1. A pediatric regimen for adolescents and young adults with Philadelphia chromosome-negative acute lymphoblastic leukemia: Results of the ALLRE08 PETHEMA trial
- Author
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Ribera, Josep Maria, Morgades, Mireia, Montesinos, Pau, Tormo, Mar, Martínez Carballeira, Daniel, González Campos, José, Gil, Cristina, Barba, Pere, García Boyero, Raimundo, Coll, Rosa, Pedreño, María, Ribera, Jordi, Mercadal, Santiago, Vives, Susana, Novo, Andrés, Genescà, Eulàlia, Hernández Rivas, Jesús María, Bergua, Juan, Amigo, María Luz, Vall Llovera, Ferran, Martínez Sánchez, Pilar, Calbacho, María, García Cadenas, Irene, Garcia Guiñon, Antonio, Sánchez Sánchez, María José, Cervera, Marta, Feliu, Evarist, Orfao, Alberto, PETHEMA Group, Josep Carreras Leukemia Foundation, Universidad Autónoma de Barcelona, CSIC-USAL - Instituto de Biología Molecular y Celular del Cancer de Salamanca (IBMCC), Institut Català de la Salut, [Ribera JM, Morgades M] Departments of Clinical Hematology, ICO-Hospital Germans Trias i Pujol. Josep Carreras Research Institute, Universitat Autònoma de Barcelona, Bellaterra, Spain. [Montesinos P] Departments of Clinical Hematology, Hospital Universitari i Politècnic La Fe, CIBERONC, Instituto Carlos III, Valencia, Spain, Madrid, Spain. [Tormo M] Departments of Clinical Hematology, Hospital Clínico Valencia, Valencia, Spain. [Martínez-Carballeira D] Hospital Central de Asturias, Oviedo, Spain. [González-Campos J] Departments of Clinical Hematology, Hospital Universitario Virgen del Rocío, Sevilla, Spain. [Barba P] Servei d’Hematologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Universitat Autònoma de Barcelona, Bellaterra, Spain, and Vall d'Hebron Barcelona Hospital Campus
- Subjects
Male ,0301 basic medicine ,Cancer Research ,Neoplasm, Residual ,Lymphoblastic Leukemia ,Adolescents ,0302 clinical medicine ,hemic and lymphatic diseases ,Antineoplastic Combined Chemotherapy Protocols ,neoplasias::neoplasias por tipo histológico::leucemia::leucemia linfoide::leucemia-linfoma linfoblástico de células precursoras [ENFERMEDADES] ,Medicine ,Philadelphia Chromosome ,Cumulative incidence ,Other subheadings::/therapeutic use [Other subheadings] ,Young adult ,Complete response ,health care economics and organizations ,Original Research ,Clinical Trials as Topic ,Remission Induction ,terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS] ,hemic and immune systems ,Precursor Cell Lymphoblastic Leukemia-Lymphoma ,Prognosis ,lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,humanities ,Survival Rate ,Oncology ,030220 oncology & carcinogenesis ,behavior and behavior mechanisms ,Female ,Adult ,acute lymphoblastic leukemia, adolescents and young adults, pediatric treatment ,medicine.medical_specialty ,Adolescent ,Philadelphia Chromosome Negative ,education ,acute lymphoblastic leukemia ,lcsh:RC254-282 ,Teenagers ,Young Adult ,03 medical and health sciences ,Internal medicine ,Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy Protocols [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT] ,Overall survival ,Humans ,Radiology, Nuclear Medicine and imaging ,In patient ,Leucèmia limfocítica crònica ,Neoplasms::Neoplasms by Histologic Type::Leukemia::Leukemia, Lymphoid::Precursor Cell Lymphoblastic Leukemia-Lymphoma [DISEASES] ,business.industry ,Otros calificadores::/uso terapéutico [Otros calificadores] ,Clinical Cancer Research ,social sciences ,personas::Grupos de Edad::adolescente [DENOMINACIONES DE GRUPOS] ,Persons::Age Groups::Adolescent [NAMED GROUPS] ,Regimen ,030104 developmental biology ,Leucèmia limfoblàstica - Quimioteràpia ,pediatric treatment ,Chronic lymphocytic leukemia ,Neoplasm Recurrence, Local ,business ,adolescents and young adults ,Follow-Up Studies - Abstract
On behalf of the PETHEMA Group, Spanish Society of Hematology., [Background]: Pediatric‐based or ‐inspired trials have improved the prognosis of adolescents and young adults (AYA) with Philadelphia chromosome‐negative (Ph‐neg) acute lymphoblastic leukemia (ALL)., [Methods]: This study reports the results of treatment of the ALLRE08 trial, a full pediatric trial for AYA aged 15‐30 years with standard‐risk (SR) ALL., [Results]: From 2008 to 2018, 89 patients (38 adolescents [15‐18 years] and 51 young adults [YA, 19‐30 years], median age: 20 [15‐29] years) were enrolled in the ALLRE08 trial. The complete response (CR) was 95%. Twenty‐two patients were transferred to a high‐risk (HR) protocol because of poor marrow response on day 14 (n = 20) or high‐level of end‐induction minimal residual response (MRD ≥ 0.25%, n = 2). Cumulative incidence of relapse (CIR) at 5 years was 35% (95%CI: 23%‐47%), with significant differences between adolescents and YA: 13% (4%‐28%) vs 52% (34%‐67%), P = .012. No treatment‐related mortality was observed in 66/66 patients following the ALLRE08 trial vs 3/23 patients moved to a HR trial. The estimated 5‐year overall survival (OS) was 74% (95%CI: 63%‐85%), with significantly higher rates for adolescents vs YA: 87% (95%CI: 74%‐100%) vs 63% (46%‐80%), P = .021. Although CIR or OS were lower in patients who were transferred to a HR trial, the differences were not statistically significant (CIR: 34% [21%‐47%] vs 37% [14%‐61%]; OS: 78% [66%‐90%] vs 61% [31%;91%])., [Conclusion]: A full pediatric trial is feasible and effective for AYA with Ph‐neg, SR‐ALL, with better results for adolescents than for YA. Outcome of patients with poor early response rescued with a HR trial was not significantly inferior., We thanks to the following institutions from Spain their support for this paper: ICO‐Hospital Germans Trias i Pujol. Josep Carreras Research Institute. Universitat Autònoma de Barcelona. Hospital Universitari i Politècnic La Fe, Valencia. Hospital Clínico Valencia. Hospital Central de Asturias, Oviedo. Hospital Universitario Virgen del Rocío, Sevilla. Hospital General Universitario de Alicante. Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona. Hospital General Universitario de Castellón. ICO‐Hospital Josep Trueta, Girona. Hospital Dr Peset, Valencia. ICO‐Hospital Duran i Reynals, L'Hospitalet de Llobregat. Hospital Son Espases, Palma de Mallorca. Hospital Clínico Universitario, Cancer Research Center (IBMCC‐CSIC/USAL), Cytometry Service, Salamanca. Hospital San Pedro de Alcántara, Cáceres. Hospital Morales Meseguer, Murcia. Hospital Mútua de Terrassa, Terrassa. Hospital Doce de Octubre, Madrid. Hospital Ramón y Cajal, Madrid. Hospital de Sant Pau, Barcelona. Hospital Arnau de Vilanova, Lleida. Hospital Lucus Augusti, Lugo. ICO‐Hospital Joan XXIII, Tarragona.
- Published
- 2020