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oai:repisalud.isciii.es:20.500.12105/228312024-11-28T17:24:10Zcom_20.500.12105_15322com_20.500.12105_2051col_20.500.12105_16960col_20.500.12105_16967

00925njm 22002777a 4500 dc Penalver, Francisco-Javier author Marquez, Jose-Antonio author Duran, Soledad author Giraldo, Pilar author Martin, Alejandro author Montalban, Carlos author Sancho, Juan-Manuel author Ramirez, Maria-Jose author Terol, Maria-Jose author Capote, Francisco-Javier author Gutierrez, Antonio author Sanchez, Blanca author Lopez, Andres author Salar, Antonio author Rodriguez-Caravaca, Gil author Canales, Miguel author Caballero, Maria Dolores author Bello Lopez, Jose Luis author Carbonell, Felix author Ferrer Bordas, Secundino author Font Lopez, Patricia author Perez Persona, Ernesto author Lopez Guillermo, Armando author Hernandez Martin, Roberto author Ramon Mayans, Jose author Palomera, Luis author Perez Ceballos, Elena author Queizan Hernandez, Jose Antonio author Riaza Grau, Rosalia author de la Cruz, Fatima author Sanchez Salinas, Andres author GELTAMO (The Spanish Lymphoma Cooperative Group) author 2019-11 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. Penalver FJ, Marquez JA, Duran S, Giraldo P, Martin A, Montalban 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;8(16):6955-66. Epub 2019 Oct 1. 10.1002/cam4.2555 2045-7634 Cancer Medicine http://hdl.handle.net/20.500.13003/14609 31573746 L2003441578 2-s2.0-85073995928 https://hdl.handle.net/20.500.12105/22831 488578100001 Bendamustine Follicular lymphoma Immunochemotherapy Refractory Relapsed 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