https://scholars.lib.ntu.edu.tw/handle/123456789/537417
標題: | 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 | 作者: | Hsiao L.-T. HWEI-FANG TIEN Kuo C.-Y. Wu J.-H. HSIN-AN HOU Wang M.-C. Liu C.-Y. Chen P.-M. Chiou T.-J. |
公開日期: | 2015 | 出版社: | John Wiley and Sons Ltd | 卷: | 33 | 期: | 4 | 起(迄)頁: | 136-144 | 來源出版物: | Hematological Oncology | 摘要: | 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. |
URI: | https://www.scopus.com/inward/record.uri?eid=2-s2.0-84954526322&doi=10.1002%2fhon.2161&partnerID=40&md5=5192b9d999a99e6050a8824941816c10 https://scholars.lib.ntu.edu.tw/handle/123456789/537417 |
ISSN: | 0278-0232 | DOI: | 10.1002/hon.2161 | SDG/關鍵字: | 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 |
顯示於: | 醫學系 |
在 IR 系統中的文件,除了特別指名其著作權條款之外,均受到著作權保護,並且保留所有的權利。