Pharmacokinetic profile and first preliminary clinical evaluation of bendamustine in Taiwanese patients with heavily pretreated indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma
Journal
Hematological Oncology
Journal Volume
33
Journal Issue
4
Pages
136-144
Date Issued
2015
Author(s)
Abstract
Prior studies found bendamustine is efficacious in patients with indolent B-cell non-Hodgkin lymphoma (NHL). To date, no studies have reported the efficacy of bendamustine in a Chinese population. This multicentre phase II trial evaluated the pharmacokinetics (PK), safety and efficacy of bendamustine monotherapy in Chinese patients in Taiwan with pretreated indolent B-cell NHL or mantle cell lymphoma (MCL). For PK assessments, patients were randomized (n=16; 11 with indolent B-cell NHL and five with MCL) to 90 or 120mg/m2 of bendamustine for the first cycle. Plasma levels of bendamustine and its two metabolites were analyzed. For efficacy and safety evaluations, bendamustine 120mg/m2 was given to all patients every 3weeks starting at cycle 2 for a minimum of a total of six cycles. The median age of patients was 61.7years, and the majority were men (75%). The median number of prior treatments was 4 (range, 1-9 regimens), and all patients were previously treated with rituximab. Bendamustine plasma concentration peaked near the end of infusion and was rapidly eliminated with a mean elimination half-life (t1/2) of 0.67-0.8h. Of the evaluable patients (n=14), the overall response rate was 78.6%, including 7.2% of patients having a complete response. Mean progression-free survival was 27.5weeks. The most common grade 3-4 adverse events were leucopenia (56.3%), neutropenia (56.3%) and thrombocytopenia (25%). In conclusion, bendamustine was efficacious and well tolerated in Taiwanese patients with indolent NHL and MCL with a similar PK profile to that of other populations. ? 2015 John Wiley & Sons, Ltd.
SDGs
Other Subjects
bendamustine; corticosteroid; cyclophosphamide; doxorubicin; fludarabine; prednisolone; rituximab; vincristine; bendamustine; adult; aged; anemia; area under the curve; Article; autologous stem cell transplantation; cancer radiotherapy; cancer survival; clinical evaluation; coughing; decreased appetite; drug dose comparison; drug efficacy; drug half life; drug safety; fatigue; human; leukopenia; lymphocytoma; mantle cell lymphoma; marginal zone lymphoma; maximum plasma concentration; monotherapy; multicenter study; multiple cycle treatment; nausea; neutropenia; nodal marginal zone lymphoma; nonhodgkin lymphoma; pharmacokinetics; phase 2 clinical trial; plasma concentration-time curve; priority journal; progression free survival; rash; Taiwanese; thrombocytopenia; time to maximum plasma concentration; treatment response; vomiting; Waldenstroem macroglobulinemia; clinical trial; controlled study; female; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; male; mantle cell lymphoma; middle aged; pathology; prognosis; randomized controlled trial; Taiwan; very elderly; Aged; Aged, 80 and over; Bendamustine Hydrochloride; Female; Humans; Lymphoma, B-Cell; Lymphoma, Mantle-Cell; Lymphoma, Non-Hodgkin; Male; Middle Aged; Prognosis; Taiwan
Publisher
John Wiley and Sons Ltd
Type
journal article