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oai:recercat.cat:11351/64402025-10-24T10:28:19Zcom_2072_378070com_2072_378040col_2072_378092

A pediatric regimen for adolescents and young adults with Philadelphia chromosome-negative acute lymphoblastic leukemia: results of the ALLRE08 PETHEMA trial Ribera, Josep-Maria Tormo, Mar Martínez-Carballeira, Daniel González-Campos, José Barba Suñol, Pere Montesinos, Pau Morgades, Mireia 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 Vall d'Hebron Barcelona Hospital Campus Leucèmia limfoblàstica - Quimioteràpia Adolescents DISEASES::Neoplasms::Neoplasms by Histologic Type::Leukemia::Leukemia, Lymphoid::Precursor Cell Lymphoblastic Leukemia-Lymphoma ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy Protocols Other subheadings::Other subheadings::/therapeutic use NAMED GROUPS::Persons::Age Groups::Adolescent ENFERMEDADES::neoplasias::neoplasias por tipo histológico::leucemia::leucemia linfoide::leucemia-linfoma linfoblástico de células precursoras TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada Otros calificadores::Otros calificadores::/uso terapéutico DENOMINACIONES DE GRUPOS::personas::Grupos de Edad::adolescente Leucèmia limfoblàstica aguda; Adolescents i adults joves; Tractament pediàtric Leucemia linfoblástica aguda; Adolescentes y adultos jóvenes; Tratamiento pediátrico Acute lymphoblastic leukemia; Adolescents and young adults; Pediatric treatment 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. Supported in part by grants PI14/01971 from Fondo de Investigaciones Sanitarias, Instituto Carlos III, SGR288 (GRC) Generalitat de Catalunya, Fundació La Caixa and CIBERONC (JMHR and AO). 2021-10-22T06:31:07Z 2021-10-22T06:31:07Z 2020-04 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Ribera J, Morgades M, Montesinos P, Tormo M, Martínez‐Carballeira D, González‐Campos J, et al. A pediatric regimen for adolescents and young adults with Philadelphia chromosome‐negative acute lymphoblastic leukemia: results of the ALLRE08 PETHEMA trial. Cancer Med. 2020 Apr;9(7):2317–29. 2045-7634 https://hdl.handle.net/11351/6440 10.1002/cam4.2814 32022463 000511017000001 http://hdl.handle.net/11351/6440 eng Cancer Medicine;9(7) https://doi.org/10.1002/cam4.2814 info:eu-repo/grantAgreement/ES/PE2013-2016/PI14%2F01971 Attribution 4.0 International http://creativecommons.org/licenses/by/4.0/ info:eu-repo/semantics/openAccess application/pdf Wiley Scientia