Chinese Journal of Clinical Oncology

, Volume 2, Issue 4, pp 706–716 | Cite as

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

  • 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
Original Articles

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.

Keywords

abnormal methylation enzymes DNA hypomethylation differentiation therapy adjuvant chemotherapy 

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Copyright information

© Chinese Anti-Cancer Association and Springer 2005

Authors and Affiliations

  • Fengyi Feng
    • 1
  • Qing Li
    • 1
  • Changquan Ling
    • 2
  • Yang Zhang
    • 3
  • Fengzhan Qin
    • 4
  • Huaqing Wang
    • 5
  • Wenxia Huang
    • 6
  • Shunchang Jiao
    • 7
  • Qiang Chen
    • 8
  • Mingzhong Li
    • 9
  • Yunzhong Zhu
    • 10
  • Meizhen Zhou
    • 11
  • Jun Ren
    • 12
  • Yetao Gao
    • 2
  • Jingpo Zhao
    • 3
  • Rongsheng Zheng
    • 4
  • Wenhua Zhao
    • 5
  • Zhiqiang Meng
    • 6
  • Fang Li
    • 7
  • Qizhong Zhang
    • 8
  • Dongli Zhao
    • 9
  • Liyan Xu
    • 10
  • Yongqiang Zhang
    • 11
  • Yanjun Zhang
    • 12
  • Zhenjiu Wang
    • 13
  • Shuanqi Liu
    • 13
  • Ming C. Liau
    • 14
  1. 1.The Cancer Hospital of the Chinese Academy of Medical ScienceBeijingChina
  2. 2.Changhai Hospital of the Second Army Medical UniversityShanghaiChina
  3. 3.The Second Affiliated Hospital of Dalian Medical UniversityDalianChina
  4. 4.The Cancer Hospital of Bengbu Medical CollegeBengbuChina
  5. 5.The Cancer Hospital of Tianjin Medical UniversityTianjinChina
  6. 6.The Affiliated Cancer Hospital of Fudan Medical UniversityShanghaiChina
  7. 7.The General Hospitalof PLABeijingChina
  8. 8.The Cancer Hospital of Fujian ProvinceFuzhouChina
  9. 9.The First Affiliated Hospital of Xi’an Communication UniversityXi’anChina
  10. 10.Beijing Chest Cancer HospitalBeijingChina
  11. 11.Department of Health Beijing HospitalBeijingChina
  12. 12.Xijing Hospital of the Fourth Military Medical UniversityXi’anChina
  13. 13.Everlife Pharmaceutical CompanyHefeiChina
  14. 14.Institute of Pharmaceutical ChemistryChina Medical UniversityTaiwan

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