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 

机构地区：[1]Department of Hematology, Shanghai Changzheng Hospital,Second Military Medical University, Shanghai 200003, China [2]Department of Hematology, First Affiliated Hospital, Medical School of Zhejiang University, Hangzhou, Zhejiang 310006, China [3]Department of Hematology, People＇s Hospital, Peking University,Beijing 100044, China [4]Department of Hematology, First Hospital, China Medical University, Shenyang, Liaoning 110001, China [5]Department of Hematology, Beijing Chaoyang Hospital, Beijing100020, China [6]Department of Hematology, Shengjing Hospital, China Medical University, Shenyang, Liaoning 110004, China [7]Department of Hematology, Xijing Hospital, Fourth Military Medical University, Xi＇an, Shaanxi 710032, China [8]Department of Hematology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China

出　　处：《Chinese Medical Journal》2011年第19期2969-2974,共6页中华医学杂志（英文版）

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 China.Methods 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）. TBackground 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 China.Methods 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）. T

关 键 词：DEXAMETHASONE multiple myeloma relapsed or refractory multiple myeloma 

分 类 号：S858.237.2[农业科学—临床兽医学] Q25[农业科学—兽医学]