Preliminary Results of the Flugaza Trial: A Phase III Randomized, Open Label Study Comparing Azacytidine Versus Fludarabine and Cytarabine (FLUGA Scheme) in Elderly Patients with Newly Diagnosed Acute Myeloid Leukemia

• Published in: Blood 2016-12, Vol.128 (22), p.4036-4036
• Main Authors: Montesinos, Pau, Vives, Susana, Martinez-Sanchez, Maria P, Bergua, Juan, Algarra, Lorenzo, Pilar, Herrera, Tormo, Mar, Lopez-Lorenzo, Jose-Luis, Ramos, Fernando, Falantes, Jose Francisco, Salamero, Olga, Serrano, Josefina, Gil, Cristina, Amador, Maria L, Lavilla, Esperanza, Sayas, Maria J, Olave, Maria Teresa, Vidriales, Belen, Martínez-Cuadrón, David, Sanz, Miguel Ángel
• Format: Article
• Language: English
• ISSN: 0006-4971; 1528-0020
• DOI: 10.1182/blood.V128.22.4036.4036

Introduction: Current recommendations for the treatment of AML in newly diagnosed elderly patients (≥ 65 years) include different therapeutic options (intensive or semi-intensive chemotherapy, low-dose chemotherapy, hypomethylating agents, and supportive care). Regardless of the selected treatment, the results are disappointing because of low overall survival (OS) rates and significant toxicity. Objectives: The primary objective of FLUGAZA trial is to compare the 1-year-OS in 350 patients aged ≥ 65 years diagnosed with AML assigned to azacytidine (n=175) or FLUGA (n=175) arms. Here we present the results of a pre-planned interim safety analysis for both outpatient treatment regimens. Methods Inclusion criteria: Patients diagnosed with de novo or secondary AML according to WHO classification (except for APL), previously untreated, age ≥ 65 years, ECOG 25 x109/L. Concomitant use of hydroxyurea was allowed in the AZA arm if WBC was between 15 and 50 x109/L. In patients with more than 50 x109/L WBC assigned to the AZA arm, the first induction cycle was FLUGA. An interim analysis to assess myelotoxicity, early mortality and response rate was planned in the trial when the last of the first 100 randomized patients completed the first 3 induction cycles. Results: From October 2014 to April 2016, 162 patients were enrolled in 26 Spanish centers from the PETHEMA group. Of them, 22 patients were screen failure and 16 patients did not receive the assigned treatment. The first 100 patients treated were analyzed (58 patients were assigned to AZA arm and 42 to FLUGA arm). Baseline characteristics are shown in Table 1. Median age was 75 [65;90] years in AZA arm vs. 77 [65;88] years in FLUGA arm; 36 (62%) vs. 19 (45%) males. Five patients from AZA arm (n=58) received the first cycle of FLUGA because of WBC > 50 x109/L. Outcomes: overall response rate (CR+CRu+PR) based on the best response accumulated with 3 cycles of treatment was 62% in the AZA arm and 57% in the FLUGA arm. CR+CRu was achieved in 14