A scoring system to predict life-threatening thromboischemic events in patients with acute promyelocytic leukemia: the PETHEMA/PALG study.
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Rodríguez-Veiga Rebeca, Gil Cristina, Sobas Marta, Torres-Miñana Laura, Botella Carmen, De la Serna Javier, Bernal Teresa, Salamero Olga, Otero Cristina, Navarro-Vicente Irene, De Miguel Carlos, Garrido Ana, Vives Susana, Bergua Juan, Pérez-Encinas Manuel, Algarra Lorenzo, González-Campos José, Gómez Maria Del Mar Caballero, Prates Maria Virginia, Benavente Celina, Tormo Mar, Cervera Marta, Fazio Patricia, Amutio Maria Elena, García Raimundo, Pomares Helena, Vidriales Belén, Serrano Josefina, Amigo Mª Luz, Rubio Vicente, Almela Ágata, Barrios Manuel, Sossa-Melo Claudia Lucia, Paluszewska Monika, Novo Andrés, Gromek Tomasz, Rodríguez-Macías Gabriela, Oleksiuk Jolanta, Lloret-Madrid Pilar, Montesinos Pau
Аннотация
Acute promyelocytic leukemia (APL) is a highly curable leukemia characterized by life-threatening coagulopathy leading to hemorrhagic and thrombo-ischemic events. We analyzed the incidence, outcomes and risk factors of thrombo-ischemic events in a large series of 1,210 patients with newly diagnosed APL reported to the PETHEMA registry. Therapy consisted of ATRA and chemotherapy (AIDA-based). Median age of patients was 46 years (range 2-90 years). Fifty-eight patients (5%) did not start the AIDA regimen either because they were unfit for chemotherapy, or because of early death before initiating ATRA. A total of 195 (16%) patients developed thrombo-ischemic events, the most frequent being superficial-vein and/or central catheter-related (6.9%) followed by central nervous system (2.2%), deep-vein thrombosis (2.1%), pulmonary embolism (2.1%), acute myocardial infarction (1.6%), or other locations (1.2%). Thrombo-ischemic events mostly occurred at diagnosis and during induction (4.0% and 9.3%, respectively). Patients developing life-threatening thrombo-ischemic events (i.e., excluding superficial and/or catheter-related) at diagnosis / induction had a 31% early death rate. Prolonged activated partial thromboplastin time (aPTT), age >40 years, ECOG performance status >1, platelets >25x109/L, and absence of bleeding at presentation were independent risk factors for life-threatening thrombo-ischemic events. Using these variables (1 point each), we developed and validated the Thromb-On risk score, identifying a high-risk group (3-5 points). The Thromb-On risk score was validated in a cohort of 585 patients treated since 2017 with arsenic trioxide plus all-trans retinoic acid (ATRA) (<10x109 leukocytes) or according to the AIDA protocol (≥10x109 leukocytes). This study could help to improve prevention and management of life-threatening thrombo-ischemic events through risk-adapted guidance, potentially leading to a decrease in early mortality in APL.