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http://dx.doi.org/10.15432/JKTO.2015.20.1.011

Review of Clinical Cancer Research Methodology of Botanical Agents  

Oh, Hye Kyung (Department of Internal Medicine, Korean Medicine Cancer Center, Kyung Hee University Hospital at Gangdong)
Lee, Jee Young (Department of Internal Medicine, Korean Medicine Cancer Center, Kyung Hee University Hospital at Gangdong)
Ryu, Han Sung (Department of Internal Medicine, Korean Medicine Cancer Center, Kyung Hee University Hospital at Gangdong)
Yoon, Seong Woo (Department of Internal Medicine, Korean Medicine Cancer Center, Kyung Hee University Hospital at Gangdong)
Publication Information
Journal of Korean Traditional Oncology / v.20, no.1, 2015 , pp. 11-21 More about this Journal
Abstract
Objectives : The cancer incidence and cancer burden is increasing. In addition, the use of botanical agents in cancer care is increasing. This article aims to review a research strategy for botanical agents. Methods : The clinical studies of anticancer botanical agents and the papers about clinical research methodology of botanical agents were reviewed. Results : In phase I study, safety confirmation, optimal dose determination and drug interaction study are important. Most botanical agents have low toxicity and some have non-monotone dose response. Therefore, dose-response curve must be evaluated separately from the dose-toxicity curve to determine optimal dose. Although anticancer botanical agents can't shrink tumor size rapidly, they do extend survival. So, in phase II study, response should be evaluated by the survival. Conclusions : Clinical research of botanical agents in cancer is different from traditional methods and strategies. Considering the characteristics of botanical agents and experimental mechanism is necessary in conducting botanical based clinical trials.
Keywords
botanical agents; Phase I; phase II; research design; clinical cancer research methodology;
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