Nice piece on SPA in HemeOnc Today, a widely circulated throwaway journal
Sapacitabine displays encouraging activity in elderly patients with AML
Kantarjian H. Lancet Oncol. 2012;doi:10.1016/S1470-2045(12)70436-9.
HemOnc Today, February 25, 2013
Sapacitabine appeared active and tolerable in elderly patients with acute myeloid leukemia, according to results of a randomized, phase 2 study.
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Hagop Kantarjian, MD, chair of the department of leukemia at The University of Texas MS Anderson Cancer Center, and colleagues recruited 105 elderly patients with acute myeloid leukemia (AML) who were previously untreated or at the point of their first relapse.
Using computer-generated randomization, the researchers assigned the patients to receive one of three schedules of oral sapacitabine: 200 mg twice a day for 1 week (group A), 300 mg twice a day for 1 week (group B) or 400 mg twice a day for 3 days each week over a 2-week period (group C). All schedules were administered in 28-day cycles. The primary endpoint was 1-year OS, analyzed by intent-to-treat in those patients who were assigned to treatment.
In all, 60 patients were assigned to treatment. For those patients, 1-year OS was 35% (95% CI, 16-59) in group A, 10% (2-33) in group B and 30% (13-54) in group C. Within 30 days, 14 of the 105 patients enrolled died; 27 died within 60 days. Seven deaths were potentially linked to sapacitabine treatment.
The results indicated that 400-mg dose schedule had the superior efficacy profile in terms of 1-year OS and the number of patients who achieved a complete response.
The most common grade 3 to 4 adverse events were anemia, neutropenia, thrombocytopenia and pneumonia. The most common grade 5 adverse events were pneumonia and sepsis.
“Our findings suggest that sapacitabine shows encouraging activity in elderly patients with AML,” Kantarjian and colleagu