Azacitidine In Compassionate Use: Response to Therapy, Survival, and Prognostic Factors In 200 Patients Diagnosed with MDS or AML

• Published in: Blood 2010-11, Vol.116 (21), p.2933-2933
• Main Authors: García, Regina, de Miguel LLorente, Dunia, Bargay, Joan, Bernal, Teresa, González Porras, Jose Ramón, Tormo, Mar, Ramos, Fernando, Lapiedra, Andreu, Falantes, Jose, Xicoy, Blanca, Sanz, Guillermo F, Nomdedeu, Benet, Brunet, Salut, Sánchez, Joaquín
• Format: Article
• Language: English
• ISSN: 0006-4971; 1528-0020
• DOI: 10.1182/blood.V116.21.2933.2933

Abstract 2933 Survival analysis need of large period of time for getting results. Survival subrogates variables provide with earlier data for clinical decisions. The current treatment paradigm is nowadays how the quality of the different treatment responses impact in patient's survival with the new treatment options. Azacitidine (AZA) is a hypomethilating agent which was available for clinical trials or compassionate use in Spain before receiving it marketing authorization in May 2009. We present the final analysis from those patients diagnosed with mielodysplastic syndromes (MDS) or acute myeloid leukemia (AML) selected from a longitudinal, multicenter Spanish patient registry. This analysis retrospectively gathers clinical data about the treatment, disease progression and survival of patients with MDS or AML who had received AZA 75mg/m2 in compassionate use conditions, with a dosage regimen documented. Three different dosage regimens at the beginning of each 28-day cycle were used; group A: days 1–5 (M-F)/group B: days 1–5, 8–9 (M-F, M-Tu)/group C: days 1–7 (M-Su). Survival analysis was stratified by patients' basal conditions, dosage schedule and best response after 4th and 6th cycles. Data were collected from 200 patients with MDS or AML according to the WHO diagnostic criteria. Basal data, effectiveness results and data from haematological tolerance are mainly summarized in table 1. Median survival time was 706 days (95% CI 588–1093) in those patients who achieved a response versus 225 days (95% CI 156–319) in those who did not. Survival analysis showed differences based on the best response achieved (p