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Different dose combinations of bortezomib and dexamethasone in the treatment of relapsed or refractory myeloma: an open-label, observational, multi-center study in China
Yuan Zhen-gang1; Jin Jie2; Huang Xiao-jun3; Li Yan4; Chen Wen-ming5; Liu Zhuo-gang6; Chen Xie-qun7; Shen Zhi-xiang8; Hou Jian1
关键词bortezomib dexamethasone multiple myeloma relapsed or refractory multiple myeloma
刊名CHINESE MEDICAL JOURNAL
2011-10-05
DOI10.3760/cma.j.issn.0366-6999.2011.19.002
124期:19页:2969-2974
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Medicine, General & Internal
研究领域[WOS]General & Internal Medicine
关键词[WOS]PROTEASOME INHIBITOR PS-341 ; MULTIPLE-MYELOMA ; CHEMOTHERAPEUTIC-AGENTS ; TRIAL ; CELLS ; TRANSPLANTATION ; SENSITIVITY ; PHASE-2
英文摘要

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/m(2) 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/m(2) (0.7-1.0 mg/m(2)) of bortezomib and dexamethasone 20 mg on the same schedule (group 2); 37 patients received 1.3 mg/m(2) of bortezomib and dexamethasone 40 mg (group 3) and 45 patients received less than 1.3 mg/m(2) (0.7-1.0 mg/m(2)) 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 any grade in the entire 4 groups were fatigue, gastrointestinal effects, peripheral neuropathy and thrombocytopenia, and there was no significance in the number of adverse events among the 4 groups (P>0.05) except that peripheral neuropathy was reported more frequently in group 3 (36.3%) than in group 2 (13.8%, P<0.05) and group 4 (14.6%, P<0.05).

Conclusions The combination of bortezomib and dexamethasone was associated with high responses in Chinese RRMM patients. No significant differences of efficacy were detected in different dose combinations of bortezomib and dexamethasone. Moreover, low dose of bortezomib reduced the incidence of peripheral neuropathy without affecting outcome in the treatment of patients with RRMM in China. Chin Med J 2011;124(19)2969-2974

语种英语
WOS记录号WOS:000296307600002
资助机构Xian-Janssen Pharmaceutical Ltd., China
引用统计
被引频次:8[WOS]   [WOS记录]     [WOS相关记录]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/62878
专题北京大学第二临床医学院_血液科
作者单位1.Beijing Chaoyang Hosp, Dept Hematol, Beijing 100020, Peoples R China
2.Second Mil Med Univ, Shanghai Changzheng Hosp, Dept Hematol, Shanghai 200003, Peoples R China
3.Zhejiang Univ, Sch Med, Affiliated Hosp 1, Dept Hematol, Hangzhou 310006, Zhejiang, Peoples R China
4.Peking Univ, Peoples Hosp, Dept Hematol, Beijing 100044, Peoples R China
5.China Med Univ, Hosp 1, Dept Hematol, Shenyang 110001, Liaoning, Peoples R China
6.China Med Univ, Shengjing Hosp, Dept Hematol, Shenyang 110004, Liaoning, Peoples R China
7.Fourth Mil Med Univ, Xijing Hosp, Dept Hematol, Xian 710032, Shaanxi, Peoples R China
8.Shanghai Jiao Tong Univ, Sch Med, Ruijin Hosp, Dept Hematol, Shanghai 200025, Peoples R China
推荐引用方式
GB/T 7714
Yuan Zhen-gang,Jin Jie,Huang Xiao-jun,et al. Different dose combinations of bortezomib and dexamethasone in the treatment of relapsed or refractory myeloma: an open-label, observational, multi-center study in China[J]. CHINESE MEDICAL JOURNAL,2011,124(19):2969-2974.
APA Yuan Zhen-gang.,Jin Jie.,Huang Xiao-jun.,Li Yan.,Chen Wen-ming.,...&Hou Jian.(2011).Different dose combinations of bortezomib and dexamethasone in the treatment of relapsed or refractory myeloma: an open-label, observational, multi-center study in China.CHINESE MEDICAL JOURNAL,124(19),2969-2974.
MLA Yuan Zhen-gang,et al."Different dose combinations of bortezomib and dexamethasone in the treatment of relapsed or refractory myeloma: an open-label, observational, multi-center study in China".CHINESE MEDICAL JOURNAL 124.19(2011):2969-2974.
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