Abstract
<h3>Objective:</h3> The primary objective is overall response rate (CR/CRi). <h3>Design:</h3> This is a single-institution, single-arm, phase II study of pre-treatment with azacytidine followed by FLAG for the treatment of relapsed or refractory AML. <h3>Setting:</h3> Salvage therapy in relapsed/refractory AML. <h3>Patients or Other Participants:</h3> Patients with relapsed or refractory AML, ECOG performance status ≤2, and patients with preserved organ function. Exclusion criteria: Patients with a diagnosis of acute promyelocytic leukemia (AML-M3), pregnant women, patients previously treated with fludarabine, and patients with uncontrolled intercurrent illness. Twenty-one patients were enrolled, and all were evaluable for toxicity and response. The median number of prior treatments was 1 (range: 1–3). Nine patients (43%) were refractory to the most recent treatment, while most other patients relapsed less than 6 months from the last treatment before enrollment. <h3>Interventions:</h3> Azacytidine was given at 75 mg/m<sup>2</sup> per day for 5 days prior to the standard FLAG therapy. <h3>Main Outcomes Measures:</h3> Primary study endpoints were safety and ORR [ORR = CR, CRi, PR, morphologic leukemia-free state (MLFS) according to the International Working Group criteria], overall survival, and relapse-free survival. <h3>Results:</h3> Bone marrow suppression was the most common adverse event and was observed in all patients. The 30-day mortality was noted in 2 patients (10%), related to infection/septic shock with multi-organ failure. The combination was tolerated, and toxicities were as expected for patients receiving salvage intensive chemotherapy. The CR/CR with incomplete blood count recovery (CRi) rate was 53%. Of the 9 primary refractory patients, 5 (56%) achieved CR/CRi. Eight of 11 patients who achieved CR/CRi also attained minimal residual disease-negative status (≤1.0% by flow cytometry), and 8 patients (73%) went for stem cell transplant. Of the 11 patients who achieved CR/CRi, 5 were still alive on the last follow-up. The overall survival for the entire cohort was 4.1 months, and relapse-free survival was 4.7 months. <h3>Conclusions:</h3> AZA FLAG combination is safe and does not seem to have an added benefit in response rate or survival.
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