We assessed the prognostic value of minimal residual disease (MRD) within the ML17638 phase 3 trial from the Fondazione Italiana Linfomi, investigating the role of rituximab maintenance in elderly follicular lymphoma (FL) patients after a brief first-line chemoimmunotherapy. MRD for the bcl-2/IgH translocation was determined on bone marrow cells in a centralized laboratory belonging to the Euro-MRD consortium, using qualitative and quantitative polymerase chain reactions (PCRs). Of 234 enrolled patients, 227 (97%) were screened at diagnosis. A molecular marker (MM) was found in 51%. Patients with an MM were monitored at 8 subsequent times. Of the 675 expected follow-up samples, 83% were analyzed. Conversion to PCR negativity predicted better progression-free survival (PFS) at all post-treatment times (eg, end of therapy: 3-year PFS, 72% vs 39%; P < .007). MRD was predictive in both maintenance (83% vs 60%; P < .007) and observation (71% vs 50%; P < .001) groups. PCR positivity at the end of induction was an independent adverse predictor (hazard ratio, 3.1; 95% confidence interval, 1.36-7.07). MRD is a powerful independent outcome predictor in FL patients who receive rituximab-intensive programs, suggesting a need to investigate its value for decision-making. This trial was registered at www.clinicaltrial.gov as #NCT01144364.

Persistence of minimal residual disease in bone marrow predicts outcome in follicular lymphomas treated with a rituximab-intensive program

LADETTO, Marco;MANTOAN, BARBARA;GENUARDI, ELISA;AGLIETTA, Massimo;SAGLIO, Giuseppe;
2013-01-01

Abstract

We assessed the prognostic value of minimal residual disease (MRD) within the ML17638 phase 3 trial from the Fondazione Italiana Linfomi, investigating the role of rituximab maintenance in elderly follicular lymphoma (FL) patients after a brief first-line chemoimmunotherapy. MRD for the bcl-2/IgH translocation was determined on bone marrow cells in a centralized laboratory belonging to the Euro-MRD consortium, using qualitative and quantitative polymerase chain reactions (PCRs). Of 234 enrolled patients, 227 (97%) were screened at diagnosis. A molecular marker (MM) was found in 51%. Patients with an MM were monitored at 8 subsequent times. Of the 675 expected follow-up samples, 83% were analyzed. Conversion to PCR negativity predicted better progression-free survival (PFS) at all post-treatment times (eg, end of therapy: 3-year PFS, 72% vs 39%; P < .007). MRD was predictive in both maintenance (83% vs 60%; P < .007) and observation (71% vs 50%; P < .001) groups. PCR positivity at the end of induction was an independent adverse predictor (hazard ratio, 3.1; 95% confidence interval, 1.36-7.07). MRD is a powerful independent outcome predictor in FL patients who receive rituximab-intensive programs, suggesting a need to investigate its value for decision-making. This trial was registered at www.clinicaltrial.gov as #NCT01144364.
2013
122
23
3759
3766
http://bloodjournal.hematologylibrary.org/content/122/23/3759.long
minimal resdual disease; bone marrow; follicular lymphomas
Ladetto M; Lobetti-Bodoni C; Mantoan B; Ceccarelli M; Boccomini C; Genuardi E; Chiappella A; Baldini L; Rossi G; Pulsoni A; Di Raimondo F; Rigacci L; Pinto A; Galimberti S; Bari A; Rota-Scalabrini D; Ferrari A; Zaja F; Gallamini A; Specchia G; Musto P; Rossi FG; Gamba E; Evangelista A; Vitolo U; Fondazione Italiana Linfomi. collaborators: Lobetti-Bodoni C; Mantoan B; Genuardi E; Boccadoro M; Ladetto M; Ciccone G; Evangelista A; Ceccarelli M; Boccomini C; Chiappella A; Botto B; Orsucci L; Vitolo U; Goldaniga M; Rossi FG; Baldini L; Bottelli C; Tucci A; Rossi G; Pulsoni A; De Angelis F; Russo E; Martelli M; Foà R; Di Raimondo F; Chiarenza A; Rigacci L; Puccini B; Bosi A; Pinto A; Petrini M; Galimberti S; Bari A; Sacchi S; Federico M; Rota-Scalabrini D; Aglietta M; Ferrari A; Alvarez De Celis I; Merli F; Zaja F; Fanin R; Castellino C; Gallamini A; Parvis G; Saglio G; Perrone T; Specchia G; Musto P; Gamba E; Corradini P; Pogliani EM; Liberati AM; Leone G; Patti C; Fioritoni G; Rusconi C; Morra E; Tonso A; Cabras G; Angelucci E; Rossi A; Rambaldi A; Cortelazzo S; Morandi S; Lanza F; Pizzolo G; Amadori S; Zinzani PL; Stelitano C; Nobile F
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2318/157628
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