Azacitidine Vs. Decitabine in Unfit Newly Diagnosed Acute Myeloid Leukemia Patients: Results from the Pethema Registry

• Published in: Blood 2020-11, Vol.136 (Supplement 1), p.25-27
• Main Authors: Labrador, Jorge, Martínez-Cuadrón, David, de la Fuente, Adolfo, Rodríguez-Veiga, Rebeca, Serrano, Josefina, Tormo, Mar, Pérez-Simón, Jose Antonio, Ramos, Fernando, Bernal del Castillo, Teresa, López-Pavía, Maria, Trigo, Fernanda, Martinez Sanchez, Pilar, Rodriguez-Gutierrez, Juan Ignacio, Rodriguez, Carlos, Gil, Cristina, Garcia, Daniel, Vives, Susana, Foncillas, Maria Angeles, Perez Encinas, Manuel, Novo, Andrés, Recio, Isabel, Rodriguez-Macías, Gabriela, Bergua Burgues, Juan Miguel, Noriega Concepcion, Victor, Lavilla, Esperanza, Roldán Pérez, Alicia, Sanz, Miguel A., Montesinos, Pau
• Format: Article
• Language: English
• ISSN: 0006-4971; 1528-0020
• DOI: 10.1182/blood-2020-141213

Background: Options to treat elderly patients with newly diagnosed AML include intensive, attenuated chemotherapy, hypomethylating agents (HMA) and supportive care (SC). HMA have proven their efficacy in DACO-016 (NCT00260832) and AML-001 (NCT01074047) clinical trials, with a median overall survival (OS) of 7.7 months (95%CI, 6.2 to 9.2) with decitabine (DEC) vs. 5.0 months (95%CI, 4.3 to 6.3) with therapy choice (TC), considered SC or low-dose Ara-C (LDAC). Median OS was 10.4 months with azacitidine (AZA) (95%CI, 8.0 to 12.7) vs. 6.5 months (95%CI, 5.0 to 8.6) with conventional care regimens (CCR), considered standard induction chemotherapy, LDAC or SC. However, there are few direct comparative data of AZA and DEC in the context of trials or real-life settings. Aims: Here, we compared clinical outcomes between AZA and DEC in AML patients not eligible for intensive chemotherapy in the epidemiologic PETHEMA registry. Methods: We included newly diagnosed AML patients treated with AZA (75 mg/m2/d IV or SC days 1-7) or DEC (20 mg/m2/d IV days 1-5) that were not eligible for intensive chemotherapy. Responses were recorded using IWG 2003 criteria. Rates of Complete Response (CR), complete response with incomplete recovery (CRi) and OS were co-primary endpoints. Results: Between 2006 and 2019, 638 patients were included. 497 (78%) received AZA and 141 (22%) received DEC as per physician judgement. Baseline characteristics were comparable in both groups (Table 1), except for bone marrow blasts count ≥ 30%, which was more frequent in DEC group (59.2% vs 77.1%, p