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Stage I of a phase 2 study assessing the efficacy, safety, and tolerability of barasertib (AZD1152) versus low‐dose cytosine arabinoside in elderly patients with acute myeloid leukemia

2013; Wiley; Volume: 119; Issue: 14 Linguagem: Inglês

10.1002/cncr.28113

1097-0142

Hagop M. Kantarjian, Giovanni Martinelli, Elias Jabbour, Alfonso Quintás‐Cardama, Kiyoshi Ando, Jacques‐Olivier Bay, Andrew H. Wei, Stefanie Gröpper, Cristina Papayannidis, Kate Owen, Laura A. Pike, Nicola Schmitt, Paul K. Stockman, Aristoteles Giagounidis,

Multiple Myeloma Research and Treatments

In this phase 2 study, the authors evaluated the efficacy, safety, and tolerability of the Aurora B kinase inhibitor barasertib compared with low-dose cytosine arabinoside (LDAC) in patients aged ≥ 60 years with acute myeloid leukemia (AML).Patients were randomized 2:1 to receive either open-label barasertib 1200 mg (as a 7-day intravenous infusion) or LDAC 20 mg (subcutaneously twice daily for 10 days) in 28-day cycles. The primary endpoint was the objective complete response rate (OCRR) (complete responses [CR] plus confirmed CRs with incomplete recovery of neutrophils or platelets [CRi] according to Cheson criteria [also requiring reconfirmation of CRi ≥21 days after the first appearance and associated with partial recovery of platelets and neutrophils]). Secondary endpoints included overall survival (OS) and safety.In total, 74 patients (barasertib, n = 48; LDAC, n = 26) completed ≥1 cycle of treatment. A significant improvement in the OCRR was observed with barasertib (35.4% vs 11.5%; difference, 23.9%; 95% confidence interval, 2.7%-39.9%; P < .05). Although the study was not formally sized to compare OS data, the median OS with barasertib was 8.2 months versus 4.5 months with LDAC (hazard ratio, 0.88; 95% confidence interval, 0.49-1.58; P = .663). Stomatitis and febrile neutropenia were the most common adverse events with barasertib versus LDAC (71% vs 15% and 67% vs 19%, respectively).Barasertib produced a significant improvement in the OCRR versus LDAC and had a more toxic but manageable safety profile, consistent with previous studies.