A pediatric regimen for adolescents and young adults with Philadelphia chromosome-negative acute lymphoblastic leukemia: Results of the ALLRE08 PETHEMA trial
Por:
Ribera, JM, Morgades, M, Montesinos, P, Tormo, M, Martinez-Carballeira, D, Gonzalez-Campos, J, Gil, C, Barba, P, Garcia-Boyero, R, Coll, R, Pedreno, M, Ribera, J, Mercadal, S, Vives, S, Novo, A, Genesca, E, Hernandez-Rivas, JM, Bergua, J, Amigo, ML, Vall-Llovera, F, Martinez-Sanchez, P, Calbacho, M, Garcia-Cadenas, I, Garcia-Guinon, A, Sanchez-Sanchez, MJ, Cervera, M, Feliu, E, Orfao, A
Publicada:
1 abr 2020
Ahead of Print:
1 feb 2020
Resumen:
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.
Filiaciones:
Ribera, JM:
Univ Autonoma Barcelona, Josep Carreras Res Inst, Dept Clin Hematol, ICO,Hosp Germans Trias & Pujol, Barcelona, Spain
Morgades, M:
Univ Autonoma Barcelona, Josep Carreras Res Inst, Dept Clin Hematol, ICO,Hosp Germans Trias & Pujol, Barcelona, Spain
Montesinos, P:
Hosp Univ & Politecn La Fe, Dept Clin Hematol, Valencia, Spain
Inst Carlos III, CIBERONC, Madrid, Spain
Tormo, M:
Hosp Clin Valencia, Dept Clin Hematol, Valencia, Spain
Martinez-Carballeira, D:
Hosp Cent Asturias, Oviedo, Spain
Gonzalez-Campos, J:
Hosp Univ Virgen del Rocio, Dept Clin Hematol, Seville, Spain
Gil, C:
Hosp Gen Univ Alicante, Dept Clin Hematol, Alicante, Spain
Barba, P:
Univ Autonoma Barcelona, Dept Clin Hematol, Hosp Univ Vall dHebron, Barcelona, Spain
Garcia-Boyero, R:
Hosp Gen Univ Castellon, Dept Clin Hematol, Castellon de La Plana, Spain
Coll, R:
Hosp Josep Trueta, ICO, Dept Clin Hematol, Girona, Spain
Pedreno, M:
Hosp Dr Peset, Dept Clin Hematol, Valencia, Spain
Ribera, J:
Univ Autonoma Barcelona, Josep Carreras Res Inst, Dept Clin Hematol, ICO,Hosp Germans Trias & Pujol, Barcelona, Spain
Mercadal, S:
Hosp Duran & Reynals, ICO, Dept Clin Hematol, Barcelona, Spain
Vives, S:
Univ Autonoma Barcelona, Josep Carreras Res Inst, Dept Clin Hematol, ICO,Hosp Germans Trias & Pujol, Barcelona, Spain
Novo, A:
Hosp Son Espases, Dept Clin Hematol, Palma De Mallorca, Spain
Genesca, E:
Univ Autonoma Barcelona, Josep Carreras Res Inst, Dept Clin Hematol, ICO,Hosp Germans Trias & Pujol, Barcelona, Spain
Hernandez-Rivas, JM:
USAL, Hosp Clin Univ, Cytometry Serv CIBERONC, Canc Res Ctr,IBMCC,CSIC,Dept Clin Hematol, Salamanca, Spain
Bergua, J:
Hosp San Pedro Alcantara, Dept Clin Hematol, Caceres, Spain
Amigo, ML:
Hosp Morales Meseguer, Dept Clin Hematol, Murcia, Spain
Vall-Llovera, F:
Hosp Mutua Terrassa, Dept Clin Hematol, Terrassa, Spain
Martinez-Sanchez, P:
Hosp Doce Octubre, Dept Clin Hematol, Madrid, Spain
Calbacho, M:
Hosp Ramon & Cajal, Dept Clin Hematol, Madrid, Spain
Garcia-Cadenas, I:
Hosp Santa Creu & Sant Pau, Dept Clin Hematol, Barcelona, Spain
Garcia-Guinon, A:
Hosp Arnau Vilanova, Dept Clin Hematol, Lleida, Spain
Sanchez-Sanchez, MJ:
Hosp Lucus Augusti, Dept Clin Hematol, Lugo, Spain
Cervera, M:
Hosp Joan 23, ICO, Dept Clin Hematol, Tarragona, Spain
Feliu, E:
Univ Autonoma Barcelona, Josep Carreras Res Inst, Dept Clin Hematol, ICO,Hosp Germans Trias & Pujol, Barcelona, Spain
Orfao, A:
USAL, Hosp Clin Univ, Cytometry Serv CIBERONC, Canc Res Ctr,IBMCC,CSIC,Dept Clin Hematol, Salamanca, Spain
Gold, Green Published
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