Chinese Journal of Clinical Oncology

, Volume 2, Issue 4, pp 706–716

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

Authors

  • Fengyi Feng
    • The Cancer Hospital of the Chinese Academy of Medical Science
  • Qing Li
    • The Cancer Hospital of the Chinese Academy of Medical Science
  • Changquan Ling
    • Changhai Hospital of the Second Army Medical University
  • Yang Zhang
    • The Second Affiliated Hospital of Dalian Medical University
  • Fengzhan Qin
    • The Cancer Hospital of Bengbu Medical College
  • Huaqing Wang
    • The Cancer Hospital of Tianjin Medical University
  • Wenxia Huang
    • The Affiliated Cancer Hospital of Fudan Medical University
  • Shunchang Jiao
    • The General Hospitalof PLA
  • Qiang Chen
    • The Cancer Hospital of Fujian Province
  • Mingzhong Li
    • The First Affiliated Hospital of Xi’an Communication University
  • Yunzhong Zhu
    • Beijing Chest Cancer Hospital
  • Meizhen Zhou
    • Department of Health Beijing Hospital
  • Jun Ren
    • Xijing Hospital of the Fourth Military Medical University
  • Yetao Gao
    • Changhai Hospital of the Second Army Medical University
  • Jingpo Zhao
    • The Second Affiliated Hospital of Dalian Medical University
  • Rongsheng Zheng
    • The Cancer Hospital of Bengbu Medical College
  • Wenhua Zhao
    • The Cancer Hospital of Tianjin Medical University
  • Zhiqiang Meng
    • The Affiliated Cancer Hospital of Fudan Medical University
  • Fang Li
    • The General Hospitalof PLA
  • Qizhong Zhang
    • The Cancer Hospital of Fujian Province
  • Dongli Zhao
    • The First Affiliated Hospital of Xi’an Communication University
  • Liyan Xu
    • Beijing Chest Cancer Hospital
  • Yongqiang Zhang
    • Department of Health Beijing Hospital
  • Yanjun Zhang
    • Xijing Hospital of the Fourth Military Medical University
  • Zhenjiu Wang
    • Everlife Pharmaceutical Company
  • Shuanqi Liu
    • Everlife Pharmaceutical Company
  • Ming C. Liau
    • Institute of Pharmaceutical ChemistryChina Medical University
Original Articles

DOI: 10.1007/BF02819536

Cite this article as:
Feng, F., Li, Q., Ling, C. et al. Chin. J. Clin. Oncol. (2005) 2: 706. doi:10.1007/BF02819536

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 enzymesDNA hypomethylationdifferentiation therapyadjuvant chemotherapy

Copyright information

© Chinese Anti-Cancer Association and Springer 2005