (range: 21-76). The median white blood cell count was 32.25×109/L (range: 0.7-254×109/L). Among them, 13 patients (68.4%) maintained sustained MRD negativity during sorafenib combined with TI regimen therapy, while 3 patients experienced morphological relapse and 3 had molecular relapse. Median overall survival (mOS) was not reached, with 12- and 24-month OS rates of 100% (19/19) and 94.7% (18/19), respectively. During maintenance therapy with sorafenib combined with ITI, median relapse-free survival (mRFS) was also not reached, with 12- and 24-month RFS rates of 73.7% (14/19) and 57.9% (11/19), respectively.

CONCLUSION

The sorafenib combined with ITI regimen is an effective maintenance therapy for FLT3-ITD (+) AML, significantly reducing relapse risk and prolonging survival.