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, F. J.; Marquez, J. A.; Duran, S.; Giraldo, P.; Martin, A.; Montalban, C.; Sancho, J. M.; Ramirez, M. J.; Terol, M. J.; Capote, F. J.; Gutierrez, A.; Sanchez, B.; Lopez, A.; Salar, A.; Rodriguez-Caravaca, G.; Canales, M.; Caballero, M. D.; Bello López, José Luis; Carbonell, F.; Bordas, S. F.; Lopez, P. F.; Persona, E. P.; Guillermo, A. L.; Martin, R. H.; Mayans, J. R.; Palomera, L.; Ceballos, E. P.; Hernandez, J. A. Q.; Grau, R. R.; de la Cruz, F.; Salinas, A. S.
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Identificadores
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Autor corporativo
GELTAMO (The Spanish Lymphoma Cooperative Group)Fecha de publicación
2019Título de revista
Cancer Medicine
Tipo de contenido
Artigo
DeCS
mitoxantrona | dexametasona | protocolos de quimioterapia antineoplásica combinada | linfoma | anciano | inmunoterapia | resistencia a medicamentos | mediana edad | humanos | tratamiento de última línea | adulto | antineoplásicosMeSH
Immunotherapy | Adult | Mitoxantrone | Middle Aged | Humans | Dexamethasone | Drug Resistance | Lymphoma | Salvage Therapy | Aged | Antineoplastic Combined Chemotherapy Protocols | Antineoplastic AgentsResumen
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.
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