Pere Barba1, Mireia Morgades2, Pau Montesinos3, Cristina Gil4, María-Laura Fox1, Juana Ciudad5, María-José Moreno6, José González-Campos7, Eulàlia Genescà8, Daniel Martínez-Carballeira9, Rodrigo Martino10, Susana Vives2, Ramon Guardia11, Santiago Mercadal12, María-Teresa Artola13, Antonia Cladera14, Mar Tormo15, Jordi Esteve16, Juan Bergua17, Ferran Vall-Llovera18, Jordi Ribera8, Pilar Martínez-Sanchez19, María-Luz Amigo20, Arantxa Bermúdez21, María Calbacho22, Jesús-Maria Hernández-Rivas23, Evaristo Feliu2, Alberto Orfao5, Josep-María Ribera2. 1. Hospital Universitari Vall Hebron, Universitat Autònoma de Barcelona, Barcelona, Spain. 2. ICO Badalona-Hospital Germans Trias i Pujol, Josep Carreras Leukemia Research Institute, Universitat Autònoma de Barcelona, Badalona, Spain. 3. Hospital Universitari i Politècnic La Fe, Valencia, Spain. 4. Hospital General de Alicante, Alicante, Spain. 5. Centro de Investigación del Cáncer (CIC, IBMCC USAL-CSIC), Servicio General de Citometría, Instituto de Investigación Biomédica de Salamanca (IBSAL), Universidad de Salamanca, Salamanca, Spain. 6. Hospital Clínico Universitario Virgen de la Victoria, Málaga, Spain. 7. Hospital Universitario Virgen del Rocío, Sevilla, Spain. 8. Josep Carreras Leukaemia Research Institute (IJC), Badalona, Spain. 9. Hospital Universitario Central de Asturias, Oviedo, Spain. 10. Hospital de la Santa Creu i Sant Pau, Barcelona, Spain. 11. ICO Girona-Hospital Josep Trueta, Girona, Spain. 12. ICO L'Hospitalet- Hospital Duran i Reynals, L'Hospitalet de Llobregat, Spain. 13. Hospital Universitario Donostia, Donostia, Spain. 14. Hospital Son Llàtzer, Palma de Mallorca, Spain. 15. Hospital Clínico Universitario de Valencia, Valencia, Spain. 16. Hospital Clínic Universitari de Barcelona, Barcelona, Spain. 17. Hospital San Pedro de Alcántara, Cáceres, Spain. 18. Hospital Universitari Mútua de Terrassa, Terrassa, Spain. 19. Hospital Universitario Doce de Octubre, Madrid, Spain. 20. Hospital Morales Meseguer, Murcia, Spain. 21. Hospital Universitario Marqués de Valdecilla, Santander, Spain. 22. Hospital Ramón y Cajal, Madrid, Spain. 23. Hospital Universitario de Salamanca, Salamanca, Spain.
Abstract
OBJECTIVE AND METHODS: Pediatric-inspired regimens have been adopted by several groups as the treatment strategy for adult patients with acute lymphoblastic leukemia (ALL). Whether subsequent modifications of these protocols have led to an improvement in the outcome of patients is uncertain, especially in T-cell ALL. We analyzed 169 patients with high-risk T-cell ALL included in two consecutive trials of the PETHEMA Group (HR-ALL03 [n = 104] and the more contemporary HR-ALL11 [n = 65]). RESULTS: Patients and disease characteristics were balanced between both groups. Regarding efficacy, we observed a similar complete remission (CR) rate, relapse and disease-free survival (DFS) between both protocols. Patients included in the HR-ALL11 trial had better 2-year overall survival (OS) compared with the HR-ALL03 (65% [95% CI 51%-79%] vs 44% [95% CI 34%-54%], P = 0.026). Regarding toxicity, we observed a better safety profile in the HR-11 protocol. Irrespective of the protocol, patients with good measurable residual disease (MRD) clearance had a promising outcome without allogeneic hematopoietic stem cell transplantation (allo-HSCT) in CR1, with 2-year OS of 67%. CONCLUSION: Patients with T-cell ALL included in the HR-11 trial showed better OS than patients in the HR-03, mostly driven by a reduction of NRM.
OBJECTIVE AND METHODS: Pediatric-inspired regimens have been adopted by several groups as the treatment strategy for adult patients with acute lymphoblastic leukemia (ALL). Whether subsequent modifications of these protocols have led to an improvement in the outcome of patients is uncertain, especially in T-cell ALL. We analyzed 169 patients with high-risk T-cell ALL included in two consecutive trials of the PETHEMA Group (HR-ALL03 [n = 104] and the more contemporary HR-ALL11 [n = 65]). RESULTS:Patients and disease characteristics were balanced between both groups. Regarding efficacy, we observed a similar complete remission (CR) rate, relapse and disease-free survival (DFS) between both protocols. Patients included in the HR-ALL11 trial had better 2-year overall survival (OS) compared with the HR-ALL03 (65% [95% CI 51%-79%] vs 44% [95% CI 34%-54%], P = 0.026). Regarding toxicity, we observed a better safety profile in the HR-11 protocol. Irrespective of the protocol, patients with good measurable residual disease (MRD) clearance had a promising outcome without allogeneic hematopoietic stem cell transplantation (allo-HSCT) in CR1, with 2-year OS of 67%. CONCLUSION:Patients with T-cell ALL included in the HR-11 trial showed better OS than patients in the HR-03, mostly driven by a reduction of NRM.