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

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Peñalver, Francisco‐Javier; Márquez, José‐Antonio; Durán, Soledad; Giraldo, Pilar; Martín, Alejandro; Montalbán, Carlos; Sancho, Juan-Manuel; Ramírez, María José; Terol, María José; Capote Huelva, Francisco Javier
Date
2019-10Source
Cancer Medicine. 2019;00:1–13.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.
Clinical trial registration: ClinicalTrials.gov # NCT01133158.
Subjects
bendamustine; follicular lymphoma; immunochemotherapy; refractory; relapsedCollections
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