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In a recent issue of Haematologica, Farhad Ravandi, University of Texas MD Anderson Cancer Center, Houston, TX, USA, and colleagues, published the results of a subgroup analysis of the randomized phase III VALOR study (NCT01191801). This study evaluated the safety and efficacy of vosaroxin, a first-in-class anticancer quinolone derivative that intercalates DNA and inhibits topoisomerase II, plus cytarabine (vos/cyt) versus placebo plus cytarabine (pla/cyt), for the treatment of patients ≥ 60 years of age with refractory/early relapsed (Ref/eRel) acute myeloid leukemia (AML).
Vosaroxin (90 mg/m2 cycle 1 [70 mg/m2 subsequent cycles]) was administered in 361 patients by short intravenous infusion on days 1 and 4, in combination with cytarabine (1 g/m2 IV over 2 hours on days 1–5). In the control arm, placebo plus cytarabine was administered. A median of one treatment cycle was administered (range, 1–4) in both cohorts. Median age was 68 years (range, 60–78).
The authors concluded that “this analysis demonstrated that vos/cyt produced clinically meaningful improvements in response and survival compared with pla/cyt in patients ≥ 60 years old with Ref/eRel AML, without increasing early mortality. The AE profile of vos/cyt in older patients was consistent with the AE profile of the overall VALOR population reported previously. Rates of SAEs were higher in the vos/cyt arm compared with the pla/cyt arm, though this would be expected with the addition of a second cytotoxic agent and has been observed in other trials of cytarabine combination regimens compared to cytarabine alone.”
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