Identifier to cite or link to this item: http://hdl.handle.net/20.500.13003/11700
A pediatric regimen for adolescents and young adults with Philadelphia chromosome-negative acute lymphoblastic leukemia: Results of the ALLRE08 PETHEMA trial
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AuthorRibera, Josep-Maria; Morgades, Mireia; Montesinos, Pau; Tormo, Mar; Martinez-Carballeira, Daniel; Gonzalez-Campos, Jose; Gil, Cristina; Barba, Pere; Garcia-Boyero, Raimundo; Coll, Rosa; Pedreno, Maria; Ribera, Jordi; Mercadal, Santiago; Vives, Susana; Novo, Andrés; Genesca, Eulalia; Hernandez-Rivas, Jesus-Maria; Bergua, Juan; Amigo, Maria-Luz; Vall-Llovera, Ferran; Martinez-Sanchez, Pilar; Calbacho, Maria; Garcia-Cadenas, Irene; Garcia-Guinon, Antoni; Sanchez-Sanchez, Maria-Jose; Cervera, Marta; Feliu, Evarist; Orfao, Alberto; Spanish Soc Hematology
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CitationRibera JM, Morgades M, Montesinos P, Tormo M, Martinez-Carballeira D, Gonzalez-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. Epub 2020 Feb 5.
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.
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