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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 Peñalver, Francisco‐Javier Márquez, Jose‐Antonio Durán, Soledad Giraldo, Pilar Martín, Alejandro Montalbán, Carlos López Hernández, Andrés [Peñalver FJ] Hospital Universitario Fundación Alcorcón, Alcorcón, Madrid, Spain. [Márquez JA] Hospital de Basurto, Vizcaya, Spain. [Durán S] Complejo Hospitalario de Jaén, Jaén, Spain. [Giraldo P] Hospital Universitario Miguel Servet, Zaragoza, Spain. [Martín A] Hospital Universitario de Salamanca, IBSAL, CIBERONC, Salamanca, Spain. [Montalbán C] Hospital Universitario Ramón y Cajal, Madrid, Spain. [López A] Vall d'Hebron Hospital Universitari, Barcelona, Spain Vall d'Hebron Barcelona Hospital Campus Limfomes Medicaments antineoplàstics Prognosi DISEASES::Neoplasms::Neoplasms by Histologic Type::Lymphoma::Lymphoma, Non-Hodgkin::Lymphoma, Follicular ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Therapeutics::Drug Therapy::Therapeutics::Drug Therapy::Drug Therapy, Combination::Antineoplastic Combined Chemotherapy Protocols ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Prognosis ENFERMEDADES::neoplasias::neoplasias por tipo histológico::linfoma::linfoma no Hodgkin::linfoma folicular TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::Diagnóstico::Pronóstico Bendamustine; Follicular lymphoma; Immunochemotherapy Bendamustina; Linfoma folicular; Inmunoquimioterapia Bendamustina; Limfoma fol·licular; Immunoquimioteràpia 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: ClinicalTrials.gov # NCT01133158 Financial support was provided by Mundipharma Spain and Roche Pharma Spain. 2020-07-31T12:38:44Z 2020-07-31T12:38:44Z 2019-11-01 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion 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 lymphoma after first‐line immunochemotherapy: results of the RBMDGELTAMO08 phase II trial. Cancer Med. 2019 Nov 1;8(16):6955–66. 2045-7634 https://hdl.handle.net/11351/5127 10.1002/cam4.2555 31573746 000488578100001 http://hdl.handle.net/11351/5127 eng Cancer Medicine;8(16) https://onlinelibrary.wiley.com/doi/full/10.1002/cam4.2555 Attribution 4.0 International http://creativecommons.org/licenses/by/4.0/ info:eu-repo/semantics/openAccess application/pdf Wiley Online Library Scientia