Early-Phase Development of Cancer Prevention Agents: Challenges and Opportunities
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Abstract:
Chemoprevention is the administration of agents (drugs, biologics, dietary supplements, or nutrients) to reduce the risk of developing cancer or prevent the recurrence of cancer. The National Cancer Institute, Division of Cancer Prevention (NCI, DCP), is a major sponsor of cancer preventive preclinical and clinical research. As such, it has developed a comprehensive drug development program specifically designed to meet the requirements needed for cancer preventive drugs to achieve initial regulatory approval. Clinical development of cancer prevention agents presents unique challenges that are not encountered with most cancer therapeutic agents. To meet these challenges, NCI, DCP has implemented new approaches and programs, including phase 0 clinical trial designs and microdose studies. In addition, the PREVENT Cancer Program was recently implemented by NCI, DCP to offer a formalized structure for moving drugs forward in the prevention pipeline using a continue/not continue decision process. Likewise, DCP has implemented a Clinical Trials Consortium to further develop these agents. These and other approaches will be discussed in this commentary.Keywords:
Cancer Prevention
Drug Development
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Recent guidance from the US Food and Drug Administration supports the conduct of a new type of exploratory clinical trials, commonly called phase 0 clinical trials, on the development of innovative anticancer agents, particularly targeted agents. Phase 0 clinical trials are controversial mainly because of the lack of clinical benefit to the participant patients. However, it was recognized that Phase 0 clinical trials can provide a platform to assessing the biological effects on the targets in tumoral human samples, evaluate biomarkers for drug effects and to generate essential human pharmacokinetics and pharmacodynamics data earlier in the drug development. It is expected that such trials will became a routine part of early-phase oncological drug development in the future.
Drug Development
Pharmacodynamics
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It has long been recognized that knowledge of cancer can influence an individual’s lifestyle and health behaviors, and it is hoped that policy makers and medical professionals will use cancer knowledge as a tool in the fight against cancer. However, it is important not only for levels of cancer prevention knowledge to be increased in the community but also for key barriers to subsequent behavioral changes to be identified and removed if the massive cancer burden in China is to be addressed.
Cancer Prevention
Causes of cancer
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Clinical Research
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MethodsClinical trials listed in the MFDS clinical trial registry from January 1 st , 2014 to December 31 st , 2016 were included in the analysis.Therapeutic areas were classified based on investigational product (IP) described in the study title by World Health Organization Anatomical Therapeutic Chemical (WHO-ATC) Classification System.If the IP code was not specified in the database, IP code was referred to ClinicalTrials.govregistry to classify therapeutic area.When reference was not found, the trial was counted as 'Other' .When IPs of different therapeutic area co-existed in a clinical trial, therapeutic area was selected in terms of relative importance considering the number of drugs and study purpose.Study phase of '0' , '1/2a' , '1/2' , '1' , '1/3' was coded as phase 1;'2/3' , '2a' , '2b' , '2' , '2b/3' was coded as phase 2; '3a' , '3b' , '3' , '3/4' was coded as phase 3; trials other than phase 1 to 4 and investigator-
Clinical Research
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Dietary components not only act as chemo preventive agents but also risk factors in the onset of cancer, which stimulating nutritional bal-ance in cancer or non-cancer populations. The supplementation of antioxidant compounds, such as vitamin A (Vit A) and few of its deriva-tives has been reported to alleviate the oxidative stress in cancer patients. This review focuses on sketching a current scenario on the Vit A role in cancer prevention and therapy. Therefore, we searched for published article on PubMed and Science Direct between 2014 and 2015. The search yielded 75 articles related to Vit A-mediated anti-oxidative or pro-oxidative effects in cancer patients. A low dose-mediated anti-cancer effect was observed with Vit A in some cancers. The clinical studies showed discrepancies between the low and high doses of Vit A in cancer. In conclusion, precautions are needed in taking Vit A and its derivatives, especially in cancer.
Cancer Prevention
Cancer Treatment
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Cancer prevention is an important strategy in cancer control and it consists of primary prevention and secondary prevention. Major avoidable or manageable risk factors for cancer identified from previous studies are tobacco, diet and infection. Some cancer could be prevented by controlling those risk factors. In Japan screenings for gastric cancer, cervical cancer, lung cancer, breast cancer and colo-rectal cancer have been widely conducted under the Law of Health Maintenance for the Aged. In planning and evaluating cancer control activities in Japan, it was considered useful to estimate the potential of primary and secondary prevention of cancer. The author estimated the potential of cancer prevention in Japan twice previously in 1990 and 1999. In this paper the potential of cancer prevention in Japan was re-estimated by using a different method and more recent data. From the present study it was estimated that about 25% of cancer occurrence could be prevented by control of smoking, diet and infection, about 9-15% of cancer deaths could be prevented by cancer screening, and about 6- 10 % of cancer deaths could be prevented by application of the state-of-the art diagnosis and treatment of cancer, altogether about 40-50% of cancer occurrences/deaths could be prevented if all possible measures for cancer prevention are applied to the general public and cancer patients in Japan.
Cancer Prevention
Cancer screening
Preventive healthcare
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