Response-adapted treatment with rituximab, bendamustine, mitoxantrone, and dexamethasone followed by rituximab maintenance in patients with relapsed or refractory follicular Llymphoma after first-line immunochemotherapy: results of the RBMDGELTAMO08 phase II trial

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• dc.contributor.author Peñalver, Francisco-Javier
• dc.contributor.author Márquez, José-Antonio
• dc.contributor.author Durán, Soledad
• dc.contributor.author Giraldo, Pilar
• dc.contributor.author Martin, Alejandro
• dc.contributor.author Montalbán, Carlos
• dc.contributor.author Sancho, Juan Manuel
• dc.contributor.author Ramírez, María-José
• dc.contributor.author Terol, María-José
• dc.contributor.author Capote, Francisco-Javier
• dc.contributor.author Gutiérrez, Antonio
• dc.contributor.author Sánchez González, Blanca
• dc.contributor.author López, Andrés
• dc.contributor.author Salar Silvestre, Antonio
• dc.contributor.author Rodríguez-Caravaca, Gil
• dc.contributor.author Canales, M.
• dc.contributor.author Caballero, María Dolores
• dc.contributor.author GELTAMO Group
• dc.date.accessioned 2020-02-20T09:39:18Z
• dc.date.available 2020-02-20T09:39:18Z
• dc.date.issued 2019
• dc.description.abstract 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.
• dc.format.mimetype application/pdf
• dc.identifier.citation Peñalver FJ, Márquez JA, Durán S, Giraldo P, Martín A, Montalbán C. et al. Response-adapted treatment with rituximab, bendamustine, mitoxantrone, and dexamethasone followed by rituximab maintenance in patients with relapsed or refractory follicular Llymphoma after first-line immunochemotherapy: results of the RBMDGELTAMO08 phase II trial. Cancer Med. 2019 Nov;8 (16):6955-66. DOI: 10.1002/cam4.2555
• dc.identifier.doi http://dx.doi.org/10.1002/cam4.2555
• dc.identifier.issn 2045-7634
• dc.identifier.uri http://hdl.handle.net/10230/43673
• dc.language.iso eng
• dc.publisher Wiley
• dc.rights This is an open access article under the terms of the Creative Commons Attribution License, https://creativecommons.org/licenses/by/4.0/, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. © 2019 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.
• dc.rights.accessRights info:eu-repo/semantics/openAccess
• dc.rights.uri https://creativecommons.org/licenses/by/4.0/
• dc.subject.keyword Bendamustine
• dc.subject.keyword Follicular lymphoma
• dc.subject.keyword Immunochemotherapy
• dc.subject.keyword Refractory
• dc.subject.keyword Relapsed
• dc.title Response-adapted treatment with rituximab, bendamustine, mitoxantrone, and dexamethasone followed by rituximab maintenance in patients with relapsed or refractory follicular Llymphoma after first-line immunochemotherapy: results of the RBMDGELTAMO08 phase II trial
• dc.type info:eu-repo/semantics/article
• dc.type.version info:eu-repo/semantics/publishedVersion