RT journal article
T1 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
A1 Peñalver, Francisco‐Javier
A1 Márquez, José‐Antonio
A1 Durán, Soledad
A1 Giraldo, Pilar
A1 Martín, Alejandro
A1 Montalbán, Carlos
A1 Sancho, Juan-Manuel
A1 Ramírez, María José
A1 Terol, María José
A1 Capote Huelva, Francisco Javier
A1 Gutiérrez, Antonio
A1 Sánchez, Blanca
A1 López, Andrés
A1 Salar, Antonio
A1 Rodríguez‐Caravaca, Gil
A1 Canales, Miguel
A1 Caballero, María‐Dolores
A1 GELTAMO (The Spanish Lymphoma Cooperative Group)
K1 bendamustine
K1 follicular lymphoma
K1 immunochemotherapy
K1 refractory
K1 relapsed
AB Background: Consensus is lacking regarding the optimal salvage therapy for patientswith follicular lymphoma who relapse after or are refractory to immunochemotherapy.Methods: This phase II trial evaluated the efficacy and safety of response‐adaptedtherapy 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 dependingon their response received an additional one (complete/unconfirmed completeresponse) or three (partial response) cycles. Patients who responded to induction receivedrituximab maintenance therapy for 2 years.Results: Thirty‐three (55%) and 42 (70%) patients achieved complete/unconfirmedcomplete response after three cycles and on completing induction therapy (4‐6 cycles),respectively (final overall response rate, 88.3%). Median progression‐free survivalwas 56.4 months (median follow‐up, 28.3 months; 95% CI, 15.6‐51.2). Overallsurvival was not reached. Progression‐free survival did not differ between patientswho received four vs six cycles (P = .6665), nor between patients who did/did notreceive 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 monthsof first‐line therapy (median, 56.4 months; 95% CI, 19.8‐56.4) than in those whoshowed 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 neutropeniaand 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 rituximabmaintenance is an effective and well‐tolerated salvage treatment for relapsed/refractoryfollicular lymphoma following first‐line immunochemotherapy.Clinical trial registration: ClinicalTrials.gov # NCT01133158.
PB WILEY
SN 2045-7634
YR 2019
FD 2019-10
LK http://hdl.handle.net/10498/21839
UL http://hdl.handle.net/10498/21839
LA eng
DS Repositorio Institucional de la Universidad de Cádiz
RD 14-nov-2026