A scoring system to predict life-threatening thromboischemic events in patients with acute promyelocytic leukemia: the PETHEMA/PALG study

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 thromboischemic events in a large series of 1210 patients with newly diagnosed APL reported to the PETHEMA registry. Therapy consisted on ATRA and chemotherapy (AIDA-based). Median age of patients was 46 years (range 2-90 years). Fifty-eight patients (5%) did not start AIDA regimen as they were unfit for chemotherapy, or they died early 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%). Thromboischemic 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 31% early death rate. Prolonged aPTT, age >40 years, ECOG more than 1, platelets > 25 x 109/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 to 5 points). The Thromb-On risk score was validated in a cohort of 585 patients treated since 2017 with arsenic trioxide plus ATRA (<10x109 leukocytes) or AIDA (≥10x109 leukocytes). This study could help to improve prevention and management of life-threatening thromboischemic events, through risk-adapted guidance, potentially leading to decrease early mortality in APL.

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Journal
Haematologica
Published
2025-11-13
DOI
https://doi.org/10.3324/haematol.2025.288112
Primary Topic
Retinoids in leukemia and cellular processes
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article
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article

A scoring system to predict life-threatening thromboischemic events in patients with acute promyelocytic leukemia: the PETHEMA/PALG study

M. Gómez, Pau Montesinos, Gabriela Rodríguez‐Macías, Olga Salamero et al.
Haematologica
Retinoids in leukemia and cellular processes
article

A scoring system to predict life-threatening thromboischemic events in patients with acute promyelocytic leukemia: the PETHEMA/PALG study

M. Gómez, Pau Montesinos, Gabriela Rodríguez‐Macías, Olga Salamero, Rebeca Rodríguez‐Veiga, Monika Paluszewska, Mar Tormo, Jolanta Oleksiuk, Andrés Novo, Marta Cervera, Laura Torres-Miñana, M. E. Amutio, Manuel Pérez‐Encinas, Lorenzo Algarra, Marta Sobas, P Di Fazio, Helena Pomares, José González Campos, Cristina Otero, Cristina Gil, Pilar Lloret Madrid, Ana Garrido, Juan Bergua, Claudia Sossa, María‐Belén Vídriales, Tomasz Gromek, Teresa Bernal, Ma Luz Amigo, Vicente Rubio, Javier de la Serna, Carmen Botella, Irene Navarro-Vicente, Susana Vives, Ágata Almela, Carlos de Miguel, Manuel Barrios, Josefina Serrano, Celina Benavente, María Virginia Prates, Raimundo García
article en

Abstract

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 thromboischemic events in a large series of 1210 patients with newly diagnosed APL reported to the PETHEMA registry. Therapy consisted on ATRA and chemotherapy (AIDA-based). Median age of patients was 46 years (range 2-90 years). Fifty-eight patients (5%) did not start AIDA regimen as they were unfit for chemotherapy, or they died early 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%). Thromboischemic 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 31% early death rate. Prolonged aPTT, age >40 years, ECOG more than 1, platelets > 25 x 109/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 to 5 points). The Thromb-On risk score was validated in a cohort of 585 patients treated since 2017 with arsenic trioxide plus ATRA (<10x109 leukocytes) or AIDA (≥10x109 leukocytes). This study could help to improve prevention and management of life-threatening thromboischemic events, through risk-adapted guidance, potentially leading to decrease early mortality in APL.

Haematologica
Medical University of Lublin (PL), Hebron University (PS), Medical University of Białystok (PL), Universidad Autónoma de Bucaramanga (CO), National University of General San Martín (AR), Medical University of Warsaw (PL), Hospital Universitario Insular de Gran Canaria (ES), Hospital de Sant Pau (ES), Hospital Maciel (UY), Hospital General Universitario Gregorio Marañón (ES), Hospital Clínico San Carlos (ES), Hospital Universitari i Politècnic La Fe (ES), Wroclaw Medical University (PL), Hospital General Universitario Morales Meseguer (ES), Complejo Hospitalario Universitario de Santiago (ES), Hospital Universitario 12 De Octubre (ES), Hospital Universitario Puerta de Hierro Majadahonda (ES), Institut Català d'Oncologia (ES), Hospital Regional Universitario de Málaga (ES), Hospital San Pedro de Alcántara (ES), Hospital Italiano La Plata (AR), Hospital Universitario Reina Sofía (ES), Hospital General Universitari de Castelló (ES), Instituto de Biomedicina de Sevilla (ES), Hospital de Cruces (ES), Hospital General Universitario de Alicante Doctor Balmis (ES), Centro de Investigación del Cáncer (ES), Hospital General Universitario de Albacete (ES), Hospital Universitari Joan XXIII de Tarragona (ES), Hospital Universitario Son Espases (ES), Hospital Universitario Virgen del Rocío (ES), Hospital Universitari Germans Trias i Pujol (ES), Hospital Jerez Puerta del Sur (ES), Hospital Universitario de León (ES), Instituto de Investigación Sanitaria del Principado de Asturias (ES)
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Retinoids in leukemia and cellular processes
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