Cancers (Feb 2023)
Toxicity of Asciminib in Real Clinical Practice: Analysis of Side Effects and Cross-Toxicity with Tyrosine Kinase Inhibitors
- Lucía Pérez-Lamas,
- Alejandro Luna,
- Concepción Boque,
- Blanca Xicoy,
- Pilar Giraldo,
- Raúl Pérez López,
- Concepción Ruiz Nuño,
- Natalia De las Heras,
- Elvira Mora Casterá,
- Javier López Marín,
- Adrián Segura Díaz,
- Valle Gómez,
- Patricia Vélez Tenza,
- Magdalena Sierra Pacho,
- Juan Antonio Vera Goñi,
- Melania Moreno Vega,
- Alberto Alvarez-Larrán,
- Montse Cortés,
- Manuel Pérez Encinas,
- Patricia Carrascosa Mastell,
- Anna Angona,
- Ana Rosell,
- Sunil Lakhwani,
- Mercedes Colorado,
- Elena Ramila,
- Carlos Cervero,
- Beatriz Cuevas,
- Lucía Villalón Blanco,
- Raquel de Paz,
- Antonio Paz Coll,
- María José Fernández,
- Luis Felipe Casado,
- Juan Manuel Alonso-Domínguez,
- María Magdalena Anguita Arance,
- Araceli Salamanca Cuenca,
- Antonio Jiménez-Velasco,
- Santiago Osorio Prendes,
- Marta Santaliestra,
- María José Lis Chulvi,
- Juan Carlos Hernández-Boluda,
- Valentín García-Gutiérrez
Affiliations
- Lucía Pérez-Lamas
- Hospital Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS), 28034 Madrid, Spain
- Alejandro Luna
- Hospital Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS), 28034 Madrid, Spain
- Concepción Boque
- Hospital Duran i Reynals-ICO, 08908 Barcelona, Spain
- Blanca Xicoy
- Josep Carreras Leukaemia Research Institute, ICO-Hospital Germans Trias i Pujol, Universitat Autònoma de Barcelona, 08916 Badalona, Spain
- Pilar Giraldo
- Hospital Quirón Salud Zaragoza, 50006 Zaragoza, Spain
- Raúl Pérez López
- Hospital Virgen de la Arrixaca, 30120 Murcia, Spain
- Concepción Ruiz Nuño
- Hospital Regional Universitario de Málaga, 29010 Málaga, Spain
- Natalia De las Heras
- Hospital Universitario de León, 24071 León, Spain
- Elvira Mora Casterá
- Hospital Universitario y Politécnico La Fe, 46026 Valencia, Spain
- Javier López Marín
- Hospital General de Alicante, 03010 Alicante, Spain
- Adrián Segura Díaz
- Hospital Universitario de Gran Canaria Doctor Negrín, 35010 Gran Canaria, Spain
- Valle Gómez
- Hospital La Princesa, 28006 Madrid, Spain
- Patricia Vélez Tenza
- Hospital Del Mar, 08003 Barcelona, Spain
- Magdalena Sierra Pacho
- Hospital Clínico Universitario de Salamanca, 37007 Salamanca, Spain
- Juan Antonio Vera Goñi
- Hospital Virgen Macarena, 41009 Sevilla, Spain
- Melania Moreno Vega
- Hospital Doctor José Molina Orosa de Lanzarote, 35500 Las Palmas, Spain
- Alberto Alvarez-Larrán
- Hospital Clínic, 08036 Barcelona, Spain
- Montse Cortés
- Hospital General de Granollers, 08402 Barcelona, Spain
- Manuel Pérez Encinas
- Hospital Clínico Universitario de Santiago de Compostela, 15706 A Coruña, Spain
- Patricia Carrascosa Mastell
- Hospital General de Castellón, 12004 Castellón, Spain
- Anna Angona
- Hospital Universitario Dr. J Trueta-CO, 17007 Girona, Spain
- Ana Rosell
- Hospital Universitario Virgen de la Victoria, 29010 Málaga, Spain
- Sunil Lakhwani
- Hospital Universitario de Canarias, 38320 Tenerife, Spain
- Mercedes Colorado
- Hospital Universitario Marqués de Valdecilla, 39008 Santander, Spain
- Elena Ramila
- Hospital Parc Tauli, 08208 Sabadell, Spain
- Carlos Cervero
- Hospital Virgen de la Luz, 16002 Cuenca, Spain
- Beatriz Cuevas
- Hospital Universitario de Burgos, 09006 Burgos, Spain
- Lucía Villalón Blanco
- Fundación Hospital Alcorcón, 28922 Madrid, Spain
- Raquel de Paz
- Hospital Universitario La Paz, 28046 Madrid, Spain
- Antonio Paz Coll
- Hospital Universitario Puerto Real, 11510 Cádiz, Spain
- María José Fernández
- Hospital Dr. Peset, 46017 Valencia, Spain
- Luis Felipe Casado
- Hospital Virgen de la Salud, 45005 Toledo, Spain
- Juan Manuel Alonso-Domínguez
- Hospital Universitario Fundación Jiménez Díaz, 28040 Madrid, Spain
- María Magdalena Anguita Arance
- Complejo Hospitalario de Jaén, 23007 Jaén, Spain
- Araceli Salamanca Cuenca
- Hospital de Jerez de la Frontera, 11407 Cádiz, Spain
- Antonio Jiménez-Velasco
- Hospital Regional Universitario de Málaga, 29010 Málaga, Spain
- Santiago Osorio Prendes
- Hospital General Universitario Gregorio Marañón, 28007 Madrid, Spain
- Marta Santaliestra
- Hospital Universitari Mútua Terrassa, 08221 Barcelona, Spain
- María José Lis Chulvi
- Hospital General Universitario de Valencia, 46014 Valencia, Spain
- Juan Carlos Hernández-Boluda
- Hospital Clínico Universitario de Valencia, 46010 Valencia, Spain
- Valentín García-Gutiérrez
- Hospital Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS), 28034 Madrid, Spain
- DOI
- https://doi.org/10.3390/cancers15041045
- Journal volume & issue
-
Vol. 15,
no. 4
p. 1045
Abstract
(1) Background: Despite the prognostic improvements achieved with tyrosine kinase inhibitors (TKIs) in chronic myeloid leukemia (CML), a minority of patients still fail TKIs. The recent introduction of asciminib may be a promising option in intolerant patients, as it is a first-in-class inhibitor with a more selective mechanism of action different from the ATP-competitive inhibition that occurs with TKIs. Therefore, our goal was to analyze toxicities shown with asciminib as well as to study cross-toxicity with previous TKIs. (2) Methods: An observational, multicenter, retrospective study was performed with data from 77 patients with CML with therapeutic failure to second-generation TKIs who received asciminib through a managed-access program (MAP) (3) Results: With a median follow-up of 13.7 months, 22 patients (28.5%) discontinued treatment: 32% (7/22) due to intolerance and 45% (10/22) due to resistance. Fifty-five percent of the patients reported adverse effects (AEs) with asciminib and eighteen percent grade 3–4. Most frequent AEs were: fatigue (18%), thrombocytopenia (17%), anemia (12%), and arthralgias (12%). None of the patients experienced cardiovascular events or occlusive arterial disease. Further, 26%, 25%, and 9% of patients required dose adjustment, temporary suspension, or definitive discontinuation of treatment, respectively. Toxicities under asciminib seemed lower than with prior TKIs for anemia, cardiovascular events, pleural/pericardial effusion, diarrhea, and edema. Cross-toxicity risk was statistically significant for thrombocytopenia, anemia, neutropenia, fatigue, vomiting, and pancreatitis. (4) Conclusion: Asciminib is a molecule with a good safety profile and with a low rate of AEs. However, despite its new mechanism of action, asciminib presents a risk of cross-toxicity with classical TKIs for some AEs.
Keywords