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学科主题临床医学
Multicenter phase ii study of a combination of cyclosporine a, methotrexate and mycophenolate mofetil for GVHD prophylaxis: results of the Chinese Bone Marrow Transplant Cooperative Group (CBMTCG)
Lai, Yong-rong1; Chen, Yu-hong2; Hu, Deng-ming3; Jiang, Ming4; Liu, Qi-fa5; Liu, Lin6; Hou, Jian7; Schwarzenberger, Paul8; Li, Qiao-chuan1; Zhang, Zhong-ming1; Liu, Kai-yan2; Huang, Xiao-jun2,9
关键词Allogeneic Hematopoietic Stem Cell Transplantation (Allo-hsct) Graft-versus-host Disease (Gvhd) Prophylaxis Mycophenolate Mofetil (Mmf)
刊名JOURNAL OF HEMATOLOGY & ONCOLOGY
2014-08-21
DOI10.1186/s13045-014-0059-3
7
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Oncology ; Hematology
资助者National Natural Science Foundation of China ; Natural Science Foundation of Beijing ; National High Technology Research and Development Program of China (Program 863) ; Clinical Subject&prime ; s Key Project of the Ministry of Health ; National Natural Science Foundation of China ; Natural Science Foundation of Beijing ; National High Technology Research and Development Program of China (Program 863) ; Clinical Subject&prime ; s Key Project of the Ministry of Health
研究领域[WOS]Oncology ; Hematology
关键词[WOS]VERSUS-HOST-DISEASE ; STEM-CELL TRANSPLANTATION ; MYELOABLATIVE CONDITIONING REGIMEN ; BUSULFAN PLUS CYCLOPHOSPHAMIDE ; HLA-IDENTICAL SIBLINGS ; PERIPHERAL-BLOOD CELLS ; RISK-FACTORS ; FREE SURVIVAL ; GRAFT ; LEUKEMIA
英文摘要

Background: Improvement of current GVHD prophylactic therapies remains an important goal in the allo-HSCT. We have described a novel prophylaxis regimen in a single institution trial. The Chinese Bone Marrow Transplant Cooperative Group (CBMTCG) initiated a phase II multicenter study.

Methods: The study was designed as a prospective, single arm phase II open-label, multicenter clinical trial. The primary endpoint was improvement of aGVHD by 25% over historical control (40%) in Chinese patients. 508 patients were enrolled. All of the patients received cyclosporine A (CsA), methotrexate (MTX) and mycophenolate mofetil (MMF) (0.5-1.0 g daily for 30 days) as GVHD prophylaxis regimen.

Results: The primary endpoint was met with cumulative incidences of grades 2 to 4 and grades 3 to 4 aGVHD of 23.2% and 10.3%, respectively. Incidence for cGVHD was 67.4%. The non-relapse mortality (NRM) rate was 18.4% at 2 years. The probabilities of leukemia free survival (LFS) for non-advanced stage and advanced stage patients at 2 years were 69.7% and 44.8% respectively (p = 0.000). Recipient age >= 40 years, advanced stage and Busulfan-Fludarabine (BuFlu) conditioning regimen were identified as major risk factors for aGVHD. Recipient age >= 40 years, BuFlu conditioning regimens, female donor/male recipient and prior aGVHD were associated with cGVHD. Despite lower RM (relapse mortality), patients with grade 2-4 aGVHD had higher NRM and worse OS and LFS compared to patients with grade 0-1 aGVHD. In contrast, patients with cGVHD had better OS and LFS and lower RM compared to patients without cGVHD.

Conclusion: The novel GVHD regimen decreased the risk for aGVHD by 42% without improving the risk for cGVHD compared to historical controls. Development of aGVHD was associated with worse OS and LFS as well as higher NRM. In contrast, cGVHD was associated with improved OS and LFS likely attributed to a GVL effect.

语种英语
所属项目编号30971292 ; 30725038 ; 7122193 ; 2011AA020105
资助者National Natural Science Foundation of China ; Natural Science Foundation of Beijing ; National High Technology Research and Development Program of China (Program 863) ; Clinical Subject&prime ; s Key Project of the Ministry of Health ; National Natural Science Foundation of China ; Natural Science Foundation of Beijing ; National High Technology Research and Development Program of China (Program 863) ; Clinical Subject&prime ; s Key Project of the Ministry of Health
WOS记录号WOS:000341664500001
引用统计
被引频次:15[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/400002259/52762
专题北京大学第二临床医学院_血液科
作者单位1.Guangxi Med Univ, Affiliated Hosp 1, Dept Hematol, Nanning, Guangxi, Peoples R China
2.Peking Univ, Peoples Hosp, Inst Hematol, Beijing Key Lab Hematopoiet Stem Cell Transplanta, Beijing 100871, Peoples R China
3.Kunming Gen Hosp Chengdu Command, Dept Hematol, Kunming, Peoples R China
4.Xinjiang Med Univ, Affiliated Hosp 1, Dept Hematol, Urumqi, Peoples R China
5.Southern Med Univ, Nanfang Hosp, Dept Hematol, Guangzhou, Guangdong, Peoples R China
6.Chongqing Med Univ, Affiliated Hosp 1, Dept Hematol, Chongqing, Peoples R China
7.Second Mil Med Univ, Changzheng Hosp, Dept Hematol, Shanghai, Peoples R China
8.Univ S Alabama, Mobile, AL 36688 USA
9.China Peking Tsinghua Ctr Life Sci, Beijing, Peoples R China
推荐引用方式
GB/T 7714
Lai, Yong-rong,Chen, Yu-hong,Hu, Deng-ming,et al. Multicenter phase ii study of a combination of cyclosporine a, methotrexate and mycophenolate mofetil for GVHD prophylaxis: results of the Chinese Bone Marrow Transplant Cooperative Group (CBMTCG)[J]. JOURNAL OF HEMATOLOGY & ONCOLOGY,2014,7.
APA Lai, Yong-rong.,Chen, Yu-hong.,Hu, Deng-ming.,Jiang, Ming.,Liu, Qi-fa.,...&Huang, Xiao-jun.(2014).Multicenter phase ii study of a combination of cyclosporine a, methotrexate and mycophenolate mofetil for GVHD prophylaxis: results of the Chinese Bone Marrow Transplant Cooperative Group (CBMTCG).JOURNAL OF HEMATOLOGY & ONCOLOGY,7.
MLA Lai, Yong-rong,et al."Multicenter phase ii study of a combination of cyclosporine a, methotrexate and mycophenolate mofetil for GVHD prophylaxis: results of the Chinese Bone Marrow Transplant Cooperative Group (CBMTCG)".JOURNAL OF HEMATOLOGY & ONCOLOGY 7(2014).
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