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| Phase Ⅲ Clinical Trials of the Cell Differentiation Agent-2 （CDA-2）： Therapeutic Efficacy on Breast Cancer, Non-Small Cell Lung Cancer and Primary Hepatoma | |
| 引用本文： | Fengyi Feng Qing Lu Changquan Ling Yang Zhang Fengzhan Qin Huaqing Wang Wenxia Huang Shunchang Jiao Qiang Chen Mingzhong Li Yunzhong Zhu Meizhen Zhou Jun Ren Yetao Gao Jingpo Zhao Rongsheng Zheng Wenhua Zhao Zhiqiang Meng Fang Li Qizhong Zhang Dongli Zhao Liyan Xu Yongqiang Zhang Yanjun Zhang Zhenjiu Wang Shuonqi Liu Ming C. Liau. Phase Ⅲ Clinical Trials of the Cell Differentiation Agent-2 （CDA-2）： Therapeutic Efficacy on Breast Cancer, Non-Small Cell Lung Cancer and Primary Hepatoma[J]. 中国肿瘤临床(英文版), 2005, 2(4): 706-716. DOI: 10.1007/BF02819536 |
| 作者姓名： | Fengyi Feng Qing Lu Changquan Ling Yang Zhang Fengzhan Qin Huaqing Wang Wenxia Huang Shunchang Jiao Qiang Chen Mingzhong Li Yunzhong Zhu Meizhen Zhou Jun Ren Yetao Gao Jingpo Zhao Rongsheng Zheng Wenhua Zhao Zhiqiang Meng Fang Li Qizhong Zhang Dongli Zhao Liyan Xu Yongqiang Zhang Yanjun Zhang Zhenjiu Wang Shuonqi Liu Ming C. Liau |
| 作者单位： | [1]The Cancer Hospital of the Chinese Academy of Medical Science, Beijing 100021, China [2]Changhai Hospital of the Second Army Medical University, Shanghai 200433, China [3]The Second Affiliated Hospital of Dalian Medical University, Dalian 116027, China [4]The Cancer Hospital of Bengbu Medical College, Bengbu 233004, China [5]The Cancer Hospital of Tianjin Medical University, Tianjin 300060, China [6]The Affiliated Cancer Hospital of Fudan Medical University, Shanghai 200032, China [7]The General Hospitalof PLA, Beijing 100835, China [8]The Cancer Hospital of Fujian Province, Fuzhou 350014, China [9]The First Affiliated Hospital of Xi＇an Communication University, Xi＇an 710061, China [10]Beijing Chest Cancer Hospital, Beijing 101149, China [11]Department of Health Beijing Hospital Beijing 100730, China [12]Xijing Hospital of the Fourth Military Medical University, Xi＇an 710033, China [13]Everlife Pharmaceutical Company, Hefei 231202, China [14]Institute of Pharmaceutical Chemistry, China Medical University, Taichung 404, Taiwan |
| 基金项目： | Sponsored by Everlife Pharmaceutical Company of Hefei, Anhui 231202, China. |
| 摘 要： | OBJECTIVE The objective of this study was to explore the effect of CDA-2, a selective inhibitor of abnormal methylation enzymes in cancer cells, on the therapeutic efficacy of cytotoxic chemotherapy. METHODS Advanced cancer patients, all of whom had previously undergone chemotherapy, were randomly divided into 2 groups, one receiving chemotherapy only as the control group, and the other receiving CDA-2 in addition to chemotherapy as the combination group. The therapeutic efficacies and the toxic maniestations of the 2 groups were compared based on the WHO criteria. RESULTS Of 454 cancer patients enrolled in phase Ⅲ clinical trials of CDA-2, 80, 188, and 186 were breast cancer, NSCLC, and primary hepatoma patients, respectively. Among them 378 patients completed treatments according to the protocols. The results showed that the overall effective rate of the combination group was 2.6 fold that of the control group, 4.8 fold in the case of breast cancer, 2.3 fold in the case of primary hepatoma, and 2.2 fold in the case of NSCLC. Surprisingly, the combination therapy appeared to work better for stage Ⅳ than stage Ⅲ patients. CDA-2 did not contribute additional toxicity. On the contrary, it reduced toxic manifestations of chemotherapy, particularly regarding white blood cells, nausea and vomiting. CONCLUSION Modulation of abnormal methylation enzymes by CDA-2 is definitely helpful to supplement chemotherapy. It significantly increased the therapeutic efficacy and reduced the toxic manifestation of cytotoxic chemotherapy on breast cancer and NSCLC. |
| 关 键 词： | 临床实验 细胞区别因子-2 乳腺癌 非小细胞肺癌 原发性肝细胞癌 |
| 收稿时间： | 2005-04-27 |
| 修稿时间： | 2005-06-08 |
Phase III clinical trials of the cell differentiation agent-2 (CDA-2): Therapeutic efficacy on breast cancer, non-small cell lung cancer and primary hepatoma1 |
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| Fengyi Feng,Qing Li,Changquan Ling,Yang Zhang,Fengzhan Qin,Huaqing Wang,Wenxia Huang,Shunchang Jiao,Qiang Chen,Mingzhong Li,Yunzhong Zhu,Meizhen Zhou,Jun REN,Yetao Gao,Jingpo Zhao,Rongsheng Zheng,Wenhua Zhao,Zhiqiang Meng,Fang Li,Qizhong Zhang,Dongli Zhao,Liyan Xu,Yongqiang Zhang,Yanjun Zhang,Zhenjiu Wang,Shuanqi Liu,Ming C. Liau. Phase III clinical trials of the cell differentiation agent-2 (CDA-2): Therapeutic efficacy on breast cancer, non-small cell lung cancer and primary hepatoma1[J]. Chinese Journal of Clinical Oncology, 2005, 2(4): 706-716. DOI: 10.1007/BF02819536 | |
| Authors: | Fengyi Feng Qing Li Changquan Ling Yang Zhang Fengzhan Qin Huaqing Wang Wenxia Huang Shunchang Jiao Qiang Chen Mingzhong Li Yunzhong Zhu Meizhen Zhou Jun REN Yetao Gao Jingpo Zhao Rongsheng Zheng Wenhua Zhao Zhiqiang Meng Fang Li Qizhong Zhang Dongli Zhao Liyan Xu Yongqiang Zhang Yanjun Zhang Zhenjiu Wang Shuanqi Liu Ming C. Liau |
| Affiliation: | 1. The Cancer Hospital of the Chinese Academy of Medical Science, Beijing100021, China 2. Changhai Hospital of the Second Army Medical University, Shanghai200433, China 3. The Second Affiliated Hospital of Dalian Medical University, Dalian 116027,China 4. The Cancer Hospital of Bengbu Medical College, Bengbu 233004, China 5. The Cancer Hospital of Tianjin Medical University, Tianjin 300060, China 6. The Affiliated Cancer Hospital of Fudan Medical University, Shanghai200032, China 7. The General Hospitalof PLA, Beijing 100835, China 8. The Cancer Hospital of Fujian Province, Fuzhou 350014, China 9. The First Affiliated Hospital of Xi'an Communication University, Xi'an710061, China 10. Beijing Chest Cancer Hospital, Beijing 101149, China 11. Department of Health Beijing Hospital Beijing 100730, China 12. Xijing Hospital of the Fourth Military Medical University, Xi'an 710033,China 13. Everlife Pharmaceutical Company, Hefei 231202, China 14. Institute of Pharmaceutical Chemistry, China Medical University, Taichung404, Taiwan |
| Abstract: | Objective The objective of this study was to explore the effect of CDA-2, a selective inhibitor of abnormal methylation enzymes in cancer cells, on the therapeutic efficacy of cytotoxic chemotherapy. Methods Advanced cancer patients, all of whom had previously undergone chemotherapy, were randomly divided into 2 groups, one receiving chemotherapy only as the control group, and the other receiving CDA-2 in addition to chemotherapy as the combination group. The therapeutic efficacies and the toxic manifestations of the 2 groups were compared based on the WHO criteria. Results Of 454 cancer patients enrolled in phase III clinical trials of CDA-2, 80, 188, and 186 were breast cancer, NSCLC, and primary hepatoma patients, respectively. Among them 378 patients completed treatments according to the protocols. The results showed that the overall effective rate of the combination group was 2.6 fold that of the control group, 4.8 fold in the case of breast cancer, 2.3 fold in the case of primary hepatoma, and 2.2 fold in the case of NSCLC. Surprisingly, the combination therapy appeared to work better for stage IV than stage III patients. CDA-2 did not contribute additional toxicity. On the contrary, it reduced toxic manifestations of chemotherapy, particularly regarding white blood cells, nausea and vomiting. Conclusion Modulation of abnormal methylation enzymes by CDA-2 is definitely helpful to supplement chemotherapy. It significantly increased the therapeutic efficacy and reduced the toxic manifestation of cytotoxic chemotherapy on breast cancer and NSCLC. Sponsered by Everlife Pharmaceutical Company of Hefei, Anhui, 231202, China. |
| Keywords: | abnormal methylation enzymes DNA hypomethylation differentiation therapy adjuvant chemotherapy |
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