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

Peñalver, Francisco-Javier; Márquez, José-Antonio; Durán, Soledad; Giraldo, Pilar; Martin, Alejandro; Montalbán, Carlos; Sancho, Juan Manuel; Ramírez, María-José; Terol, María-José; Capote, Francisco-Javier; Gutiérrez, Antonio; Sánchez González, Blanca; López, Andrés; Salar Silvestre, Antonio; Rodríguez-Caravaca, Gil; Canales, M.; Caballero, María Dolores; GELTAMO Group

doi:http://dx.doi.org/10.1002/cam4.2555

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

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

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.