Bendamustine is effective in relapsed or refractory aggressive non-Hodgkin’s lymphoma

Weidmann, Eckhart; Kim, S.-Z.; Rost, Andreas; Schuppert, H.; Seipelt, G.; Hoelzer, Dieter; Mitrou, Paris S.

doi:10.1093/annonc/mdf189

Cited by 92 publications

(52 citation statements)

References 12 publications

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“…Previous phase II studies of monotherapy BM demonstrated impressive remission rates combined with good tolerability in relapsing and/or refractory non-Hodgkin's lymphoma (NHL) (Heider and Niederle, 2001;Bremer, 2002;Weidmann et al, 2002;Friedberg et al, 2004). Moreover, in combination with vincristine and prednisone (BOP), BM demonstrated higher 5-year survival rates (61 vs 46%) compared to cyclophosphamide containing standard regimen .…”

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confidence: 99%

A phase I study of bendamustine hydrochloride administered day 1+2 every 3 weeks in patients with solid tumours

et al. 2007

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The aim of the study was to determine the maximum tolerated dose (MTD), the dose limiting toxicity (DLT), and the pharmacokinetic profile (P k ) of bendamustine (BM) on a day 1 and 2 every 3 weeks schedule and to recommend a safe phase II dose for further testing. Patients with solid tumours beyond standard therapy were eligible. A 30-min intravenous infusion of BM was administered d1 þ d2 q 3 weeks. The starting dose was 120 mg m À2 per day and dose increments of 20 mg m À2 were used. Plasma and urine samples were analysed using validated high-performance liquid chromatography/fluorescence assays. Fifteen patients were enrolled. They received a median of two cycles (range 1 -8). The MTD was reached at the fourth dose level. Thrombocytopaenia (grade 4) was dose limiting in two of three patients at 180 mg m À2 . One patient also experienced febrile neutropaenia. Lymphocytopaenia (grade 4) was present in every patient. Nonhaematologic toxicity including cardiac toxicity was not dose limiting with this schedule. Mean plasma P k values of BM were t max 35 min, t 1/2 49.1 min, V d 18.3 l m À2 , and clearance 265 ml min À1 m À2 . The mean total amount of BM and its metabolites recovered in the first micturition was 8.3% (range 2.7 -26%). The MTD of BM in the present dose schedule was 180 mg m À2 on day 1 þ 2. Thrombocytopaenia was dose limiting. The recommended dose for future phase II trials with this schedule is 160 mg m À2 per day.

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A phase I study of bendamustine hydrochloride administered day 1+2 every 3 weeks in patients with solid tumours

et al. 2007

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“…Bendamustine as a single agent is effective against aggressive lymphoma, even in cases of refractory disease. In a phase II study of 21 patients reported by Weidmann et al 22 with relapsed or refractory high-grade NHLs, 18 were evaluated for response and toxicity with 10 of these refractory to previous chemotherapy. Three patients achieved a complete response (at 6, 8, and 22 months) and five achieved partial response (three at 2 months, one at 3 months, and one at 10 months); the total response rate of evaluated patients was 44% (8 out of 18, 38% of all patients).…”

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confidence: 99%

“…Three patients achieved a complete response (at 6, 8, and 22 months) and five achieved partial response (three at 2 months, one at 3 months, and one at 10 months); the total response rate of evaluated patients was 44% (8 out of 18, 38% of all patients). 22 Subsequently in 2011, Weidman et al also reported a phase II study of bendamustine and rituximab as first-line treatment in elderly patients ($80 years) with aggressive B-cell lymphomas who were not eligible for R-CHOP or who did not agree to aggressive treatment. 23 Thirteen patients were assessed for response.…”

Section: Discussionmentioning

confidence: 99%

Adult Atypical Sporadic Burkitt Lymphoma Successfully Treated with Bendamustine and Rituximab

Kancharla¹,

Singh²,

Gohari³

et al. 2013

Lymphoma and Chronic Lymphocytic Leukemias

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Sporadic Burkitt lymphoma (BL) accounts for 1% to 2% of lymphomas in adults. The abdomen is the most common site of involvement. The 2008 World Health Organization Classification of Tumors of Haematopoietic and Lymphoid Tissues introduced a new category of high-grade B-cell lymphomas: an entity with overlapping features of both diffuse large B-cell lymphoma and Burkitt lymphoma (DLBCL/BL). These lymphomas reportedly have poor overall survival rates. We present a case of an elderly adult atypical sporadic BL with jaw and bone marrow involvement. The tumor had the typical characteristic of BL including atypical monotonous lymphoid infiltrate with a starry-sky appearance and a high Ki67 proliferate index of 95%. MYC/IgH rearrangement was seen in 93.5% of the cells with 92% of cells also positive for IgH/Bcl-2, a feature of double-hit lymphoma. This atypical case of adult sporadic BL had features as classified of DLBCL/BL. Though high intensity regimen is used in BL and atypical BL, elderly patients tend to not tolerate these regimens well. Our patient was treated with bendamustine and bituximab given herelderly age and poor cardiac status. The patient responded well to chemotherapy and remains in complete remission two years after diagnosis up to the date of this report. The atypical presentation and excellent response to bendamustine plus rituximab has not been previously reported.

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“…Bendamustine, originally designed to have both alkylating 1) and antimetabolite properties, 2) has shown clinical activity against various human malignancies including non-Hodgkin's lymphoma [3][4][5][6][7] and chronic lymphocytic leukemia. 8) According to the National Comprehensive Cancer Network (NCCN) guidelines for patients with non-Hodgkin's lymphoma, 9) bendamustine alone or bendamustine with rituximab is used for patients with follicular lymphoma or mantle cell lymphoma.…”

Section: Decrease In Venous Irritation By Adjusting the Concentrationmentioning

confidence: 99%

Decrease in Venous Irritation by Adjusting the Concentration of Injected Bendamustine

Watanabe

Ikesue

Tsujikawa

et al. 2013

Biological & Pharmaceutical Bulletin

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Intravenous injection of bendamustine often causes venous irritation and also deteriorates the patient's quality of life. Thus, we evaluated the risk factors associated with venous irritation induced by bendamustine in patients with follicular lymphoma or mantle cell lymphoma. We also evaluated the effectiveness of intervention of changing the preparation procedure for bendamustine. All data were retrospectively collected from the electronic medical record system. In the initial analysis of the total 43 courses of bendamustine therapy, most patients (88%) were administered bendamustine with 250 mL of diluent according to the bendamustine package insert in Japan. The median concentration of bendamustine solution (0.56 mg/ mL vs. 0.24 mg/mL) and the incidences of venous irritation (66% vs. 0%, p=0.01) were significantly different between the patients receiving bendamustine at 250 mL and 500 mL of diluent. Based on this result, we proposed changing the final volume of bendamustine dissolution from 250 to 500 mL, which is recommended in other countries. After this intervention, the incidence of venous irritation was significantly reduced from 58 to 20% (p=0.02). The incidence of venous irritation increased in a concentration-dependent manner (≤0.40 mg/mL: 6%; 0.41-0.60 mg/mL: 62%, p<0.001; >0.60 mg/mL: 75%, p<0.001). We conclude that a high concentration bendamustine solution is a risk factor for venous irritation and that 500 mL of diluent is ideal. To further reduce the incidence of venous irritation, the concentration of bendamustine solution is recommended to be 0.40 mg/mL or less.

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Bendamustine is effective in relapsed or refractory aggressive non-Hodgkin’s lymphoma

Abstract: Bendamustine as a single agent is effective against aggressive lymphoma, even in cases of refractory disease. Further studies are warranted to determine the significance of bendamustine in the treatment of aggressive lymphomas.

Cited by 92 publications

References 12 publications

A phase I study of bendamustine hydrochloride administered day 1+2 every 3 weeks in patients with solid tumours

A phase I study of bendamustine hydrochloride administered day 1+2 every 3 weeks in patients with solid tumours

Adult Atypical Sporadic Burkitt Lymphoma Successfully Treated with Bendamustine and Rituximab

Decrease in Venous Irritation by Adjusting the Concentration of Injected Bendamustine

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