Farhad Ravandi, MD, from the University of Texas MD Anderson Cancer Center in Houston, describes results from the phase III VALOR trial that explored vosaroxin plus cytarabine versus placebo and cytarabine in patients with first relapsed or refractory acute myeloid leukemia (AML).
The phase III study randomized 711 adult patients with AML to receive vosaroxin plus cytarabine (n = 356) or placebo plus cytarabine (n = 355). The primary endpoint of the study was overall survival (OS). Secondary endpoints included safety, complete remission (CR) rate, and tolerability.
The median OS was 7.5 months with vosaroxin compared with 6.1 months with placebo, Ravandi notes. This difference was not statistical significance (P
= .06). A preplanned censored analysis that accounted for specific stratification factors, such as transplantation, found a median OS with vosaroxin of 6.7 versus 5.3 months with placebo (P
The CR rate with vosaroxin was 30.1% versus 16.3% with placebo. The event-free survival and leukemia-free survival favored the vosaroxin arm, and the transplant rate was similar between the two arms of the study, Ravandi notes.
There was a higher incidence of toxicity in the vosaroxin arm, which could be expected with the addition of a second cytotoxic agent, Ravandi notes. Overall, toxicity was primarily related to myelosuppression, which included infection, cytopenia, and fever. The 30-day and 60-day mortality were similar between the two arms of the study, Ravandi said.
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