All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional. If you are a patient or carer, please visit Know AML.
The aml Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the aml Hub cannot guarantee the accuracy of translated content. The aml and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.
The AML Hub is an independent medical education platform, sponsored by Astellas, Daiichi Sankyo, Johnson & Johnson, Kura Oncology and Syndax, and has been supported through educational grants from Bristol Myers Squibb and the Hippocrate Conference Institute, an association of the Servier Group. The funders are allowed no direct influence on our content. The levels of sponsorship listed are reflective of the amount of funding given. View funders.
Now you can support HCPs in making informed decisions for their patients
Your contribution helps us continuously deliver expertly curated content to HCPs worldwide. You will also have the opportunity to make a content suggestion for consideration and receive updates on the impact contributions are making to our content.
Find out more
Create an account and access these new features:
Bookmark content to read later
Select your specific areas of interest
View AML content recommended for you
Sorafenib in combination with azacitidine in older patients with FLT3-ITD mutated acute myeloid leukemia
Sorafenib in combination with azacitidine have been shown to be well tolerated and effective in older patients with relapsed/refractory FMS-like tyrosine kinase 3–internal tandem duplication (FLT3-ITD) acute myeloid leukemia (AML).1 Based on this, a group of researchers from the MD Anderson Cancer Center, Houston, Texas, investigated the safety and efficacy of sorafenib, a multi-kinase inhibitor with significant FMS–like tyrosine kinase 3 (FLT3) inhibitory activity, in combination with azacitidine in older patients who are unsuitable for standard chemotherapy with newly diagnosed FLT3-ITD mutated AML. The results of this study were published in the American Journal of Hematology in July 2018.2
In this study, 27 patients (median age = 74 years; range, 61–86) with newly diagnosed untreated AML who underwent frontline therapy in two separate clinical trials (NCT02196857 [phase II portion of a phase I/II study] and NCT01254890 [phase II study]) were included. Patients were treated with a regimen consisting of azacitidine (75 mg/m2 daily for 7 days) and sorafenib (400 mg twice daily). Patients underwent a median of three (range; 1–35) treatment cycles.
Key findings:
Efficacy
- Overall response rate: 78% (21/27)
- Complete response (CR): 26% (7/27)
- CR with incomplete recovery of peripheral blood counts (CRi)/CRp: 44% (12/27)
- Partial response: 7% (2/27)
- Median time to achieve response: 1.8 months (range, 0.62–4.96 months)
- Median duration of CR/CRp/CRi: 14.5 months (range, 11–28.7 months)
- Three responding patients (11%) proceeded to allogeneic stem cell transplantation
- Median follow-up time: 4.1 months (range, 3.0–17.3 months)
- Median overall survival (OS): 8.3 months (range, 1–63 months)
- Median OS in responders (n = 19) and non-responders (n = 8): 9.2 (range, 2 – 63) vs 2.8 (range, 1–9) months, respectively, P = 0.007
- Median relapse-free survival in all patients: 7.1 months (range, 1–29 months)
Safety
- The most common grade 1–2 adverse events (AEs) were hyperbilirubinemia (22%), diarrhea (22%), fatigue (22%), and nausea (19%)
- The most common grade 3–4 AEs were infections (26%) and neutropenic fever (26%)
- There were no early deaths recorded within 14 days of the study
In summary, findings of this study suggests that the combination of sorafenib and azacitidine is “well tolerated” and effective in older patients with newly diagnosed FLT3-ITD mutated AML. The authors noted that the results of this study were “encouraging”.
Key limitation of this study includes the small sample size. The researchers recommend larger studies that can examine fully the benefit of sorafenib plus azacitidine in elderly patients with AML.
References