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SORAML: Sorafenib demonstrates improved survival in AML
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SAN FRANCISCO — The addition of sorafenib was associated with improved EFS compared with placebo in a cohort of adult patients with acute myeloid leukemia, according to findings presented here.
Christopher Röllig, MD, of the University of Dresden in Germany, presented study results comparing sorafenib (Nexavar, Bayer HealthCare. Onyx Pharmaceuticals) with placebo as an add-on to standard induction and consolidation treatment in a cohort of 276 patients with AML. Eligible participants were aged ≤60 years.
Patients were accrued at 25 centers between March 2009 and October 2011.
Induction therapy consisted of daunorubicin 60 mg/m2 on days 3-5 plus cytarabine 100 mg/m2 continuously infused on days 1-7, followed by three cycles of high-dose cytarabine consolidation (3 g/m2 once a day on days 1, 3, 5). Patients who failed to respond after the initial induction were inducted with cytarabine 3 g/m2 once a day on days 1-3 plus mitoxantrone 10 mg/ m2 days 3-5. Patients were randomly assigned sorafenib at 800 mg/day or placebo in a double-blinded fashion, according to the results.
Intermediate-risk patients in first complete remission who met certain eligibility criteria were scheduled for allogeneic stem cell transplantation.
EFS served as the primary outcome measure. Events were defined as failure to reach complete remission after induction, relapse or death. Relapse-free survival, OS, complete relapse rate and incidence of adverse events served as secondary endpoints.
Sorafenib was associated with a 3-year EFS rate of 40%, compared with 22% for placebo, according to Röllig. The median EFS was 21 months for sorafenib and 9 months for placebo (P=.013).
For relapse-free survival, outcomes were 56% for the study drug and 38% for placebo. The median relapse-free survival was not reached for sorafenib, compared with 23 months in the placebo arm (P=.017).
Three-year OS results were 63% in the sorafenib group and 56% in the placebo group. The median OS endpoint was not reached in either arm (P=.382).
“Interestingly, at this point in time, we can see no clear OS benefit in patients treated with sorafenib,” Röllig said.
The study drug was associated with a higher risk of fever, diarrhea, bleeding events, liver toxicity, hand-foot syndrome and rash, according to Röllig.
However, he concluded that the findings are the first high level suggestion of the efficacy of sorafenib in younger patients with AML.
“These data constitute the first randomized evidence that kinase inhibitors work in AML,” he said. “According to the principles of evidence-based medicine, a confirmatory trial would be desirable.”
For more information:
Röllig C. Abstract #6. Presented at: ASH Annual Meeting and Exhibition; Dec. 6-9, 2014; San Francisco.
Disclosure: Röllig reports no relevant financial disclosures.
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David Steensma, MD
Sorafenib has been shown to block activity in acute myeloid cells. These results suggest that sorafenib appears to provide a lasting response when added to chemotherapy. This is the first study to add a tyrosine kinase inhibitor to conventional therapy for AML.
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