Response-adapted treatment with rituximab, bendamustine, mitoxantrone, and dexamethasone followed by rituximab maintenance in patients with relapsed or refractory follicular lymphoma after first-line immunochemotherapy: Results of the RBMDGELTAMO08 phase II trial
Por:
Penalver, F, Marquez, J, Duran, S, Giraldo, P, Martin, A, Montalban, C, Sancho, J, Ramirez, M, Terol, M, Capote, F, Gutierrez, A, Sanchez, B, Lopez, A, Salar, A, Rodriguez-Caravaca, G, Canales, M, Caballero, M, Lopez, J, Carbonell, F, Bordas, S, Lopez, P, Persona, E, Guillermo, A, Martin, R, Mayans, J, Palomera, L, Ceballos, E, Hernandez, J, Grau, R, de la Cruz, F and Salinas, A
Publicada:
1 nov 2019
Ahead of Print:
1 oct 2019
Resumen:
Background Consensus is lacking regarding the optimal salvage therapy for patients with follicular lymphoma who relapse after or are refractory to immunochemotherapy. Methods This phase II trial evaluated the efficacy and safety of response-adapted therapy with rituximab, bendamustine, mitoxantrone, and dexamethasone (RBMD) in follicular lymphoma patients who relapsed after or were refractory to first-line immunochemotherapy. Sixty patients received three treatment cycles, and depending on their response received an additional one (complete/unconfirmed complete response) or three (partial response) cycles. Patients who responded to induction received rituximab maintenance therapy for 2 years. Results Thirty-three (55%) and 42 (70%) patients achieved complete/unconfirmed complete response after three cycles and on completing induction therapy (4-6 cycles), respectively (final overall response rate, 88.3%). Median progression-free survival was 56.4 months (median follow-up, 28.3 months; 95% CI, 15.6-51.2). Overall survival was not reached. Progression-free survival did not differ between patients who received four vs six cycles (P = .6665), nor between patients who did/did not receive rituximab maintenance after first-line therapy (P = .5790). Median progression-free survival in the 10 refractory patients was 25.5 months (95% CI, 0.6-N/A) and was longer in patients who had shown progression of disease after 24 months of first-line therapy (median, 56.4 months; 95% CI, 19.8-56.4) than in those who showed early progression (median, 42.31 months; 95% CI, 24.41-NA) (P = .4258). Thirty-six (60%) patients had grade 3/4 neutropenia. Grade 3/4 febrile neutropenia and infection were recorded during induction (4/60 [6.7%] and 5/60 [8.3%] patients, respectively) and maintenance (2/43 [4.5%] and 4/43 [9.1%] patients, respectively). Conclusions This response-adapted treatment with RBMD followed by rituximab maintenance is an effective and well-tolerated salvage treatment for relapsed/refractory follicular lymphoma following first-line immunochemotherapy. Clinical trial registration # NCT01133158.
Filiaciones:
Penalver, F:
Hosp Univ Fdn Alcorcon, Madrid, Spain
Marquez, J:
Hosp Basurto, Vizcaya, Spain
Duran, S:
Complejo Hosp Jaen, Jaen, Spain
Giraldo, P:
Hosp Univ Miguel Servet, Zaragoza, Spain
Martin, A:
Hosp Univ Salamanca, CIBERONC, IBSAL, Salamanca, Spain
Montalban, C:
Hosp Univ Ramon Y Cajal, Madrid, Spain
Sancho, J:
ICO IJC Hosp Germans Trias & Pujol, Barcelona, Spain
Ramirez, M:
Hosp Especialidades Jerez de la Frontera, Cadiz, Spain
Terol, M:
Hosp Clin Univ Valencia, Valencia, Spain
Capote, F:
Hosp Puerta Mar, Cadiz, Spain
Gutierrez, A:
Hosp Univ Son Dureta, Palma De Mallorca, Spain
Sanchez, B:
Hosp del Mar, Barcelona, Spain
Lopez, A:
Hosp Valle De Hebron, Barcelona, Spain
Salar, A:
Hosp del Mar, Barcelona, Spain
Rodriguez-Caravaca, G:
Univ Rey Juan Carlos, Madrid, Spain
Canales, M:
Hosp Univ La Paz, Madrid, Spain
Caballero, M:
Hosp Univ Salamanca, CIBERONC, IBSAL, Salamanca, Spain
Lopez, J:
HU Santiago de Compostela, Santiago De Compostela, Spain
Carbonell, F:
HGU Valencia, Valencia, Spain
:
hEMATOLOGÍA. HU Doctor Peset, Valencia, Spain
Lopez, P:
HU Gregorio Maranon, Madrid, Spain
Persona, E:
Hosp Txagorritxu, Vitoria, Spain
Guillermo, A:
Hosp Clin Barcelona, Barcelona, Spain
Martin, R:
Hosp Virgen de la Concha, Zamora, Spain
Mayans, J:
HU Arnau de Vilanova, Lleida, Spain
Palomera, L:
HCU Lozano Blesa, Zaragoza, Spain
Ceballos, E:
HGU Morales Meseguer, Murcia, Spain
Hernandez, J:
Hosp Gen Segovia, Segovia, Spain
Grau, R:
HU Severo Ochoa, Leganes, Spain
de la Cruz, F:
HU Virgen del Rocio, Seville, Spain
Salinas, A:
HCU Virgen de la Arrixaca, Murcia, Spain
Open Access
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