Different dose combinations of bortezomib and dexamethasone in the treatment of relapsed or refractory myeloma： an open-label,observational, multi-center study in China

作     者：YUAN Zhen-gang JIN Jie HUANG Xiao-jun LI Yan CHEN Wen-ming LIU Zhuo-gang CHEN Xie-qun SHEN Zhi-xiang HOU Jian 

作者机构：Department of Hematology Shanghai Changzheng HospitalSecond Military Medical University Shanghai 200003 China Department of Hematology First Affiliated Hospital Medical School of Zhejiang University Hangzhou Zhejiang 310006 China Department of Hematology People＇s Hospital Peking UniversityBeijing 100044 China Department of Hematology First Hospital China Medical University Shenyang Liaoning 110001 China Department of Hematology Beijing Chaoyang Hospital Beijing100020 China Department of Hematology Shengjing Hospital China Medical University Shenyang Liaoning 110004 China Department of Hematology Xijing Hospital Fourth Military Medical University Xi＇an Shaanxi 710032 China Department of Hematology Ruijin Hospital Shanghai Jiao Tong University School of Medicine Shanghai 200025 China 

出 版 物：《Chinese Medical Journal》 (中华医学杂志（英文版）)

年 卷 期：2011年第124卷第19期

页      面：2969-2974页

核心收录：

学科分类：090603[农学-临床兽医学] 0710[理学-生物学] 07[理学] 071009[理学-细胞生物学] 09[农学] 0906[农学-兽医学] 0901[农学-作物学] 090102[农学-作物遗传育种] 

基　　金：Xian-Janssen Pharmaceutical Ltd.  China 

主　　题：dexamethasone multiple myeloma relapsed or refractory multiple myeloma 

摘      要：Background Although previous clinical study revealed that bortezomib combined with dexamethasone had improved the outcomes of relapsed or refractory multiple myeloma （RRMM）, the optimal dose combinations of bortezomib and dexamethasone remain unknown. This trial aimed to observe the efficacy and safety of different dose combinations of bortezomib and dexamethasone in the treatment of RRMM patients in *** A total of 168 patients with relapsed multiple myeloma （MM） who were refractory to at lest two prior treatments were enrolled in this multicenter, open-label, non-randomized, prospective clinical trial. Twenty patients received 1.3 mg/m2 of bortezomib twice weekly for 2 weeks of a 3-week cycle for up to 8 cycles and oral or intravenous dexamethasone 20 mg on the day of and after each bortezomib dose （group 1）; 66 patients received less than 1.3 mg/m2（0.7-1.0 mg/m2） of bortezomib and dexamethasone 20 mg on the same schedule （group 2）; 37 patients received 1.3 mg/m2 of bortezomib and dexamethasone 40 mg （group 3） and 45 patients received less than 1.3 mg/m2 （0.7-1.0 mg/m2）of bortezomib and dexamethasone 40 mg （group 4）. The response was evaluated according to the criteria of the European Group for Blood and Marrow Transplantation and confirmed by an independent review committee. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria, version 3.0. Results The median age of groups 1 to 4 was 61,62, 56, and 60 years, respectively. Most patients were in stages Ⅱ/Ⅲ of MM and the most common subtype was IgG The rate of overall response to bortezomib and dexamethasone of group 1 to 4 was 72.2% （13/18）, 73.8% （48/65）, 78.8% （26/33） and 78.0% （32/41） （P=0.91）, including a complete response rate of 22.2% （4/18）, 20.0% （13/65）, 33.3% （11/33） and 29.3% （12/41） （P=0.67）, respectively. There was no statistical significance in time to progression and overall survival among these 4 groups （P 〉0.05）. The most commonly adverse events of