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

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,...

Descripción completa

Detalles Bibliográficos
Autores: Penalver, FJ, Marquez, JA, Duran, S, Giraldo, P, Martin, A, Montalban, C, Sancho, JM, Ramirez, MJ, Terol, MJ, Capote, FJ, Gutierrez, A, Sanchez, B, Lopez, A, Salar, A, Rodriguez-Caravaca, G, Canales, M, Caballero, MD, Lopez, JLB, Carbonell, F, Bordas, SF, Lopez, PF, Persona, EP, Guillermo, AL, Martin, RH, Mayans, JR, Palomera, L, Ceballos, EP, Hernandez, JAQ, Grau, RR, de la Cruz, F, Salinas, AS, GELTAMO Spanish Lymphoma Cooperati
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2019
País:España
Institución:INCLIVA
Repositorio:r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA
OAI Identifier:oai:incliva.fundanetsuite.com:p4128
Acceso en línea:https://incliva.portalinvestigacion.com/publicaciones/4128
Access Level:acceso abierto
Palabra clave:bendamustine
follicular lymphoma
immunochemotherapy
refractory
relapsed
id ES_0dc216e8f36cbdfcd3ae1e5073f90abd
oai_identifier_str oai:incliva.fundanetsuite.com:p4128
network_acronym_str ES
network_name_str España
repository_id_str
spelling 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 trialPenalver, FJMarquez, JADuran, SGiraldo, PMartin, AMontalban, CSancho, JMRamirez, MJTerol, MJCapote, FJGutierrez, ASanchez, BLopez, ASalar, ARodriguez-Caravaca, GCanales, MCaballero, MDLopez, JLBCarbonell, FBordas, SFLopez, PFPersona, EPGuillermo, ALMartin, RHMayans, JRPalomera, LCeballos, EPHernandez, JAQGrau, RRde la Cruz, FSalinas, ASGELTAMO Spanish Lymphoma Cooperatibendamustinefollicular lymphomaimmunochemotherapyrefractoryrelapsedBackground 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.WILEY2019info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://incliva.portalinvestigacion.com/publicaciones/4128Cancer MedicineISSN: 20457634reponame:r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVAinstname:INCLIVAInglésinfo:eu-repo/semantics/openAccessoai:incliva.fundanetsuite.com:p41282026-06-07T16:35:31Z
dc.title.none.fl_str_mv 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
title 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
spellingShingle 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
Penalver, FJ
bendamustine
follicular lymphoma
immunochemotherapy
refractory
relapsed
title_short 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_sort 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
dc.creator.none.fl_str_mv Penalver, FJ
Marquez, JA
Duran, S
Giraldo, P
Martin, A
Montalban, C
Sancho, JM
Ramirez, MJ
Terol, MJ
Capote, FJ
Gutierrez, A
Sanchez, B
Lopez, A
Salar, A
Rodriguez-Caravaca, G
Canales, M
Caballero, MD
Lopez, JLB
Carbonell, F
Bordas, SF
Lopez, PF
Persona, EP
Guillermo, AL
Martin, RH
Mayans, JR
Palomera, L
Ceballos, EP
Hernandez, JAQ
Grau, RR
de la Cruz, F
Salinas, AS
GELTAMO Spanish Lymphoma Cooperati
author Penalver, FJ
author_facet Penalver, FJ
Marquez, JA
Duran, S
Giraldo, P
Martin, A
Montalban, C
Sancho, JM
Ramirez, MJ
Terol, MJ
Capote, FJ
Gutierrez, A
Sanchez, B
Lopez, A
Salar, A
Rodriguez-Caravaca, G
Canales, M
Caballero, MD
Lopez, JLB
Carbonell, F
Bordas, SF
Lopez, PF
Persona, EP
Guillermo, AL
Martin, RH
Mayans, JR
Palomera, L
Ceballos, EP
Hernandez, JAQ
Grau, RR
de la Cruz, F
Salinas, AS
GELTAMO Spanish Lymphoma Cooperati
author_role author
author2 Marquez, JA
Duran, S
Giraldo, P
Martin, A
Montalban, C
Sancho, JM
Ramirez, MJ
Terol, MJ
Capote, FJ
Gutierrez, A
Sanchez, B
Lopez, A
Salar, A
Rodriguez-Caravaca, G
Canales, M
Caballero, MD
Lopez, JLB
Carbonell, F
Bordas, SF
Lopez, PF
Persona, EP
Guillermo, AL
Martin, RH
Mayans, JR
Palomera, L
Ceballos, EP
Hernandez, JAQ
Grau, RR
de la Cruz, F
Salinas, AS
GELTAMO Spanish Lymphoma Cooperati
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv bendamustine
follicular lymphoma
immunochemotherapy
refractory
relapsed
topic bendamustine
follicular lymphoma
immunochemotherapy
refractory
relapsed
description 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.
publishDate 2019
dc.date.none.fl_str_mv 2019
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://incliva.portalinvestigacion.com/publicaciones/4128
url https://incliva.portalinvestigacion.com/publicaciones/4128
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv WILEY
publisher.none.fl_str_mv WILEY
dc.source.none.fl_str_mv Cancer Medicine
ISSN: 20457634
reponame:r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA
instname:INCLIVA
instname_str INCLIVA
reponame_str r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA
collection r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA
repository.name.fl_str_mv
repository.mail.fl_str_mv
_version_ 1869403357478649856
score 15,812429

Similares en LA Referencia