Bendamustine is effective therapy in patients with rituximab‐refractory, indolent B‐cell non‐Hodgkin lymphoma

Abstract

BACKGROUND:Bendamustine hydrochloride is a novel alkylating agent. In this multicenter study, the authors evaluated the efficacy and toxicity of single‐agent bendamustine in patients with rituximab‐refractory, indolent B‐cell lymphoma.METHODS:Eligible patients (N = 100, ages 31‐84 years) received bendamustine at a dose of 120 mg/m2 by intravenous infusion on Days 1 and 2 every 21 days for 6 to 8 cycles. Histologies included follicular (62%), small lymphocytic (21%), and marginal zone (16%) lymphomas. Patients had received a median of 2 previous regimens (range, 0‐6 previous regimens), and 36%were refractory to their most recent chemotherapy regimen. Primary endpoints included overall response rate (ORR) and duration of response (DOR). Secondary endpoints were safety and progression‐free survival (PFS).RESULTS:An ORR of 75% (a 14% complete response rate, a 3% unconfirmed complete response rate, and a 58% partial response rate) was observed. The median DOR was 9.2 months, and median PFS was 9.3 months. Six deaths were considered to be possibly treatment related. Grade 3 or 4 (determined using National Cancer Institute Common Toxicity Criteria [version 3.0.19]. reversible hematologic toxicities included neutropenia (61%), thrombocytopenia (25%), and anemia (10%). The most frequent nonhematologic adverse events (any grade) included nausea (77%), infection (69%), fatigue (64%), diarrhea (42%), vomiting (40%), pyrexia (36%), constipation (31%), and anorexia (24%).CONCLUSIONS:Single‐agent bendamustine produced a high rate of objective responses with acceptable toxicity in patients with recurrent, rituximab‐refractory indolent B‐cell lymphoma. Cancer 2010. © 2010 American Cancer Society.

An Open-Label Expanded-Access Trial of Bendamustine in Patients with Rituximab-Refractory Indolent Non-Hodgkin Lymphoma or Previously Untreated Chronic Lymphocytic Leukemia: BEND-ACT

“…Those results are consistent with findings in two phase ii North American clinical trialsFriedberg et al 34 and Kahl et al 24 -that also examined bendamustine monotherapy in a rituximab-refractory inhl patient population. Interestingly, compared with incidences in the latter two trials, the incidences of grade 3 or 4 neutropenia and thrombocytopenia were lower in the bend-act trial.…”

“…Moreover, only 1 death (1%) was considered to be related to bendamustine treatment. In the study by Kahl et al 24 , 7 deaths were reported in the inhl patient population (7%), 4 of which were considered to be related to, or most likely related to, bendamustine (4%). However, the Friedberg et al 34 trial did not report any deaths in patients with inhl during bendamustine treatment.…”

“…Interestingly, compared with incidences in the latter two trials, the incidences of grade 3 or 4 neutropenia and thrombocytopenia were lower in the bend-act trial. The Canadian prescribing information for bendamustine suggests a 21-day treatment cycle for patients with inhl because that regimen was the one used in early clinical trials 24,32,34,35 . However, the bend-act study allowed a 21-or 28-day treatment cycle for inhl, consistent with the recommendations from a panel of international investigators indicating that a 4-week cycle should be used to reduce hematologic toxicity, dose modifications, and treatment delays 36 .…”

“…The Health Canada approval was based on a single-arm study in 100 patients with relapsed B-cell inhl that had progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen 24 . The overall response rate (orr) was 75%, and the median duration of response was 9.2 months.…”

An Aggressive Transformation to EBV-Positive Hodgkin Lymphoma after Bendamustine-Containing Chemotherapy for Marginal Zone Lymphoma

“…It has been demonstrating a comparably favorable tolerability and effectiveness for patients with low grade B-cell neoplasms [8,9]. Besides prolonged T-cell lymphopenia, its low profile of toxicity entails only a few reported cases of myelodysplastic syndrome as second hematologic malignancy [8,9].…”